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List of largest pharmaceutical settlements

Index List of largest pharmaceutical settlements

The following is a list of the 20 largest settlements reached between the United States Department of Justice and pharmaceutical companies from 1991 to 2012, ordered by the size of the total settlement. [1]

79 relations: Abbott Laboratories, Adrenaline, Allergan, Alosetron, Amgen, Aripiprazole, AstraZeneca, Botulinum toxin, Bristol-Myers Squibb, Bupropion, Cephalon, Darbepoetin alfa, Eli Lilly and Company, Epinephrine autoinjector, False Claims Act, Famotidine, Federal Food, Drug, and Cosmetic Act, Fentanyl, Fluticasone propionate, Fluticasone propionate/salmeterol, Food and Drug Administration, Franklin v. Parke-Davis, Gabapentin, GlaxoSmithKline, Good manufacturing practice, Goserelin, Granisetron, Interferon alfa-2b, Johnson & Johnson, Kickback (bribery), Lamotrigine, Leuprorelin, Linezolid, List of off-label promotion pharmaceutical settlements, Loratadine, Medicaid Drug Rebate Program, Medicare fraud, Merck & Co., Metformin, Modafinil, Monopoly, Mupirocin, Mylan, Nefazodone, Nesiritide, Novartis, Off-label use, Olanzapine, Ondansetron, Oxcarbazepine, ..., Oxycodone, Paliperidone, Paroxetine, Pfizer, Pharmaceutical fraud, Pharmaceutical industry, Potassium chloride, Pregabalin, Prescription Drug Marketing Act, Purdue Pharma, Quetiapine, Risperidone, Rofecoxib, Rosiglitazone, Schering-Plough, Serono, Serostim, Simvastatin, Sumatriptan, TAP Pharmaceuticals, Temozolomide, The New York Times, The Philadelphia Inquirer, Tiagabine, United States Department of Justice, Valaciclovir, Valdecoxib, Valproate, Ziprasidone. Expand index (29 more) »

Abbott Laboratories

Abbott Laboratories is an American health care company with headquarters in Lake Bluff, Illinois, United States.

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Adrenaline

Adrenaline, also known as adrenalin or epinephrine, is a hormone, neurotransmitter, and medication.

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Allergan

Allergan plc is a multinational company in the pharmaceutical industry that produces branded drugs and performs pharmaceutical research and development.

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Alosetron

Alosetron (original brand name: Lotronex; originator: GSK) is a 5-HT3 antagonist used for the management of severe diarrhea-predominant irritable bowel syndrome (IBS) in women only.

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Amgen

Amgen Inc. (formerly Applied Molecular Genetics Inc.) is an American multinational biopharmaceutical company headquartered in Thousand Oaks, California.

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Aripiprazole

Aripiprazole, sold under the brand name Abilify among others, is an atypical antipsychotic. It is recommended and primarily used in the treatment of schizophrenia and bipolar disorder. Other uses include as an add-on treatment in major depressive disorder, tic disorders, and irritability associated with autism. According to a Cochrane review, evidence for the oral form in schizophrenia is not sufficient to determine effects on general functioning. Additionally, because many people dropped out of the medication trials before they were completed, the overall strength of the conclusions is low. Side effects include neuroleptic malignant syndrome, a movement disorder known as tardive dyskinesia, and high blood sugar in those with diabetes. In the elderly there is an increased risk of death. It is thus not recommended for use in those with psychosis due to dementia. It is pregnancy category C in the United States and category C in Australia, meaning there is possible evidence of harm to the fetus. It is not recommended for women who are breastfeeding. It is unclear whether it is safe or effective in people less than 18 years old. It is a partial dopamine agonist. Aripiprazole was developed by Otsuka in Japan. In the United States, Otsuka America markets it jointly with Bristol-Myers Squibb. From April 2013 to March 2014, sales of Abilify amounted to almost $6.9 billion.

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AstraZeneca

AstraZeneca plc is an Anglo–Swedish multinational pharmaceutical and biopharmaceutical company.

