Madrigal Pharmaceuticals Receives Notice of Allowance from U.S. Patent and Trademark Office for New U.S. Patent Covering Rezdiffra™ (Resmetirom)
Madrigal Pharmaceuticals (NASDAQ:MDGL) has received a Notice of Allowance from the USPTO for a new patent covering Rezdiffra™ (resmetirom), their FDA-approved treatment for adults with noncirrhotic MASH with moderate to advanced liver fibrosis.
The patent, which will be listed in the FDA's Orange Book, provides protection through September 30, 2044. It specifically covers Rezdiffra's commercial weight-threshold dosing regimen as prescribed in the FDA-approved label. This development strengthens Madrigal's market position as the provider of the first and only FDA-approved treatment for MASH (also known as NASH).
Madrigal Pharmaceuticals (NASDAQ:MDGL) ha ricevuto un Avviso di Concessione dall'USPTO per un nuovo brevetto relativo a Rezdiffra™ (resmetirom), il loro trattamento approvato dalla FDA per adulti con MASH non cirrotico e fibrosi epatica da moderata a avanzata.
Il brevetto, che sarà inserito nell'Orange Book della FDA, garantisce protezione fino al 30 settembre 2044. Copre specificamente il regime di dosaggio commerciale basato sul peso di Rezdiffra, come indicato nell'etichetta approvata dalla FDA. Questo sviluppo rafforza la posizione di Madrigal nel mercato come fornitore del primo e unico trattamento approvato dalla FDA per il MASH (noto anche come NASH).
Madrigal Pharmaceuticals (NASDAQ:MDGL) ha recibido un Aviso de Concesión por parte de la USPTO para una nueva patente que cubre Rezdiffra™ (resmetirom), su tratamiento aprobado por la FDA para adultos con MASH no cirrótico y fibrosis hepática de moderada a avanzada.
La patente, que será incluida en el Orange Book de la FDA, ofrece protección hasta el 30 de septiembre de 2044. Cubre específicamente el régimen de dosificación comercial basado en el peso de Rezdiffra, tal como se prescribe en la etiqueta aprobada por la FDA. Este avance fortalece la posición de Madrigal en el mercado como proveedor del primer y único tratamiento aprobado por la FDA para MASH (también conocido como NASH).
Madrigal Pharmaceuticals (NASDAQ:MDGL)가 비간경변성 중등도에서 중증 간섬유증을 동반한 성인 MASH 치료제로 FDA 승인을 받은 Rezdiffra™ (resmetirom)에 대한 새로운 특허에 대해 USPTO로부터 허가통지서를 받았습니다.
이 특허는 FDA의 오렌지 북에 등재될 예정이며, 2044년 9월 30일까지 보호를 제공합니다. 특허는 FDA 승인 라벨에 명시된 Rezdiffra의 체중 기준 상업용 투여 요법을 구체적으로 포함합니다. 이 발전은 MASH(일명 NASH)에 대해 FDA 승인된 최초이자 유일한 치료제를 제공하는 Madrigal의 시장 입지를 강화합니다.
Madrigal Pharmaceuticals (NASDAQ:MDGL) a reçu un avis d'acceptation de la part de l'USPTO pour un nouveau brevet couvrant Rezdiffra™ (resmetirom), leur traitement approuvé par la FDA pour les adultes atteints de MASH non cirrhotique avec fibrose hépatique modérée à avancée.
Le brevet, qui sera inscrit dans l'Orange Book de la FDA, offre une protection jusqu'au 30 septembre 2044. Il couvre spécifiquement le schéma posologique commercial basé sur le poids de Rezdiffra, tel que prescrit dans l'étiquette approuvée par la FDA. Ce développement renforce la position de Madrigal sur le marché en tant que fournisseur du premier et unique traitement approuvé par la FDA pour le MASH (également connu sous le nom de NASH).
Madrigal Pharmaceuticals (NASDAQ:MDGL) hat von der USPTO eine Zulassungsmitteilung für ein neues Patent erhalten, das Rezdiffra™ (Resmetirom) abdeckt, ihre von der FDA zugelassene Behandlung für Erwachsene mit nicht-zirrhotischer MASH und mittelschwerer bis fortgeschrittener Leberfibrose.
