Esperion Reaches Settlement Agreement with Third ANDA Filer Not to Market Generic Version of NEXLETOL庐 (bempedoic acid) Prior to April 19, 2040
Esperion (NASDAQ: ESPR) has reached a settlement agreement with Accord Healthcare Inc. regarding patent litigation over NEXLETOL, a bempedoic acid medication. Under the agreement, Accord Healthcare has committed not to market a generic version of NEXLETOL in the United States before April 19, 2040, except under specific limited circumstances.
The company continues to pursue patent litigation against several other defendants, including Alkem Laboratories, Aurobindo Pharma, Dr. Reddy's Laboratories, MSN Pharmaceuticals, Renata Limited, and Sandoz. The outcome of these ongoing patent disputes remains uncertain regarding potential generic versions of NEXLETOL and NEXLIZET entering the U.S. market before 2040.
Esperion (NASDAQ: ESPR) ha raggiunto un accordo di transazione con Accord Healthcare Inc. riguardo a una controversia brevettuale su NEXLETOL, un farmaco a base di acido bempedoico. Secondo l'accordo, Accord Healthcare si impegna a non commercializzare una versione generica di NEXLETOL negli Stati Uniti prima del 19 aprile 2040, salvo circostanze specifiche e limitate.
L'azienda continua a portare avanti cause brevettuali contro altri imputati, tra cui Alkem Laboratories, Aurobindo Pharma, Dr. Reddy's Laboratories, MSN Pharmaceuticals, Renata Limited e Sandoz. L'esito di queste controversie brevettuali in corso rimane incerto riguardo alla possibile introduzione sul mercato statunitense di versioni generiche di NEXLETOL e NEXLIZET prima del 2040.
Esperion (NASDAQ: ESPR) ha llegado a un acuerdo de conciliaci贸n con Accord Healthcare Inc. en relaci贸n con una disputa por patentes sobre NEXLETOL, un medicamento con 谩cido bempedoico. Seg煤n el acuerdo, Accord Healthcare se compromete a no comercializar una versi贸n gen茅rica de NEXLETOL en Estados Unidos antes del 19 de abril de 2040, salvo en circunstancias limitadas y espec铆ficas.
La compa帽铆a contin煤a con litigios por patentes contra varios otros demandados, incluyendo a Alkem Laboratories, Aurobindo Pharma, Dr. Reddy's Laboratories, MSN Pharmaceuticals, Renata Limited y Sandoz. El resultado de estas disputas en curso es incierto respecto a la posible entrada de versiones gen茅ricas de NEXLETOL y NEXLIZET en el mercado estadounidense antes de 2040.
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Esperion (NASDAQ : ESPR) a conclu un accord de r猫glement avec Accord Healthcare Inc. concernant un litige sur le brevet de NEXLETOL, un m茅dicament 脿 base d'acide bemp茅do茂que. Selon cet accord, Accord Healthcare s'engage 脿 ne pas commercialiser une version g茅n茅rique de NEXLETOL aux 脡tats-Unis avant le 19 avril 2040, sauf dans des circonstances sp茅cifiques et limit茅es.
L'entreprise poursuit 茅galement des actions en justice pour brevets contre plusieurs autres d茅fendeurs, notamment Alkem Laboratories, Aurobindo Pharma, Dr. Reddy's Laboratories, MSN Pharmaceuticals, Renata Limited et Sandoz. L'issue de ces litiges en cours reste incertaine quant 脿 l'茅ventuelle entr茅e sur le march茅 am茅ricain de versions g茅n茅riques de NEXLETOL et NEXLIZET avant 2040.
Esperion (NASDAQ: ESPR) hat eine Vergleichsvereinbarung mit Accord Healthcare Inc. bez眉glich Patentstreitigkeiten um NEXLETOL, ein Medikament mit Bempedoins盲ure, erzielt. Im Rahmen der Vereinbarung verpflichtet sich Accord Healthcare, keine generische Version von NEXLETOL in den USA vor dem 19. April 2040 zu vermarkten, au脽er in bestimmten, begrenzten F盲llen.
