Evoke Pharma Receives Notice of Allowance for U.S. Patent Application for GIMOTI Extending Orange Book listings to 2036
Evoke Pharma (NASDAQ: EVOK) has received a Notice of Allowance from the USPTO for a patent application covering 骋滨惭翱罢滨庐 (metoclopramide nasal spray) use in moderate to severe gastroparesis patients. The new patent, upon issuance, will extend market exclusivity until December 2036 and will be listed in the FDA's Orange Book.
骋滨惭翱罢滨庐 is the only FDA-approved, non-oral, self-administered metoclopramide formulation for treating symptoms of acute and recurrent diabetic gastroparesis in adults. The treatment is particularly valuable as gastroparesis can impair the absorption of oral medications. The company has filed an additional U.S. continuation application for further claims related to this patient population.
Evoke Pharma (NASDAQ: EVOK) ha ricevuto un Avviso di Concessione dall'USPTO per una domanda di brevetto riguardante l'uso di 骋滨惭翱罢滨庐 (spray nasale a base di metoclopramide) nei pazienti con gastroparesi da moderata a grave. Il nuovo brevetto, una volta rilasciato, estender脿 l'esclusiva di mercato fino a dicembre 2036 e sar脿 inserito nell'Orange Book della FDA.
骋滨惭翱罢滨庐 猫 l'unica formulazione di metoclopramide approvata dalla FDA, non orale e auto-somministrata per il trattamento dei sintomi della gastroparesi diabetica acuta e ricorrente negli adulti. Il trattamento 猫 particolarmente importante poich茅 la gastroparesi pu貌 compromettere l'assorbimento dei farmaci orali. L'azienda ha inoltre presentato una domanda di continuazione negli Stati Uniti per ulteriori rivendicazioni relative a questa popolazione di pazienti.
Evoke Pharma (NASDAQ: EVOK) ha recibido un Aviso de Concesi贸n por parte de la USPTO para una solicitud de patente que cubre el uso de 骋滨惭翱罢滨庐 (spray nasal de metoclopramida) en pacientes con gastroparesia de moderada a grave. La nueva patente, una vez emitida, extender谩 la exclusividad en el mercado hasta diciembre de 2036 y ser谩 incluida en el Orange Book de la FDA.
骋滨惭翱罢滨庐 es la 煤nica formulaci贸n de metoclopramida aprobada por la FDA, no oral y auto-administrada para tratar los s铆ntomas de la gastroparesia diab茅tica aguda y recurrente en adultos. Este tratamiento es especialmente valioso ya que la gastroparesia puede afectar la absorci贸n de medicamentos orales. La compa帽铆a ha presentado adem谩s una solicitud de continuaci贸n en EE.UU. para reclamos adicionales relacionados con esta poblaci贸n de pacientes.
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Evoke Pharma (NASDAQ : EVOK) a re莽u un avis d'acceptation de l'USPTO pour une demande de brevet couvrant l'utilisation de 骋滨惭翱罢滨庐 (spray nasal de m茅toclopramide) chez les patients atteints de gastroparesie mod茅r茅e 脿 s茅v猫re. Le nouveau brevet, une fois d茅livr茅, prolongera l'exclusivit茅 commerciale jusqu'en d茅cembre 2036 et sera inscrit dans l'Orange Book de la FDA.
骋滨惭翱罢滨庐 est la seule formulation de m茅toclopramide approuv茅e par la FDA, non orale et auto-administr茅e pour traiter les sympt么mes de la gastroparesie diab茅tique aigu毛 et r茅currente chez l'adulte. Ce traitement est particuli猫rement pr茅cieux car la gastroparesie peut alt茅rer l'absorption des m茅dicaments oraux. La soci茅t茅 a 茅galement d茅pos茅 une demande am茅ricaine de continuation pour des revendications suppl茅mentaires concernant cette population de patients.
Evoke Pharma (NASDAQ: EVOK) hat von der USPTO eine Zulassungsmitteilung f眉r eine Patentanmeldung erhalten, die die Verwendung von 骋滨惭翱罢滨庐 (Metoclopramid-Nasenspray) bei Patienten mit mittelschwerer bis schwerer Gastroparese abdeckt. Das neue Patent wird nach Erteilung die Marktexklusivit盲t bis Dezember 2036 verl盲ngern und im Orange Book der FDA aufgef眉hrt.
骋滨惭翱罢滨庐 ist die einzige von der FDA zugelassene, nicht orale, selbst anzuwendende Metoclopramid-Formulierung zur Behandlung der Symptome der akuten und wiederkehrenden diabetischen Gastroparese bei Erwachsenen. Die Behandlung ist besonders wertvoll, da Gastroparese die Aufnahme oraler Medikamente beeintr盲chtigen kann. Das Unternehmen hat zudem eine weitere US-Fortsetzungsanmeldung f眉r zus盲tzliche Anspr眉che in Bezug auf diese Patientengruppe eingereicht.
- Patent extension provides market exclusivity until December 2036
- GIMOTI maintains unique position as only FDA-approved non-oral metoclopramide treatment
- Additional patent applications filed to further strengthen IP protection
- None.
