Sun Pharma to license key escitalopram patent applications to Lundbeck

Mumbai: Sun Pharmaceutical Industries Ltd today said that along with its US subsidiary Caraco Pharmaceutical Laboratories, it had entered into settlement agreements with US-based Forest Laboratories, Inc., its wholly-owned subsidiary, Forest Laboratories Holdings, Ltd. and H. Lundbeck A/S to settle the legal proceedings related to Lexapro (escitalopram oxalate) tablets.

Lundbeck had licensed to Forest cetain patents for Forest's Lexapro-branded escitalopram oxalate tablet products.on an exclusive basis in the United States. The product has two patents, one od which is due to expire in 2012.

In July 2006,  Lundbeck, Forest Laboratories and Forest Laboratories Holdings filed a lawsuit in the US District Court for the Eastern District of Michigan against Caraco Pharmaceutical over the Indian company's abbreviated new drug application (ANDA) to make a generic equivalent to Lexapro.

Under the terms of the agreement with Sun Pharma and Caraco, and subject to review of the settlement terms by the U.S. Federal Trade Commission:

Sun Pharma will license to Lundbeck on a worldwide basis patent applications related to the synthesis of escitalopram and citalopram in exchange for an upfront payment and, if the technology is used, royalties on sales.

Forest will provide licenses to Caraco for any patents related to Lexapro and with respect to the marketing of Caraco's generic version of the product as of the date that any third party generic that has received final approval from the FDA enters the market other than an authorised generic or the first filer with Hatch-Waxman related exclusivity.