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Botulinum toxin

Botulinum toxin (BTX) or Botox is a neurotoxic protein produced by the bacterium Clostridium botulinum and related species.

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Bristol-Myers Squibb

Bristol-Myers Squibb (BMS) is an American pharmaceutical company, headquartered in New York City.

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Bupropion

Bupropion, sold under the brand names Wellbutrin and Zyban among others, is a medication primarily used as an antidepressant and smoking cessation aid.

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Cephalon

Cephalon, Inc. was a U.S. biopharmaceutical company co-founded in 1987 by Frank Baldino, Jr, pharmacologist, Michael Lewis, neuroscientist and James C. Kauer, organic chemist, all three former scientists with the DuPont Company.

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Darbepoetin alfa

Darbepoetin alfa (INN) is a re-engineered form of erythropoietin containing 5 amino acid changes (N30, T32, V87, N88, T90) resulting in the creation of 2 new sites for N-linked carbohydrate addition.

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Eli Lilly and Company

Eli Lilly and Company is a global pharmaceutical company headquartered in Indianapolis, Indiana, with offices in 18 countries.

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Epinephrine autoinjector

An epinephrine autoinjector is a medical device for injecting a measured dose or doses of epinephrine (adrenaline) by means of autoinjector technology.

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False Claims Act

The False Claims Act, also called the "Lincoln Law") is an American federal law that imposes liability on persons and companies (typically federal contractors) who defraud governmental programs. It is the federal Government's primary litigation tool in combating fraud against the Government. The law includes a qui tam provision that allows people who are not affiliated with the government, called "relators" under the law, to file actions on behalf of the government (informally called "whistleblowing" especially when the relator is employed by the organization accused in the suit). Persons filing under the Act stand to receive a portion (usually about 15–25 percent) of any recovered damages. As of 2012, over 70 percent of all federal Government FCA actions were initiated by whistleblowers. Claims under the law have typically involved health care, military, or other government spending programs, and dominate the list of largest pharmaceutical settlements. The government recovered $38.9 billion under the False Claims Act between 1987 and 2013 and of this amount, $27.2 billion or 70% was from qui tam cases brought by relators.

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Famotidine

Famotidine, sold under the trade name Pepcid among others, is a histamine H2 receptor antagonist that inhibits stomach acid production.

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Federal Food, Drug, and Cosmetic Act

The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C), is a set of laws passed by Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, and cosmetics.

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Fentanyl

Fentanyl, also spelled fentanil, is an opioid which is used as a pain medication and together with other medications for anesthesia. Fentanyl is also made illegally and used as a recreational drug, often mixed with heroin or cocaine. It has a rapid onset and effects generally last less than an hour or two. Medically, fentanyl is used by injection, as a patch on the skin, as a nasal spray, or in the mouth. Common side effects include vomiting, constipation, sedation, confusion, hallucinations, and injuries related to poor coordination. Serious side effects may include decreased breathing (respiratory depression), serotonin syndrome, low blood pressure, addiction, or coma. In 2016, more than 20,000 deaths occurred in the United States due to overdoses of fentanyl and fentanyl analogues, half of all reported opioid related deaths. Fentanyl works primarily by activating μ-opioid receptors. It is around 100 times stronger than morphine, and some analogues such as carfentanil are around 10,000 times stronger. Fentanyl was first made by Paul Janssen in 1960 and approved for medical use in the United States in 1968.In 2015, were used in healthcare globally., fentanyl was the most widely used synthetic opioid in medicine. Fentanyl patches are on the WHO List of Essential Medicines, the most effective and safe medicines needed in a health system. For a 100 microgram vial, the average wholesale cost in the developing world is 0.66 (2015). and in the USA it costs 0.49 (2017).

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Fluticasone propionate

Fluticasone propionate belongs to a class of drugs known as corticosteroids, specifically glucocorticoids, which are hormones that predominantly affect the metabolism of carbohydrates and, to a lesser extent, fat and protein.

