Pliva d.o.o. is a pharmaceutical company based in Zagreb , Croatia that primarily manufactures and sells generic drugs . It is a subsidiary of Teva Pharmaceuticals .
123-462: Pliva is one of the world's largest producers of generic Adderall . The company was founded in 1921. A team of Pliva's researchers, Gabrijela Kobrehel , Gorjana Radobolja-Lazarevski and Zrinka Tamburašev led by Dr. Slobodan Đokić , discovered azithromycin in 1980. In June 2002, the company acquired Sidmak for $ 152.9 million. Also in June 2002, Zeljko Peric, the chief financial officer of
246-442: A sui generis political entity combining the characteristics of both a federation and a confederation . Containing 5.8% of the world population in 2020, EU member states generated a nominal gross domestic product (GDP) of around US$ 16.6 trillion in 2022, constituting approximately one sixth of global nominal GDP . Additionally, all EU states except Bulgaria have a very high Human Development Index according to
369-637: A European customs union for the struggling post-war European economies, and in 1923 the oldest organisation for European integration, the Paneuropean Union was founded, led by Richard von Coudenhove-Kalergi , who later would found in June 1947 the European Parliamentary Union (EPU). Aristide Briand —who was Prime Minister of France , a follower of the Paneuropean Union, and Nobel Peace Prize laureate for
492-478: A patent that, until it expires, the company can use to exclude competitors by suing them for patent infringement . Pharmaceutical companies that develop new drugs generally only invest in drug candidates with strong patent protection as a strategy to recoup their costs of drug development (including the costs of the drug candidates that fail) and to make a profit. The average cost to a brand-name company of discovering, testing, and obtaining regulatory approval for
615-669: A proposal that linked funding with adherence to the rule of law . The budget included a COVID-19 recovery fund of €750 billion. The budget may still be approved if Hungary and Poland withdraw their vetoes after further negotiations in the council and the European Council . Bodies combatting fraud have also been established, including the European Anti-fraud Office and the European Public Prosecutor's Office . The latter
738-529: A " collective head of state " and ratifies important documents (for example, international agreements and treaties). Tasks for the president of the European Council are ensuring the external representation of the EU, driving consensus and resolving divergences among member states, both during meetings of the European Council and over the periods between them. The European Council should not be mistaken for
861-413: A "scalloped" curve, which usually starts at the brand-name price on the day of generic launch and then falls as competition intensifies. After some years, the graph typically flattens out at approximately 20% of the original brand price. In about 20% of cases, the price "bounces": Some license holders withdraw from the market when the selling price dips below their cost of goods, and the price then rises for
984-411: A brand different from the one prescribed unless the consumer requests it. A series of scandals around the approval of generic drugs in the late 1980s shook public confidence in generic drugs; there were several instances in which companies obtained bioequivalence data fraudulently, by using the branded drug in their tests instead of their own product, and a congressional investigation found corruption at
1107-611: A broad forum to further cooperation and shared issues, achieving for example the European Convention on Human Rights in 1950. Essential for the actual birth of the institutions of the EU was the Schuman Declaration on 9 May 1950 (the day after the fifth Victory in Europe Day ) and the decision by six nations (France, Belgium, Netherlands, Luxembourg, West Germany and Italy) to follow Schuman and draft
1230-670: A drug patent lasts, a brand-name company enjoys a period of market exclusivity, or monopoly , in which the company is able to set the price of the drug at a level that maximizes profit. This profit often greatly exceeds the development and production costs of the drug, allowing the company to offset the cost of research and development of other drugs that are not profitable or do not pass clinical trials. The impact of loss of patent exclusivity on pharmaceutical products varies significantly across different product classes (e.g., biologics vs. small molecules), largely due to regulatory, legal and manufacturing hurdles associated with such products. Indeed,
1353-511: A focus on biosimilars . European Union in Europe (dark grey) The European Union ( EU ) is a supranational political and economic union of 27 member states that are located primarily in Europe. The Union has a total area of 4,233,255 km (1,634,469 sq mi) and an estimated total population of over 449 million. The EU has often been described as
SECTION 10
#17327727064061476-610: A majority of generic drug manufacturing sites in India and China. Two women, each claiming to have suffered severe medical complications from a generic version of metoclopramide , lost their Supreme Court appeal on June 23, 2011. In a 5–4 ruling in PLIVA, Inc. v. Mensing , the court held that generic companies cannot be held liable for information, or the lack of information, on the originator's label. The Indian government began encouraging more drug manufacturing by Indian companies in
1599-538: A narrow therapeutic window and requires frequent blood tests to make sure patients do not have a subtherapeutic or a toxic level. A study performed in Ontario showed that replacing Coumadin with generic warfarin was safe, but many physicians are not comfortable with their patients taking branded generic equivalents. In some countries (for example, Australia) where a drug is prescribed under more than one brand name, doctors may choose not to allow pharmacists to substitute
1722-413: A new drug, with a new chemical entity , was estimated to be as much as US$ 800 million in 2003 and US$ 2.6 billion in 2014. Drug companies that bring new products have several product line extension strategies they use to extend their exclusivity, some of which are seen as gaming the system and labeled " evergreening " by critics, but at some point there is no patent protection available. For as long as
1845-746: A particular company, generic drugs are usually subject to government regulations in the countries in which they are dispensed. They are labeled with the name of the manufacturer and a generic non-proprietary name such as the United States Adopted Name (USAN) or International Nonproprietary Name (INN) of the drug. A generic drug must contain the same active ingredients as the original brand-name formulation. The U.S. Food and Drug Administration (FDA) requires generics to be identical to or within an acceptable bioequivalent range of their brand-name counterparts, with respect to pharmacokinetic and pharmacodynamic properties. (The FDA's use of
