EVOK - Evoke Pharma Announces FDA Orange Book Listing of New GIMOTI Patent | Benzinga
SOLANA BEACH, Calif., Nov. 27, 2023 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ:EVOK), a specialty pharmaceutical company focused primarily on treatments for gastrointestinal (GI) diseases with an emphasis on GIMOTI® (metoclopramide) nasal spray, announced that its recently issued U.S. patent related to GIMOTI, No. 11,813,231 is now listed in the U.S. Food and Drug Administration (FDA) publication, "Approved Drug Products with Therapeutic Equivalence Evaluations", commonly known as the "Orange Book".
The patent titled "Nasal Formulations of Metoclopramide" covers a collection of nasal solutions of metoclopramide and its characteristics when formulated. This new patent is now listed in the FDA's Orange Book and carries a patent term to 2029. The listing of the patent in the Orange Book adds additional patent protection for GIMOTI beyond the prior three listed patents.
"Due to our relentless efforts to continuously realize the significant commercial potential of GIMOTI and the need for an improved treatment solution for diabetic gastroparesis, our IP portfolio now boasts an impressive set of patents and four FDA Orange Book listings," commented Matt D'Onofrio, President and Chief Operating Officer of Evoke Pharma. "We are proud to have achieved this milestone as we aim to redefine the standard for gastroparesis treatment by providing GIMOTI, a direct route to deliver medication leading to less hospitalizations than oral metoclopramide."
Patents listed in the Orange Book cover drugs that the FDA has approved and deemed both safe and effective for the general public's use. Inclusion in the book's list of patents can make it easier for drug makers to monitor for new generic drugs that could potentially arrive on the U.S. market and infringe on their patents.
About Evoke Pharma, Inc.
Evoke is a specialty pharmaceutical company focused primarily on the development of drugs to treat GI disorders and diseases. The company developed, commercialized and markets GIMOTI, a nasal spray formulation of metoclopramide, for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adults. Diabetic gastroparesis is a GI disorder affecting millions of patients worldwide, in which the stomach takes too long ...