Content about Company Legal Issues

May 29, 2012

A unit of generic drug maker Mylan has settled with Sunovion Pharmaceuticals over a drug used to treat chronic obstructive pulmonary disease and asthma.

PITTSBURGH — A unit of generic drug maker Mylan has settled with Sunovion Pharmaceuticals over a drug used to treat chronic obstructive pulmonary disease and asthma.

Mylan announced Tuesday that it had reached a settlement in a patent litigation suit that Sunovion, which used to operate under the name Sepracor, had filed against Dey Pharma, now known as Mylan Specialty, concerning the drug Xopenex (levalbuterol hydrochloride).

May 10, 2012

Generic drug maker Watson Pharmaceuticals is hoping to be the first to market a generic version of a drug used to treat ulcerative colitis, the company said.

PARSIPPANY, N.J. — Generic drug maker Watson Pharmaceuticals is hoping to be the first to market a generic version of a drug used to treat ulcerative colitis, the company said.

Watson announced that it had filed with the Food and Drug Administration through a subsidiary for melamine delayed-release tablets, a generic version of Shire Development's Lialda, in the 1.2-g strength. Watson's filing included a Paragraph IV certification, a legal assertion that Lialda's patent protection is invalid, unenforceable or won't be infringed.

May 8, 2012

Community pharmacy operators are the "canary in the coal mine" when it comes to federal or state prescription programs, said Douglas Hoey, CEO for the National Community Pharmacists Association, during a press conference held Tuesday afternoon.

WASHINGTON — Community pharmacy operators are the "canary in the coal mine" when it comes to federal or state prescription programs, said Douglas Hoey, CEO for the National Community Pharmacists Association, during a press conference held Tuesday afternoon.

April 30, 2012

Mylan will be barred from marketing a generic version of a Merck cardiovascular drug until the drug's patent expires, under a court ruling announced Friday.

WHITEHOUSE STATION, N.J. — Mylan will be barred from marketing a generic version of a Merck cardiovascular drug until the drug's patent expires, under a court ruling announced Friday.

Merck said the U.S. District Court for the District of New Jersey ruled against Mylan in two patent infringement suits related to the drugs Zetia (ezetimibe) and Vytorin (ezetimibe and simvastatin). Specifically, the court ruled that a patent covering the drug, RE 42,461, is valid and enforceable and enjoined Mylan from launching until the patents expiration in April 2017.

April 3, 2012

Watson is challenging the patent protection on two eye drugs made by Allergan, the generic drug maker said Tuesday.

PARSIPPANY, N.J. — Watson is challenging the patent protection on two eye drugs made by Allergan, the generic drug maker said Tuesday.

Watson announced that it had filed with the Food and Drug Administration for generic versions of Allergan's Lumigan and Latisse (bimatoprost) ophthalmic solution. The products contain the same active ingredient in the 0.01% and 0.03% strengths, respectively, and are used to reduce pressure within the eye in patients with open-angle glaucoma or ocular hypertension.

March 28, 2012

Three companies have launched generic versions of a psychiatric drug made by AstraZeneca following a court decision turning down the Anglo-Swedish drug maker's request for an injunction against the Food and Drug Administration's approval of the generics.

NEW YORK — Three companies have launched generic versions of a psychiatric drug made by AstraZeneca following a court decision turning down the Anglo-Swedish drug maker's request for an injunction against the Food and Drug Administration's approval of the generics.

Dr. Reddy's Labs, Teva and Mylan announced Wednesday the launch of their respective versions of quetiapine fumarate tablets, generic formulations of AstraZeneca's Seroquel, in strengths ranging from 25 mg to 400 mg.

March 26, 2012

A federal court has dismissed a case that drug maker AstraZeneca filed against regulators regarding a drug used to treat psychotic and bipolar disorders, the company said Monday.

NEW YORK — A federal court has dismissed a case that drug maker AstraZeneca filed against regulators regarding a drug used to treat psychotic and bipolar disorders, the company said Monday.

March 19, 2012

Watson Pharmaceuticals is challenging the patent protection on a drug made by Abbott for treating cholesterol, the company said.

PARSIPPANY, N.J. — Watson Pharmaceuticals is challenging the patent protection on a drug made by Abbott for treating cholesterol, the company said.

Watson, through a subsidiary, filed with the Food and Drug Administration for approval of niacin extended-release tablets in the 500-mg and 1,000-mg strengths. The drug is a generic version of Abbott's Niaspan.

March 16, 2012

Another generic drug maker has joined efforts to challenge the patent on a drug made by Forest Labs for treating hypertension.

