VIVUS Reports Issuance Of 2 Key US Patents For Qsymia - Quick Facts

(RTTNews) - VIVUS Inc. (VVUS), a biopharmaceutical company commercializing Qsymia capsules CIV for the treatment of obesity, announced that the United States Patent and Trademark Office has issued U.S. Patent Nos. 8,580,298, covering compositions of Qsymia, and 8,580,299, covering methods for effecting weight loss using Qsymia.

The newly issued patents are assigned to VIVUS and adds to the existing foundational patents - listed in the U.S. Food & Drug Administration or FDA Orange Book, which provides market exclusivity for Qsymia. Earlier to the 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 likely to extend to June 2029.

According to Seth H. Z. Fischer, chief executive, "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 comprises unit dosage forms of Qsymia that include 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.