MOUNTAIN VIEW, Calif., Nov. 13, 2013 (GLOBE NEWSWIRE) -- VIVUS,Inc. (Nasdaq:VVUS), a biopharmaceutical company commercializing Qsymia ® (phentermine and topiramate extended-release) capsules CIV for the treatment of obesity, today announced that the United States Patent and Trademark Office has issued U.S. 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 U.S. Food & Drug Administration (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 FDA Orange Book, patent exclusivity for Qsymia in the U.S. is expected to extend to June 2029.
"The issuance of these new Qsymia patents is an important achievement for VIVUS," stated Seth H. Z. Fischer, CEO. "Extension of our patent coverage by an additional nine years adds significant value to the Qsymia franchise. The new patents provide us with a greater opportunity to promote Qsymia as a highly effective therapy of choice for obese patients and for overweight patients with one or more comorbidities."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.