Generic competition for GlaxoSmithKline (NYSE:GSK) AIDS drug Epzicom is on its way around the world, if not the United States. Yet.
The U.S. Food and Drug Administration has given tentative approval for a formulation of the drug made by Cipla, a pharmaceutical company based in Mumbai, India. The tentative approval comes under expedited review from the President’s Emergency Plan for AIDS Relief, or PEPFAR, a federal program launched by President George W. Bush in 2003 to fight AIDS globally.
With tentative approval, Cipla’s version of Epzicom is not yet eligible for sale or marketing in the United States because of existing patent protections. But the FDA has concluded that the Cipla generic drug has met quality, safety and efficacy standards, and is eligible for purchase outside of the United States under the PEPFAR program. The FDA on Jan. 31 also gave tentative approval for a pediatric formulation from Indian company Mylan Pharmaceuticals. Cipla received tentative approval on a dosage for pediatric patients last year.
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Epzicom is GSK’s top-selling HIV treatment and generated $860 million in 2010 sales, $325 million in the United States. The drug is now a product of ViiV Healthcare, a joint venture formed in 2009 with Pfizer (NYSE:PFE) to develop and market HIV treatments. London-based ViiV’s U.S. headquarters is on GSK’s campus in Research Triangle Park, North Carolina.
Epzicom received FDA approval in 2004. The drug combines antiretroviral drugs abacavir and lamivudine in one pill. Epzicom’s patent expires in 2016, but GSK has already been actively fighting to keep generic competitors at bay. Last year, GSK filed suit against Teva Pharmaceuticals (NASDAQ:TEVA) for infringing on a 2002 Epzicom patent.
Image from the CDC