1968-493: A permanent president of the European Council , the first of which was Herman Van Rompuy , and strengthened the position of the high representative of the union for foreign affairs and security policy . In 2012, the EU received the Nobel Peace Prize for having "contributed to the advancement of peace and reconciliation, democracy, and human rights in Europe". In 2013, Croatia became the 28th EU member. From
2091-549: A pooled military aid package to Ukraine for lethal weapons funded via the European Peace Facility off-budget instrument. Next Generation EU ( NGEU ) is a European Commission economic recovery package to support the EU member states to recover from the COVID-19 pandemic , in particular those that have been particularly hard hit. It is sometimes styled NextGenerationEU and Next Gen EU , and also called
2214-460: A possibility of strong changes in the 2024 elections. Since the end of World War II , sovereign European countries have entered into treaties and thereby co-operated and harmonised policies (or pooled sovereignty ) in an increasing number of areas, in the European integration project or the construction of Europe ( French : la construction européenne ). The following timeline outlines
2337-713: A post-war world and Europe increasingly became a part of the agenda. This led to a decision at the Yalta Conference in 1944 to form a European Advisory Commission , later replaced by the Council of Foreign Ministers and the Allied Control Council , following the German surrender and the Potsdam Agreement in 1945. By the end of the war, European integration became seen as an antidote to
2460-598: A right of unilateral withdrawal under Article 50 of the Treaty on European Union. In addition, the principle of subsidiarity requires that only those matters that need to be determined collectively are so determined. Under the principle of supremacy , national courts are required to enforce the treaties that their member states have ratified, even if doing so requires them to ignore conflicting national law, and (within limits) even constitutional provisions. The direct effect and supremacy doctrines were not explicitly set out in
2583-732: A set number of seats and is divided into sub-national constituencies where this does not affect the proportional nature of the voting system. In the ordinary legislative procedure , the European Commission proposes legislation, which requires the joint approval of the European Parliament and the Council of the European Union to pass. This process applies to nearly all areas, including the EU budget . The parliament
SECTION 20
#17327727064062706-546: A while until the license holders re-enter the market with new stock. The NHS spent about £4.3 billion on generic medicines in 2016–17. In 2012, 84 percent of prescriptions in the US were filled with generic drugs, and in 2014, the use of generic drugs in the United States led to US$ 254 billion in health care savings. In the mid-2010s the generics industry began transitioning to the end of an era of giant patent cliffs in
2829-646: Is a decentralized independent body of the European Union (EU), established under the Treaty of Lisbon between 22 of the 27 states of the EU following the method of enhanced cooperation . The European Public Prosecutor's Office investigate and prosecute fraud against the budget of the European Union and other crimes against the EU's financial interests including fraud concerning EU funds of over €10,000 and cross-border VAT fraud cases involving damages above €10 million. Member states retain in principle all powers except those that they have agreed collectively to delegate to
2952-652: Is a large part of the pharmaceutical industry in China. Western observers have said that China lacks administrative protection for patents. However, entry to the World Trade Organization has brought a stronger patent system. China remains the largest exporter of active pharmaceutical ingredients , accounting for 40% of the world market per a 2017 estimate. Bioequivalence studies are required for new generic drugs starting from 2016, with older drugs planned as well. In addition, in vitro dissolution behavior
3075-411: Is able to spend on marketing alone, thus earning higher profits and driving costs down. For example, the largest revenues of Ranbaxy , now owned by Sun Pharma , came from branded generics. Generic drug names are constructed using standardized affixes that distinguish drugs between and within classes and suggest their action. When a pharmaceutical company first markets a drug, it is usually under
3198-503: Is approved, the FDA adds the generic drug to its Approved Drug Products with Therapeutic Equivalence Evaluations list and annotates the list to show the equivalence between the reference-listed drug and the generic. The FDA also recognizes drugs that use the same ingredients with different bioavailability and divides them into therapeutic equivalence groups. For example, as of 2006, diltiazem hydrochloride had four equivalence groups, all using
3321-640: Is based in Kirchberg, Luxembourg City alongside the Court of Justice of the European Union and the European Court of Auditors. Constitutionally, the EU bears some resemblance to both a confederation and a federation , but has not formally defined itself as either. (It does not have a formal constitution: its status is defined by the Treaty of European Union and the Treaty on the Functioning of
3444-467: Is inconsistent with EU law. It is not possible to appeal against the decisions of national courts in the CJEU, but rather national courts refer questions of EU law to the CJEU. However, it is ultimately for the national court to apply the resulting interpretation to the facts of any given case. Although, only courts of final appeal are bound to refer a question of EU law when one is addressed. The treaties give
3567-598: Is organised as a directorial system , where the executive power is jointly exercised by several people. The executive branch consists of the European Council and European Commission. The European Council sets the broad political direction of the Union. It convenes at least four times a year and comprises the president of the European Council (presently Charles Michel ), the president of the European Commission and one representative per member state (either its head of state or head of government ). The high representative of
3690-562: Is regulated to try to balance the aspirations of private initiatives with public interest decision-making process. The European Union had an agreed budget of €170.6 billion in 2022. The EU had a long-term budget of €1,082.5 billion for the period 2014–2020, representing 1.02% of the EU-28's GNI. In 1960, the budget of the European Community was 0.03 per cent of GDP. Of this, €54bn subsidised agriculture enterprise , €42bn
