FDA Approves Four Generic Forms of Zidovudine for U.S. Sales After Retrovir's Patent Expires

Wednesday, September 21, 2005

FDA on Monday announced it has granted approval for four forms of the generic antiretroviral drug zidovudine to be sold in the U.S., after GlaxoSmithKline's patent on the drug -- sold under the brand name Retrovir -- expired on Saturday, Dow Jones reports. The agency gave full approval to a generic zidovudine oral solution made by India-based Aurobindo Pharma and generic zidovudine tablets made by Aurobindo, India-based Ranbaxy Laboratories and Columbus, Ohio-based Roxane Laboratories (Corbett Dooren, Dow Jones, 9/19). FDA already had given tentative approval to all of the drugs for inclusion under the President's Emergency Plan for AIDS Relief (FDA release, 9/19). The tentative approval designation meant that the generic drugs met FDA safety and efficacy standards but could not be sold in the U.S. because of existing patents or exclusivity agreements (Kaiser Daily HIV/AIDS Report, 9/12). The drugs are the first generic versions of Retrovir to be approved for marketing in the U.S. (Bloomberg News, 9/19). GSK does not expect its revenue to be affected by the patent expiration because it will not affect the price of Combivir and Trizivir, its newest drugs containing zidovudine, which in 2004 brought in combined sales of $1.6 billion (Kaiser Daily HIV/AIDS Report, 9/20).