Content about Company Legal Issues

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.

September 16, 2011

U.S. District Court judge Marvin Aspen ruled in favor of Walgreens on Thursday; Express Scripts' federal suit against Walgreens will be halted pending arbitration.

CHICAGO — U.S. District Court judge Marvin Aspen ruled in favor of Walgreens on Thursday; Express Scripts' federal suit against Walgreens will be halted pending arbitration.

The Express Scripts charges against Walgreens of breach of contract now will move to arbitration. Express Scripts originally had objected to arbitration because the process would be too slow. However, there may be some sense of urgency as Judge Aspen scheduled a status hearing for Dec. 8.

September 13, 2011

Impax Labs has hit a roadblock in its attempt to market a generic version of a symptomatic benign prostatic hyperplasia drug.

HAYWARD, Calif. — Impax Labs has hit a roadblock in its attempt to market a generic version of a symptomatic benign prostatic hyperplasia drug.

August 17, 2011

Mylan announced Wednesday that it filed with the Food and Drug Administration for approval of a generic version of a drug for migraine headaches made by Endo Pharmaceuticals.

PITTSBURGH — Mylan announced Wednesday that it filed with the Food and Drug Administration for approval of a generic version of a drug for migraine headaches made by Endo Pharmaceuticals.

Mylan said it was the first to file for approval of a generic version of Frova (frovatriptan succinate EQ) tablets in the 2.5-mg strength. In response, Endo has filed a patent infringement lawsuit against Mylan in response to the filing.

Frova had sales of $68.2 million during the 12-month period ended in June, according to IMS Health.

August 10, 2011

The Food and Drug Administration has granted tentative approval to a generic cholesterol drug made by Watson Pharmaceuticals, the company said Wednesday.

MORRISTOWN, N.J. — The Food and Drug Administration has granted tentative approval to a generic cholesterol drug made by Watson Pharmaceuticals, the company said Wednesday.

Watson announced the tentative approval of Watson's rosuvastatin zinc tablets in the 5-mg, 10-mg, 20-mg and 40-mg strengths. The drug is a generic version of AstraZeneca's Crestor. Tentative approval means that the drug meets the FDA's conditions for approval, but the agency can't allow it to be marketed because patents covering the branded version have yet to expire.

July 28, 2011

Generic drug maker Watson Pharmaceuticals has launched a generic version of a contraceptive made by Duramed Pharmaceuticals, Watson said Thursday.

PARSIPPANY, N.J. — Generic drug maker Watson Pharmaceuticals has launched a generic version of a contraceptive made by Duramed Pharmaceuticals, Watson said Thursday.

Watson announced the launch of Amethia (levonorgestrel and ethinyl estradiol [0.15 mg/0.03 mg] and ethinyl estradiol [0.01 mg]) after the U.S. Court of Appeals for the Federal Circuit denied Duramed’s request for a temporary injunction; a patent infringement lawsuit that Duramed filed against Watson remains pending.

July 14, 2011

Watson Pharmaceuticals last week confirmed that the United States Court of Appeals for the Federal Circuit has affirmed the United States District Court for the Southern District of Florida's February 2011 decision that Watson's generic versions of Mucinex, Mucinex D and Mucinex DM extended-release products do not infringe Reckitt Benckiser’s U.S. Patent No. 6,372,252.

PARSIPPANY, N.J. — Watson Pharmaceuticals last week confirmed that the United States Court of Appeals for the Federal Circuit has affirmed the United States District Court for the Southern District of Florida's February 2011 decision that Watson's generic versions of Mucinex, Mucinex D and Mucinex DM extended-release products do not infringe Reckitt Benckiser’s U.S. Patent No. 6,372,252. 

Watson stated it is continuing to seek final approval of the products from the Food and Drug Administration. 

June 21, 2011

Winn-Dixie has filed suit against Dolgencorp, the parent company of Dollar General. The grocer confirmed that the suit was filed because Dolgencorp “knowingly violates legal, noncompete provisions of Winn-Dixie leases in shopping centers in which both businesses operate,” Winn-Dixie told the Jacksonville Business Journal in an email.

NEW YORK — Winn-Dixie has filed suit against Dolgencorp, the parent company of Dollar General. The grocer confirmed that the suit was filed because Dolgencorp “knowingly violates legal, noncompete provisions of Winn-Dixie leases in shopping centers in which both businesses operate,” Winn-Dixie told the Jacksonville Business Journal in an email.

June 21, 2011

Watson subsidiary Watson Labs is seeking approval for a drug designed to treat symptomatic benign prostatic hyperplasia in men with an enlarged prostate.

PARSIPPANY, N.J. — Watson subsidiary Watson Labs is seeking approval for a drug designed to treat symptomatic benign prostatic hyperplasia in men with an enlarged prostate.

