Generics

MORRISTOWN, N.J. — Drug maker Watson Pharmaceuticals said it has filed a regulatory approval application for a generic painkiller, challenging the patent that covers the branded version.

Watson announced Tuesday that it had filed an application with the Food and Drug Administration seeking approval for hydromorphone hydrochloride extended-release tablets in the 8-mg, 12-mg and 16-mg strengths. The drug is a generic version of Mallinckrodt’s Exalgo.

WASHINGTON — New York’s state Medicaid program could save $2.2 billion over 10 years by managing Medicaid pharmacy benefits more like private-sector employer plans, state employee plans and Medicare, according to a new study by healthcare policy research firm The Lewin Group.

NEW YORK — Legislation to ban patent litigation settlements between branded and generic drug companies appears unlikely to find success, according to published reports.

The Hill, a newspaper that covers Congress, reported on Sunday that language in the Senate appropriations bill that would ban so-called “pay for delay” settlements between drug makers did not appear likely to pass. The newspaper reported that the Senate appeared likely to support a resolution supported by the House that did not contain the language.

MINNETONKA, Minn. — More retailers have signed on for UnitedHealthcare's prescription savings program that caters to Medicare Part D members.

Target, H-E-B, Hy-Vee, Publix Super Markets, Food Lion, Bloom, Harveys and Sweetbay Supermarket have joined the insurance company's Pharmacy Saver program, which allows members to purchase some scripts for $2 for 30-day and some 90-day supplies, and applies to hundreds of prescription drugs, including 8-of-the-10 most commonly used by UnitedHealthcare Medicare plan members.

JERUSALEM — Teva Pharmaceutical Industries has filed a citizen petition with the Food and Drug Administration, hoping to keep purported generic versions of its multiple sclerosis treatment off the market, the company said Sunday.

Teva said its petition, concerning the drug Copaxone (glatiramer acetate), is based on what it called the inability to establish acceptable “sameness” due to the active ingredient’s complexity.

DUBLIN — Drug maker Shire has filed a patent infringement suit against Watson Pharmaceuticals and Impax Labs in response to their attempt to win approval from the Food and Drug Administration for a generic version of a Shire drug.

Shire announced that it had filed the suit in the U.S. District Court for the Northern District of California following the two generic drug makers’ filing of an approval application for guanfacine hydrochloride, a version of Shire’s Intuniv, used to treat hypertension.

PITTSBURGH — The Food and Drug Administration has approved a generic drug for hypertension made by Mylan.

Mylan announced Friday the approval of nifedipine extended-release tablets in the 30-mg, 60-mg and 90-mg strengths. The drug is a generic version of Bayer’s Adalat CC.

Nifedipine tablets had sales of around $82 million during the 12-month period ended in June, according to IMS Health.

BRIDGEWATER, N.J. — Amneal Pharmaceuticals has named a drug industry attorney as SVP and general counsel, the generic drug maker said Thursday.

Amneal announced the appointment of Robert Loewenstein, who previously served as head of law firm Budd Larner, P.C.’s corporate generic pharmaceuticals practice.