The companies filed this lawsuit under the Hatch-Waxman Act in response to the notice from Upsher-Smith of its filing of an abbreviated new drug application with the FDA containing a paragraph IV certification under 21 USC section 355(j) for testosterone gel.
The paragraph IV certification notice states that Upsher-Smith does not believe that the testosterone gel product for which it is seeking approval infringes the patent and that it would seek to market its generic product before the expiration of the patent.
Under the Hatch-Waxman Act, final FDA approval of Upsher-Smith’s proposed generic product will be stayed until the earlier of 30 months or resolution of the patent infringement lawsuit.
Should Upsher-Smith receive a tentative approval of its generic version of Testim from the FDA, it cannot lawfully launch its generic version of Testim in the US before the earlier of the expiration of the currently pending 30-month stay or a district court decision in its favor. Upsher-Smith will also not be able to lawfully launch a generic version of Testim in the US without the necessary final approval from the FDA.