3813-590: Is required to match. Since 2018, 44 classes of drugs are exempt from testing (requiring only a dissolution check), and 13 classes only require simplified testing. As of 2021, several major companies traditionally dominate the generic drugs market, including Viatris (merger of Mylan and Upjohn ), Teva , Novartis' Sandoz , and Sun Pharma . Prices in traditional generic drugs have declined and newer companies such as India-based Sun Pharma , Aurobindo Pharma , and Dr. Reddy's Laboratories , as well as Canada-based Apotex , have taken market share, which has led to
Pliva - Misplaced Pages Continue
3936-512: Is the final body to approve or reject the proposed membership of the commission, and can attempt motions of censure on the commission by appeal to the Court of Justice . The president of the European Parliament carries out the role of speaker in Parliament and represents it externally. The president and vice-presidents are elected by MEPs every two and a half years. The judicial branch of
4059-485: Is then able to recruit staff from among the pool of candidates selected by EPSO. On average, EPSO receives around 60,000–70,000 applications a year with around 1,500–2,000 candidates recruited by the European Union institutions. The European Ombudsman is the ombudsman branch of the European Union that holds the institutions, bodies and agencies of the EU to account, and promotes good administration. The Ombudsman helps people, businesses and organisations facing problems with
4182-628: The Common Foreign and Security Policy , the union has developed a role in external relations and defence . It maintains permanent diplomatic missions throughout the world and represents itself at the United Nations , the World Trade Organization , the G7 and the G20 . Due to its global influence, the European Union has been described by some scholars as an emerging superpower . The EU
4305-669: The Council of Europe , an international organisation independent of the EU and based in Strasbourg. The European Commission acts both as the EU's executive arm , responsible for the day-to-day running of the EU, and also the legislative initiator , with the sole power to propose laws for debate. The commission is 'guardian of the Treaties' and is responsible for their efficient operation and policing. It has 27 European commissioners for different areas of policy, one from each member state, though commissioners are bound to represent
4428-547: The Court of Justice of the European Union , the European Central Bank and the European Court of Auditors . Competence in scrutinising and amending legislation is shared between the Council of the European Union and the European Parliament, while executive tasks are performed by the European Commission and in a limited capacity by the European Council (not to be confused with the aforementioned Council of
4551-742: The Declaration of St James's Palace of 1941, when Europe's resistance gathered in London. This was expanded on by the 1941 Atlantic Charter , establishing the Allies and their common goals, inciting a new wave of global international institutions like the United Nations ( founded 1945 ) or the Bretton Woods System (1944). In 1943 at the Moscow Conference and Tehran Conference , plans to establish joint institutions for
4674-693: The European Union and the United States , may grant up to five years of additional protection ("patent term restoration") if manufacturers meet specific goals, such as conducting clinical trials for pediatric patients. Manufacturers, wholesalers, insurers, and drugstores can all increase prices at various stages of production and distribution. In 2014, according to an analysis by the Generic Pharmaceutical Association, generic drugs accounted for 88 percent of
4797-512: The European Union Recovery Instrument . Agreed in principle by the European Council on 21 July 2020 and adopted on 14 December 2020, the instrument is worth € 750 billion . NGEU will operate from 2021 to 2026, and will be tied to the regular 2021–2027 budget of the EU's Multiannual Financial Framework (MFF). The comprehensive NGEU and MFF packages are projected to reach €1824.3 billion. Preparing
4920-634: The French Union was installed by the new Fourth French Republic to direct the decolonization of its colonies so that they would become parts of a European community. By 1947 a growing rift between the western Allied Powers and the Soviet Union became evident as a result of the rigged 1947 Polish legislative election , which constituted an open breach of the Yalta Agreement . March of that year saw two important developments. First
5043-571: The Locarno Treaties —delivered a widely recognized speech at the League of Nations in Geneva on 5 September 1929 for a federal Europe to secure Europe and settle the historic Franco-German enmity . With large-scale war being waged in Europe once again in the 1930s and becoming World War II , the question of what to fight against and what for, had to be agreed on. A first agreement was
Pliva - Misplaced Pages Continue
5166-666: The Medical Council of India in 2002 calls for physicians to prescribe drugs by their generic names only. India is a leading country in the world's generic drugs market, with Sun Pharmaceuticals being the largest pharmaceutical company in India. Indian generics companies exported US$ 17.3 billion worth of drugs in the 2017–18 (April–March) year. In 1945–2017, bioequivalence studies were only required for generics of drugs that are less than four years old. Since 2017, all generic drugs of certain classes, irrespective of age, require bioequivalence to be approved. Generic drug production
5289-920: The Treaty of Brussels was signed, establishing the Western Union (WU), followed by the International Authority for the Ruhr . Furthermore, the Organisation for European Economic Co-operation (OEEC), the predecessor of the OECD, was also founded in 1948 to manage the Marshall Plan , which led to the Soviets creating Comecon in response. The ensuing Hague Congress of May 1948 was a pivotal moment in European integration, as it led to
5412-716: The Treaty of Paris . This treaty was created in 1952 the European Coal and Steel Community (ECSC), which was built on the International Authority for the Ruhr , installed by the Western Allies in 1949 to regulate the coal and steel industries of the Ruhr area in West Germany. Backed by the Marshall Plan with large funds coming from the United States since 1948, the ECSC became a milestone organisation, enabling European economic development and integration and being
