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76-476: Epinephrine autoinjectors are hand-held devices carried by those who have severe allergies; the epinephrine delivered by the device is an emergency treatment for anaphylaxis . When anaphylaxis is suspected, epinephrine solution should be given as soon as possible as an intramuscular injection , in the middle of the outer side of the thigh, which corresponds to the location of the vastus lateralis muscle . The injection may be repeated every 5 to 15 minutes if there

152-484: A 505(b)(2) New Drug Application for the product, then known as "e-cue"; Pfizer, Mylan and Sanofi settled in 2012 under a deal that allowed the device to enter the market no earlier than November 2012, pending FDA approval. In August 2012, the FDA approved the autoinjector, called "Auvi-Q" after the FDA required a name change from "e-cue". The device is equipped with a sound chip to provide electronic voice instructions to guide

228-489: A Silicon Valley engineering consultancy performed a teardown analysis of the EpiPen and estimated the manufacturing and packaging costs at about $ 10 for a two-pack. The EpiPen, manufactured by Meridian Medical Technologies, and marketed by Mylan, has dominated the market. In 2007 when Mylan acquired the rights to market the product, annual sales of all epinephrine autoinjectors were about $ 200 million and EpiPen had around 90% of

304-574: A buildup of adrenochrome pigments in the conjunctiva, iris, lens, and retina. Rarely, exposure to medically administered epinephrine may cause Takotsubo cardiomyopathy . Use is contraindicated in people on nonselective β-blockers because severe hypertension and even cerebral hemorrhage may result. The most common side effects of epinephrine nasal spray include throat irritation, tingling nose (intranasal paresthesia), headache, nasal discomfort, feeling jittery, tingling sensation (paresthesia), fatigue, tremor, runny nose (rhinorrhea), itchiness inside

380-402: A child in a school (previously, only trained professionals or the affected person were allowed to administer the drug, and were open to liability), and it provided some financial incentives for schools that didn't already stock epinephrine autoinjector to start stocking them. Joe Manchin, the father of Mylan's CEO, was a senator at that time. In January 2015 Mylan filed a citizen petition with

456-550: A deal that allowed Teva to start selling the device in mid-2015, pending FDA approval. In 2009, Intelliject, a US startup developing a new epinephrine autoinjector, licensed their product to Sanofi . King was acquired by Pfizer in 2010 for $ 3.6 billion in cash. In 2010, Sciele/Shionogi faced a recall of Twinject devices and launched Adrenaclick, a modified version of the Twinject that could deliver only one dose. In 2010, European regulators approved Twinject, and also approved

532-601: A new epinephrine autoinjector made by ALK and sold under the brand name Jext. Jext was launched in the European Union in September 2011. Also in 2010, Shionogi authorized Greenstone, the authorized generics division of Pfizer, to begin selling an authorized generic of Adrenaclick. The media noted that Pfizer, through Greenstone, was marketing a generic epinephrine autoinjector when Pfizer acquired King later that year. At that time, King and Mylan's EpiPen had 91% of

608-711: A sales force of over 1,000 individuals. King Pharmaceuticals, Inc. was incorporated in the State of Tennessee in 1993. According to the King Pharmaceutcals, Inc. Form 10-K for the year ended December 31, 2007 filed with the U.S. Securities and Exchange Commission, the wholly owned subsidiaries of King Pharmaceuticals, Inc. are Monarch Pharmaceuticals, Inc.; King Pharmaceuticals Research and Development, Inc.; Meridian Medical Technologies, Inc.; Parkedale Pharmaceuticals, Inc.; King Pharmaceuticals Canada Inc.; and Monarch Pharmaceuticals Ireland Limited. King Pharmaceuticals

684-469: A strategy of acquiring branded prescription drugs, which have a much higher gross margin than contract manufactured drugs. In February 1998, King acquired 15 branded pharmaceuticals, a sterile products manufacturing facility located in Rochester, Michigan that it called the "Parkedale Facility") and some contract manufacturing contracts. By December 1998 King had placed its sterile products business into

