Watson Pharmaceuticals, Inc. and Natco Pharma Limited 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 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