Content about Company Legal Issues

July 18, 2012
Mylan, Somaxon settle insomnia drug suit

Mylan has settled a patent litigation suit filed by Somaxon Pharmaceutical concerning an insomnia drug, Mylan said.

PITTSBURGH — Mylan has settled a patent litigation suit filed by Somaxon Pharmaceutical concerning an insomnia drug, Mylan said.

The generic drug maker said that under the settlement, it would have the right to sell doxepin hydrochloride tablets in the 3-mg and 6-mg strengths starting in January 2020. The drug is a generic version of Somaxon's Silenor.

July 13, 2012
Federal court rules in favor of Innovation Associates in 2006 patent-infringement case

A federal judge has ruled in favor of pharmacy technology manufacturer Innovation Associates in a 6-year-old case brought by ScriptPro concerning a component of one of Innovation's dispensing robots, the companies said.

NEW YORK — A federal judge has ruled in favor of pharmacy technology manufacturer Innovation Associates in a 6-year-old case brought by ScriptPro concerning a component of one of Innovation's dispensing robots, the companies said.

July 10, 2012
Reports: Mylan sues Warner Chilcott over antibiotic drug

Generic drug maker Mylan is suing Warner Chilcott and an Australian company, alleging that they illegally tried to protect one of their drugs from generic competition, according to published reports.

NEW YORK — Generic drug maker Mylan is suing Warner Chilcott and an Australian company, alleging that they illegally tried to protect one of their drugs from generic competition, according to published reports.

Reuters reported that Mylan filed a suit against Warner Chilcott and Mayne Pharma Group over the antibiotic and acne drug Doryx (doxycycline), saying they made minor and insignificant changes to the drug so that approval of generic versions would be delayed.

June 26, 2012
Watson seeks approval for generic antidepressant

Generic drug maker Watson Pharmaceuticals is challenging the patent protection on an antidepressant made by Pfizer, the company said.

PARSIPPANY, N.J. — Generic drug maker Watson Pharmaceuticals is challenging the patent protection on an antidepressant made by Pfizer, the company said.

Watson filed a regulatory approval application with the Food and Drug Administration for desvenlafaxine succinate extended-release tablets in the 50-mg and 100-mg strengths. The drug is a generic version of Pfizer's Pristiq.

June 25, 2012
Federal court rules against Mylan in MS drug case

A federal court has ruled against Mylan in a case filed by Teva Pharmaceutical Industries over a drug to treat multiple sclerosis.

PITTSBURGH — A federal court has ruled against Mylan in a case filed by Teva Pharmaceutical Industries over a drug to treat multiple sclerosis.

The U.S. District Court for the Southern District of New York ruled Monday that Mylan's proposed generic version of the drug Copaxone (glatiramer acetate) infringed Teva's patents.

Mylan responded that it was "disappointed" by the decision and would appeal once it had the opportunity to review it in full.

June 19, 2012
Appeals court rules in favor of Watson in Sanctura XR patent suit

The U.S. Court of Appeals for the Federal Circuit ruled in favor of Watson Pharmaceuticals during patent litigation concerning the drug maker's abbreviated new drug application for an overactive bladder treatment.

PARSIPPANY, N.J. — The U.S. Court of Appeals for the Federal Circuit ruled in favor of Watson Pharmaceuticals during patent litigation concerning the drug maker's abbreviated new drug application for an overactive bladder treatment.

The appeals court affirmed a U.S. District Court for the District of Delaware's decision — made March 31 — that asserted that patents related to Allergan's Sanctura XR (trospium chloride extended-release capsules) are invalid. Watson's ANDA for a generic version of Sanctura XR is pending with the Food and Drug Administration.

June 18, 2012
Court rules against Merck in Nasonex patent case

Merck announced that the U.S. District Court for the District of New Jersey ruled against the company in a patent infringement suit against Canada-based drug maker Apotex.

WHITEHOUSE STATION, N.J. — Merck announced that the U.S. District Court for the District of New Jersey ruled against the company in a patent infringement suit against Canada-based drug maker Apotex.

May 29, 2012
Mylan settles with Sunovion over generic asthma, COPD drug

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
Watson seeks approval for generic ulcerative colitis drug

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
NCPA seeks legislative relief to the business challenges faced by community pharmacy

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
Merck wins patent infringement suits against Mylan

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 seeks approval for generic Lumigan, Latisse

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 generic versions of psychiatric drug launched

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
Court dismisses AstraZeneca case against FDA

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 challenges Abbott patent on Niaspan

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
Amerigen joins Bystolic patent challenge

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 files suit over generic versions of hypertension drug

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
Federal court upholds DEA action against Cardinal Health

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 resolves defamation suit against Pittsburgh Post-Gazette, two reporters

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
Mylan to challenge court decision over generic asthma, COPD drug

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
Watson, J&J settle lawsuit over generic contraceptive

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, Mallinckrodt settle over generic painkiller

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
Mylan seeks approval for generic diabetes drug

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
Impax Labs looks to market generic cancer pain drug

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
Appeals court rejects Teva request to stop Watson from selling generic Seasonique

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.