Evoke Pharma, Inc. has been granted new drug product exclusivity by the (FDA for GIMOTI (metoclopramide) nasal spray. Evoke now has exclusive marketing rights over a period of three (3) years from the original date of approval under the Hatch-Waxman Act to protect the product from generic drug competition. Enacted by Congress in 1984, the Hatch-Waxman Amendments include provisions that involve patents and exclusivities related to new drug applications.
In addition to the market exclusivity, Evoke maintains a robust patent estate, with currently two Orange book-listed patents entitled “Nasal Formulations of Metoclopramide,” U.S. Patent No. 11,020,361, and U.S. Patent No. 8,334,281, that expire in 2029 and 2030, respectively. The Company has also been granted gender-specific patents in the E.U., Japan, and Mexico with coverage until 2032. Furthermore, the Company has other pending patent applications with individual expiration dates of 2032, 2037, and 2038, if approved.
“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.
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