Evoke Pharma Announces Issuance of New U.S. Patent for GIMOTI With Extended Exclusivity to Late 2038
Evoke Pharma (NASDAQ: EVOK) has secured a new U.S. patent (No. 12,377,064) for its product 骋滨惭翱罢滨庐, 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.
Evoke Pharma (NASDAQ: EVOK) ha ottenuto un nuovo brevetto negli Stati Uniti (n. 12.377.064) per il suo prodotto 骋滨惭翱罢滨庐, uno spray nasale per il trattamento della gastroparesi. L'Ufficio Brevetti e Marchi degli Stati Uniti ha esteso la durata del brevetto fino a novembre 2038, garantendo quasi due anni in pi霉 di esclusiva di mercato rispetto alla precedente scadenza di dicembre 2036.
Il brevetto copre specificamente l'uso del metoclopramide per via intranasale in pazienti con sintomi da moderati a gravi di gastroparesi. L'azienda intende registrare questo brevetto nel Orange Book della FDA per rafforzare la posizione della propriet脿 intellettuale di GIMOTI e sta perseguendo ulteriori rivendicazioni correlate tramite una domanda di continuazione.
Evoke Pharma (NASDAQ: EVOK) ha asegurado una nueva patente en EE.UU. (No. 12,377,064) para su producto 骋滨惭翱罢滨庐, un spray nasal para el tratamiento de la gastroparesia. La Oficina de Patentes y Marcas de los Estados Unidos ha extendido el plazo de la patente hasta noviembre de 2038, proporcionando casi dos a帽os adicionales de exclusividad en el mercado m谩s all谩 de la expiraci贸n previa en diciembre de 2036.
La patente cubre espec铆ficamente el uso de metoclopramida intranasal para pacientes con s铆ntomas moderados a severos de gastroparesia. La compa帽铆a planea incluir esta patente en el Orange Book de la FDA para fortalecer la posici贸n de propiedad intelectual de GIMOTI y est谩 buscando reclamos adicionales relacionados mediante una solicitud de continuaci贸n.
Evoke Pharma (NASDAQ: EVOK)臧� 鞙勲牍� 旃橂鞖� 牍勱皶 鞀ろ攧霠堨澊 鞝滍拡 骋滨惭翱罢滨庐鞐� 雽�頃� 氙戈淡 韸鬼棃(No. 12,377,064)毳� 靸堧 旆摑頄堨姷雼堧嫟. 氙戈淡 韸鬼棃觳潃 韸鬼棃 旮瓣皠鞚� 2038雲� 11鞗�旯岇 鞐办灔頃橃棳 旮办〈 2036雲� 12鞗� 毵岆鞚茧炒雼� 瓯办潣 2雲� 雿� 鞁滌灔 霃呾爯甓岇潉 頇曤炒頄堨姷雼堧嫟.
鞚� 韸鬼棃電� 欷戨摫霃勳棎靹� 欷戩 鞙勲牍� 歃濎儊鞚� 臧�歆� 頇橃瀽鞐愱矊 牍勱皶 雮� 氅旐啝韥措頂勲澕氙鸽摐 靷毄鞚� 甑泊鞝侅溂搿� 氤错樃頃╇媹雼�. 須岇偓電� 鞚� 韸鬼棃毳� FDA鞚� 鞓る爩歆� 攵侅棎 霌膘灛頃橃棳 GIMOTI鞚� 歆�鞝� 鞛偘甓岇潉 臧曧檾頃� 瓿勴殟鞚措┌, 瓿勳啀 於滌洂鞙茧 於旉皜 甏�霠� 觳惮霃� 歆勴枆 欷戩瀰雼堧嫟.
Evoke Pharma (NASDAQ : EVOK) a obtenu un nouveau brevet am茅ricain (n掳 12 377 064) pour son produit 骋滨惭翱罢滨庐, un spray nasal destin茅 au traitement de la gastroparesie. L'Office des brevets et des marques des 脡tats-Unis a prolong茅 la dur茅e du brevet jusqu'en novembre 2038, offrant pr猫s de deux ann茅es suppl茅mentaires d'exclusivit茅 commerciale par rapport 脿 la date d'expiration pr茅c茅dente en d茅cembre 2036.
Le brevet couvre sp茅cifiquement l'utilisation du m茅toclopramide par voie intranasale chez les patients pr茅sentant des sympt么mes mod茅r茅s 脿 s茅v猫res de gastroparesie. L'entreprise pr茅voit d'inscrire ce brevet dans le Orange Book de la FDA afin de renforcer la protection de la propri茅t茅 intellectuelle de GIMOTI et poursuit des revendications suppl茅mentaires connexes via une demande de continuation.
Evoke Pharma (NASDAQ: EVOK) hat ein neues US-Patent (Nr. 12.377.064) f眉r sein Produkt 骋滨惭翱罢滨庐, ein Nasenspray zur Behandlung der Gastroparese, erhalten. Das US-Patent- und Markenamt hat die Patentlaufzeit bis November 2038 verl盲ngert und gew盲hrt damit fast zwei zus盲tzliche Jahre Marktexklusivit盲t 眉ber das bisherige Ablaufdatum im Dezember 2036 hinaus.
Das Patent deckt speziell die Anwendung von intranasalem Metoclopramid bei Patienten mit mittelschweren bis schweren Symptomen der Gastroparese ab. Das Unternehmen plant, dieses Patent im Orange Book der FDA einzutragen, um die geistigen Eigentumsrechte von GIMOTI zu st盲rken, und verfolgt weitere verwandte Anspr眉che durch eine Fortsetzungsanmeldung.
- 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
- None.
Insights
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 骋滨惭翱罢滨庐 (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 骋滨惭翱罢滨庐 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庐 (metoclopramide) nasal spray, today announced the official issuance of a new U.S. patent related to its product GIMOTI庐. 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庐 two years beyond the previously projected expiration in December 2036. The Company plans to list this newly issued patent in the FDA鈥檚 Orange Book, further strengthening GIMOTI鈥檚 intellectual property position.
鈥淲e鈥檙e very pleased with the issuance of this important patent and the extension of exclusivity to November 2038, especially as we observe Gastroparesis Awareness Month,鈥� said Matt D鈥橭nofrio, CEO of Evoke Pharma. 鈥淭his 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鈥檙e better positioned to support the product鈥檚 role in addressing the unique needs of patients with diabetic gastroparesis who require an effective non-oral treatment option.鈥�
The patent鈥檚 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.
痴颈蝉颈迟听聽for more information.
Follow聽Evoke Pharma聽on聽
Follow聽Evoke Pharma聽on聽
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�
痴颈蝉颈迟听聽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 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 updated listing in the Orange Book and the Company鈥檚 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鈥檚 business, including, without limitation: Evoke鈥檚 ability to maintain or expand intellectual property protection for GIMOTI; 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
When does Evoke Pharma's new GIMOTI patent expire?
What does Evoke Pharma's new GIMOTI patent cover?
What is EVOK's plan for the new GIMOTI patent?
How does the new patent benefit Evoke Pharma (EVOK)?
