Evoke Pharma announced that the FDA has granted new drug product exclusivity for Gimoti metoclopramide nasal spray, giving the company exclusive marketing rights for 3 following the initial approval date. The FDA approved Gimoti for the treatment of diabetic gastroparesis in June 2020.
The company also noted that it has two patents covering Gimoti listed in the Orange Book: US Patent Nos. 11,020,361 and 8,334,281, both titled “Nasal Formulations of Metoclopramide,” that are in effect through 2029 and 2030. Patents in the EU, Japan, and Mexico cover the nasal spray through 2032.
Evoke Pharma Chief Business Officer Matt D’Onofrio said, “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 US.”
Read the Evoke Pharma press release.