Insights
Evoke's new patent allowance extends GIMOTI's market exclusivity to 2036, strengthening their commercial position in the gastroparesis treatment market.
Evoke Pharma has secured a significant intellectual property win with this Notice of Allowance from the USPTO. The patent application covers the use of GIMOTI庐 (intranasal metoclopramide) specifically for patients with moderate to severe gastroparesis symptoms. This extends the exclusivity period by an additional 6 years to December 2036, which substantially enhances the product's commercial lifecycle.
The strategic value here is considerable. By securing this patent and subsequently listing it in the FDA's Orange Book, Evoke creates a stronger barrier to generic competition, protecting their revenue stream for an extended period. This continuation of their existing patent (U.S. Patent No. 11,517,545) specifically reinforces protection around the method of use and target patient population.
What makes this particularly valuable is how it aligns with GIMOTI's unique positioning as a non-oral treatment for diabetic gastroparesis. The nasal spray delivery system addresses a fundamental challenge in treating this condition 鈥� the compromised gastric absorption of oral medications due to delayed gastric emptying, which is the hallmark of gastroparesis. This method-of-use patent strengthens Evoke's market position by protecting not just the formulation, but specifically how and for whom the therapy is prescribed.
The company's mention of an additional continuation application suggests they're implementing a layered patent strategy to maximize protection, which is standard practice for extending pharmaceutical product lifecycles. This patent allowance represents a material enhancement to GIMOTI's long-term commercial potential in the gastroparesis treatment market.
Extends patent exclusivity period an additional 6 years once granted
SOLANA BEACH, Calif., July 09, 2025 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused primarily on treatments for gastrointestinal (GI) diseases with an emphasis on 骋滨惭翱罢滨庐 (metoclopramide) nasal spray, today announced that it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for a U.S. patent application covering the use of 骋滨惭翱罢滨庐 in patients with moderate to severe symptoms of gastroparesis.
The allowed application is a continuation of U.S. Patent No. 11,517,545, and further expands Evoke鈥檚 intellectual property estate around intranasal metoclopramide. Upon issuance, the patent will be expected to expire in December 2036 and the company intends to list the patent in the FDA鈥檚 Orange Book, extending market exclusivity for 骋滨惭翱罢滨庐 beyond other existing patents.
鈥淭his new patent allowance adds meaningful value to the 骋滨惭翱罢滨庐 franchise by reinforcing protection around how and in whom the therapy is used,鈥� said Matt D鈥橭nofrio, CEO of Evoke Pharma. 鈥淏acked by extensive market research, GIMOTI continues to stand out as an effective non-oral treatment for a disease that can compromise the effectiveness of pills due to slowed gastric absorption of oral medications. We remain focused on maximizing GIMOTI鈥檚 potential as an effective patient-friendly treatment for diabetic gastroparesis.鈥�
Evoke Pharma has filed another U.S. continuation application to pursue additional claims directed to treatments for this patient population.
As part of its commitment to the gastroparesis community, Evoke is proud to support Gastroparesis Awareness Month this August, and recognizes the importance of improving treatment options and disease awareness for patients facing this chronic and often debilitating condition.
GIMOTI is the only FDA-approved, non-oral, self-administered formulation of metoclopramide and is indicated for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adults. Non-oral delivery is an important treatment option as gastroparesis causes oral medications to be unpredictably absorbed and is vulnerable to one of the key symptoms of the disease, vomiting.
About聽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聽the United States聽to treat gastroparesis.
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About Gimoti庐聽(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 (鈮�
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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 鈥渕ay,鈥� 鈥渨ill,鈥� 鈥渟hould,鈥� 鈥渆xpect,鈥� 鈥減lan,鈥� 鈥渁nticipate,鈥� 鈥渃ould,鈥� 鈥渋ntend,鈥� 鈥渢arget,鈥� 鈥減roject,鈥� 鈥渃ontemplates,鈥� 鈥渂elieves,鈥� 鈥渆stimates,鈥� 鈥減redicts,鈥� 鈥減otential鈥� or 鈥渃ontinue鈥� or the negatives of these terms or other similar expressions. These statements are based on the company鈥檚 current beliefs and expectations. These forward-looking statements include statements regarding: the timing of the USPTO granting the patent application and the Company鈥檚 plans to list the patent in the Orange Book and pursue additional claims directed to treatments for certain patient populations; and the additional value of the GIMOTI franchise as a result of the patent application. 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鈥檚 business, including, without limitation: Evoke鈥檚 ability to obtain and maintain intellectual property protection for GIMOTI and the FDA ultimately updating the Orange Book listing with the new patent; Evoke and EVERSANA may not be able to successfully drive market demand for GIMOTI; the results of market research studies may not predict acceptance by patients, healthcare providers or payors; Evoke is entirely dependent on the success of GIMOTI; inadequate efficacy or unexpected adverse side effects relating to GIMOTI that could result in recalls or product liability claims; and other risks and uncertainties detailed in Evoke鈥檚 prior press releases and in the periodic reports it files with the聽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
FAQ
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