Mylan, Inc. (MYL) recently announced that it has launched the first generic equivalent of Forest Laboratories‘ (FRX) antidepressant Lexapro. The drug is indicated for the treatment of acute and maintenance treatment of major depressive disorder (MDD) and acute treatment of generalized anxiety disorder (GAD).
Lexapro is protected by a composition-of-matter patent that will expire on March 14, 2012. As per terms of a patent litigation settlement between Forest and Mylan’s subsidiary Alphapharm, the latter was allowed to launch an authorized generic version of Lexapro two weeks prior to patent expiry. Accordingly, Mylan will have two weeks of exclusivity for Lexapro.
Lexapro has been one of the largest selling drugs of Forest and has generated US sales of approximately $2.9 billion for the 12 months ending December 31, 2011. Forest has settled patent infringement litigations with two other generic drug makers, Caraco Pharmaceutical Laboratories and Sun Pharmaceuticals, over Lexapro. Under the settlement, Caraco can start selling a generic version of the drug once other companies have begun to do so.
As of February 29, 2012, Mylan had 172 ANDAs pending clearance by the FDA, targeting $98.1 billion in branded sales according to data released by IMS Health. Mylan believes that about 41 of these ANDAs are first-to-file opportunities, representing more than $26.1 billion in branded sales. Mylan expects 2012 to be a year of significant growth driven by product launches in the US. In 2012, Mylan anticipates the launch of more than 650 new products with more than 100 in the US. We believe the generic segment will post strong sales in 2012 and 2013 benefiting from major launches in 2012.
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