Evoke Pharma Announces Listing of New GIMOTI庐 Patent in FDA Orange Book
Evoke Pharma (NASDAQ: EVOK) has announced the listing of a new patent (U.S. Patent No. 12,377,064) for GIMOTI庐 (metoclopramide) nasal spray in the FDA's Orange Book. The patent covers the use of GIMOTI庐 in treating patients with moderate to severe gastroparesis symptoms.
The newly listed patent extends protection until November 17, 2038, approximately eight years beyond their previous patent expiration date of May 15, 2030. This strategic move strengthens Evoke's position in providing non-oral treatment options for diabetic gastroparesis while protecting their innovation investment.
Evoke Pharma (NASDAQ: EVOK) ha annunciato l'inserimento di un nuovo brevetto (U.S. Patent No. 12,377,064) per il spray nasale GIMOTI庐 (metoclopramide) nell'Orange Book della FDA. Il brevetto riguarda l'uso di GIMOTI庐 nel trattamento dei pazienti con sintomi da moderati a gravi di gastroparesi.
Il brevetto appena registrato estende la protezione fino al 17 novembre 2038, circa otto anni oltre la precedente scadenza del 15 maggio 2030. Questa mossa strategica rafforza la posizione di Evoke nel fornire opzioni di trattamento non orali per la gastroparesi diabetica, proteggendo al contempo l'investimento nell'innovazione.
Evoke Pharma (NASDAQ: EVOK) ha anunciado la inclusi贸n de una nueva patente (U.S. Patent No. 12,377,064) para el aerosol nasal GIMOTI庐 (metoclopramida) en el Orange Book de la FDA. La patente cubre el uso de GIMOTI庐 en el tratamiento de pacientes con s铆ntomas de gastroparesia de moderados a severos.
La patente recientemente listada extiende la protecci贸n hasta el 17 de noviembre de 2038, aproximadamente ocho a帽os m谩s all谩 de la fecha de vencimiento anterior del 15 de mayo de 2030. Este movimiento estrat茅gico refuerza la posici贸n de Evoke al ofrecer opciones de tratamiento no orales para la gastroparesia diab茅tica, protegiendo su inversi贸n en innovaci贸n.
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Evoke Pharma (NASDAQ: EVOK) a annonc茅 l'inscription d'un nouveau brevet (U.S. Patent No. 12,377,064) pour le spray nasal GIMOTI庐 (m茅toclopramide) dans l'Orange Book de la FDA. Le brevet couvre l'utilisation de GIMOTI庐 pour traiter des patients pr茅sentant des sympt么mes mod茅r茅s 脿 s茅v猫res de gastroparesie.
Le brevet r茅cemment inscrit 茅tend la protection jusqu'au 17 novembre 2038, soit environ huit ans de plus que la date d'expiration pr茅c茅dente du 15 mai 2030. Cette d茅cision strat茅gique renforce la position d'Evoke dans l'offre d'options de traitement non orales pour la gastroparesie diab茅tique, tout en prot茅geant son investissement en innovation.
Evoke Pharma (NASDAQ: EVOK) hat die Eintragung eines neuen Patents (U.S. Patent No. 12,377,064) f眉r das GIMOTI庐 (Metoclopramid) Nasenspray im Orange Book der FDA bekanntgegeben. Das Patent deckt die Anwendung von GIMOTI庐 zur Behandlung von Patienten mit m盲脽igen bis schweren Symptomen der Gastroparese ab.
Das neu eingetragene Patent verl盲ngert den Schutz bis zum 17. November 2038, also etwa acht Jahre 眉ber das vorherige Ablaufdatum am 15. Mai 2030 hinaus. Dieser strategische Schritt st盲rkt Evokes Position bei nicht-oralen Behandlungsoptionen f眉r diabetische Gastroparese und sch眉tzt zugleich die Investition in die Innovation.
- Patent protection extended by 8 years until November 2038
- Enhanced intellectual property protection for GIMOTI庐 nasal spray
- Strengthened market position in gastroparesis treatment
- None.
SOLANA BEACH, Calif., Aug. 21, 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 that U.S. Patent No. 12,377,064 covering the use of GIMOTI庐 (metoclopramide) nasal spray in patients with moderate to severe symptoms of gastroparesis, has been listed in the U.S. Food and Drug Administration鈥檚 (FDA) Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the 鈥淥range Book鈥�.
鈥淲e believe the listed patent shows our commitment to developing innovative products that expand options for patients and providers, while also protecting our hard work and investment in innovation,鈥� said Matt D鈥橭nofrio, Chief Executive Officer of Evoke Pharma.
The newly listed patent has an expected expiration date of November 17, 2038, which is approximately eight years past our prior last to expire Orange Book listed patent of May 15, 2030. The newly listed patent reinforces Evoke鈥檚 long-term strategy to maximize GIMOTI鈥檚 commercial life and support continued access for patients requiring a non-oral and effective treatment for diabetic gastroparesis, while protecting Evoke鈥檚 investment in innovation.
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 expected patent term exclusivity for GIMOTI and potential benefits related thereto. 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
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