The company filed an abbreviated new drug application to market dutasteride capsules in the 0.5-mg strength. The drug is a generic version of Avodart, which is made by GlaxoSmithKline.

June 17, 2011

A federal court has rejected Teva Pharmaceutical Industries’ efforts to prevent Watson from launching a generic version of one of its drugs, Watson said Friday.

PARSIPPANY, N.J. — A federal court has rejected Teva Pharmaceutical Industries’ efforts to prevent Watson from launching a generic version of one of its drugs, Watson said Friday.

The U.S. District Court for the District of Nevada denied Duramed Pharmaceuticals’ request for an injunction to keep Watson’s generic version of the contraceptive Seasonique (levonorgestrel and ethinyl estradiol 0.15 mg/0.03 mg) and ethinyl estradiol 0.01 mg from being launched.

Seasonique is made by Teva Women’s Health, the successor of Duramed.

June 9, 2011

A federal court has ruled in favor of drug maker Eli Lilly & Co. in a dispute with Amylin Pharmaceuticals over Lilly’s partnership with German drug maker Boehringer Ingelheim.

INDIANAPOLIS — A federal court has ruled in favor of drug maker Eli Lilly in a dispute with Amylin Pharmaceuticals over Lilly’s partnership with German drug maker Boehringer Ingelheim.

June 3, 2011

Pfizer has filed suit against generic drug maker Impax Labs in connection with the latter’s attempt to market a generic drug for bladder problems.

HAYWARD, Calif. — Pfizer has filed suit against generic drug maker Impax Labs in connection with the latter’s attempt to market a generic drug for bladder problems.

Impax said Friday that Pfizer filed a patent infringement suit in the U.S. District Court of the District of New Jersey in connection with Impax’s attempt to market a generic version of Detrol (tolterodine tartrate) immediate-release tablets in the 1-mg and 2-mg strengths. The drug is used to treat overactive bladder and urinary incontinence.

May 16, 2011

Amylin Pharmaceuticals filed suit against Eli Lilly in federal court Monday concerning an agreement between the latter and German drug maker Boehringer Ingelheim to develop drugs for diabetes.

SAN DIEGO — Amylin Pharmaceuticals filed suit against Eli Lilly in federal court Monday concerning an agreement between the latter and German drug maker Boehringer Ingelheim to develop drugs for diabetes.

In a complaint filed in the U.S. District Court for the Southern District of California, Amylin said Lilly engaged in unlawful and anticompetitive activity in its development and commercialization agreement with BI for Tradjenta (linagliptin), an orally administered Type 2 diabetes drug that the Food and Drug Administration recently approved.

May 9, 2011

Napo Pharmaceuticals has filed a lawsuit against Salix Pharmaceuticals, alleging that the latter breached commitments under an agreement to develop and commercialize a proprietary gastrointestinal compound.

RALEIGH, N.C. — Napo Pharmaceuticals has filed a lawsuit against Salix Pharmaceuticals, alleging that the latter breached commitments under an agreement to develop and commercialize a proprietary gastrointestinal compound.

Salix said that Napo's claims over its collaboration agreement concerning the development of crofelemer are without merit, adding that the drug maker plans to continue with the development and commercialization of crofelemer, in accordance with its past guidance and the terms of its collaboration agreement with Napo.

May 3, 2011

Sales at generic drug maker Mylan increased by 12% during first quarter 2011, compared with first quarter 2010, the company said Tuesday.

PITTSBURGH — Sales at generic drug maker Mylan increased by 12% during first quarter 2011, compared with first quarter 2010, the company said Tuesday.

Sales for the three months ended March 31 were $1.45 billion, compared with $1.29 billion during the same period a year ago. Profits, meanwhile, were $104.2 million, compared with $61.1 million in first quarter 2010.

April 21, 2011

Watson Pharmaceuticals is hoping to become the first company to market a generic treatment for cholesterol.

PARSIPPANY, N.J. — Watson Pharmaceuticals is hoping to become the first company to market a generic treatment for cholesterol.

The drug maker said Wednesday that it had filed with the Food and Drug Administration for approval of a generic version of Welchol (colesevelam hydrochloride) tablets in the 625-mg strength, made by Daiichi Sankyo, thus challenging the patents covering the drug.

April 6, 2011

British drug maker Shire has filed suit against Watson Pharmaceuticals and subsidiaries, alleging patent infringement in a case concerning a drug used to treat attention deficit hyperactivity disorder.

DUBLIN — British drug maker Shire has filed suit against Watson Pharmaceuticals and subsidiaries, alleging patent infringement in a case concerning a drug used to treat attention deficit hyperactivity disorder.

Shire announced Wednesday that it had filed the suit in the U.S. District Court for the Southern District of New York against Watson and several subsidiaries over their attempt to market a generic version of Adderall XR (amphetamine, dextroamphetamine mixed salts) and breach of contract.