Watson Pharmaceuticals gets FDA OK for generic testosterone gel

By Lisa Kerner

Erie, Pa., Jan. 30 - Watson Pharmaceuticals, Inc. said it has received final approval from the Food and Drug Administration on its abbreviated New Drug Application for testosterone gel 1% CIII.

The product 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 ended November, Androgel 1% CIII had total U.S. sales of about $330 million, according to IMS Health data.

Watson has been awarded 180 days of marketing exclusivity for being the first to file an abbreviated NDA containing a paragraph IV certification for the product, according to a company news release. The market exclusivity begins 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.

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.

Watson is a specialty pharmaceutical company based in Corona, Calif.

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