CARACO APPLIES TO MARKET GENERIC LEXAPRO

Forest Laboratories and Lundbeck said July 11 they have filed a patent infringement lawsuit against Caraco Pharmaceutical Laboratories after it applied to market a generic version of the two drugmakers' blockbuster antidepressant Lexapro.

Lexapro is a selective serotonin reuptake inhibitor indicated for the initial and maintenance treatment of major depressive disorder and generalized anxiety disorder in adults. Sales of the drug increased 17 percent to $1.9 billion in the year ending March 31.

Forest and Lundbeck -- a Danish drugmaker that licenses Lexapro (escitalopram oxalate) to New York-based Forest -- filed their suit in the U.S. District Court for the Eastern District of Michigan after Caraco notified Forest that it had filed an abbreviated new drug application with a Paragraph IV certification to market generic Lexapro. A Paragraph IV certification implies the drug patent is invalid or the generic product would not infringe on the patent.

Howard Solomon, chairman and CEO of Forest, said the company believes the drug's patent is valid and enforceable and intends to vigorously pursue its lawsuit against Caraco.

Forest is also involved in patent litigation with Israeli drugmaker Teva Pharmaceutical, which now owns Ivax, the first generic firm to challenge Lexapro's patent in August 2003 Alphapharm also filed an ANDA for Lexapro in April 2004 but settled with Forest last October.