Endo International plc is an American Irish-domiciled generics and specialty branded pharmaceutical company that generated over 93% of its 2017 sales from the U.S. healthcare system. While Endo's management, operations, and customers are almost exclusively U.S.–based, in 2013 Endo executed a corporate tax inversion to Ireland to avoid U.S. corporate taxes on their U.S. drug sales, and to avail of Ireland's corporate tax system .
21-460: In 1920, Intravenous Products of America was incorporated as a privately owned pharmaceutical business operating in New York. By 1935 it had changed its name to Endo Products. The product line focused on medication for the treatment of pain (e.g. Percodan ), a focus which continued during its acquisition by DuPont in 1969 (e.g. Percocet ). Endo Pharmaceuticals Holdings was created as a result of
42-464: A "Pregnancy Category" per 21 CFR 201.57. One characteristic of the FDA definitions of the pregnancy categories is that the FDA requires a relatively large amount of high-quality data on a pharmaceutical for it to be defined as Pregnancy Category A. As a result of this, many drugs that would be labelled as safe in other countries are allocated to Category C by the FDA. On December 13, 2014, the FDA published
63-528: A $ 277 million management buyout of the division from DuPont Merck in 1997, led by Carol Ammon. Through the merger with Algos, it changed name again to Endo Pharmaceuticals Holdings Inc. and began trading as a public company . In 2012 shareholders voted to again change name to Endo Health Solutions, with Endo Pharmaceuticals becoming a segment of the business. Through the 2014 acquisition of Paladin Labs and subsequent corporate restructuring, Endo International plc
84-518: A limited number of key phrases, but now Appendix 4 (which was the Pregnancy table) has been removed. Appendix 4 is now titled "Intravenous Additives". However, information that was previously available in the former Appendix 4 (pregnancy) and Appendix 5 (breastfeeding) is now available in the individual drug monographs. American law requires that certain drugs and biological products must be labelled very specifically. Title 21, Part 201.57 (9)(i) of
105-437: A majority of the company's US revenue in 2016 was derived from the sale of prescription pain killers, predominantly opioids . On June 8, 2017, the U.S. Food and Drug Administration (FDA) released a press statement in which it announced that it requested Endo to withdraw its opioid drug, oxymorphone hydrochloride (Opana ER), from the market. Opana has been linked to outbreaks of HIV, hepatitis C and serious blood disorders. It
126-456: A medication is an assessment of the risk of fetal injury due to the pharmaceutical, if it is used as directed by the mother during pregnancy . It does not include any risks conferred by pharmaceutical agents or their metabolites in breast milk . Every drug has specific information listed in its product literature. The British National Formulary used to provide a table of drugs to be avoided or used with caution in pregnancy, and did so using
147-415: Is a combination drug marketed by Endo Pharmaceuticals . It is a tablet containing a mixture of 325 mg (5 grains ) of aspirin and 4.8355 mg of oxycodone HCl (equivalent to 4.3346 mg of oxycodone as the free base); it is an opioid/non-opioid combination used to treat moderate to moderately severe pain. The safety of the combination during pregnancy has not been established, although aspirin
168-411: Is an implied assumption that the alphabetical code is one of safety when this is not always the case. Categorisation does not indicate which stages of fetal development might be affected and does not convey information about the balance between risks and benefits in a particular situation. Additionally, categories are not necessarily maintained or updated with availability of new data. The data presented
189-607: Is generally contraindicated during pregnancy, and the drug has been placed in pregnancy category D . Inactive ingredients include D&C Yellow 10 , FD&C Yellow 6 , microcrystalline cellulose , and corn starch . Percodan was first marketed by DuPont Pharmaceuticals and prescribed in the United States in 1950. Once a widely prescribed painkiller, it has largely been replaced by alternative oxycodone compounds containing paracetamol (acetaminophen) instead of aspirin , such as Percocet . The oxycodone component in
210-966: The Code of Federal Regulations lists specific requirements regarding the labeling of drugs with respect to their effects on pregnant populations, including a definition of a "pregnancy category". These rules are enforced by the Food and Drug Administration . To supplement this information, the FDA publishes additional rules regarding pregnancy and lactation labeling. The FDA does not regulate labeling for all hazardous and non-hazardous substances. Many substances, including alcohol , are widely known to cause serious hazards to pregnant women and their fetuses, including fetal alcohol syndrome . Many other pollutants and hazardous materials are similarly known to cause reproductive harm. However, some of these substances are not subject to drug labeling laws, and are therefore not assigned
