Esperion settles patent litigation with Micro Labs, extending protection for NEXLETOL until April 2040, with ongoing litigation against other defendants.
Quiver AI Summary
Esperion has reached a settlement with Micro Labs USA, Inc. regarding patent litigation over the generic version of its cholesterol-lowering medication, NEXLETOL. Under the agreement, Micro Labs is prohibited from marketing a generic version in the U.S. until April 19, 2040, barring certain conditions. The litigation involving other defendants continues, and no outcome is guaranteed for those cases. Esperion, a biopharmaceutical company, is dedicated to developing innovative treatments for cardiovascular disease and has FDA-approved non-statin medications backed by significant clinical trial data. The company is also advancing its research in ATP citrate lyase inhibitors.
Potential Positives
- Esperion successfully entered into a settlement agreement with Micro Labs, preventing the early marketing of a generic version of NEXLETOL in the U.S. until at least April 19, 2040.
- The resolution of the litigation against Micro Labs strengthens Esperion's patent protection and market position for its cardiovascular medications.
- Esperion's status as the only company with FDA-approved oral, once-daily, non-statin medications for cardiovascular disease enhances its competitive advantage in the biopharmaceutical market.
- The announcement reflects Esperion's commitment to continue evolving as a global biopharmaceutical leader through its research and development initiatives.
Potential Negatives
- Esperion is currently involved in ongoing patent litigation with multiple defendants, which raises uncertainties about the potential for generic competition and could impact the company’s market position.
- The settlement with Micro Labs does not guarantee protection from future generic competition, as pending litigations may still allow other companies to introduce generics before the patent expiration date in 2040.
- The company’s reliance on litigation outcomes for the protection of its key products could suggest vulnerability in its business model, particularly if ongoing legal battles do not result in favorable outcomes.
FAQ
What is the settlement agreement between Esperion and Micro Labs?
Esperion and Micro Labs agreed that Micro Labs will not market a generic NEXLETOL in the U.S. until April 19, 2040.
How does this agreement affect the availability of NEXLETOL?
The agreement ensures NEXLETOL will remain on the market without generic competition until at least April 19, 2040.
What ongoing legal actions does Esperion face?
Esperion is still engaged in patent litigation against several other defendants concerning NEXLETOL and NEXLIZET.
What does Esperion specialize in?
Esperion focuses on developing non-statin oral medicines for cardiovascular disease and LDL-C reduction.
How can I learn more about Esperion?
Visit esperion.com or follow Esperion on LinkedIn and X for more information about the company and its products.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$ESPR Insider Trading Activity
$ESPR insiders have traded $ESPR stock on the open market 13 times in the past 6 months. Of those trades, 0 have been purchases and 13 have been sales.
Here’s a breakdown of recent trading of $ESPR stock by insiders over the last 6 months:
- SHELDON L. KOENIG (President and CEO) has made 0 purchases and 2 sales selling 25,494 shares for an estimated $50,316.
- BENJAMIN HALLADAY (Chief Financial Officer) has made 0 purchases and 5 sales selling 6,808 shares for an estimated $13,156.
- ERIC WARREN (Chief Commercial Officer) has made 0 purchases and 6 sales selling 5,334 shares for an estimated $10,300.
To track insider transactions, check out Quiver Quantitative's insider trading dashboard.
$ESPR Hedge Fund Activity
We have seen 72 institutional investors add shares of $ESPR stock to their portfolio, and 92 decrease their positions in their most recent quarter.
Here are some of the largest recent moves:
- MORGAN STANLEY added 3,663,178 shares (+138.4%) to their portfolio in Q4 2024, for an estimated $8,058,991
- MARSHALL WACE, LLP removed 3,092,629 shares (-100.0%) from their portfolio in Q4 2024, for an estimated $6,803,783
- INDABA CAPITAL MANAGEMENT, L.P. added 3,000,000 shares (+inf%) to their portfolio in Q4 2024, for an estimated $6,600,000
- MILLENNIUM MANAGEMENT LLC removed 2,573,645 shares (-75.6%) from their portfolio in Q4 2024, for an estimated $5,662,019
- CITADEL ADVISORS LLC added 1,621,016 shares (+1213.2%) to their portfolio in Q4 2024, for an estimated $3,566,235
- CENTERBOOK PARTNERS LP removed 1,306,259 shares (-100.0%) from their portfolio in Q1 2025, for an estimated $1,881,012
- GOLDMAN SACHS GROUP INC removed 1,225,974 shares (-44.5%) from their portfolio in Q1 2025, for an estimated $1,765,402
To track hedge funds' stock portfolios, check out Quiver Quantitative's institutional holdings dashboard.
$ESPR Analyst Ratings
Wall Street analysts have issued reports on $ESPR in the last several months. We have seen 1 firms issue buy ratings on the stock, and 0 firms issue sell ratings.
Here are some recent analyst ratings:
- Cantor Fitzgerald issued a "Overweight" rating on 12/17/2024
To track analyst ratings and price targets for $ESPR, check out Quiver Quantitative's $ESPR forecast page.
Full Release
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
[email protected]
(734) 887-3903
Media:
Tiffany Aldrich
[email protected]
(616) 443-8438
