Favorable US court ruling for Ranbaxy over simvastatin

Indian drugmaker Ranbaxy Laboratories says that the US Court of Appeals for the District of Columbia Circuit has affirmed an earlier District Circuit holding on simvastatin, preserving 180-day exclusivity when patents are delisted from the Food and Drug Administration's Orange Book.

Earlier, Merck & Co had delisted two patents on its branded drug, Zocor (simvastatin), which the FDA interpreted as eliminating Ranbaxy's 180-day exclusivity on the 80mg strength of simvastatin tablets. Ranbaxy challenged this decision on the basis that it was inconsistent with the Hatch-Waxman Act.

The US Generic Pharmaceutical Association (GPhA) filed an amicus brief supporting Ranbaxy's position, with which the District Court agreed, and Ranbaxy launched its 80mg simvastatin tablets with 180-day exclusivity in June. The company currently has an over 60% market share share for this strength of the lipid-lowering drug.