Watson Pharmaceuticals, Inc. announced today that it has received final approval from the United States (U.S.) Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) for testosterone gel 1% CIII. Testosterone gel 1% CIII is the generic equivalent to Solvay Pharmaceutical's AndroGel, which is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone. For the 12-months ending November 2005, Androgel 1% CIII had total U.S. sales of approximately $330 million, according to IMS Health data.
Watson has been awarded 180 days of marketing exclusivity for being the first to file an ANDA containing a paragraph IV certification for the product. Watson's market exclusivity will begin upon the earlier of a commercial launch or a final court decision concerning pending litigation between Watson and Unimed Pharmaceuticals, a division of Solvay Pharmaceuticals.
Watson is currently involved in patent litigation on this product in the U.S. District Court for the Northern District of Georgia. Unimed Pharmaceuticals brought suit against Watson in August 2003 as a result of Watson's paragraph IV certification to U.S. Patent No. 6,503,894 which expires in August 2020.
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