760-509: A subsidiary it named Parkedale Pharmaceuticals. King Pharmaceuticals obtained about twenty smaller branded drugs from the start up of the company until it went public in June 1998. The King Pharmaceuticals subsidiary Monarch Pharmaceuticals acquired one of its most profitable branded drugs, Altace, later the same year on December 18, 1998 from Hoechst Marion Roussel . Hoechst merged with Marion Merrill Dow of Kansas City, Missouri in 1995, forming

836-416: A technique for obtaining multiple additional doses of epinephrine from used, single dose autoinjectors EpiPen and Adrenaclick. It was emphasized this was an emergency adaptation of the intended design for austere environments when no additional epinephrine was available. In 2016, Robinson and Lareau published a similar technique adapted to used AuviQ autoinjectors. Autoinjectors were originally developed for

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912-467: Is 2.25% w/v epinephrine in solution, which contains 22.5 mg/mL, while a 1% solution is typically used for aerosolization. King Pharmaceuticals King Pharmaceuticals, Inc. is a pharmaceutical company, a wholly owned subsidiary of Pfizer based in Bristol, Tennessee . Before being acquired by Pfizer, it was the world's 39th largest pharmaceutical company . On October 12, 2010, King

988-540: Is ARS Pharmaceuticals IRL Limited. Eurneffy was approved for medical use in the European Union in August 2024. Epinephrine is available in an autoinjector delivery system and a nasal spray . There is an epinephrine metered-dose inhaler sold over the counter in the United States to relieve bronchial asthma . It was introduced in 1963 by Armstrong Pharmaceuticals. A common concentration for epinephrine

1064-416: Is a medication and hormone . As a medication, it is used to treat several conditions, including anaphylaxis , cardiac arrest , asthma , and superficial bleeding. Inhaled epinephrine may be used to improve the symptoms of croup . It may also be used for asthma when other treatments are not effective. It is given intravenously , by injection into a muscle, by inhalation, or by injection just under

1140-716: Is insufficient response. A second dose is needed in 16–35% of episodes with more than two doses rarely required; in around 80% of the cases where a second dose is administered, it is by a medical professional. It is not clear which are the people who might need a second injection at the outset. The intramuscular route is preferred over subcutaneous administration because the latter may have delayed absorption. Minor adverse effects from epinephrine include tremors , anxiety, headaches, and palpitations . The epinephrine in autoinjectors expires after one year. A study in rabbits showed that intramuscular epinephrine has decreased effectiveness after it expires; that study also recommended that if

1216-776: Is mixed with local anesthetics, such as bupivacaine or lidocaine , and used for local anesthesia or intrathecal injection, it prolongs the numbing effect and motor block effect of the anesthetic by up to an hour. Epinephrine is frequently combined with local anesthetic and can cause panic attacks. Epinephrine is mixed with cocaine to form Moffett's solution , used in nasal surgery . Upper airway obstruction with edema and stridor can be treated with racemic epinephrine. Adverse reactions to adrenaline include palpitations , tachycardia , arrhythmia , anxiety , panic attack , headache , anorexia , tremor , hypertension , and acute pulmonary edema . The use of epinephrine based eye-drops, commonly used to treat glaucoma, may also lead to

1292-462: Is not marketed. From 2015 to 2020 the only autoinjector marketed in Canada was EpiPen and production issues led to supply shortages during that period. During a 2018 shortage of EpiPens, Health Canada temporarily permitted the importation of Auvi-Q autoinjectors from the United States. As of 2005, epinephrine autoinjectors were not available in most of the developing world. As of May 2019, in Canada

1368-541: Is on the World Health Organization's List of Essential Medicines . It is available as a generic medication . In 2021, it was the 221st most commonly prescribed medication in the United States, with more than 1   million prescriptions. The word epinephrine is formed from the Ancient Greek ἐπι- ( epi -, "on") and νεφρός ( nephros , " kidney ") because the adrenal glands, where it

1444-592: Is produced, are located just above the kidneys. Epinephrine is used to treat a number of conditions, including cardiac arrest , anaphylaxis , and superficial bleeding. It has been used historically for bronchospasm and low blood sugar , but newer treatments for these that are selective for β 2 adrenoceptors , such as salbutamol , are preferred. While epinephrine is often used to treat cardiac arrest , it has not been shown to improve long-term survival or mental function after recovery. It does, however, improve return of spontaneous circulation . Epinephrine

