Evoke Pharma Receives Market Exclusivity for its Nasal Spray

Apr 26, 2022 By MarketDepth

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Evoke Pharma, Inc. (NASDAQ: EVOK) today announced that it has been granted new drug product exclusivity by the U.S. Food and Drug Administration (FDA) for GIMOTI (metoclopramide) nasal spray.

Shares up 225%

Shares of Evoke Pharma, Inc. (NASDAQ: EVOK) surged over 225% in premarket trading following the announcement.

Evoke now has exclusive marketing rights over a three year period from the original date of approval under the Hatch-Waxman Act to protect the product from generic drug competition. Furthermore, 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.” 

Matt D’Onofrio, MBA, Evoke Pharma Chief Business Officer