5535-547: The United Kingdom . Norway had negotiated to join at the same time, but Norwegian voters rejected membership in a referendum . The Ostpolitik and the ensuing détente led to establishment of a first truly pan-European body, the Conference on Security and Co-operation in Europe (CSCE), predecessor of the modern Organization for Security and Co-operation in Europe (OSCE). In 1979, the first direct elections to
5658-559: The United Nations Development Programme . Its cornerstone, the Customs Union , paved the way to establishing an internal single market based on standardised legal framework and legislation that applies in all member states in those matters, and only those matters, where the states have agreed to act as one. EU policies aim to ensure the free movement of people, goods, services and capital within
5781-607: The Western Union , the International Authority for the Ruhr , the European Coal and Steel Community , the European Economic Community and the European Atomic Energy Community , which were established by treaties. These increasingly amalgamated bodies grew, with their legal successor the EU, both in size through the accessions of a further 22 states from 1973 to 2013, and in power through acquisitions of policy areas. In 2012,
5904-687: The extreme nationalism that had caused the war. On 19 September 1946, in a much recognized speech, Winston Churchill , speaking at the University of Zürich , reiterated his calls since 1930 for a "European Union" and "Council of Europe", coincidentally parallel to the Hertenstein Congress of the Union of European Federalists , one of the then founded and later constituting members of the European Movement . One month later,
6027-635: The monetary branch of the European Union, the prime component of the Eurosystem and the European System of Central Banks. It is one of the world's most important central banks . The ECB Governing Council makes monetary policy for the Eurozone and the European Union, administers the foreign exchange reserves of EU member states, engages in foreign exchange operations, and defines the intermediate monetary objectives and key interest rate of
6150-447: The principle of conferral (which says that it should act only within the limits of the competences conferred on it by the treaties ) and of subsidiarity (which says that it should act only where an objective cannot be sufficiently achieved by the member states acting alone). Laws made by the EU institutions are passed in a variety of forms. Generally speaking, they can be classified into two groups: those which come into force without
6273-612: The 1960s, tensions began to show, with France seeking to limit supranational power. Nevertheless, in 1965 an agreement was reached, and on 1 July 1967 the Merger Treaty created a single set of institutions for the three communities, which were collectively referred to as the European Communities . Jean Rey presided over the first merged commission ( Rey Commission ). In 1973, the communities were enlarged to include Denmark (including Greenland), Ireland, and
SECTION 50
#17327727064066396-458: The 4.3 billion prescriptions filled in the United States. "Branded generics" on the other hand are defined by the FDA and National Health Service as "products that are (a) either novel dosage forms of off-patent products produced by a manufacturer that is not the originator of the molecule, or (b) a molecule copy of an off-patent product with a trade name." Since the company making branded generics can spend little on research and development , it
6519-415: The CJEU the power for consistent application of EU law across the EU as a whole. The court also acts as an administrative and constitutional court between the other EU institutions and the Member States and can annul or invalidate unlawful acts of EU institutions, bodies, offices and agencies. The General Court is a constituent court of the European Union. It hears actions taken against the institutions of
6642-417: The Council of the European Union and the "Council of Ministers", its former title), forms one half of the EU's legislature. It consists of a representative from each member state's government and meets in different compositions depending on the policy area being addressed . Notwithstanding its different configurations, it is considered to be one single body. In addition to the legislative functions, members of
6765-401: The ECB and the national central banks (NCBs) of all 27 member states of the European Union. The ESCB is not the monetary authority of the eurozone, because not all EU member states have joined the euro. The ESCB's objective is price stability throughout the European Union. Secondarily, the ESCB's goal is to improve monetary and financial cooperation between the Eurosystem and member states outside
6888-401: The EU administration by investigating complaints, as well as by proactively looking into broader systemic issues. The current Ombudsman is Emily O'Reilly . The European Public Prosecutor's Office (EPPO) is the prosecutory branch of the union with juridical personality, established under the Treaty of Lisbon between 23 of the 27 states of the EU following the method of enhanced cooperation. It
7011-474: The EU was awarded the Nobel Peace Prize . The United Kingdom became the only member state to leave the EU , in 2020; ten countries are aspiring or negotiating to join it . Internationalism and visions of European unity had existed since well before the 19th century, but gained particularly as a reaction to World War I and its aftermath. In this light the first advances for the idea of European integration were made. In 1920 John Maynard Keynes proposed
7134-420: The EU, which together with the Council of the European Union is tasked with amending and approving the European Commission's proposals. 705 members of the European Parliament (MEPs) are directly elected by EU citizens every five years on the basis of proportional representation . MEPs are elected on a national basis and they sit according to political groups rather than their nationality. Each country has
7257-436: The EU. The ECB Executive Board enforces the policies and decisions of the Governing Council, and may direct the national central banks when doing so. The ECB has the exclusive right to authorise the issuance of euro banknotes . Member states can issue euro coins , but the volume must be approved by the ECB beforehand. The bank also operates the TARGET2 payments system. The European System of Central Banks (ESCB) consists of
7380-437: The Euro . After the economic crisis caused by the COVID-19 pandemic , the EU leaders agreed for the first time to create common debt to finance the European Recovery Program called Next Generation EU (NGEU). On 24 February 2022, after massing on the borders of Ukraine, the Russian Armed Forces undertook an attempt for a full-scale invasion of Ukraine. The European Union imposed heavy sanctions on Russia and agreed on
