Content about Company Legal Issues

May 13, 2013
FDA ruling on opioid painkiller deals blow to Endo

A ruling by the Food and Drug Administration means that generic versions of an opioid painkiller made by Endo Pharmaceuticals can stay on the market, drawing criticism from the drug maker.

SILVER SPRING, Md. — A ruling by the Food and Drug Administration means that generic versions of an opioid painkiller made by Endo Pharmaceuticals can stay on the market, drawing criticism from the drug maker.

March 14, 2013
Mylan can launch generic diabetes drug in August

Mylan has settled a patent-infringement lawsuit filed by Shionogi over its generic version of a drug for diabetes, Mylan said.

PITTSBURGH — Mylan has settled a patent-infringement lawsuit filed by Shionogi over its generic version of a drug for diabetes, Mylan said.

The generic drug maker said that under the agreement, it can launch a generic version of Shionogi's Fortamet (metformin hydrochloride) extended-release tablets in the 500-mg and 1,000-mg strengths on Aug. 1.

Metformin hydrochloride extended-release tablets in those two strengths had sales of about $125 million during the 12-month period that ended in September, according to IMS Health.

 

February 28, 2013
Battle over 'pay for delay' intensifies

The battle over "pay for delay" continues to heat up, and its resolution likely won't come until the nation's highest court decides on the legality of the practice.

The battle over "pay for delay" continues to heat up, and its resolution likely won't come until the nation's highest court decides on the legality of the practice.

February 15, 2013
Costco sued over diamond engagement rings

Jewelry maker Tiffany & Co. is suing Costco Wholesale, alleging that the club retailer falsely marketed diamond engagement rings as coming from the New York-based jeweler, according to published reports.

NEW YORK — Jewelry maker Tiffany & Co. is suing Costco Wholesale, alleging that the club retailer falsely marketed diamond engagement rings as coming from the New York-based jeweler, according to published reports.

News media reported that Tiffany filed suit against Issaquah, Wash.-based Costco in the Federal District Court in Manhattan.

February 15, 2013
FDA approves Teva ADHD drug

The Food and Drug Administration has approved a generic drug for attention deficit hyperactivity disorder made by Teva Pharmaceutical Industries, the Israeli generic drug maker said.

JERUSALEM — The Food and Drug Administration has approved a generic drug for attention deficit hyperactivity disorder made by Teva Pharmaceutical Industries, the Israeli generic drug maker said.

February 11, 2013
Shire to pay Impax $48 million in authorized generic Adderall XR case

Generic drug maker Impax Labs has settled with Shire Labs over an authorized generic version of a Shire drug for treating attention deficit hyperactivity disorder, Impax said.

HAYWARD, Calif. — Generic drug maker Impax Labs has settled with Shire Labs over an authorized generic version of a Shire drug for treating attention deficit hyperactivity disorder, Impax said.

January 3, 2013
FDA approves Watson heavy menstrual bleeding drug

The Food and Drug Administration has approved a generic drug for heavy menstrual bleeding made by Watson Pharmaceuticals, the drug maker said.

PARSIPPANY, N.J. — The Food and Drug Administration has approved a generic drug for heavy menstrual bleeding made by Watson Pharmaceuticals, the drug maker said Thursday.

Watson announced the approval of tranexamic acid tablets through a subsidiary and plans to ship it immediately. The drug is a generic version of Ferring Pharmaceuticals' Lysteda.

Ferring has filed suit against Watson, alleging that the generic drug infringes two of its patents. Lysteda had sales of about $25 million during the 12-month period that ended in November, according to IMS Health.

January 3, 2013
Ranbaxy preserves exclusivity period for generic hypertension drug

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
Mylan generic heart drug suit against FDA dismissed

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 confirms Velcade patent challenge

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
Federal court rules against Endo in painkiller case

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
Reports: Merz Pharmaceuticals sues Par over cerebral palsy drug

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
Federal court upholds validity of Crestor patent

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
NewsBytes — Chain Pharmacy, 11/19/12

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 fends off faulty class action suit

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
NRF files brief opposing class action settlement of swipe fee case

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
Federal court orders FDA to allow Watson diabetes drug launch

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
NewsBytes — Generics, 9/24/12

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
NCPA and several independents file amended claim against ESI-Medco

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
Mylan settles with Pfizer over generic bladder drug

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 seeks approval for generic bronchospasm drug

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 dismisses most elements of antitrust suit against ESI-Medco

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 seeks approval for generic leukemia drug

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
Watson seeks approval for acne, bronchospasm drugs

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
Court rules in favor of Pfizer, Northwestern University in Lyrica patent case

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).