According to Evoke Pharma, the United States Patent and Trademark Office (USPTO) has issued a new patent covering Evoke’s Gimoti metoclopramide nasal spray. The new patent (No. 11,517,545), which expires in 2038, is titled “Treatment of Moderate and Severe Gastroparesis.” The FDA approved Gimoti for the treatment of diabetic gastroparesis in June 2020 and granted 3 years of market exclusivity for the nasal spray in April 2022.
US Patent Nos. 11,020,361 and 8,334,281, both titled “Nasal Formulations of Metoclopramide,” were already listed in the Orange Book and provide coverage until 2029 and 2030. Several patents in the EU, Japan, and Mexico cover Gimoti through 2032.
Evoke Pharma Chief Business Officer Matt D’Onofrio commented, “The grant of this patent validates the efficacy signals we observed in our Phase 3 trial results from utilizing nasal metoclopramide to treat patients suffering from moderate-to-severe gastroparesis. We are thrilled to add this new patent to our IP estate, primarily focused on ensuring the long-term availability of our novel product, Gimoti, to help patients and healthcare providers in need of a revolutionary solution to treat diabetic gastroparesis symptoms.”
Read the Evoke Pharma press release.