Vivus Receives Qysmia Patents

The U.S. Patent and Trademark Office has issued to Vivus Patent Nos. 8,580,298 (link: 8580298; ‘298), covering compositions of Qsymia, and 8,580,299 (link: 8580299; ‘299), covering methods for effecting weight loss using Qsymia.

The newly issued patents are assigned to Vivus and are a significant addition to the existing foundational patents, listed in the FDA Orange Book, that provide market exclusivity for Qsymia. Prior to issuance of these new patents, patent protection for Qsymia in the U.S. was expected to expire in June 2020. With the addition of the two new patents, both of which have been submitted for listing in the Orange Book, patent exclusivity for Qsymia in the U.S. is expected to extend to June 2029.

The ‘298 patent covers unit dosage forms of Qsymia that contain a combination of 2 to 8 mg of immediate release phentermine and 15 to 50 mg controlled release topiramate at a certain ratio and with specific pharmacokinetic parameters, as found in the once-a-day capsule formulation of the approved Qsymia product.

The claims of the ‘299 patent are directed to methods of using Qsymia that include administration of the approved Starting dose for two weeks followed by the approved Recommended or Top dose for an extended period. The claims of the ‘299 patent also include certain pharmacokinetic parameters that describe the approved Qsymia product.