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Fluticasone propionate/salmeterol

The combination preparation fluticasone/salmeterol is a formulation containing fluticasone propionate and salmeterol xinafoate, used in the management of asthma and chronic obstructive pulmonary disease (COPD).

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Food and Drug Administration

The Food and Drug Administration (FDA or USFDA) is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments.

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Franklin v. Parke-Davis

Franklin v. Parke-Davis is a lawsuit filed in 1996 against Parke-Davis, a division of Warner-Lambert Company, and eventually against Pfizer (which bought Warner-Lambert in 2000) under the qui tam provisions of the False Claims Act.

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Gabapentin

Gabapentin, sold under the brand name Neurontin among others, is a medication which is used to treat epilepsy (specifically partial seizures), neuropathic pain, hot flashes, and restless legs syndrome.

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GlaxoSmithKline

GlaxoSmithKline plc (GSK) is a British pharmaceutical company headquartered in Brentford, London.

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Good manufacturing practice

Good manufacturing practices (GMP) are the practices required in order to conform to the guidelines recommended by agencies that control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutical products, dietary supplements, and medical devices.

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Goserelin

Goserelin, or goserelin acetate, sold under the brand name Zoladex (by AstraZeneca) among others, is a medication which is used to suppress production of the sex hormones (testosterone and estrogen), particularly in the treatment of breast and prostate cancer.

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Granisetron

Granisetron is a serotonin 5-HT3 receptor antagonist used as an antiemetic to treat nausea and vomiting following chemotherapy.

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Interferon alfa-2b

Interferon alfa 2b is an antiviral or antineoplastic drug, that was originally discovered in the laboratory of Charles Weissmann at the University of Zurich.

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Johnson & Johnson

Johnson & Johnson is an American multinational medical devices, pharmaceutical and consumer packaged goods manufacturing company founded in 1886.

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Kickback (bribery)

A kickback is a form of negotiated bribery in which a commission is paid to the bribe-taker in exchange for services rendered.

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Lamotrigine

Lamotrigine, sold as the brand name Lamictal among others, is an anticonvulsant medication used to treat epilepsy and bipolar disorder.

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Leuprorelin

Leuprorelin, also known as leuprolide, is a manufactured version of a hormone used to treat prostate cancer, breast cancer, endometriosis, uterine fibroids, and early puberty.

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Linezolid

Linezolid is an antibiotic used for the treatment of infections caused by Gram-positive bacteria that are resistant to other antibiotics.

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List of off-label promotion pharmaceutical settlements

The following are settlements reached with US authorities against pharmaceutical companies to resolve allegations of "off-label" promotion of drugs.

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Loratadine

Loratadine, sold under the brand name Claritin among others, is a medication used to treat allergies.

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Medicaid Drug Rebate Program

The Medicaid Drug Rebate Program is a program in the United States that was created by the Omnibus Budget Reconciliation Act of 1990 (OBRA'90).

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Medicare fraud

In the United States, Medicare fraud is the claiming of Medicare health care reimbursement to which the claimant is not entitled.

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Merck & Co.

Merck & Company, Inc., d.b.a. Merck Sharp & Dohme (MSD) outside the United States and Canada, is an American pharmaceutical company and one of the largest pharmaceutical companies in the world.

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Metformin

Metformin, marketed under the trade name Glucophage among others, is the first-line medication for the treatment of type 2 diabetes, particularly in people who are overweight.

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Modafinil

Modafinil, sold under the brand name Provigil among others, is a medication to treat sleepiness due to narcolepsy, shift work sleep disorder, or obstructive sleep apnea (OSA). In OSA continuous positive airway pressure is the preferred treatment. While it has seen off-label use as a purported cognitive enhancer, evidence for any benefit is lacking. It is taken by mouth. Common side effects include headache, anxiety, trouble sleeping, and nausea. Serious side effects may include allergic reactions such as anaphylaxis, Stevens–Johnson syndrome, abuse, or hallucinations. It is unclear if use during pregnancy is safe. The amount of medication used may need to be adjusted in those with kidney or liver problems. It is not recommended in those with an arrhythmia, significant hypertension, or left ventricular hypertrophy. How it works is not entirely clear. One possibility is that it may affect the areas of the brain involved with the sleep cycle. Modafinil was approved for medical use in the United States in 1998. In the United States it is classified as a schedule IV controlled substance due to concerns about addiction. In the United Kingdom it is a prescription only medication. It is avaliable as a generic medication. In the United Kingdom it costs the NHS about £105.21 a month as of 2018. In the United States the wholesale cost per month is about 34.20 USD as of 2018.

