The newly issued patents are assigned to VIVUS and will be submitted for listing in the FDA’s Approved Drug Products With Therapeutic Equivalence Evaluations (the Orange Book) and add to the existing patents listed in the Orange Book that provide market exclusivity for Qsymia.
"Our efforts continue toward enhancing the value of the Qsymia patent portfolio," said Seth H. Z. Fischer, CEO. "The patents issued today reflect this ongoing commitment."
Qsymia is approved in the U.S. and is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of 30 kg/m2 or greater (obese) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related medical condition such as high blood pressure, type 2 diabetes, or high cholesterol.
The effect of Qsymia on cardiovascular morbidity and mortality has not been established. The safety and effectiveness of Qsymia in combination with other products intended for weight loss, including prescription and over-the-counter drugs, and herbal preparations, have not been established.