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Home Bio/Med/Pharma

Evoke Pharma (NASDAQ: EVOK) Receives FDA Grant of New Drug Product Exclusivity for GIMOTI

by admin

April 26, 2022

in Bio/Med/Pharma

Evoke Pharma NASDAQ EVOK GIMOTI FDA Exclusivity Spotlight Growth

Evoke Pharma, Inc. (NASDAQ: EVOK) is engaged as a specialty pharmaceutical company, which is focused on the research and development of drugs to treat GI disorders and diseases. Shares of the specialty pharma company are skyrocketing 162% through early trading on Tuesday, April 26, 2022. Over the past three months, Evoke Pharma has seen average daily volume of 104,280 shares. However, volume of 131.1 million shares or dollar volume of around $135.03 million, has already exchanged hands through early trading.

Shares of Evoke Pharma are soaring after the company announced that its GIMOTI nasal spray has been granted new drug product exclusivity by the U.S. Food and Drug Administration (FDA). The market exclusivity grant now gives Evoke Pharma exclusive marketing rights for three years from the original date of approval. This gives the company protection under the Hatch-Waxman Act to shield GIMOTI from genetic drug competitors.

The specialty pharmaceutical company also holds a strong patent portfolio, which further protects GIMOTI from outside competition. Evoke Pharma currently has two Orange book-lsited patents entitled “Nasal Formulations of Metaclopramide,” U.S. Patent No. 11,020,361 and U.S. Patent No. 8,334,281, which expire in 2029 and 2030, respectively. Outside the U.S., the company has been granted gender-specific patents in the European Union, Japan and Mexico. Additional patents are pending.

Matt D’Onofrio, Evoke Pharma Chief Business Officer: “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.”

Disclosure: No position. Spotlight Growth has no relationships with any of the companies mentioned in this article and did not receive payment in any form for its creation. This is an opinion article and is not meant to be financial advise. We are not broker-dealers or investment professionals. Please conduct your own due diligence. For more information on our disclosures, please visit: https://spotlightgrowth.com/disclosures/