1520-736: Is sold under various brand names including Asthmanefrin, Micronefrin, Neffy, Nephron, VapoNefrin, and Primatene Mist, among others. In June 2024, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Eurneffy, intended for emergency treatment of allergic reactions (anaphylaxis) due to insect stings or bites, foods, medicinal products, and other allergens as well as idiopathic or exercise-induced anaphylaxis. The applicant for this medicinal product

1596-490: Is spring loaded or not), the angle at which the device is placed on the skin and the force used to activate the device as well as how well the user follows the instructions for injection." It found that how well the user was trained was the most important factor determining successful delivery, and requested companies to develop better training materials for doctors and people to whom the devices are prescribed. In 2013, emergency physician Seth C. Hawkins and coauthors published

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1672-756: Is the first nasal spray for the treatment of anaphylaxis approved by the US Food and Drug Administration (FDA). The approval epinephrine nasal spray is based on four studies in 175 healthy adults, without anaphylaxis, that measured the epinephrine concentrations in the blood following administration of epinephrine nasal spray or approved epinephrine injection products. Results from these studies showed comparable epinephrine blood concentrations between epinephrine nasal spray and approved epinephrine injection products. Epinephrine nasal spray also demonstrated similar increases in blood pressure and heart rate as epinephrine injection products, two critical effects of epinephrine in

1748-467: Is the only life-saving treatment for anaphylaxis. The commonly used epinephrine autoinjector delivers a 0.3 mg epinephrine injection (0.3 mL, 1:1000). It is indicated in the emergency treatment of allergic reactions, including anaphylaxis to stings, contrast agents, medicines, or people with a history of anaphylactic reactions to known triggers. A lower-strength product is available for children. Intramuscular injection can be complicated in that

1824-470: The adrenal gland were first obtained by Polish physiologist Napoleon Cybulski in 1895. These extracts, which he called nadnerczyna , contained adrenaline and other catecholamines. American ophthalmologist William H. Bates discovered adrenaline's usage for eye surgeries prior to 20 April 1896. Japanese chemist Jōkichi Takamine and his assistant Keizo Uenaka independently discovered adrenaline in 1900. In 1901, Takamine successfully isolated and purified

1900-656: The 400 richest Americans. The bulk of Gregory's personal fortune was due in large part due to the ability of King Pharmaceuticals, Inc. to reintroduce the Hoechst branded prescription drug Altace back into the U.S. market under the King Pharmaceuticals, Inc. subsidiary Monarch Pharmaceuticals brand following the 1998 U.S. marketing and distribution agreement between King Pharmaceuticals/Monarch Pharmaceuticals and Hoechst AG/HMR. In late December 1998, King Pharmaceuticals (d.b.a. Monarch Pharmaceuticals, Inc.) purchased

1976-731: The Emerade epinephrine autoinjector developed by the Swedish company Medeca was approved in Sweden and Germany; it had been approved in the UK in 2013. Also in 2015 Valeant , which had licensed the rights from Medeca, abandoned its efforts to get Emerade approved in the US. In October 2015, Auvi-Q and Allerject devices were voluntarily recalled by Sanofi in North America. The reason stated by Sanofi

2052-502: The EpiPen. In 1998 there was a recall of one million EpiPens, the second such recall in a year. In 2001 Meridian and Dey introduced a two-pack version of the EpiPen; at that time the device had $ 23.9 million in annual sales and accounted for 75% of the market in the United States. In 2002 King Pharmaceuticals acquired Meridian for $ 247.8 million in cash; the deal was completed in January 2003. Kaplan continued to improve his designs over

2128-594: The FDA raising concerns about TEVA's ANDA application to market a generic EpiPen and filed an additional supplement later in May; the FDA rejected the petition in June. In March 2015, Impax Laboratories acquired the parent company of Amedra and Lineage, and placed Amedra and the Adrenaclick in its Impax Specialty Pharma division; at the same time it acquired Lineage, which it placed, along with its generic version of Adrenaclick, in its Impax Generics division. In May 2015,