7503-400: The European Community and the EU, and then made amendments to those founding treaties. These are power-giving treaties which set broad policy goals and establish institutions with the necessary legal powers to implement those goals. These legal powers include the ability to enact legislation which can directly affect all member states and their inhabitants. The EU has legal personality , with
SECTION 60
#17327727064067626-428: The European Council of its decision to leave on 29 March 2017, initiating the formal withdrawal procedure for leaving the EU ; following extensions to the process, the UK left the European Union on 31 January 2020, though most areas of EU law continued to apply to the UK for a transition period which lasted until 31 December 2020. The early 2020s saw Denmark abolishing one of its three opt-outs and Croatia adopting
7749-420: The European Council. The other 25 commissioners are subsequently appointed by the Council of the European Union in agreement with the nominated president. The 27 commissioners as a single body are subject to approval (or otherwise) by a vote of the European Parliament . All commissioners are first nominated by the government of the respective member state. The council, as it is now simply called (also called
7872-420: The European Parliament were held. Greece joined in 1981. In 1985, Greenland left the Communities , following a dispute over fishing rights. During the same year, the Schengen Agreement paved the way for the creation of open borders without passport controls between most member states and some non-member states. In 1986, the Single European Act was signed. Portugal and Spain joined in 1986. In 1990, after
7995-432: The European Treaties but were developed by the Court of Justice itself over the 1960s, apparently under the influence of its then most influential judge, Frenchman Robert Lecourt . The question whether the secondary law enacted by the EU has a comparable status in relation to national legislation, has been a matter of debate among legal scholars. The European Union is based on a series of treaties . These first established
8118-402: The European Union by individuals and member states, although certain matters are reserved for the Court of Justice. Decisions of the General Court can be appealed to the Court of Justice, but only on a point of law. Prior to the coming into force of the Lisbon Treaty on 1 December 2009, it was known as the Court of First Instance. The European Central Bank (ECB) is one of the institutions of
8241-410: The European Union ). It is more integrated than a traditional confederation of states because the general level of government widely employs qualified majority voting in some decision-making among the member states, rather than relying exclusively on unanimity. It is less integrated than a federal state because it is not a state in its own right: sovereignty continues to flow 'from the bottom up', from
8364-419: The European Union is formally called the Court of Justice of the European Union (CJEU) and consists of two courts: the Court of Justice and the General Court . The Court of Justice is the supreme court of the European Union in matters of European Union law . As a part of the CJEU, it is tasked with interpreting EU law and ensuring its uniform application across all EU member states under Article 263 of
8487-417: The European Union). The monetary policy of the eurozone is determined by the European Central Bank. The interpretation and the application of EU law and the treaties are ensured by the Court of Justice of the European Union. The EU budget is scrutinised by the European Court of Auditors. There are also a number of ancillary bodies which advise the EU or operate in a specific area. The Union's executive branch
8610-464: The FDA, where employees were accepting bribes to approve some generic companies' applications and delaying or denying others. In 2007, North Carolina Public Radio 's The People's Pharmacy began reporting on consumers' complaints that generic versions of bupropion (Wellbutrin) were yielding unexpected effects. Subsequently, Impax Laboratories 's 300 mg extended-release tablets, marketed by Teva Pharmaceutical Industries , were withdrawn from
8733-403: The Food and Drug Administration, seeking to demonstrate therapeutic equivalence to a previously approved "reference-listed drug" and proving that it can manufacture the drug safely and consistently. For an ANDA to be approved, the FDA requires that the 90% confidence interval of the geometric mean test/reference ratios for the total drug exposure (represented by the area under the curve or AUC) and
8856-466: The Hatch-Waxman act granted a 180-day administrative exclusivity period to generic drug manufacturers who are the first to file an ANDA. When faced with patent litigation from the drug innovator or patent holder, generic companies will often counter-sue, challenging the validity of the patent. Like any litigation between private parties, the innovator and generic companies may choose to settle
8979-548: The Hatch–Waxman Act, standardized procedures for recognition of generic drugs. In 2007, the FDA launched the Generic Initiative for Value and Efficiency (GIVE): an effort to modernize and streamline the generic drug approval process, and to increase the number and variety of generic products available. Before a company can market a generic drug, it needs to file an Abbreviated New Drug Application (ANDA) with
9102-516: The Netherlands , and West Germany signed the Treaty of Rome , which created the European Economic Community (EEC) and established a customs union . They also signed another pact creating the European Atomic Energy Community (Euratom) for cooperation in developing nuclear power. Both treaties came into force in 1958. Although the EEC and Euratom were created separately from the ECSC, they shared
9225-782: The Soviets. Immediately following the February 1948 coup d'état by the Communist Party of Czechoslovakia , the London Six-Power Conference was held, resulting in the Soviet boycott of the Allied Control Council and its incapacitation, an event marking the beginning of the Cold War . The year 1948 marked the beginning of the institutionalised modern European integration . In March 1948
9348-541: The Treaty of the Functioning of the European Union (TFEU). The Court was established in 1952, and is based in Luxembourg . It is composed of one judge per member state – currently 27 – although it normally hears cases in panels of three, five or fifteen judges. The Court has been led by president Koen Lenaerts since 2015. The CJEU is the highest court of the European Union in matters of Union law . Its case-law provides that EU law has supremacy over any national law that
