Evoke Pharma, Inc. (NASDAQ: EVOK) has announced that the FDA has granted new drug product exclusivity for the company’s GIMOTI nasal spray. Evoke has been given exclusive marketing rights for three years from the original date of approval under the Hatch-Waxman Act to protect the product from generic drug competition. The Company has also been granted gender-specific patents in the E.U., Japan, and Mexico with coverage until 2032.
“Receiving marketing exclusivity rights from the FDA for GIMOTI further establishes our proprietary concept of delivering an effective medication through the nasal pathway for the treatment of symptoms associated with diabetic gastroparesis. We are excited to continue our mission of getting GIMOTI to patients who are in need of a non-oral treatment for gastroparesis and capitalize on this large and growing market opportunity in the U.S.,” commented Matt D’Onofrio, MBA, Evoke Pharma Chief Business Officer.
Evoke is a specialty pharmaceutical company focused primarily on the development of drugs to treat GI disorders and diseases. The company developed, commercialized and markets GIMOTI, a nasal spray formulation of metoclopramide, for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adults.