2204-493: The Hoechst U.S. pharmaceutical subsidiary Hoechst Marion Roussel (HMR). Altace was bringing in under $ 90 million in U.S. revenues for HMR and Hoechst had stopped promoting Altace within the United States., and King Pharmaceuticals President Jefferson "Jeff" Gregory also began negotiations in 1995 with Hoechst to acquire U.S. distribution rights to Altace. The King Pharmaceuticals wholly owned subsidiary Monarch Pharmaceuticals, Inc. (another brother of John Gregory - Joseph Gregory -

2280-503: The U.S. marketing and distribution rights of the company's most successful drug, Altace, for $ 362.5 million from the U.S. subsidiary of Hoechst AG , Hoechst Marion Roussel of Kansas City. As a result of increasing the number of sales representatives and the findings of the Heart Outcomes Prevention Evaluation (HOPE), Altace sales increased. Using profits from Altace, King continued to add product lines,

2356-580: The US through marketing and advocacy, and the company launched a marketing campaign to increase awareness of the dangers of anaphylaxis for people with severe allergies that made the EpiPen brand as identified with epinephrine autoinjectors as Kleenex is for facial tissue; the company also successfully lobbied the FDA to broaden the label to include risk of anaphylaxis and in parallel, successfully lobbied Congress to generate legislation making EpiPens available in public places like defibrillators are, and hired

Epinephrine autoinjector - Misplaced Pages Continue

2432-420: The alpha-adrenergic receptors in the airway, with resultant mucosal vasoconstriction and decreased subglottic edema, and by stimulating the β adrenergic receptors, with resultant relaxation of the bronchial smooth muscle. There is a lack of consensus as to whether inhaled nebulized epinephrine is beneficial in the treatment of bronchiolitis , with most guidelines recommending against its use. When epinephrine

2508-599: The association in 2010, and shortly after had discussed donations from her "daughter's company" to the association. Manchin had been appointed to the West Virginia state school board by her husband Joe Manchin , then-governor of the state, in 2012. In 2012, Shionogi, the manufacturer of Adrenaclick and Twinject, announced it would stop making them; it had sold the rights to the NDA to a company called Amedra Pharmaceuticals. In June 2013, Amedra relaunched Adrenaclick. and at

2584-525: The brain, where it acts as a neurotransmitter . It plays an essential role in the fight-or-flight response by increasing blood flow to muscles, heart output, pupil dilation , and blood sugar . Epinephrine does this through its effects on alpha and beta receptors . It is found in many animals and some single-celled organisms , but the medication is produced synthetically and is not harvested from animals. Jōkichi Takamine first isolated epinephrine in 1901, and it came into medical use in 1905. It

2660-567: The company when it refused to provide the documentation the state requested. In October 2016, Mylan announced a $ 465M settlement with the US Department of Justice over rebates paid by Mylan to states under the Medicaid Drug Rebate Program . On 5 September 2017, FDA posted a warning letter to the manufacturer, Meridian Medical Technologies. The agency warned Meridian Medical for failing to investigate problems with

2736-684: The cost of the EpiPen and Mylan was widely and harshly criticized. In September 2016, the New York State Attorney General began an investigation into Mylan's EpiPen4Schools program in New York to determine if the program's contracts violated antitrust law and the West Virginia State Attorney General opened an investigation into whether Mylan had given the state the correct discount under the Medicaid Drug Rebate Program and subpoenaed

2812-524: The cost to redesign the device and packaging may have been "several million dollars" and the cost to retool the manufacturing process may have "run into the double-digit millions." In 2009, Teva Pharmaceuticals filed an ANDA to market a generic EpiPen in collaboration with Antares Pharma Inc, a maker of injection systems; Pfizer and King sued them for infringing US Patent 7,449,012 that was due to expire in 2025; Pfizer, Mylan, and Teva settled in April 2012 in

2888-543: The depth of subcutaneous fat varies and may result in subcutaneous injection , or may be injected intravenously in error, or the wrong strength used. Intramuscular injection gives a faster and higher pharmacokinetic profile compared to subcutaneous injection. In August 2024, an epinephrine nasal spray (brand name Neffy) was approved in the United States for the emergency treatment of allergic reactions (type I), including those that are life-threatening (anaphylaxis), in people who weigh at least 30 kilograms (66 lb). It

