The FDA has approved Watson’s Abbreviated New Drug Application (ANDA) for its testosterone gel 1% CIII. This gel 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.
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 US 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 the company’s patent which expires in August 2020.
For the 12-months ending November 2005, Androgel 1% CIII had total US sales of approximately $330 million, according to IMS Health data.