Generic Line

Drug companies’ patent settlements may no longer need clauses preventing authorized generic (AG) launches after last month’s landmark court decision on pay-for-delay deals, a pharma lawyer says.

The European Commission (EC) has accused two brand drugmakers of violating antitrust rules by engaging in “pay-for-delay” agreements with a slew of generic companies, sending both the brand and generic companies Statement of Objections notices.

Pfizer is trumpeting its exclusive rights to one of its best-selling products until late 2018 after a Delaware district court upheld its patents on pain and seizure drug Lyrica.

The FDA is an important part of the solution to drug shortage crises — not a contributing factor, the agency is asserting in response to a congressional report that blamed its regulatory actions for limiting the manufacturing capacity of much-needed products.

Jazz Pharmaceuticals is calling on the FDA to rescind its acceptance of Roxane Laboratories’ ANDA for a generic version of Jazz’s narcolepsy drug Xyrem.

Sandoz, a division of Swiss drugmaker Novartis, has purchased U.S. dermatology company Fougera, making it the largest generic dermatology medicine company globally.

A coalition of physicians, clinicians and health officials is asking the FDA to tighten up the language in opioid labels regarding indications and long-term use for non-cancer pain.

Bristol-Myers Squibb (BMS) is fighting off competition for its hepatitis B treatment Baraclude, this time with a patent infringement lawsuit against Sandoz as the company seeks to introduce its generic form of the drug, according to an SEC filing by BMS.

Dr. Reddy’s can once again export products from its Morelos, Mexico, manufacturing facility to the U.S. thanks to an FDA closeout letter and the removal of an import alert that stemmed from an unfavorable agency inspection more than a year ago.

The FDA has approved Qualitest Pharmaceuticals’ ANDA for extended-release levetiracetam tablets, the generic equivalent of UCB’s anti-epileptic med Keppra.