Esperion Reaches Settlement Agreement with ANDA Filer Not to Market Generic Version of NEXLETOL® (bempedoic acid) Prior to April 19, 2040
Esperion (NASDAQ: ESPR) has reached a settlement agreement with Micro Labs USA, Inc. and its affiliate regarding patent litigation over NEXLETOL. The settlement prevents Micro Labs from marketing a generic version of NEXLETOL in the United States before April 19, 2040, except under specific limited circumstances. The agreement resolves the litigation initiated by Esperion in response to Micro Labs' Abbreviated New Drug Application (ANDA). However, patent litigation continues with eight other defendants, including Accord Healthcare, Alkem Laboratories, Aurobindo Pharma, Dr. Reddy's Laboratories, Hetero USA, MSN Pharmaceuticals, Renata Limited, and Sandoz Inc., with no guarantee of preventing generic versions before 2040.
Esperion (NASDAQ: ESPR) ha raggiunto un accordo di risoluzione con Micro Labs USA, Inc. e la sua affiliata riguardo a una controversia brevettuale su NEXLETOL. L'accordo impedisce a Micro Labs di commercializzare una versione generica di NEXLETOL negli Stati Uniti prima del 19 aprile 2040, salvo specifiche circostanze limitate. L'intesa chiude la causa legale avviata da Esperion in risposta alla Domanda di Nuovo Farmaco Abbreviata (ANDA) di Micro Labs. Tuttavia, la controversia brevettuale continua con altri otto imputati, tra cui Accord Healthcare, Alkem Laboratories, Aurobindo Pharma, Dr. Reddy's Laboratories, Hetero USA, MSN Pharmaceuticals, Renata Limited e Sandoz Inc., senza garanzie di evitare versioni generiche prima del 2040.
Esperion (NASDAQ: ESPR) ha alcanzado un acuerdo de conciliación con Micro Labs USA, Inc. y su afiliada respecto a una disputa por patentes relacionada con NEXLETOL. El acuerdo impide que Micro Labs comercialice una versión genérica de NEXLETOL en Estados Unidos antes del 19 de abril de 2040, salvo en circunstancias específicas y limitadas. El acuerdo resuelve la litigación iniciada por Esperion en respuesta a la Solicitud Abreviada de Nuevo Fármaco (ANDA) de Micro Labs. Sin embargo, la litigación por patentes continúa con otros ocho demandados, incluidos Accord Healthcare, Alkem Laboratories, Aurobindo Pharma, Dr. Reddy's Laboratories, Hetero USA, MSN Pharmaceuticals, Renata Limited y Sandoz Inc., sin garantía de impedir versiones genéricas antes de 2040.
Esperion (NASDAQ: ESPR)은 Micro Labs USA, Inc. 및 그 계열사와 NEXLETOL 관련 특허 소송에 대해 합의에 도달했습니다. 이 합의로 Micro Labs는 특정 제한된 경우를 제외하고 2040년 4월 19일 이전에 미국 내에서 NEXLETOL의 제네릭 버전을 판매할 수 없게 되었습니다. 이 합의는 Micro Labs의 약물 허가 신청(ANDA)에 대응하여 Esperion이 제기한 소송을 해결합니다. 그러나 Accord Healthcare, Alkem Laboratories, Aurobindo Pharma, Dr. Reddy's Laboratories, Hetero USA, MSN Pharmaceuticals, Renata Limited, Sandoz Inc. 등 8명의 다른 피고들과의 특허 소송은 계속 진행 중이며, 2040년 이전에 제네릭 버전을 막을 수 있다는 보장은 없습니다.
Esperion (NASDAQ : ESPR) a conclu un accord de règlement avec Micro Labs USA, Inc. et sa filiale concernant un litige en matière de brevets sur NEXLETOL. Cet accord empêche Micro Labs de commercialiser une version générique de NEXLETOL aux États-Unis avant le 19 avril 2040, sauf dans des circonstances limitées spécifiques. L'accord met fin au litige initié par Esperion en réponse à la demande abrégée de nouveau médicament (ANDA) de Micro Labs. Cependant, le litige sur les brevets se poursuit avec huit autres défendeurs, dont Accord Healthcare, Alkem Laboratories, Aurobindo Pharma, Dr. Reddy's Laboratories, Hetero USA, MSN Pharmaceuticals, Renata Limited et Sandoz Inc., sans garantie d'empêcher les versions génériques avant 2040.
Esperion (NASDAQ: ESPR) hat eine Vergleichsvereinbarung mit Micro Labs USA, Inc. und deren Tochtergesellschaft bezüglich eines Patentstreits um NEXLETOL erzielt. Die Vereinbarung verhindert, dass Micro Labs vor dem 19. April 2040 eine generische Version von NEXLETOL in den USA vermarktet, außer unter bestimmten eingeschränkten Bedingungen. Die Vereinbarung beendet die von Esperion eingeleitete Klage als Reaktion auf den Abbreviated New Drug Application (ANDA) von Micro Labs. Der Patentstreit läuft jedoch weiterhin mit acht weiteren Beklagten, darunter Accord Healthcare, Alkem Laboratories, Aurobindo Pharma, Dr. Reddy's Laboratories, Hetero USA, MSN Pharmaceuticals, Renata Limited und Sandoz Inc., ohne Garantie, dass generische Versionen vor 2040 verhindert werden können.
- Settlement protects NEXLETOL from Micro Labs' generic competition until April 2040
- Agreement secures nearly 15 years of market exclusivity against one potential competitor
- Ongoing litigation with eight other companies could still result in earlier generic competition
- Legal expenses continue due to pending litigation with multiple defendants
ANN ARBOR, Mich., May 12, 2025 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today announced that it has entered into a settlement agreement with Micro Labs USA, Inc. and its affiliate Micro Labs Limited (together, Micro Labs). This agreement resolves the patent litigation brought by Esperion against Micro Labs in response to Micro Labs’ 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, Micro Labs 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 (Accord Healthcare Inc; Alkem Laboratories Ltd.; Aurobindo Pharma Limited (along with an affiliate); Dr. Reddy’s Laboratories Inc. (along with an affiliate); Hetero USA Inc. (along with affiliates); 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 esperion.com and follow Esperion on LinkedIn and X.
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 “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “suggest,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” 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’s actual results to differ significantly from those projected, including, without limitation, the net sales, profitability, and growth of Esperion’s 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’s 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
investorrelations@esperion.com
(734) 887-3903
Media:
Tiffany Aldrich
corporateteam@esperion.com
(616) 443-8438
FAQ
What is the settlement agreement between Esperion (ESPR) and Micro Labs for NEXLETOL?
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