9471-536: The US market after the FDA determined in 2012 that they were not bioequivalent. Problems with the quality of generic drugs – especially those produced outside the United States – are widespread as of 2019. The FDA does infrequent – less than annual – inspections of production sites outside the United States. The FDA normally gives advance notice of inspections, which can lead to cover-ups of problems before inspectors arrive; inspections performed with little or no advance notice have produced evidence of serious problems at
9594-430: The Union as a whole, though the exact delimitation has on occasions become a subject of scholarly or legal disputes. In certain fields, members have awarded exclusive competence and exclusive mandate to the Union. These are areas in which member states have entirely renounced their own capacity to enact legislation. In other areas, the EU and its member states share the competence to legislate. While both can legislate,
9717-554: The Union for a new great enlargement is a political priority for the Union, with the goal of achieving over 35 member states by 2030. Institutional and budgetary reforms are being discussed in order to the Union to be ready for the new members. In May 2024, concerns rise, that the outcome of the elections in June, can undermine some of the crucial policies of the EU in the domain of environment, diplomacy, economy . The war in Ukraine by creating inflation, lowering life level created
9840-675: The WEU and NATO in 1955, prompting the Soviet Union to form the Warsaw Pact in 1955 as an institutional framework for its military domination in the countries of Central and Eastern Europe . Assessing the progress of European integration the Messina Conference was held in 1955, ordering the Spaak report , which in 1956 recommended the next significant steps of European integration. In 1957, Belgium , France , Italy , Luxembourg ,
9963-443: The active chemical substance is the same, the medical profile of generics is equivalent in performance compared to their performance at the time when they were patented drugs. A generic drug has the same active pharmaceutical ingredient (API) as the original, but it may differ in some characteristics such as the manufacturing process, formulation , excipients , color, taste, and packaging. Although they may not be associated with
10086-512: The beginning of the 2010s, the cohesion of the European Union has been tested by several issues, including a debt crisis in some of the Eurozone countries , a surge in asylum seekers in 2015 , and the United Kingdom's withdrawal from the EU . A referendum in the UK on its membership of the European Union was held in 2016, with 51.9 per cent of participants voting to leave. The UK formally notified
10209-616: The company, resigned. In May 2004, the company received approval from the Food and Drug Administration to sell trospium chloride . In June 2005, the company received approval to sell a generic version of erythropoietin in Croatia. In November 2005, the company received approval from the Food and Drug Administration to sell a generic version of Azithromycin , Citalopram , and Ondansetron . In October 2006, Barr Pharmaceuticals acquired Pliva. On December 23, 2008, Barr Pharmaceuticals
10332-524: The cost of manufacturing, without the costs of drug discovery and drug development —and are therefore able to maintain profitability at a lower price. The prices are often low enough for users in less-prosperous countries to afford them. Generic drug companies may also receive the benefit of the previous marketing efforts of the brand-name company, including advertising, presentations by drug representatives, and distribution of free samples. Many drugs introduced by generic manufacturers have already been on
10455-416: The council also have executive responsibilities, such as the development of a Common Foreign and Security Policy and the coordination of broad economic policies within the Union. The Presidency of the council rotates between member states, with each holding it for six months. Beginning on 1 July 2024, the position is held by Hungary. The European Parliament is one of three legislative institutions of
10578-574: The creation of the European Movement International , the College of Europe and most importantly to the foundation of the Council of Europe on 5 May 1949 (which is now Europe Day ). The Council of Europe was one of the first institutions to bring the sovereign states of (then only Western) Europe together, raising great hopes and fevered debates in the following two years for further European integration. It has since been
10701-537: The curve (AUC) and maximum concentration (C max ) are within a 90% confidence interval of 80–125%; most approved generics in the US are well within this limit. For more complex products—such as inhalers , patch delivery systems , liposomal preparations , or biosimilar drugs—demonstrating pharmacodynamic or clinical equivalence is more challenging. Enacted in 1984, the Drug Price Competition and Patent Term Restoration Act , informally known as
10824-547: The early 1960s, and with the Patents Act in 1970. The Patents Act removed composition patents for foods and drugs, and though it kept process patents, these were shortened to a period of five to seven years. The resulting lack of patent protection created a niche in both the Indian and global markets that Indian companies filled by reverse-engineering new processes for manufacturing low-cost drugs. The code of ethics issued by
10947-456: The entire cabinet, the final say in accepting or rejecting a candidate submitted for a given portfolio by a member state, and oversees the commission's permanent civil service. After the President, the most prominent commissioner is the high representative of the union for foreign affairs and security policy, who is ex-officio a vice-president of the European Commission and is also chosen by
11070-464: The euro, followed by Cyprus and Malta in 2008, Slovakia in 2009, Estonia in 2011, Latvia in 2014, and Lithuania in 2015. On 1 December 2009, the Lisbon Treaty entered into force and reformed many aspects of the EU. In particular, it changed the legal structure of the European Union, merging the EU three pillars system into a single legal entity provisioned with a legal personality , created
11193-481: The eurozone. The European Court of Auditors (ECA) is the auditory branch of the European Union. It was established in 1975 in Luxembourg in order to improve EU financial management. It has 27 members (1 from each EU member-state) supported by approximately 800 civil servants. The European Personnel Selection Office (EPSO) is the EU's civil service recruitment body and operates its selection of candidates via generalist and specialist competitions. Each institution
11316-554: The fall of the Eastern Bloc , the former East Germany became part of the communities as part of a reunified Germany . The European Union was formally established when the Maastricht Treaty —whose main architects were Horst Köhler , Helmut Kohl and François Mitterrand —came into force on 1 November 1993. The treaty also gave the name European Community to the EEC, even if it was referred to as such before
