genglob magazine

Hyderabad based NATCO Pharma Limited today confirmed that the company has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market lenalidomide capsules in 5, 10, 15 and 25mg strengths prior to the expiration of various U.S. patents. NATCO’s lenalidomide capsules are the generic version of Celgene Corporation’s Revlimid®.

On August 30, 2010, pursuant to the Hatch-Waxman Act, NATCO notified Celgene that its ANDA requesting approval from the FDA for a generic version of Revlimid® contained a paragraph IV certification asserting that various Revlimid® patents are invalid, unenforceable and/or not infringed. Lenalidomide, which is presently marketed as Revlimid by Celgene, is a derivative of thalidomide and is used in the treatment for multiple myeloma. Lenalidomide has also shown efficacy in the class of hematological disorders known as myelodysplastic syndromes (MDS). Read the rest of this entry »