Mylan Launches Generic Lexapro - Analyst Blog
March 01 2012 - 7:45AM
Zacks
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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