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Monopoly

A monopoly (from Greek μόνος mónos and πωλεῖν pōleîn) exists when a specific person or enterprise is the only supplier of a particular commodity.

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Mupirocin

Mupirocin, sold under the brand name Bactroban among others, is a topical antibiotic useful against superficial skin infections such as impetigo or folliculitis.

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Mylan

Mylan N.V. is an American global generic and specialty pharmaceuticals company registered in the Netherlands, with principal executive offices in Hatfield, Hertfordshire, UK and global headquarters in Canonsburg, Pennsylvania, US.

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Nefazodone

Nefazodone, sold formerly under the brand names Serzone, Dutonin, and Nefadar among others, is an atypical antidepressant which was first marketed by Bristol-Myers Squibb in 1994 but has since largely been discontinued.

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Nesiritide

Nesiritide (Natrecor) is the recombinant form of the 32 amino acid human B-type natriuretic peptide, which is normally produced by the ventricular myocardium.

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Novartis

Novartis International AG is a Swiss multinational pharmaceutical company based in Basel, Switzerland.

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Off-label use

Off-label use is the use of pharmaceutical drugs for an unapproved indication or in an unapproved age group, dosage, or route of administration.

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Olanzapine

Olanzapine (originally branded Zyprexa) is an antipsychotic medication used to treat schizophrenia and bipolar disorder.

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Ondansetron

Ondansetron, marketed under the brand name Zofran, is a medication used to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy, or surgery.

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Oxcarbazepine

Oxcarbazepine is an anticonvulsant drug primarily used in the treatment of epilepsy. There is some evidence for oxcarbazepine as a mood-stabilizing agent and thus, it can be used as add-on therapy for bipolar disorder in patients that have failed or are unable to tolerate approved treatments. Common side effects include nausea, vomiting, dizziness, drowsiness, headache, double vision and trouble with walking. Although not common, anaphylaxis may occur. Due to its structural similarities to carbamazepine there is approximately a 25–30% chance of cross-reactivity between the two medications. Oxcarbazepine is marketed as Trileptal by Novartis and available in some countries as a generic drug. There is also an extended-release formulation marketed as Oxtellar XR by Supernus Pharmaceuticals.

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Oxycodone

Oxycodone, sold under brand names such as Percocet and OxyContin among many others, is an opioid medication which is used for the relief of moderate to severe pain.

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Paliperidone

Paliperidone, sold under the trade name Invega among others, is a dopamine antagonist and 5-HT2A antagonist of the atypical antipsychotic class of medications.

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Paroxetine

Paroxetine, also known by trade names including Paxil and Seroxat among others, is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class. It is used to treat major depressive disorder, obsessive-compulsive disorder, social anxiety disorder, panic disorder, posttraumatic stress disorder, generalized anxiety disorder and premenstrual dysphoric disorder. It has also been used in the treatment of hot flashes and night sweats associated with menopause. It has a similar tolerability profile to other SSRIs. The common side effects include drowsiness, dry mouth, loss of appetite, sweating, trouble sleeping and delayed ejaculation. It may also be associated with a slightly increased risk of birth defects. The rate of withdrawal symptoms in young people may be higher with paroxetine and venlafaxine than other SSRIs and SNRIs. Several studies have associated paroxetine with suicidal thinking and behavior in children and adolescents. Marketing of the drug began in 1992 by the pharmaceutical company SmithKline Beecham, known since 2000 as GlaxoSmithKline. Generic formulations have been available since 2003 when the patent expired. The United States Department of Justice fined GlaxoSmithKline $3 billion in 2012, including a sum for withholding data on paroxetine, unlawfully promoting it for under-18s and preparing an article, following one of its clinical trials, study 329, that misleadingly reported the drug was effective in treating adolescent depression.

