US Patent No. RE34712 covering escitalopram oxalate has received a patent term extension under 35 USC § 156 for 828 days. Marketed by Forest laboratories under the brand name Lexapro was earlier due to expire on June 08, 2009 and December 08, 2009 with pediatric exclusivity, will now be valid upto September 14, 2011 and upto March 14, 2012 with pediatric exclusivity. This extension will be a major boost up for Forest Laboratories in its battle against generic competitors.
In 2004, Forest received notification from two generic manufactures, namely, Ivax Pharmaceuticals and Alphapharm Pty. Ltd., that they had filed abbreviated new drug applications (ANDAs) with a Para IV certification with the Food and Drug Administration (FDA) for approval of generic version of escitalopram oxalate. In response, Forest along with its licensing partner Lundbeck A/S filed a suit against Ivax jointly with Cipla Ltd. and Alphapharm. However, on 04th October ’05, Forest and Lundbeck entered into a Settlement Agreement with Alphapharm but does not settle the pending patent litigation against Ivax and Cipla. On October 26, 2005 the Federal District Court, District of Delaware, rescheduled the start of the trial from December 05, 2005 to March 15, 2006.