Watson, Natco confirm development agreement for generic Revlimid

Dec 7 2010

Watson Pharmaceuticals, Inc. (NYSE: WPI) and Natco Pharma Limited (BSE: 524816) today confirmed an exclusive, U.S. development and license agreement, to develop and commercialize lenalidomide 5, 10, 15 and 25 mg tablets.  The companies also confirmed that Natco has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market its lenalidomide 5, 10, 15 and 25 mg product.  Natco's lenalidomide tablets are generic versions of Celgene's Revlimid ® Tablets.  

Based on available information, the companies believe that Natco may be the "first applicant" to file an ANDA for the 5, 10, 15 and 25 mg generic versions of Revlimid® and, should the ANDA be approved, may be entitled to 180 days of generic market exclusivity.

Upon successful commercialization, Watson and Natco will share net profits on sales.  Other terms of the agreement have not been disclosed.  Watson will assume responsibility for ongoing regulatory, legal, and commercial expenses related to Natco's lenalidomide product.