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www.fdanews.com/articles/81635-ivax-denies-rumors-of-settlement-over-lexapro

IVAX DENIES RUMORS OF SETTLEMENT OVER LEXAPRO

October 14, 2005

Ivax has denied rumors it is negotiating a patent settlement with Forest Laboratories over Forest's antidepressant Lexapro.

Lexapro (escitalopram oxalate), which is used for the initial and maintenance treatment of major depressive disorder and for generalized anxiety disorder in adults, was launched in 2002 and is Forest's best-selling product, with $1.6 billion in sales during the 12 months ended March 31.

"Ivax believes it has valid claims against the Lexapro patents and that its abbreviated new drug application (ANDA) for escitalopram oxalate pending with the FDA is a first-to-file application that will entitle Ivax to a six-month period of exclusivity," Ivax said in a recent statement.

If Forest does lose the patent suit, Alphapharm -- which had also challenged the Lexapro patent -- will launch Forest's authorized generic of Lexapro as part of a patent settlement Forest announced Thursday. Under the settlement, Forest agreed to make Alphapharm the "exclusive distributor" of either a standard generic version of Lexapro when Forest's patent expires, or an authorized generic to be launched if Ivax or any other company begins distributing generic Lexapro.

Ivax was the first generic firm to challenge Lexapro's patent in August 2003, spurring Forest to sue Ivax a month later in the U.S. District Court in Delaware. Alphapharm filed its ANDA for Lexapro in April 2004.