Evoke Pharma has secured a new U.S. patent (No. 12,377,064) for the use of its GIMOTI (metoclopramide) nasal spray in patients with moderate to severe gastroparesis symptoms. The patent, listed in the FDA’s Orange Book, extends protection until November 17, 2038—significantly beyond the previous expiration date of May 15, 2030.
This move reinforces Evoke’s strategy to maximize GIMOTI’s commercial lifecycle, particularly crucial given the challenges of bringing novel therapies to market for gastrointestinal disorders. 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. It also signals Evoke’s confidence in GIMOTI’s long-term market viability.
The patent extension arrives as the landscape for gastroparesis treatments remains relatively limited. 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.
This development significantly impacts Evoke’s competitive positioning. The longer patent life creates a barrier to entry for generic competitors, providing Evoke with a substantial period of market exclusivity. This strengthens the company’s negotiating position with payers and could lead to wider formulary inclusion for GIMOTI. However, Evoke will likely face increased scrutiny regarding pricing strategies during this extended exclusivity period.
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.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