2964-403: The device is mistaken for a pen or the user mistakes which end of the device contains the needle. The European Medicines Agency conducted a review of the safety of devices then on the market and found several factors that determine whether the devices successfully deliver drug into muscle, including "needle length, the thickness of fat under the skin, the way the auto-injector works (e.g., if it

3040-442: The devices, recall bad batches, and follow-up on problems found. According to the FDA, the manufacturer of EpiPen devices failed to address known malfunctions in its auto-injectors even as hundreds of customer complaints rolled in and failures were linked to deaths. During an inspection, Meridian employees told inspectors that they weren't allowed to disassemble and investigate complain samples, because they were allowed to do if only it

3116-424: The drug in an expired device has not started to precipitate (if the solution is not cloudy and has no particles in it) using the expired device is better than no injection at all in an emergency situation. The devices contain a fixed dose of epinephrine and a spring-loaded needle (or, in the case of AuviQ, a CO 2 -driven needle) that exits the tip or edge of the device and penetrates the recipient's skin, to deliver

Epinephrine autoinjector - Misplaced Pages Continue

3192-423: The expense of the capillary beds where perfusion takes place. Epinephrine, or adrenaline, also known as 3,4,β-trihydroxy- N -methylphenethylamine, is a substituted phenethylamine and catecholamine . It is the N - methylated analogue of norepinephrine (noradrenaline; 3,4,β-trihydroxyphenethylamine) and the N -methylated and β- hydroxylated analogue of dopamine (3,4-dihydroxyphenethylamine). Extracts of

3268-658: The following epinephrine autoinjectors were available in various parts of Europe: Adrenalina WZF, Adrenaline (epinephrine) 1 in 1000 solution for injection BP auto-injector, Altellus, Anapen, Emerade, EpiPen, Fastjekt, FastPen, and Jext. As of 2018, three branded products were available in the United States: Adrenaclick, Auvi-Q, and EpiPen. As of 2020, three brands of autoinjectors are available in Canada: Allerject, Emerade, and EpiPen. One generic autoinjector has been approved by Health Canada but

3344-414: The global market share for epinephrine autoinjectors and 96% of the US market. In 2010, Pfizer and King sued Novartis ' Sandoz generic unit for patent infringement after Sandoz submitted an ANDA to sell a generic EpiPen. In response, Sandoz challenged the validity of the patents, and as of July 2016 this litigation was ongoing. In 2011, Pfizer and King sued Intelliject and Sanofi after the companies filed

3420-444: The high intrinsic efficacy (receptor binding ability) of epinephrine, high drug concentrations cause adverse side effects when treating asthma. The value of using nebulized epinephrine in acute asthma is unclear. Racemic epinephrine has been used for the treatment of croup . Racemic adrenaline is a 1:1 mixture of the two enantiomers of adrenaline. The L -form is the active component. Racemic adrenaline works by stimulating

3496-440: The high price by buying EpiPens online from pharmacies outside the US, forgoing new EpiPens and relying on their expired EpiPen, or forgoing an autoinjector altogether and having their children carry pre-loaded syringes. Former Mylan CEO, Heather Bresch testified before the U.S. Senate Special Committee on Aging to argue that the price change was "fair". Epinephrine (medication) Epinephrine , also known as adrenaline ,

3572-426: The hormone from the adrenal glands of sheep and oxen. Adrenaline was first synthesized in the laboratory by Friedrich Stolz and Henry Drysdale Dakin , independently, in 1904. Epinephrine is the generic name of the drug and its INN Tooltip International Nonproprietary Name and USAN Tooltip United States Adopted Name , while adrenaline is its BAN Tooltip British Approved Name . Epinephrine

3648-439: The major subtypes α 1 , α 2 , β 1 , β 2 , and β 3 . Epinephrine's binding to these receptors triggers several metabolic changes. Binding to α-adrenergic receptors inhibits insulin secretion by the pancreas , stimulates glycogenolysis in the liver and muscle , and stimulates glycolysis and inhibits insulin-mediated glycogenesis in muscle. β adrenergic receptor binding triggers glucagon secretion in

