Evoke Pharma's GIMOTI Patent Listed in FDA's Orange Book

Evoke Pharma announced the listing of a new patent for GIMOTI nasal spray in the FDA's Orange Book, covering its use in patients with moderate to severe gastroparesis symptoms. The company believes this demonstrates its commitment to developing innovative products and protecting its investment in innovation.

Evoke Pharma, Inc. (NASDAQ: EVOK) has announced the listing of a new U.S. patent (No. 12,377,064) in the FDA’s Orange Book, covering the use of its GIMOTI nasal spray in patients with moderate to severe gastroparesis symptoms. The patent, which was listed on August 21, 2025, extends protection until November 17, 2038, significantly beyond the previous expiration date of May 15, 2030 [1].

The listing of this patent is part of Evoke’s long-term strategy to maximize the commercial life of GIMOTI and support continued access for patients requiring a non-oral and effective treatment for diabetic gastroparesis. The extended patent protection provides a longer runway for return on investment, allowing Evoke to potentially recoup R&D costs and establish a stronger market share before facing generic competition [2].

The patent extension is particularly significant given the challenges of bringing novel therapies to market for gastrointestinal disorders. GIMOTI offers a non-oral delivery method for metoclopramide, potentially addressing patient compliance and absorption challenges associated with oral medications, especially in a condition where gastric emptying is delayed. This alternative route of administration distinguishes GIMOTI from existing oral and injectable metoclopramide formulations [2].

The success of this strategy hinges on continued clinical validation of GIMOTI’s efficacy and safety, along with effective market penetration. Evoke will need to demonstrate the clinical advantages of its nasal formulation over existing options to justify potential premium pricing and secure preferred formulary placement. The company must also address the ongoing safety concerns associated with metoclopramide, including the risk of tardive dyskinesia, to maintain patient and physician confidence. Further post-marketing surveillance data and comparative effectiveness studies will be key factors influencing long-term adoption and the ultimate return on this extended patent protection [2].

Evoke Pharma, a specialty pharmaceutical company focused primarily on the development of drugs to treat gastrointestinal disorders and diseases, 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 [1].

References:

[1] https://www.biospace.com/press-releases/evoke-pharma-announces-listing-of-new-gimoti-patent-in-fda-orange-book

[2] https://www.clinicaltrialvanguard.com/news/evoke-pharma-gimoti-patent-listed-in-fda-orange-book/