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|Item 8.01|| |
On April 26, 2022, Evoke Pharma, Inc. (“Evoke” or the “Company”) announced that it has been granted new drug product exclusivity by the U.S. Food and Drug Administration (“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. Evoke 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.
Safe Harbor Statement
Evoke cautions you that statements included in this report that are not a description of historical facts are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negatives of these terms or other similar expressions. These statements are based on the Company’s current beliefs and expectations. These forward-looking statements include statements regarding: the expected benefits from market exclusivity GIMOTI and expectations on the scope of intellectual property protection; and the ability of Evoke to capitalize on the gastroparesis market opportunity. The inclusion of forward-looking statements should not be regarded as a representation by Evoke that any of its plans will be achieved. Actual results may differ from those set forth in this report due to the risks and uncertainties inherent in Evoke’s business, including, without limitation: Evoke’s ability to maintain intellectual property protection for GIMOTI; and other risks and uncertainties detailed in Evoke’s prior periodic reports it files with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Evoke undertakes no obligation to revise or update this report to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
April 26, 2022
|EVOKE PHARMA, INC.|
|Matthew J. D’Onofrio|
Executive Vice President,
Chief Business Officer and Secretary