Generics

ALEXANDRIA, Va. — A study by the Government Accountability Office confirmed that the health-reform law enacted earlier this year established a more reasonable reimbursement level for pharmacies dispensing generic drugs to patients covered by Medicaid. But pharmacy retailers still face the continued threat of further Medicaid cuts at the state level, the independent pharmacy lobby warned Friday.

SILVER SPRING, Md. — Drugs for bacterial infections and cancer, and one that could help shape regulations for biosimilars, are featured in the Food and Drug Administration’s annual "Generic Drug Roundup."

The roundup is an annual highlighting of what the agency considers the most significant generic drug approvals.

MORRISTOWN, N.J. — A subsidiary of Watson Pharmaceuticals has entered a licensing agreement with a subsidiary of Hungarian drug maker Richter to develop and market a drug for uterine fibroids, the two companies said Thursday.

Watson Labs and PregLem said European studies had shown Esmya (ulipristal acetate) to be a safe and effective treatment for the disease, a benign tumor condition that affects between one-fifth and one-fourth of women of reproductive age worldwide. Watson expected to start phase-3 studies of the drug in the United States in 2011.

WEST DES MOINES, Iowa — Midwestern supermarket chain Hy-Vee will offer 366 commonly prescribed generic prescription drugs for as little as $2 to select Medicare beneficiaries through a program offered in collaboration with UnitedHealthcare, Hy-Vee said.

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.

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.