Evoke Pharma Announces Issuance of New Patent for GIMOTI With Extended Exclusivity to Late 2038
Evoke Pharma, Inc. recently announced the official issuance of a new US patent related to its product GIMOTI. The patent, US Patent No. 12,377,064, covers the use of intranasal metoclopramide in patients with moderate-to-severe symptoms of gastroparesis, and has now been issued by the United States Patent and Trademark Office (USPTO).
Importantly, the patent term has been extended by the USPTO to November 2038, due to patent term adjustments (PTA), extending market exclusivity for GIMOTI 2 years beyond the previously projected expiration in December 2036. The company plans to list this newly issued patent in the FDA’s Orange Book, further strengthening GIMOTI’s intellectual property position.
“We’re very pleased with the issuance of this important patent and the extension of exclusivity to November 2038, especially as we observe Gastroparesis Awareness Month,” said Matt D’Onofrio, CEO of Evoke Pharma. “This outcome meaningfully strengthens our intellectual property position around GIMOTI and reflects the rigor of our development efforts. With this longer protection period in place, we’re better positioned to support the product’s role in addressing the unique needs of patients with diabetic gastroparesis who require an effective non-oral treatment option.”
The patent’s claims cover methods of treating symptoms associated with gastroparesis by intranasal administration of metoclopramide specifically in patients with defined symptom severity. The company is continuing to pursue additional related claims via a continuation application.
As part of its ongoing support of the gastroparesis community, Evoke recognizes Gastroparesis Awareness Month this August and reaffirms its dedication to improving the lives of patients facing this often-debilitating condition.
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 to empty its contents resulting in serious GI symptoms as well as other systemic complications. The gastric delay caused by gastroparesis can compromise absorption of orally administered medications. Prior to FDA approval to commercially market GIMOTI, metoclopramide was only available in oral and injectable formulations and remains the only drug currently approved in the United States to treat gastroparesis. Visit www.EvokePharma.com for more information.
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