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Pfizer

Pfizer Inc. is an American pharmaceutical conglomerate headquartered in New York City, with its research headquarters in Groton, Connecticut.

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Pharmaceutical fraud

Pharmaceutical fraud involves activities that result in false claims to insurers or programs such as Medicare in the United States or equivalent state programs for financial gain to a pharmaceutical company.

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Pharmaceutical industry

The pharmaceutical industry (or medicine industry) is the commercial industry that discovers, develops, produces, and markets drugs or pharmaceutical drugs for use as different types of medicine and medications.

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Potassium chloride

Potassium chloride (KCl) is a metal halide salt composed of potassium and chlorine.

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Pregabalin

Pregabalin, marketed under the brand name Lyrica among others, is a medication used to treat epilepsy, neuropathic pain, fibromyalgia, and generalized anxiety disorder.

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Prescription Drug Marketing Act

The Prescription Drug Marketing Act (PDMA) of 1987 (P.L. 100-293, 102 Stat. 95) is a law of the United States federal government.

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Purdue Pharma

Purdue Pharma L.P. is a privately held pharmaceutical company owned principally by parties and descendants of Mortimer and Raymond Sackler.

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Quetiapine

Quetiapine, marketed as Seroquel among other names, is an atypical antipsychotic used for the treatment of schizophrenia, bipolar disorder, and major depressive disorder.

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Risperidone

Risperidone, sold under the trade name Risperdal among others, is an antipsychotic medication.

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Rofecoxib

Rofecoxib is a nonsteroidal anti-inflammatory drug (NSAID) that has now been withdrawn over safety concerns.

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Rosiglitazone

Rosiglitazone (trade name Avandia) is an antidiabetic drug in the thiazolidinedione class.

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Schering-Plough

Schering-Plough Corporation was a United States-based pharmaceutical company.

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Serono

Serono was a biotechnology company headquartered in Geneva, Switzerland.

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Serostim

Serostim (recombinant DNA somatropin) is Serono's brand name prescription drug form of synthetic growth hormone, marketed for HIV-associated wasting.

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Simvastatin

Simvastatin, marketed under the trade name Zocor among others, is a lipid-lowering medication.

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Sumatriptan

Sumatriptan is a medication used for the treatment of migraine and cluster headaches.

