Forest’s Lexapro Retains Exclusivity In Case With Teva
This article was originally published in The Pink Sheet Daily
Executive Summary
The Forest breadwinner will enjoy patent protection into 2012 following a Delaware federal court decision July 13.
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Forest Laboratories will enjoy patent protection for its blockbuster antidepressant Lexapro (escitalopram) through March 14, 2012 as the result of a Wilmington, Del. federal court decision issued July 13. Judge Joseph Farnan ruled that Forest's composition of matter patent (no. RE 34,712) covering Lexapro is valid and enforceable. Teva's recently acquired subsidiary Ivax was the first to file a Paragraph IV certification on the 5 mg, 10 mg and 20 mg doses of the antidepressant, challenging the Forest patent. Although FDA approved Teva's abbreviated NDA May 22, the generic company agreed to postpone launch of generic Lexapro pending the outcome of the patent litigation (1 (Also see "Teva’s Lexapro ANDA Receives FDA Approval" - Pink Sheet, 23 May, 2006.)). Lexapro sales generated $1.87 bil. for Forest for the fiscal year ending March 31, 2006, accounting for 67% of total sales, according to the company's annual report. Additionally, Lexapro gained a 20.1% share of total prescriptions of antidepressants in the SSRI/SNRI category according to IMS Health. The '712 patent was originally slated to expire in December 2009, which included an additional six months of pediatric exclusivity. However, the U.S. Patent & Trademark Office granted the patent an 828-day extension in March. -Kathryn Phelps |