Generic Line

The country’s highest court is likely to mull Hatch-Waxman’s safe-harbor provision now that the U.S. Court of Appeals for the Federal Circuit has issued contradictory rulings on when the law allows drugmakers to use others’ patents without fear of infringement.

CDER is looking to elevate the Office of Generic Drugs (OGD) into a “super” office, a move necessitated by the recent passage of the Generic Drug User Fee Amendments (GDUFA) and a heightened public focus on generic medicines, Center Director Janet Woodcock said.

Teva has scored a victory on the road to biosimilar approvals with the FDA’s OK of its copycat version of Amgen’s Neupogen, a win that could halve Amgen’s U.S. market share by the end of 2016, analysts say.

Impax Laboratories can market generic versions of Genzyme’s kidney disease drugs Renvela and Renagel in 2014 under a settlement with the brand drugmaker.

Merck and Upsher-Smith are urging the Supreme Court to take up the issue of reverse patent settlements now that the Third Circuit Court of Appeals has created a split among the U.S. appeals courts.

Wyeth is urging the court to dismiss an FTC amicus brief in a case involving its antidepressant Effexor XR, saying the agency is wrongly trying to turn the case into a pay-for-delay issue.

A federal appeals court is reviving, at least in part, Santarus’ efforts to stop Par Pharmaceutical from marketing a generic version of heartburn drug Zegerid.

Sun Pharmaceutical is recalling one lot of its 30-mg nimodipine after a customer complaint about possible crystallization of the solution inside the capsule.

Mylan will be able to sell a generic version of Pfizer’s long-acting overactive bladder drug Detrol LA on Jan. 1, 2014, or earlier pending certain undisclosed terms of a settlement negotiated by the two drugmakers.

The FDA has approved Aurobindo’s ANDA for amlodipine besylate and benazepril hydrochloride capsules, the generic equivalent of Novartis’ hypertension drug Lotrel.

GlaxoSmithKline (GSK) is suing Apotex, saying the generic maker’s proposed version of enlarged prostate drug Avodart would infringe on a GSK patent and should be prohibited from the U.S. market until the patent expires in late 2015.

Teva is suing Perrigo and Catalent Pharma Solutions to stop the companies’ plans to market and develop generic versions of its asthma drug ProAir HFA before two key patents pop.