3724-572: The market; in 2015 the market size was around $ 1.5 billion and Mylan still had about 90% of the market. Mylan raised the price from around $ 100 for a package of two EpiPens in 2007 to around $ 600 in 2016. In the United Kingdom, an EpiPen costs £26.45 as of 2015. In Canada they are about 120 CAD each. Mylan acquired the right to market the EpiPen line of epinephrine autoinjector devices from Merck KGaA as part of their 2007 deal. Heather Bresch , Mylan's CEO, saw an opportunity to increase sales in

3800-518: The medication via intramuscular injection . People to whom epinephrine autoinjectors are prescribed need to be trained how to use the specific device prescribed. The rate of unintentional injections using these devices is unknown but a 2009 review found that the rate is increasing. Unintentional injections are delivered to a finger or thumb around 90% of the time; they cause intense pain locally but usually completely resolve. The cause of unintentional injections has been attributed to design flaws, where

3876-575: The merger, saying that Mylan was overpaying for King. The next year the deal was called off. In 2008 King Pharmaceuticals acquired Alpharma Pharmaceuticals to expand into the pain treatment market. From the acquisition, King gained the patents on the pain management drugs, Flector and Embeda. They also gained a completely separate animal health division, which focuses on the many agricultural and animal health needs of livestock animals. On October 12, 2010, Pfizer Inc. ( NYSE :  PFE ) announced it would acquire Bristol-based King Pharmaceuticals, Inc. for

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3952-502: The most significant purchases being Levoxyl , Thrombin , and Cytomel in 2000. Also in 2000, seeing fewer opportunities to obtain branded drugs, the company acquired an R&D company based in North Carolina. In 2002, King and Meridian Medical Technologies agreed that King would purchase Merdian for $ 247.8 million in cash; Meridian was a manufacturer of autoinjectors, including EpiPen, an epinephrine autoinjector . The deal

4028-459: The nose (nasal pruritus), sneezing, abdominal pain, gum (gingival) pain, numbness in the mouth (hypoesthesia oral), nasal congestion, dizziness, nausea and vomiting. The FDA granted the application of epinephrine nasal spray fast track designation and granted the approval of Neffy to ARS Pharmaceuticals. Epinephrine acts by binding to a variety of adrenergic receptors . Epinephrine is a nonselective agonist of all adrenergic receptors, including

4104-446: The nose (nasal pruritus), sneezing, abdominal pain, gum (gingival) pain, numbness in the mouth (hypoesthesia oral), nasal congestion, dizziness, nausea and vomiting. The FDA granted the application of epinephrine nasal spray fast track designation and granted the approval of Neffy to ARS Pharmaceuticals. Epinephrine is also used as a bronchodilator for asthma if specific β 2 agonists are unavailable or ineffective. Because of

4180-421: The pancreas, increased adrenocorticotropic hormone (ACTH) secretion by the pituitary gland , and increased lipolysis by adipose tissue . Together, these effects increase blood glucose and fatty acids , providing substrates for energy production within cells throughout the body. In the heart, the coronary arteries have a predominance of β 2 receptors, which cause vasodilation of the coronary arteries in

4256-578: The presence of epinephrine. Its actions increase peripheral resistance via α 1 receptor -dependent vasoconstriction and increase cardiac output via its binding to β 1 receptors. The goal of reducing peripheral circulation is to increase coronary and cerebral perfusion pressures and therefore increase oxygen exchange at the cellular level. While epinephrine does increase aortic, cerebral, and carotid circulation pressure, it lowers carotid blood flow and end-tidal CO 2 or E T CO 2 levels. It appears that epinephrine may improve macrocirculation at

4332-506: The price of EpiPens starting in 2009: in 2007, the wholesale price of two EpiPens was about $ 100; the price was about the same in 2009; by July 2013, the price was about $ 265; in May 2015, it was around $ 461; and in May 2016, the price rose again to around $ 609, around a 500% jump from the price in 2009. The last price increase sparked widespread outrage in the late summer as parents prepared to send their children back to school and went to pharmacies to get new EpiPens. Some Americans responded to