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TAP Pharmaceuticals

TAP Pharmaceuticals was formed in 1977 as a joint venture between the two global pharmaceutical companies, Abbott Laboratories and Takeda Pharmaceutical Co. and was dissolved in 2008; its two most successful products were proton-pump inhibitor lansoprazole (Prevacid) and the prostate cancer drug, leuprorelin ((Lupron). The intention of the joint venture was to get products that Takeda had discovered developed, approved, and marketed in the US and Canada. The company was established at a time when Japanese pharmaceutical companies were seeking partnerships to access the US market. These efforts were supported by the Japanese government at the time to help the national economy compete in higher technology, as countries like South Korea, Taiwan were beginning to catch up with Japan in commodity production. Japanese pharmaceutical companies were especially strong in the fields of generating analogs of known cephalosporin antibiotics, cancer drugs, and cardiovascular drugs. The first products TAP file new drug applications for, were two cephalosporins, cefmenoxime (Cefmax) and cefsulodin (Cefonomil), estazolam for sleep disorders, and leuprorelin; leuprorelin was the first one approved, in 1985. In 1998 Takeda established its own US R&D and sales force, for the diabetes drug pioglitazone (Actos). In 2000, TAP's withdrew its new drug application for apomorphine (branded as "Uprima") as a treatment for erectile dysfunction after an FDA review panel raised questions about the drug's safety, due to many clinical trial subjects fainting after taking the drug. In 2001, the US Department of Justice, states attorneys general, and TAP Pharmaceutical Products settled criminal and civil charges against TAP related to federal and state medicare fraud and illegal marketing of the drug leuprorelin. TAP paid a total of $875 million, which was a record high at the time. The $875 million settlement broke down to $290 million for violating the Prescription Drug Marketing Act, $559.5 million to settle federal fraud charges for overcharging Medicare, and $25.5 million reimbursement to 50 states and Washington, D.C., for filing false claims with the states' Medicaid programs. The case arose under the False Claims Act with claims filed by Douglas Durand, a former TAP vice president of sales, and Joseph Gerstein, a doctor at Tufts University's HMO practice. Durand, Gerstein, and Tufts shared $95 million of the settlement. When the settlement was announced, the Department of Justice also announced that seven people were indicted on criminal charges by a grand jury; the DoJ also said that four doctors had already pled guilty for receiving kickbacks. As of 2003 around 12 TAP employees had been indicted and were contested the charges, and one had pled guilty. Abbott and Takeda agreed to end the partnership in 2008, with Abbott keeping the rights to leuprorelin, which had sales in 2007 of $600 million and a patent expiring in 2015 and the approximately 300 employees who worked on the product, and Takeda keeping the rights to lansoprazole, which had sales of $2.3 billion in 2007 but was facing imminent generic competition, along with 800 employees in the U.S. and all the drugs in the TAP pipeline. Takeda was also obligated to pay Abbott about $1.5 billion over several years. By 2008, Takeda's own sales in the US outside of TAP had grown to $3 billion, mostly from sales of pioglitazone which by then was the best-selling diabetes drug in the world.

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Temozolomide

Temozolomide (TMZ; brand names Temodar and Temodal and Temcad) is an oral chemotherapy drug.

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The New York Times

The New York Times (sometimes abbreviated as The NYT or The Times) is an American newspaper based in New York City with worldwide influence and readership.

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The Philadelphia Inquirer

The Philadelphia Inquirer is a morning daily newspaper that serves the Philadelphia metropolitan area of the United States.

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Tiagabine

Tiagabine (trade name Gabitril) is an anticonvulsant medication used in the treatment of epilepsy that is produced by Cephalon.

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United States Department of Justice

The United States Department of Justice (DOJ), also known as the Justice Department, is a federal executive department of the U.S. government, responsible for the enforcement of the law and administration of justice in the United States, equivalent to the justice or interior ministries of other countries. The department was formed in 1870 during the Ulysses S. Grant administration. The Department of Justice administers several federal law enforcement agencies including the Federal Bureau of Investigation (FBI), and the Drug Enforcement Administration (DEA). The department is responsible for investigating instances of financial fraud, representing the United States government in legal matters (such as in cases before the Supreme Court), and running the federal prison system. The department is also responsible for reviewing the conduct of local law enforcement as directed by the Violent Crime Control and Law Enforcement Act of 1994. The department is headed by the United States Attorney General, who is nominated by the President and confirmed by the Senate and is a member of the Cabinet. The current Attorney General is Jeff Sessions.

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Valaciclovir

Valaciclovir, also spelled valacyclovir, is an antiviral drug used in the management of herpes simplex, herpes zoster (shingles), and herpes B. It is a prodrug, being converted in vivo to aciclovir.

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Valdecoxib

Valdecoxib is a nonsteroidal anti-inflammatory drug (NSAID) used in the treatment of osteoarthritis, rheumatoid arthritis, and painful menstruation and menstrual symptoms.

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Valproate

Valproate (VPA), and its valproic acid, sodium valproate, and valproate semisodium forms, are medications primarily used to treat epilepsy and bipolar disorder and to prevent migraine headaches.

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Ziprasidone

Ziprasidone, sold under the brand name Geodon among others, is an atypical antipsychotic which is used for the treatment of schizophrenia as well as acute mania and mixed states associated with bipolar disorder.

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Redirects here:

List of Largest Pharmaceutical Settlements, List of largest pharmaceutical settlements in the United States.

References

[1] https://en.wikipedia.org/wiki/List_of_largest_pharmaceutical_settlements

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