Das Unternehmen setzt die Patentstreitigkeiten gegen mehrere weitere Beklagte fort, darunter Alkem Laboratories, Aurobindo Pharma, Dr. Reddy's Laboratories, MSN Pharmaceuticals, Renata Limited und Sandoz. Das Ergebnis dieser laufenden Patentstreitigkeiten ist ungewiss hinsichtlich m枚glicher generischer Versionen von NEXLETOL und NEXLIZET, die vor 2040 auf den US-Markt kommen k枚nnten.
- Settlement protects NEXLETOL from generic competition by Accord Healthcare until April 2040
- Agreement helps secure long-term market exclusivity for a key product
- Ongoing patent litigation with six other companies creates uncertainty
- No guarantee of preventing other generic versions before 2040
ANN ARBOR, Mich., July 08, 2025 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today announced that it has entered into a settlement agreement with Accord Healthcare Inc. This agreement resolves the patent litigation brought by Esperion against Accord Healthcare Inc. in response to Accord Healthcare Inc鈥檚 Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of NEXLETOL prior to the expiration of the applicable patents. Pursuant to the agreement, Accord Healthcare Inc. has agreed not to market a generic version of NEXLETOL in the United States prior to April 19, 2040, unless certain limited circumstances customarily included in these types of agreements occur.
The pending patent litigation against the remaining defendants (Alkem Laboratories Ltd.; Aurobindo Pharma Limited (along with an affiliate); Dr. Reddy鈥檚 Laboratories Inc. (along with an affiliate); MSN Pharmaceuticals Inc. (along with an affiliate); Renata Limited; and Sandoz Inc.) is ongoing, and there can be no assurance whether such ongoing patent litigation will allow a generic version of NEXLETOL and/or NEXLIZET, as applicable, to be marketed in the U.S. prior to April 19, 2040.
About Esperion Therapeutics
Esperion Therapeutics, Inc. is a commercial stage biopharmaceutical company focused on bringing new medicines to market that address unmet needs of patients and healthcare professionals. The Company developed and is commercializing the only U.S. Food and Drug Administration (FDA) approved oral, once-daily, non-statin medicines for patients who are at risk for cardiovascular disease and are struggling with elevated low density lipoprotein cholesterol (LDL-C). These medications are supported by the nearly 14,000 patient CLEAR Cardiovascular Outcomes Trial. Esperion continues to build on its success with its next generation program which is focused on developing ATP citrate lyase inhibitors (ACLYi). New insights into the structure and function of ACLYi fully enables rational drug design and the opportunity to develop highly potent and specific inhibitors with allosteric mechanisms.
Esperion continues to evolve into a leading global biopharmaceutical company through commercial execution, international partnerships and collaborations and advancement of its pre-clinical pipeline. For more information, visit and follow Esperion on and .
Forward-Looking Statements
This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding pending patent litigation and other statements containing the words 鈥渁nticipate,鈥� 鈥渂elieve,鈥� 鈥渆stimate,鈥� 鈥渆xpect,鈥� 鈥渋ntend,鈥� 鈥渕ay,鈥� 鈥減lan,鈥� 鈥減redict,鈥� 鈥減roject,鈥� 鈥渟uggest,鈥� 鈥渢arget,鈥� 鈥減otential,鈥� 鈥渨ill,鈥� 鈥渨ould,鈥� 鈥渃ould,鈥� 鈥渟hould,鈥� 鈥渃ontinue,鈥� and similar expressions. Any express or implied statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Forward-looking statements involve risks and uncertainties that could cause Esperion鈥檚 actual results to differ significantly from those projected, including, without limitation, the net sales, profitability, and growth of Esperion鈥檚 commercial products, clinical activities and results, supply chain, commercial development and launch plans, the outcomes and anticipated benefits of legal proceedings and settlements, and the risks detailed in Esperion鈥檚 filings with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Esperion disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release, other than to the extent required by law.
Esperion Contact Information:
Investors:
Alina Venezia
(734) 887-3903
Media:
Tiffany Aldrich
(616) 443-8438
FAQ
When will Accord Healthcare be allowed to market generic NEXLETOL (ESPR)?
How many companies are still in patent litigation with Esperion (ESPR) over NEXLETOL?
What is the significance of the Esperion (ESPR) settlement with Accord Healthcare?
Will other companies be able to sell generic NEXLETOL before 2040?
