StockNews.AI
ESPR
StockNews.AI
99 days

Esperion Reaches Settlement Agreement with ANDA Filer Not to Market Generic Version of NEXLETOL® (bempedoic acid) Prior to April 19, 2040

1. Esperion settles patent litigation with Micro Labs over NEXLETOL. 2. Generic version of NEXLETOL cannot be marketed before April 2040. 3. Ongoing litigation against other defendants may still impact NEXLETOL's market. 4. Esperion's innovations continue to target unmet needs in cardiovascular disease. 5. Company aims for growth through product development and international partnerships.

6m saved
Insight
Article

FAQ

Why Very Bullish?

The settlement significantly extends NEXLETOL's market exclusivity, preserving revenue streams. Historical examples show stock price increases with positive litigation outcomes.

How important is it?

The significance of patent settlements compared to generic competition directly influences valuation. The news solidifies Esperion's market position, boosting investor sentiment.

Why Long Term?

The settlement secures profit potential until 2040, establishing long-term pricing power. Similar cases in the biotech industry tend to reflect sustained price stability post-settlement.

May 12, 2025 08:00 ET  | Source: Esperion Therapeutics, Inc. 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 TherapeuticsEsperion 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 StatementsThis 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 Veneziainvestorrelations@esperion.com (734) 887-3903 Media: Tiffany Aldrich corporateteam@esperion.com (616) 443-8438

Related News