NEW YORK — Another generic drug maker has joined efforts to challenge the patent on a drug made by Forest Labs for treating hypertension.

March 14, 2012

Forest Labs has filed suit against Glenmark Generics and several other companies, alleging that they infringed on its patent for a drug to treat hypertension by seeking regulatory approval for generic versions.

NEW YORK — Forest Labs has filed suit against Glenmark Generics and several other companies, alleging that they infringed on its patent for a drug to treat hypertension by seeking regulatory approval for generic versions.

Forest and Johnson & Johnson subsidiary Janssen Pharmaceutica NV have sued Glenmark, Hetero USA, Torrent Pharmaceuticals and Watson Labs in response to their filing regulatory approval applications with the Food and Drug Administration for generic versions of Bystolic (nebivolol).

February 29, 2012

A federal district court has turned down a request by Cardinal Health for an injunction against the Drug Enforcement Administration's suspension of the company's license to ship painkiller drugs from one of its distribution centers, the company said Wednesday.

COLUMBUS, Ohio — A federal court has turned down Cardinal Health's request for an injunction against the Drug Enforcement Administration's suspension of the its ability to ship controlled medications from one of its distribution centers, the company said Wednesday.

Reggie Walton, a judge for the U.S. District Court for the District of Columbia, ruled against Cardinal's request to enjoin the DEA from preventing the company from shipping controlled substances from the distribution center, in Lakeland, Fla.

February 21, 2012

Mylan on Friday announced that the company and its subsidiary, Mylan Pharmaceuticals, have resolved the defamation and other related litigation filed by Mylan against the Pittsburgh Post-Gazette and two of its reporters.

PITTSBURGH — Mylan on Friday announced that the company and its subsidiary, Mylan Pharmaceuticals, have resolved the defamation and other related litigation filed by Mylan against the Pittsburgh Post-Gazette and two of its reporters.

"The litigation has been resolved to the satisfaction of both parties," the parties said in a joint statement. "The Post-Gazette did not find and did not intend to report that Mylan had manufactured or distributed any defective drugs. The Post-Gazette regrets if any reader of the article thought otherwise."

February 14, 2012

Generic drug maker Mylan plans to challenge a court decision that requires it to pay almost $20 million to a drug company whose product it tried to market as a generic.

PITTSBURGH — Generic drug maker Mylan plans to challenge a court decision that requires it to pay almost $20 million to a drug company whose product it tried to market as a generic.

Sunovion Pharmaceuticals sued Mylan and several subsidiaries in the U.S. District Court for the District of Delaware when the latter sought to market a generic version of Sunovion's Xopenex (levalbuterol hydrochloride) inhalation solution, a drug for asthma and chronic obstructive pulmonary disease. The jury's verdict includes an $18 million award.

February 8, 2012

Subsidiaries of Watson Pharmaceuticals and Johnson & Johnson have settled a lawsuit filed by the latter when Watson attempted to market a generic version of one of its contraceptive drugs.

PARSIPPANY, N.J. — Subsidiaries of Watson Pharmaceuticals and Johnson & Johnson have settled a lawsuit filed by the latter when Watson attempted to market a generic version of one of its contraceptive drugs.

January 27, 2012

Watson Pharmaceuticals and Mallinckrodt have reached a settlement concerning a painkiller for which the former had sought Food and Drug Administration approval.

PARSIPPANY, N.J. — Watson Pharmaceuticals and Mallinckrodt have reached a settlement concerning a painkiller for which the former had sought Food and Drug Administration approval.

January 9, 2012

Generic drug maker Mylan is challenging the patent on a drug used to treat diabetes, the company said Monday.

PITTSBURGH — Generic drug maker Mylan is challenging the patent on a drug used to treat diabetes, the company said Monday.

Mylan said that it was sued by Takeda Pharmaceutical, Watson Pharmaceuticals and Andrx Labs in the U.S. District Court for the Southern District of New York in response to Mylan's filing a regulatory approval application with the Food and Drug Administration for a generic version of Actoplus Met XR (pioglitazone hydrochloride and metformin hydrochloride) extended-release tablets in the 15-mg/1,000-mg and 30-mg/1,000-mg strengths.

November 21, 2011

Drug maker Impax Labs is looking to challenge the patent protection on a drug used to treat pain related to cancer, the company said Monday.

HAYWARD, Calif. — Drug maker Impax Labs is looking to challenge the patent protection on a drug used to treat pain related to cancer, the company said Monday.

Impax said it had filed a regulatory approval application with the Food and Drug Administration for a generic version of Cephalon's Fentora (fentanyl) buccal tablets in the 100 mcg, 200 mcg, 400 mcg, 600 mcg and 800 mcg strengths. The drug is used to treat breakthrough cancer pain, defined as pain related to cancer that can't be controlled by other drugs.

