TWi Gets FDA Approval for Generic Megace ES, but Launch Is Delayed by Patent Appeal

Taiwan-based TWi Pharmaceuticals has won final FDA approval for a generic version of Par Pharmaceutical’s AIDS drug Megace ES, but the product’s launch remains on hold as the brandmaker appeals its 2011 patent infringement lawsuit.

Par has asked a federal appellate court to overturn a Maryland federal district judge’s Feb. 21 ruling that Megace ES’s (megestrol acetate) ’576 patent was invalid because it would have been obvious for other drugmakers to try, according to court documents. Marketing of the generic is blocked by an injunction pending the outcome of the appeal.

TWi said that its version is ready to go, and that it has filed a motion seeking permission to launch.
Par, which has an exclusive license to the drug from Alkermes Pharma, argues in court documents that generics competition on Megace would force it to shut down its entire branded division, Strativa. TWi has expressed doubt about that claim.

Once authorized, TWi will have 180 days of generic market exclusivity as the first to file against Megace, which is prescribed for appetite loss, severe malnutrition and significant weight loss in AIDS patients. The drug generated $57 million in U.S. sales in the 12 months ending June 30, according to IMS Health data, TWi said. — Bryan Koenig

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.