Content about Company Legal Issues

January 3, 2013

A court has ruled in favor of Indian generic drug maker Ranbaxy Labs in a case concerning a generic blood pressure drug, the legal firm representing the drug maker said.

WASHINGTON — A court has ruled in favor of Indian generic drug maker Ranbaxy Labs in a case concerning a generic blood pressure drug, the legal firm representing the drug maker said.

Zuckerman Spaeder LLP said the U.S. District Court for the District of Columbia upheld a Food and Drug Administration decision protecting Ranbaxy's market exclusivity for a generic version of Novartis' drug Diovan (valsartan).

December 28, 2012

A federal judge in Washington has dismissed a suit against the FDA brought up by Mylan for withholding approval for the company to sell a generic version of Novartis AG’s heart pill, Diovan.

WASHINGTON — A federal judge in Washington has dismissed a suit against the FDA brought up by Mylan for withholding approval for the company to sell a generic version of Novartis AG’s heart pill, Diovan.

U.S. District Court Judge John D. Bates said in an opinion filed on Dec. 27, that the FDA did not act “capriciously” when it denied Mylan exclusivity to market its version of Diovan. Bates also said Mylan did not show it suffered “irreparable harm” as a result.

December 28, 2012

Watson Pharmaceuticals on Friday confirmed that Actavis, which was acquired by Watson in October, has filed an abbreviated new drug applications with the Food and Drug Administration seeking approval to market bortezomib, a generic version of Millennium Pharmaceuticals' Velcade.

PARSIPPANY, N.J. — Watson Pharmaceuticals on Friday confirmed that Actavis, which was acquired by Watson in October, has filed an abbreviated new drug applications with the U.S. Food and Drug Administration seeking approval to market bortezomib, a generic version of Millennium Pharmaceuticals' Velcade.

Bortezomib is a proteasome inhibitor for intravenous or subcutaneous administration, approved for treatment of patients with multiple myeloma and patients with mantle cell lymphoma who have received at least one prior therapy.

December 21, 2012

A federal court decision means that a nontamper-resistant formulation of a painkiller made by Endo Health Solutions can enter the market early next month, the drug maker said.

CHADDS FORD, Pa. — A federal court decision means that a nontamper-resistant formulation of a painkiller made by Endo Health Solutions can enter the market early next month, the drug maker said.

The U.S. District Court for the District of Columbia dismissed a case filed by Endo subsidiary Endo Pharmaceuticals against the Food and Drug Administration, in which the company had argued that the FDA failed meet a legal obligation to determine whether the original formulation of Opana ER (oxymorphone) extended-release tablets was withdrawn from the market for safety reasons.

December 18, 2012

Drug maker Merz Pharmaceuticals is suing Par Pharmaceutical over the latter's attempt to market a generic drug for cerebral palsy patients, according to published reports.

NEW YORK — Drug maker Merz Pharmaceuticals is suing Par Pharmaceutical over the latter's attempt to market a generic drug for cerebral palsy patients, according to published reports.

Bloomberg reported that Merz sued Par in the U.S. District Court for the District of Delaware after Par attempted to apply for Food and Drug Administration approval for a generic version of Cuvposa (glycopyrrolate) oral solution, used to treat severe drooling in cerebral palsy patients.

The drug received FDA approval this year, and Merz bought rights to the drug in August.

December 14, 2012

A federal court has ruled in favor of AstraZeneca in a case regarding a cholesterol drug, the company said.

WILMINGTON, Del. — A federal court has ruled in favor of AstraZeneca in a case regarding a cholesterol drug, the company said.

AstraZeneca said the Court of Appeals for the Federal Circuit upheld a decision by the U.S. District Court for the District of Delaware ruling that a patent covering the drug Crestor (rosuvastatin calcium) was valid and enforceable. The patent, which expires in 2016, covers the active ingredient of Crestor.

November 15, 2012

The Food and Drug Administration has approved a generic drug for leukemia made by a subsidiary of Par Pharmaceutical Cos.


FDA approves Par leukemia drug
WOODCLIFF LAKE, N.J. — The Food and Drug Administration has approved a generic drug for leukemia made by a subsidiary of Par Pharmaceutical Cos.


Par said Oct. 25 that the FDA had approved Anchen Pharmaceuticals’ tretinoin capsules in the 10-mg strength.


The drug is a generic version of Roche’s Vesanoid, various versions of which have annual sales of about $29 million, according to IMS Health.



 

November 6, 2012

Nutramax Laboratories recently announced the defeat of a class action lawsuit brought against the company in a California court. In April, Nutramax was named in a class action regarding its CosaminDS Joint Health Supplement. Plaintiffs claimed the glucosamine/chondroitin supplement did not work in relieving joint pain as advertised.

EDGEWOOD, Md. — Nutramax Laboratories recently announced the defeat of a class action lawsuit brought against the company in a California court. In April, Nutramax was named in a class action regarding its CosaminDS Joint Health Supplement. Plaintiffs claimed the glucosamine/chondroitin supplement did not work in relieving joint pain as advertised. 