November 11, 2011

An appeals court has thrown out an attempt by Teva Pharmaceutical Industries to stop Watson Pharmaceuticals from selling a generic contraceptive, Watson said.

PARSIPPANY, N.J. — An appeals court has thrown out an attempt by Teva Pharmaceutical Industries to stop Watson Pharmaceuticals from selling a generic contraceptive, Watson said.

The U.S. Court of Appeals for the Federal Circuit affirmed a lower court's June 16 decision to deny Duramed Pharmaceuticals' request for an injunction that would stop Watson from selling a generic version of Seasonique (levonorgestrel and ethinyl estradiol [0.15 mg/0.03 mg] and ethinyl estradiol [0.01 mg]). Duramed originally was a subsidiary of Barr Pharmaceuticals, which Teva acquired in 2008.

November 11, 2011

Watson Pharmaceuticals is challenging Swiss drug maker Novartis' patent on a drug used to treat dementia, Watson said.

PARSIPPANY, N.J. — Watson Pharmaceuticals is challenging three of Swiss drug maker Novartis' patents on a drug used to treat dementia, Watson said.

The company said subsidiary Watson Labs had filed for approval generic rivastigmine transdermal system patches in the 4.6-mg and 9.5-mg strengths, both designed to last for 24 hours, with the Food and Drug Administration. The patches are used to treat mild to moderate dementia associated with Alzheimer's or Parkinson's disease.

November 8, 2011

In an amendment dated Nov. 7 and filed to the Securities Exchange Commission on Tuesday, Express Scripts reduced its termination fee by 32% to $650 million.

ST. LOUIS — In an amendment dated Nov. 7 and filed to the Securities Exchange Commission on Tuesday, Express Scripts reduced its termination fee by 32% to $650 million. The termination fee is paid to one company when the other terminates the merger agreement.

November 2, 2011

Drug maker Perrigo has filed for regulatory approval of a generic topical drug for treating testosterone deficiency, prompting a patent infringement suit from the branded version's manufacturer.

ALLEGAN, Mich. — Drug maker Perrigo has filed for regulatory approval of a generic topical drug for treating testosterone deficiency, prompting a patent infringement suit from the branded version's manufacturer.

October 17, 2011

Generic drug maker Watson Pharmaceuticals is seeking Food and Drug Administration approval for a generic treatment for attention deficit hyperactivity disorder, the company said.

PARSIPPANY, N.J. — Generic drug maker Watson Pharmaceuticals is seeking Food and Drug Administration approval for a generic treatment for attention deficit hyperactivity disorder, the company said.

Watson announced that it filed a regulatory approval application with the FDA for methylphenidate transdermal system, a patch designed to deliver the central nervous system stimulant methylphenidate over a nine-hour period. The drug is a generic version of Noven Pharmaceuticals' Daytrana.

October 7, 2011

Watson Pharmaceuticals is looking to become the first to market a generic version of a painkiller made by Pfizer, the drug maker said Friday.

PARSIPPANY, N.J. — Watson Pharmaceuticals is looking to become the first to market a generic version of a painkiller made by Pfizer, the drug maker said Friday.

Watson said it filed a regulatory approval application with the Food and Drug Administration for morphine sulfate and naltrexone hydrochloride extended-release capsules in the 30-mg/1.2-mg, 50-mg/2-mg, 60-mg/2.4-mg, 80-mg/3.2-mg and 100-mg/4-mg strengths. The drug is a generic version of Embeda, made by Pfizer subsidiary King Pharmaceuticals.

October 6, 2011

The Food and Drug Administration has granted tentative approval to a drug made by Perrigo for dermatosis of the scalp.

ALLEGAN, Mich. — The Food and Drug Administration has granted tentative approval to a drug made by Perrigo for dermatosis of the scalp.

Perrigo's clobetasol propionate emulsion foam in the 0.05% strength is a generic version of Stiefel Labs' Olux-E Foam. Sales for the branded version of the drug were $40 million during the 12-month period ended in September, according to Wolters Kluwer.

October 4, 2011

Mylan must pay $77 million to four health insurers over allegations that it sought to control the market on ingredients used for two anti-anxiety medicines, according to published reports.

NEW YORK — Mylan may have to pay $77 million to four health insurers over allegations that it sought to control the market on ingredients used for two anti-anxiety medicines, according to published reports.

Bloomberg reported that the Supreme Court rejected the drug maker's appeal of a 2005 jury verdict in a case that involved antitrust allegations regarding the drugs lorazepam and clorazepate.