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Medical News

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

September 21, 2005

A note from TheBody.com: Since this article was written, the HIV pandemic has changed, as has our understanding of HIV/AIDS and its treatment. As a result, parts of this article may be outdated. Please keep this in mind, and be sure to visit other parts of our site for more recent information!

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).

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Reprinted with permission from kaisernetwork.org. You can view the entire Kaiser Daily HIV/AIDS Report, search the archives, or sign up for email delivery at www.kaisernetwork.org/dailyreports/hiv. The Kaiser Daily HIV/AIDS Report is published for kaisernetwork.org, a free service of the Kaiser Family Foundation, by The Advisory Board Company. © 2005 by The Advisory Board Company and Kaiser Family Foundation. All rights reserved.

A note from TheBody.com: Since this article was written, the HIV pandemic has changed, as has our understanding of HIV/AIDS and its treatment. As a result, parts of this article may be outdated. Please keep this in mind, and be sure to visit other parts of our site for more recent information!



  
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This article was provided by Henry J. Kaiser Family Foundation. It is a part of the publication Kaiser Daily HIV/AIDS Report. Visit the Kaiser Family Foundation's website to find out more about their activities, publications and services.
 
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