The first generic version of Lexapro, one of the most widely prescribed antidepressants, with more than $2 billion in sales last year, received federal approval Monday.

Ivax Corp. of Miami, part of Israel’s Teva Pharmaceutical Industries Ltd., becomes the first company cleared to make a generic version of the prescription drug, according to the Web site of the Food and Drug Administration. The agency approved 5, 10 and 20 milligram doses of the drug, also called escitalopram oxalate, for the treatment of major depression.

Lexapro, the brand-name version of the drug, is made by New York-based Forest Laboratories Inc. In 2005, Lexapro was the No. 2 antidepressant in the United States, behind Zoloft, with 29.6 million prescriptions filled, according to IMS Health, a prescription information provider. Lexapro’s U.S. sales last year were $2.1 billion.

Feb. 2007 Update

After reviewing the status of generic Lexapro, we discovered that the company that was trying to bring it to market, Teva, lost a patent fight with Lexapro’s maker, Forest Labs. To put this in perspective of how big a deal this was for Forest, in the 2nd quarter of 2006, Lexapro made up 60% of Forest’s revenues (according to this blog entry). Bloomberg News also carried the judge’s July 12 2006 ruling.

What this means is that although the FDA approved a generic formulation of Lexapro, a generic version of Lexapro is not coming to a store near you anytime soon. The Lexapro patent does not run out until 2012. Sorry!

Dr. John Grohol is the founder & CEO of Psych Central. He is an author, researcher and expert in mental health online, and has been writing about online behavior, mental health and psychology issues -- as well as the intersection of technology and human behavior -- since 1992. Dr. Grohol sits on the editorial board of the journal Cyberpsychology, Behavior and Social Networking and is a founding board member and treasurer of the Society for Participatory Medicine.

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    Last reviewed: By John M. Grohol, Psy.D. on 12 Feb 2007
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