231-534: The United States Senate Committee on Finance began an investigation into the relationships between narcotic manufacturers and pain advocacy organisations. APF cited "irreparable economic circumstances" in its decision to close. In 2018, Endo paid $ 200 million to settle over 1,200 lawsuits related to its testosterone replacement therapy, Testim, and its undisclosed side effects. Percodan Oxycodone/aspirin (trade name Percodan )
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#1732790127421252-510: The Pregnancy and Lactation Labeling Final Rule (PLLR), which changed the labeling requirements for the pregnancy and lactation sections for prescription drugs and biological agents. The final rule removed the pregnancy letter categories, and created descriptive subsections for pregnancy exposure and risk, lactation, and effects to reproductive potential for females and males. Labeling changes from this rule began on June 30, 2015, with all submissions for prescription drugs and biological agents using
273-456: The combination is technically 14-hydroxy-7,8-dihydrocodein-6-one, a white odorless , crystalline powder which is synthesized from the opium alkaloid thebaine . Thebaine by itself has no therapeutic value . Oxycodone is metabolized into oxymorphone . Unlike morphine and like codeine , oxycodone has a good oral potency . Prior to the introduction of paracetamol, Percodan was the mainstay in post-operative oral pain treatment due to
294-512: The labeling changes immediately. Previously approved drugs from June 30, 2001, will switch to the new labeling gradually. The rule does not affect the labeling of over-the-counter drugs or of drugs approved prior to June 30, 2001. Australia has a slightly different pregnancy category system from the United States. The categorisation of medicines for use in pregnancy does not follow a hierarchical structure. The system, as outlined below,
315-663: The opioid crisis for publication in a public online archive. In 2024, Endo agreed to a civil settlement of $ 464.9 Million to resolve its civil liability under the federal False Claims Act by unlawfully promoting Opana ER, a dangerous opioid drug that was removed from the market by Endo at the FDA’s request. Endo Pharmaceuticals at various times was a significant funder of the American Pain Foundation, which has been accused of producing misleading and biased materials relating to opiod prescribing. APF shut down in 2012 after
336-458: The oxycodone terephthalate. Percodan was patented in 1953 by Mozes J. Lewenstein. The combination oxycodone/aspirin is also sold under the brand name Endodan . All products containing oxycodone (including Percodan, Percocet, OxyContin) have the potential to be habit-forming. Oxycodone can produce drug dependence of the morphine type and, therefore, has the potential for being addictive. Pregnancy category The pregnancy category of
357-479: The plans, claiming they violate bankruptcy law. After facing lawsuits over its production of vaginal mesh implants, Endo shut down its production in 2016 to avoid further litigation It had set aside more than $ 2.6 billion to payments for such cases. Endo is one of the companies named in lawsuits by the states of Ohio, Missouri and Mississippi as responsible for the US opioid epidemic . Its 10-K statement indicates that
378-429: The potency and long half-life of oxycodone. It originally contained a small amount of caffeine . Percodan was reformulated in 2005; prior to 2005, it contained two oxycodone salts —4.62 mg of oxycodone hydrochloride and 0.38 mg of oxycodone terephthalate. Since the latter salt is unusual in the pharmacopeia , the manufacturer increased the amount of oxycodone hydrochloride to 4.8355 mg and discontinued
399-495: Was developed by medical and scientific experts based on available evidence of risks associated with taking particular medicines while pregnant. Being general in nature, it is not presented as medical advice to health professionals or the public. Some prescribing guides, such as the Australian Medicines Handbook , are shifting away from using pregnancy categories since, inherent in these categories, there
420-434: Was formed. In 2022, Endo's stock fell below $ 1 as the company faced restructuring of its $ 8 billion of debt. On August 17, 2022 Endo International Plc filed for Chapter 11 bankruptcy protection after reaching a $ 6 billion deal with some of its creditors. That related to opioid litigation in the US and a $ 6 billion deal with creditors, including for settling lawsuits. The United States Department of Justice has objected to
441-566: Was the first time that the FDA had "taken steps to remove a currently marketed opioid pain medication from sale due to the public health consequences of abuse." In 2021, New York Attorney General Letitia James filed a lawsuit against Endo and several other opioid manufacturers for their alleged contribution to the opioid epidemic in New York. As part of Endo's 2022 bankruptcy proceedings, it agreed to spend more than $ 500 million settling opiod relating lawsuits. These proceedings now require Endo to turn over all court documents related to its role in
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