4408-556: The rapid administration of nerve gas antidotes in kits like the Mark I NAAK . The first modern epinephrine autoinjector, the EpiPen, was invented in the mid-1970s at Survival Technology in Bethesda , Maryland, US by Sheldon Kaplan and was first approved for marketing by the FDA in 1987. One of the people who helped in making the EpiPen was Richard B. Toren. He had the idea to use this technology for allergic reactions because his daughter

4484-552: The same people that Medtronic had worked with on defibrillator legislation to do so. Mylan's efforts to maintain its market dominance were aided when Sanofi 's competing product was recalled in November 2015 and further when Teva 's generic competitor was rejected by the FDA in March 2016. By the first half of 2015, sales of EpiPen accounted for 40% of Mylan's profit. Those profits were also due in part to Mylan's continually raising

4560-468: The same time, Lineage Therapeutics launched its authorized generic version of Adrenaclick. Lineage was a wholly owned subsidiary of Amedra that had acquired the rights to the Adrenaclick authorized generic from Greenstone/Pfizer. After successful lobbying from Mylan, in 2013, the "School Access to Emergency Epinephrine Act" became law after passing Congress with broad and bipartisan support; it protected anyone from liability if they administered epinephrine to

4636-425: The skin. Common side effects include shakiness, anxiety , and sweating. A fast heart rate and high blood pressure may occur. Occasionally, it may result in an abnormal heart rhythm . While the safety of its use during pregnancy and breastfeeding is unclear, the benefits to the mother must be taken into account. Epinephrine is normally produced by both the adrenal glands and a small number of neurons in

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4712-482: The treatment of anaphylaxis. A study of epinephrine nasal spray in children weighing more than 66 pounds showed that epinephrine concentrations in children were similar to adults who received epinephrine nasal spray. The most common side effects of epinephrine nasal spray include throat irritation, tingling nose (intranasal paresthesia), headache, nasal discomfort, feeling jittery, tingling sensation (paresthesia), fatigue, tremor, runny nose (rhinorrhea), itchiness inside

4788-817: The user in the proper use of the device. In 2012, Mylan launched a program called EpiPen4Schools to sell EpiPens in bulk and with discounts to schools; to participate in the program schools had to agree not to buy epinephrine autoinjectors from any other company for a year. In December 2012, the National Association of State Boards of Education launched a policy initiative designed to "help state boards of education as they develop student health policies regarding anaphylaxis and epinephrine auto-injector access and use", and advocated for state laws protecting school from legal liability for stocking and using epinephrine autoinjectors. Gayle Conelly Manchin , mother of Mylan's CEO, Heather Bresch , had become president of

4864-641: The wholesale cost of a single EpiPen is approximately CA$ 95.00 . As of September 2016, two EpiPens cost around $ 100 in France and at maximum 10€ for members of the statutory health insurance in Germany. As of September 2016, two Jext autoinjectors cost users about £8.50 (US$ 11.64) in Britain, and the National Health Service pays around £48 (US$ 65.75) in order to make them available; that price

4940-447: The wholesale price of two EpiPens was about $ 100; by July 2013, the price was about $ 265; in May 2015, it was around $ 461; and in May 2016, the price rose again to around $ 609, around a 500% jump from the price in 2009. The cost of the drug and device to Mylan as of 2016 was about $ 35. In the summer of 2016, as parents prepared to send their children back to school and went to pharmacies to get new EpiPens, people began to express outrage at

5016-438: The year it had about 85% share and Auvi-Q had about 10% share. In March 2016, Teva's ANDA for a generic EpiPen, which had already faced several delays, was rejected by the FDA. In 2015 Mylan had about $ 1.5 billion in sales of EpiPens, which accounted for 40% of Mylan's profit. Mylan had maintained about a 90% market share since it had acquired the product, and had continually raised the price of EpiPens starting in 2009: in 2009,

