US generic drugs maker Watson Pharmaceuticals (NYSE: WPI) and India’s Natco Pharma (BSE: 524816) have confirmed an exclusive, US agreement, to develop and commercialize lenalidomide 5, 10, 15 and 25mg tablets, a copy version of US biotech firm Celgene’s (Nasdaq: CELG) blockbuster multiple myeloma drug Revlimid, which generated third-quarter sales of $641 million for the company, and $1.76 billion in 2009.
Celgene has started a law suit against Natco accusing the company of violating patents that protect Revlimid. The company said that Revlimid is currently protected by 12 issued patents listed in the Food and Drug Administration’s Approved Drug Products List (Orange Book) and has additional patent applications pending (The Pharma Letter September 6). The issued patents comprise composition of matter, polymorph and method of use claims as well as claims related to Celgene’s proprietary RevAssist system, the company said.
ANDA filed with FDA
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