Evoke Pharma Announces Issuance of New U.S. Patent for GIMOTI With Extended Exclusivity to Late 2038

Rhea-AI Summary

Evoke Pharma (NASDAQ: EVOK) has secured a new U.S. patent (No. 12,377,064) for its product GIMOTI®, a nasal spray treatment for gastroparesis. The United States Patent and Trademark Office has extended the patent term to November 2038, providing nearly two additional years of market exclusivity beyond the previous December 2036 expiration.

The patent specifically covers the use of intranasal metoclopramide for patients with moderate to severe gastroparesis symptoms. The company plans to list this patent in the FDA's Orange Book to strengthen GIMOTI's intellectual property position and is pursuing additional related claims through a continuation application.

Positive

• Patent term extended to November 2038, providing 2 additional years of market exclusivity
• New patent strengthens intellectual property protection for GIMOTI
• Opportunity to pursue additional related claims via continuation application

Negative

• None.

Insights

Pharmaceutical Patent Analyst

Evoke Pharma secures extended market exclusivity for GIMOTI until 2038, strengthening its commercial position in the gastroparesis treatment market.

Evoke Pharma has secured a significant intellectual property victory with the issuance of U.S. Patent No. 12,377,064 for GIMOTI® (metoclopramide) nasal spray. This new patent specifically covers the intranasal administration of metoclopramide for patients with moderate to severe gastroparesis symptoms - a critical distinction that helps protect the company's unique delivery method.

The most valuable aspect of this development is the patent term adjustment (PTA) granted by the USPTO, extending GIMOTI's market exclusivity to November 2038 - nearly two years beyond the previously expected December 2036 expiration. This extension represents substantial additional revenue potential during those years when GIMOTI can be marketed without generic competition.

The planned listing in the FDA's Orange Book is particularly significant as it formally notifies potential competitors about the patent protection, creating a stronger barrier to generic entry. The company's mention of pursuing additional related claims via continuation applications suggests a comprehensive strategy to build multiple layers of patent protection.

For context, gastroparesis is a chronic condition that slows or stops the movement of food from the stomach to the small intestine, commonly affecting diabetic patients. GIMOTI's nasal spray formulation bypasses the compromised GI tract, offering an alternative to oral medications that may be ineffective in these patients.

This patent strengthening comes at a strategic time during Gastroparesis Awareness Month, potentially amplifying the marketing narrative around GIMOTI as a specialized solution for this underserved patient population.

Extends market exclusivity for GIMOTI® to November 2038, nearly two additional years beyond original 2036 projection

SOLANA BEACH, Calif., Aug. 06, 2025 (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, today announced the official issuance of a new U.S. patent related to its product GIMOTI^®. The patent, U.S. 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^® two 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.

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 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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About Gimoti^® (metoclopramide) nasal spray

GIMOTI is indicated for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis. Important Safety Information:

WARNING: TARDIVE DYSKINESIA

• Metoclopramide can cause tardive dyskinesia (TD), a serious movement disorder that is often irreversible. The risk of developing TD increases with duration of treatment and total cumulative dosage.
• Discontinue GIMOTI in patients who develop signs or symptoms of TD. In some patients, symptoms may lessen or resolve after metoclopramide is stopped.
• Avoid treatment with metoclopramide (all dosage forms and routes of administration) for longer than 12 weeks because of the increased risk of developing TD with longer-term use.
  

GIMOTI is not recommended for use in:

• Pediatric patients due to the risk of developing tardive dyskinesia (TD) and other extrapyramidal symptoms as well as the risk of methemoglobinemia in neonates.
• Moderate or severe hepatic impairment (Child-Pugh B or C), moderate or severe renal impairment (creatinine clearance less than 60 mL/minute), and patients concurrently using strong CYP2D6 inhibitors due to the risk of increased drug exposure and adverse reactions.

GIMOTI is contraindicated:

• In patients with a history of tardive dyskinesia (TD) or a dystonic reaction to metoclopramide.
• When stimulation of gastrointestinal motility might be dangerous (e.g., in the presence of gastrointestinal hemorrhage mechanical obstruction, or perforation).
• In patients with pheochromocytoma or other catecholamine-releasing paragangliomas. Metoclopramide may cause a hypertensive/pheochromocytoma crisis, probably due to release of catecholamines from the tumor.
• In patients with epilepsy. Metoclopramide may increase the frequency and severity of seizures.
• In patients with hypersensitivity to metoclopramide. Reactions have included laryngeal and glossal angioedema and bronchospasm.
  

Potential adverse reactions associated with metoclopramide include: Tardive dyskinesia (TD), other extrapyramidal effects (EPS), parkinsonism symptoms, motor restlessness, neuroleptic malignant syndrome (NMS), depression, suicidal ideation and suicide, hypertension, fluid retention, hyperprolactinemia, effects on the ability to drive and operate machinery. Most common adverse reactions (≥5%) for GIMOTI are: dysgeusia, headache, and fatigue. These are not all of the possible side effects of GIMOTI. Call your doctor for medical advice about whether you should take GIMOTI and the possible risk factors and side effects. You are encouraged to report negative side effects of prescription drugs to the FDA.

Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Safe Harbor Statement

Evoke cautions you that statements included in this press release 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 timing of updated listing in the Orange Book and the Company’s plans to pursue additional intellectual property protections via a continuation application or otherwise. 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 press release due to the risks and uncertainties inherent in Evoke’s business, including, without limitation: Evoke’s ability to maintain or expand intellectual property protection for GIMOTI; and other risks and uncertainties detailed in Evoke’s prior press releases and in the 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 press release 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.

Investor & Media Contact:
Daniel Kontoh-Boateng
DKB Partners
Tel: 862-213-1398
dboateng@dkbpartners.net

FAQ

When does Evoke Pharma's new GIMOTI patent expire?

The new patent for GIMOTI extends market exclusivity until November 2038, which is two years beyond the previous December 2036 expiration date.

What does Evoke Pharma's new GIMOTI patent cover?

The patent covers the use of intranasal metoclopramide specifically for treating patients with moderate to severe symptoms of gastroparesis.

What is EVOK's plan for the new GIMOTI patent?

Evoke Pharma plans to list the patent in the FDA's Orange Book and is pursuing additional related claims through a continuation application.

How does the new patent benefit Evoke Pharma (EVOK)?

The patent strengthens GIMOTI's intellectual property position and extends market exclusivity by two years, better positioning the company to support gastroparesis patients requiring non-oral treatment.