5092-441: The years, filing for example US Patent 6,767,336 in 2003. In 2003, Hollister-Stier received approval from the FDA to market an epinephrine autoinjector called Twinject that could deliver two shots of epinephrine, which it had spent ten years developing. In 2005, it sold the product to Verus Pharmaceuticals, which launched the product the same year. In March 2008, Sciele Pharma acquired Twinject from Verus and later that year, Sciele

5168-617: Was about 17 percent less than 2013. Supplies of 150 microgram adrenaline auto-injectors were said to be “critical” in the United Kingdom in October 2018. Community pharmacists were told to prioritise supplies for children weighing 25 kg or less. Mylan identified shortages because of manufacturing problems in May 2018. In October 2016 the CEO of Mylan testified to Congress that Pfizer/King charged Mylan about $ 34.50 for one EpiPen. The devices deliver about $ 1 worth of drug. In September 2016,

5244-477: Was acquired by Pfizer for $ 14.25 per share. King produced a wide range of pharmaceuticals , including Altace for heart attack prevention, Levoxyl for hypothyroidism , Sonata , a sleeping aid , and Skelaxin , a muscle relaxant . King Pharmaceuticals operated manufacturing facilities in Bristol, Tennessee ; Rochester, Michigan ; St. Louis, Missouri ; St. Petersburg, Florida ; and Middleton, Wisconsin . They employed approximately 2,700 people including

5320-452: Was acquired by Shionogi. In 2007, Mylan acquired the right to market the EpiPen from Merck KGaA as part of a larger transaction. At that time annual sales were around $ 200 million and the EpiPen had about 90% of the market. In 2009, Mylan and King started marketing a new version of EpiPen with the same basic mechanism but a stronger spring, better safety features, and clearer markings and instructions; an expert for NBC News estimated that

5396-416: Was allergic to bees and had to carry around a complex kit if she was ever stung. He then helped to slightly alter the technology in order to create EpiPen's current design. In 1996, Survival Technology merged with a company called Brunswick Biomedical and the new company was called Meridian Medical Technologies . In 1997, Dey, a subsidiary of Merck KGaA , acquired the exclusive right to market and distribute

5472-547: Was completed in January 2003. In 2002, John Gregory stepped down as CEO, and his brother Jefferson Gregory took over. Then in 2004, Jeff Gregory stepped down as well after the SEC began investigations into King's Medicaid billing practices. The board named Brian Markison to replace him. Soon after, in July 2004, a deal was made for Mylan Laboratories to acquire King for $ 4 billion. Investors, most notably Carl Icahn , were critical of

5548-541: Was founded in 1993 John M. Gregory , Randal J. Kirk , Joseph "Joe" R. Gregory, Jefferson "Jeff" J. Gregory, and James E. Gregory. In January 1994, King acquired a former King College campus plant in Bristol, Tennessee. The 500,000-square-foot (46,000 m ) facility was purchased for $ 1.18 million from RSR Pharmaceutical, who had been using it after Beecham merged with SmithKline . King initially manufactured drugs for other pharmaceutical companies, but soon established

5624-458: Was that the products had been found to potentially have inaccurate dosage delivery, which may include failure to deliver drug. In February 2016, Sanofi terminated its license to manufacture and market the Auvi-Q, leaving Kaléo (Intelliject was renamed) to consider how and whether to re-introduce the device. The EpiPen had 89% of the market for epinephrine autoinjectors in 2015; in the first half of

5700-441: Was then the president of Monarch Pharmaceuticals) acquired ownership of the U.S. distribution and marketing rights to Altace and other Hoechst products from Hoechst AG subsidiary Hoechst Marion Roussel of Kansas City, Missouri on December 18, 1998, and following a January 1999 merger a few weeks later with Rhône-Poulenc , Hoechst assumed the new corporate identity of Aventis ). In 2001, Forbes magazine ranked John Gregory among

5776-489: Was “approved by management”. On 16 August 2018 the FDA approved the first generic EpiPen from Teva Pharmaceuticals. In an effort to address the supply shortage of EpiPens, on August 21, 2018 the FDA approved extending the expiration dates on some products by four months. The Sandoz division of Novartis announced on 9 July 2019 the availability of Symjepi, a manual epinephrine injection as an alternative to autoinjectors, in 0.3 mg and 0.15 mg versions. As of 2015,

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