November 2, 2012

The National Retail Federation and more than a dozen retailers on Thusday asked a judge to reject a proposed class-action settlement of a federal antitrust lawsuit filed against Visa and MasterCard because of credit card swipe fees.

WASHINGTON — The National Retail Federation and more than a dozen retailers on Thusday asked a judge to reject a proposed class-action settlement of a federal antitrust lawsuit filed against Visa and MasterCard because of credit card swipe fees. The NRF suggested the settlement would not bring credit card swipe fees under control and does not give retailers who oppose it an adequate mechanism to opt out.

October 23, 2012

A federal court has ordered the Food and Drug Administration to approve a generic diabetes drug made by Watson Pharmaceuticals, the drug maker said.

PARSIPPANY, N.J. — A federal court has ordered the Food and Drug Administration to approve a generic diabetes drug made by Watson Pharmaceuticals, the drug maker said.

Watson said the U.S. District Court for the District of Columbia granted summary judgment in favor of Watson, ruling that the FDA would have to approve its generic version of Takeda's Actos (pioglitazone hydrochloride) tablets in the 15-mg, 30-mg and 45-mg strengths.

September 18, 2012

Generic drug makers Hospira, Sagent Pharmaceuticals and Teva Pharmaceutical Industries have launched generic versions of a chemotherapy drug made by Sanofi, the three companies said last month.


NEW YORK — Generic drug makers Hospira, Sagent Pharmaceuticals and Teva Pharmaceutical Industries have launched generic versions of a chemotherapy drug made by Sanofi, the three companies said last month.


September 11, 2012

The National Community Pharmacists Association and a number of independent pharmacy entities on Monday refiled its complaint against Express Scripts concerning its acquisition of Medco, demanding either Express Scripts be compelled to "unwind their merger" or alternatively be required to divest assets acquired from Medco.

 PITTSBURGH — The National Community Pharmacists Association and a number of independent pharmacy entities on Monday refiled its complaint against Express Scripts concerning its acquisition of Medco, demanding either Express Scripts be compelled to "unwind their merger" or alternatively be required to divest assets acquired from Medco. The independent pharmacy plaintiffs are also suing for the cost of the suit as well as "such other relief as the Court may deem just and proper."

September 7, 2012

Generic drug maker Mylan has settled a patent litigation suit with Pfizer concerning a drug for treating bladder disorders, Mylan said Friday.

PITTSBURGH — Generic drug maker Mylan has settled a patent litigation suit with Pfizer concerning a drug for treating bladder disorders, Mylan said Friday.

The Pittsburgh-based company said it settled with Pfizer over its generic version of Detrol LA (tolterodine tartrate) extended-release capsules in the 2-mg and 4-mg strengths. The drug is used to treat urge urinary incontinence, urgency and frequency.

September 7, 2012

Perrigo is seeking regulatory approval for what it called the first generic version of a drug for treating bronchospasm.

ALLEGAN, Mich. — Perrigo is seeking regulatory approval for what it called the first generic version of a drug for treating bronchospasm.

August 28, 2012

U.S. District Court judge Cathy Bissoon on Monday dismissed many of the claims levied against Express Scripts by the National Association of Chain Drug Stores, the National Community Pharmacist Association and nine independent pharmacies, regarding the allegedly anti-competitive nature of Express Scripts' merger with Medco.

PITTSBURGH — U.S. District Court judge Cathy Bissoon on Monday dismissed many of the claims levied against Express Scripts by the National Association of Chain Drug Stores, the National Community Pharmacist Association and nine independent pharmacies, regarding the allegedly anti-competitive nature of Express Scripts' merger with Medco.

July 31, 2012

Abon Pharmaceuticals is challenging the patent protection on an injected drug used to treat leukemia in children and adolescents, the company said Tuesday.

NORTHVALE, N.J. — Abon Pharmaceuticals is challenging the patent protection on an injected drug used to treat leukemia in children and adolescents, the company said Tuesday.

Abon said it filed with the Food and Drug Administration for regulatory approval of clofarabine in the 1 mg-per-mL strength. The drug is a generic version of Genzyme's Clolar, used to treat relapsed or refractory acute lymphoblastic leukemia in patients ages one to 21 years, who already have undergone at least two regimens.

July 30, 2012

Generic drug maker Watson Pharmaceuticals is challenging the patent protection on a drug for acne and a drug for bronchospasm, the company said Monday.

PARSIPPANY, N.J. — Generic drug maker Watson Pharmaceuticals is challenging the patent protection on a drug for acne and a drug for bronchospasm, the company said Monday.

July 24, 2012

A district court ruled in favor of Pfizer and Northwestern University in a patent infringement case relating to Lyrica (pregabalin).

NEW YORK — A district court ruled in favor of Pfizer and Northwestern University in a patent infringement case relating to Lyrica (pregabalin).

July 18, 2012

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

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

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

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

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

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

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.