Das Patent, das im FDA Orange Book aufgeführt wird, bietet Schutz bis zum 30. September 2044. Es umfasst speziell das kommerzielle Gewichts-basierte Dosierungsschema von Rezdiffra, wie im FDA-zugelassenen Etikett vorgeschrieben. Diese Entwicklung stärkt Madrigals Marktposition als Anbieter der ersten und einzigen von der FDA zugelassenen Behandlung für MASH (auch bekannt als NASH).
- Patent protection secured until September 2044
- Patent will be listed in FDA's Orange Book, providing additional market exclusivity
- Protects commercial dosing regimen of first and only FDA-approved MASH treatment
- None.
• Provides Protection Through Sept. 2044; Will Be Listed in FDA’s Orange Book
CONSHOHOCKEN, Pa., July 16, 2025 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ: MDGL), a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), today announced that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance covering the FDA-approved use of Rezdiffra™ (resmetirom), the first and only FDA-approved treatment for adults with noncirrhotic MASH (also known as NASH) with moderate to advanced liver fibrosis.
The Notice of Allowance includes claims directed to Rezdiffra’s commercial weight-threshold dosing regimen as prescribed in the FDA-approved label. The U.S. patent scheduled to issue from this application provides protection through Sept. 30, 2044, and will be listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book.
“This issuance marks a pivotal milestone in our long-term Rezdiffra strategy,” said Bill Sibold, Chief Executive Officer of Madrigal. “It recognizes the value of our pioneering clinical development program and will allow our team to continue driving innovation for patients with MASH for years to come.”
About Madrigal Pharmaceuticals
Madrigal Pharmaceuticals, Inc. (Nasdaq: MDGL) is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a liver disease with high unmet medical need. Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. Rezdiffra is the first and only medication approved by the FDA for the treatment of MASH with moderate to advanced fibrosis (consistent with stages F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (consistent with stage F4c). For more information, visit www.madrigalpharma.com.
Forward-Looking Statements
This press release includes “forward-looking statements” made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended, including statements related to the expected benefit of the new patent, when issued, and Rezdiffra’s role as a potential foundational therapy for the treatment of MASH. Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to: the assumptions underlying the forward-looking statements; risks of obtaining and maintaining regulatory approvals, including, but not limited to, potential regulatory delays or rejections; the challenges with the commercial launch of a new product, particularly for a company that did not have commercial experience prior to 2024; our history of operating losses and the possibility that we may never achieve or maintain profitability; risks associated with meeting the objectives of Madrigal’s clinical trials, including, but not limited to Madrigal’s ability to achieve enrollment objectives concerning patient numbers (including an adequate safety database), outcomes objectives and/or timing objectives for Madrigal’s trials; any delays or failures in enrollment, and the occurrence of adverse safety events; risks related to the effects of Rezdiffra’s (resmetirom’s) mechanism of action; market demand for and acceptance of Rezdiffra; the potential inability to raise sufficient capital to fund ongoing operations as currently planned or to obtain financing on acceptable terms; our ability to service indebtedness and otherwise comply with debt covenants; outcomes or trends from competitive trials; future topline data timing or results; our ability to prevent and/or mitigate cyber-attacks; the uncertainties inherent in clinical testing; uncertainties concerning analyses or assessments outside of a controlled clinical trial; and changes in laws and regulations applicable to our business and our ability to comply with such laws and regulations. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Madrigal undertakes no obligation to update any forward-looking statements to reflect new information, events, or circumstances after the date they are made, or to reflect the occurrence of unanticipated events. Please refer to Madrigal’s submissions filed with the U.S. Securities and Exchange Commission (“SEC”), for more detailed information regarding these risks and uncertainties and other factors that may cause actual results to differ materially from those expressed or implied. Madrigal specifically discusses these risks and uncertainties in greater detail in the sections appearing in Part I, Item 1A of its Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on February 26, 2025, and as updated from time to time by Madrigal’s other filings with the SEC.
Investor Contact
Tina Ventura, IR@madrigalpharma.com
Media Contact
Christopher Frates, media@madrigalpharma.com
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