11439-584: The federal government is guaranteed by the First Amendment to the United States Constitution. For this reason, the FDA has promulgated regulations that provide, among other things, that at any time, any "interested person" can request that the FDA "issue, amend, or revoke a regulation or order," and set forth a procedure for doing so. Some generic drugs are viewed with suspicion by doctors. For example, warfarin (Coumadin) has
11562-449: The generic and the brand-name drug was 3.5 percent, comparable to the difference between two batches of a brand-name drug. Non-innovator versions of biologic drugs, or biosimilars, require clinical trials for immunogenicity in addition to tests establishing bioequivalency. These products cannot be entirely identical because of batch-to-batch variability and their biological nature, and they are subject to extra rules. When an application
11685-436: The greater degree of 'brand-brand' competitive dynamics seen in the biologics and complex generics space allows manufacturers of originators to better protect market share following loss of patent exclusivity. Large pharmaceutical companies often spend millions protecting their patents from generic competition. Apart from litigation, they may reformulate a drug or license a subsidiary (or another company) to sell generics under
11808-778: The institutions of the developing European community under the European Political Community , which was to include the also proposed European Defence Community , an alternative to West Germany joining NATO which was established in 1949 under the Truman Doctrine . In 1954 the Modified Brussels Treaty transformed the Western Union into the Western European Union (WEU). West Germany eventually joined both
11931-425: The interests of the EU as a whole rather than their home state. The leader of the 27 is the president of the European Commission (presently Ursula von der Leyen for 2019–2024, reelected for the 2024-2029 term), proposed by the European Council , following and taking into account the result of the European elections, and is then elected by the European Parliament. The President retains, as the leader responsible for
12054-468: The internal market; enact legislation in justice and home affairs; and maintain common policies on trade , agriculture , fisheries and regional development . Passport controls have been abolished for travel within the Schengen Area . The eurozone is a group composed of the 20 EU member states that have fully implemented the economic and monetary union and use the euro currency . Through
12177-534: The legal inception of the European Union (EU)—the principal framework for this unification. The EU inherited many of its present responsibilities from the European Communities (EC), which were founded in the 1950s in the spirit of the Schuman Declaration . The European Union operates through a hybrid system of supranational and intergovernmental decision-making, and according to
12300-399: The litigation. Some of these settlement agreements have been struck down by courts when they took the form of reverse payment patent settlement agreements, in which the generic company basically accepts a payment to drop the litigation, delaying the introduction of the generic product and frustrating the purpose of the Hatch–Waxman Act. Innovator companies sometimes try to maintain some of
12423-508: The market for a decade or more and may already be well known to patients and providers, although often under their branded name. India is a leading country in the world's generic drugs market, exporting US$ 20.0 billion worth of drugs in the 2019–20 (April–March) year. India exports generic drugs to the United States and the European Union. also the according to market research community the Global Generic Drugs Market
12546-436: The maximum plasma concentration (Cmax) should fall within limits of 80–125%. (This range is part of a statistical calculation, and does not mean that generic drugs are allowed to differ from their brand-name counterparts by up to 25 percent.) The FDA evaluated 2,070 studies conducted between 1996 and 2007 that compared the absorption of brand-name and generic drugs into a person's body. The average difference in absorption between
12669-486: The member states can only legislate to the extent to which the EU has not. In other policy areas, the EU can only co-ordinate, support and supplement member state action but cannot enact legislation with the aim of harmonising national laws. That a particular policy area falls into a certain category of competence is not necessarily indicative of what legislative procedure is used for enacting legislation within that policy area. Different legislative procedures are used within
12792-507: The member states. Since then, the eurozone has increased to encompass 20 countries. The euro currency became the second-largest reserve currency in the world. In 2004, the EU saw its biggest enlargement to date when Cyprus, the Czech Republic, Estonia , Hungary , Latvia , Lithuania , Malta , Poland , Slovakia , and Slovenia joined the union. In 2007, Bulgaria and Romania became EU members. Later that year, Slovenia adopted
12915-420: The necessity for national implementation measures (regulations) and those which specifically require national implementation measures (directives). EU policy is in general promulgated by EU directives , which are then implemented in the domestic legislation of its member states , and EU regulations , which are immediately enforceable in all member states. Lobbying at the EU level by special interest groups
13038-549: The origin of the main institutions of the EU such as the European Commission and Parliament . Founding fathers of the European Union understood that coal and steel were the two industries essential for waging war, and believed that by tying their national industries together, a future war between their nations became much less likely. In parallel with Schuman, the Pleven Plan of 1951 tried but failed to tie
13161-414: The original patent. Generics sold under license from the patent holder are known as authorized generics . Generic drugs are usually sold for significantly lower prices than their branded equivalents and at lower profit margins . One reason for this is that competition increases among producers when a drug is no longer protected by patents. Generic companies incur fewer costs in creating generic drugs—only
