Madrigal Pharmaceuticals Receives Notice of Allowance from U.S. Patent and Trademark Office for New U.S. Patent Covering Rezdiffraā� (Resmetirom)
Madrigal Pharmaceuticals (NASDAQ:MDGL) has received a Notice of Allowance from the USPTO for a new patent covering Rezdiffraā� (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 Rezdiffraā� (resmetirom), il loro trattamento approvato dalla FDA per adulti con MASH non cirrotico e fibrosi epatica da moderata a avanzata.
Il brevetto, che sarĆ 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 ConcesiĆ³n por parte de la USPTO para una nueva patente que cubre Rezdiffraā� (resmetirom), su tratamiento aprobado por la FDA para adultos con MASH no cirrĆ³tico y fibrosis hepĆ”tica de moderada a avanzada.
La patente, que serĆ” incluida en el Orange Book de la FDA, ofrece protecciĆ³n hasta el 30 de septiembre de 2044. Cubre especĆficamente el rĆ©gimen de dosificaciĆ³n comercial basado en el peso de Rezdiffra, tal como se prescribe en la etiqueta aprobada por la FDA. Este avance fortalece la posiciĆ³n de Madrigal en el mercado como proveedor del primer y Ćŗnico tratamiento aprobado por la FDA para MASH (tambiĆ©n conocido como NASH).
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ģ� ķ¹ķė� FDAģ� ģ¤ė ģ§ ė¶ģ ė±ģ¬ė� ģģ ģ“ė©°, 2044ė � 9ģ� 30ģ�ź¹ģ§ ė³“ķøė„� ģ ź³µķ©ėė�. ķ¹ķė� FDA ģ¹ģø ė¼ė²Øģ� ėŖ ģė� Rezdiffraģ� ģ²“ģ¤ źø°ģ¤ ģģ ģ� ķ¬ģ¬ ģė²ģ� źµ¬ģ²“ģ ģ¼ė”� ķ¬ķØķ©ėė�. ģ� ė°ģ ģ MASH(ģ¼ėŖ NASH)ģ� ėķ� FDA ģ¹ģøė� ģµģ“ģ“ģ ģ ģ¼ķ� ģ¹ė£ģ ė„¼ ģ ź³µķė Madrigalģ� ģģ„ ģ ģ§ė„� ź°ķķ©ėė�.
Madrigal Pharmaceuticals (NASDAQ:MDGL) a reƧu un avis d'acceptation de la part de l'USPTO pour un nouveau brevet couvrant Rezdiffraā� (resmetirom), leur traitement approuvĆ© par la FDA pour les adultes atteints de MASH non cirrhotique avec fibrose hĆ©patique modĆ©rĆ©e Ć avancĆ©e.
Le brevet, qui sera inscrit dans l'Orange Book de la FDA, offre une protection jusqu'au 30 septembre 2044. Il couvre spƩcifiquement le schƩma posologique commercial basƩ sur le poids de Rezdiffra, tel que prescrit dans l'Ʃtiquette approuvƩe par la FDA. Ce dƩveloppement renforce la position de Madrigal sur le marchƩ en tant que fournisseur du premier et unique traitement approuvƩ par la FDA pour le MASH (Ʃgalement connu sous le nom de NASH).
Madrigal Pharmaceuticals (NASDAQ:MDGL) hat von der USPTO eine Zulassungsmitteilung fĆ¼r ein neues Patent erhalten, das Rezdiffraā� (Resmetirom) abdeckt, ihre von der FDA zugelassene Behandlung fĆ¼r Erwachsene mit nicht-zirrhotischer MASH und mittelschwerer bis fortgeschrittener Leberfibrose.
Das Patent, das im FDA Orange Book aufgefĆ¼hrt 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 stƤrkt Madrigals Marktposition als Anbieter der ersten und einzigen von der FDA zugelassenen Behandlung fĆ¼r 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.
ā� Provides Protection Through Sept. 2044; Will Be Listed in FDAās 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 Rezdiffraā� (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 Rezdiffraās 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 FDAās Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book.
āThis issuance marks a pivotal milestone in our long-term Rezdiffra strategy,ā� said Bill Sibold, Chief Executive Officer of Madrigal. āIt 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.ā�
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. Madrigalās medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-Ī² 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 .
Forward-Looking Statements
This press release includes āforward-looking statementsā� 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 Rezdiffraās 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 Madrigalās clinical trials, including, but not limited to Madrigalās ability to achieve enrollment objectives concerning patient numbers (including an adequate safety database), outcomes objectives and/or timing objectives for Madrigalās trials; any delays or failures in enrollment, and the occurrence of adverse safety events; risks related to the effects of Rezdiffraās (resmetiromās) 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 Madrigalās submissions filed with the U.S. Securities and Exchange Commission (āSECā�), 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 Madrigalās other filings with the SEC.
Investor Contact
Tina Ventura, [email protected]
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FAQ
When does Madrigal's new patent for Rezdiffra (MDGL) expire?
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