13284-532: The pharmaceutical industry; patented drugs with sales of around US$ 28 billion were set to come off patent in 2018, but in 2019 only about US$ 10 billion in revenue was set to open for competition, and less the next year. Companies in the industry have responded with consolidation or turning to try to generate new drugs. Most developed nations require generic drug manufacturers to prove that their formulations are bioequivalent to their brand-name counterparts. Bioequivalence does not mean generic drugs must be exactly
13407-524: The revenue from their drug after patents expire by allowing another company to sell an authorized generic ; a 2011 FTC report found that consumers benefitted from lower costs when an authorized generic was introduced during the 180 day exclusivity period, as it created competition. Innovator companies may also present arguments to the FDA that the ANDA should not be accepted by filing an FDA citizen petition . The right of individuals or organizations to petition
13530-465: The same active ingredient, but considered equivalent only within each group. In order to start selling a drug promptly after the patent on innovator drug expires, a generic company has to file its ANDA well before the patent expires. This puts the generic company at risk of being sued for patent infringement, since the act of filing the ANDA is considered "constructive infringement" of the patent. In order to incentivize generic companies to take that risk
13653-463: The same as the brand-name product ("pharmaceutical equivalent"). Chemical differences may exist; a different salt or ester may be used, for instance. Different inactive ingredients means that the generic may look different from the originator brand; however, the therapeutic effect of the drug must be the same ("pharmaceutical alternative"). Most small molecule drugs are accepted as bioequivalent if their pharmacokinetic parameters of area under
13776-439: The same as those of their reference products. In most cases, generic products become available after the patent protections afforded to the drug's original developer expire. Once generic drugs enter the market, competition often leads to substantially lower prices for both the original brand-name product and its generic equivalents. In most countries, patents give 20 years of protection. However, many countries and regions, such as
13899-478: The same category of competence, and even with the same policy area. The distribution of competences in various policy areas between member states and the union is divided into the following three categories: The European Union has seven principal decision-making bodies, its institutions : the European Parliament , the European Council , the Council of the European Union , the European Commission ,
14022-553: The same courts and the Common Assembly. The EEC was headed by Walter Hallstein ( Hallstein Commission ) and Euratom was headed by Louis Armand ( Armand Commission ) and then Étienne Hirsch ( Hirsch Commission ). The OEEC was in turn reformed in 1961 into the Organisation for Economic Co-operation and Development (OECD) and its membership was extended to states outside of Europe, the United States and Canada. During
14145-449: The several peoples of the separate member states, rather than from a single undifferentiated whole. This is reflected in the fact that the member states remain the 'masters of the Treaties', retaining control over the allocation of competences to the union through constitutional change (thus retaining so-called Kompetenz-kompetenz ); in that they retain control of the use of armed force; they retain control of taxation; and in that they retain
14268-505: The treaty. With further enlargement planned to include the former communist states of Central and Eastern Europe, as well as Cyprus and Malta , the Copenhagen criteria for candidate members to join the EU were agreed upon in June 1993. The expansion of the EU introduced a new level of complexity and discord. In 1995, Austria, Finland, and Sweden joined the EU. In 2002, euro banknotes and coins replaced national currencies in 12 of
14391-487: The union for foreign affairs and security policy (presently Josep Borrell ) also takes part in its meetings. Described by some as the union's "supreme political leadership", it is actively involved in the negotiation of treaty changes and defines the EU's policy agenda and strategies. Its leadership role involves solving disputes between member states and the institutions, and to resolving any political crises or disagreements over controversial issues and policies. It acts as
14514-410: The word "identical" is a legal interpretation , not literal.) Biopharmaceuticals , such as monoclonal antibodies , differ biologically from small-molecule drugs . Biosimilars have active pharmaceutical ingredients that are almost identical to the original product and are typically regulated under an extended set of rules, but they are not the same as generic drugs as the active ingredients are not
14637-405: Was acquired by Teva Pharmaceuticals and the company became part of Teva Active Pharmaceutical Ingredients (TAPI) . Generic drug A generic drug , or simply generic , is a pharmaceutical drug that contains the same chemical substance as a drug that was originally protected by chemical patents . Generic drugs are allowed for sale after the patents on the original drugs expire. Because
14760-476: Was established, along with its citizenship , when the Maastricht Treaty came into force in 1993, and was incorporated as an international legal juridical person upon entry into force of the Treaty of Lisbon in 2009 . Its beginnings can be traced to the Inner Six states (Belgium, France, Italy, Luxembourg, the Netherlands, and West Germany ) at the start of modern European integration in 1948, and to
14883-493: Was evaluated US$ 465.96 million in 2021 and is expected to rise with a CAGR of 5.5% from 2022- 2028 during the forecast period. In the United Kingdom, generic drug pricing is controlled by the government's reimbursement rate. The price paid by pharmacists and doctors is determined mainly by the number of license holders, the sales value of the original brand, and the ease of manufacture. A typical price decay graph will show
15006-474: Was spent on transport , building and the environment, €16bn on education and research , €13bn on welfare, €20bn on foreign and defence policy, €2bn in finance , €2bn in energy , €1.5bn in communications, and €13bn in administration. In November 2020, two members of the union, Hungary and Poland, blocked approval to the EU's budget at a meeting in the Committee of Permanent Representatives (Coreper), citing
15129-475: Was the signing of the Treaty of Dunkirk between France and the United Kingdom . The treaty assured mutual assistance in the event of future military aggression against either nation. Though it officially named Germany as a threat, in reality the actual concern was for the Soviet Union. A few days later came the announcement of the Truman Doctrine which pledged American support for democracies to counter
#405594