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

Rhea-AI Summary

Esperion (NASDAQ: ESPR) announced a settlement with Alkem Laboratories resolving patent litigation over NEXLETOL and NEXLIZET. Under the agreement, Alkem agreed not to market generic versions in the U.S. prior to April 19, 2040, subject to customary limited exceptions.

Litigation against four other ANDA filers remains pending, and there is no assurance those cases will prevent earlier generic entry.

Positive

• Alkem settlement delays generic competition until April 19, 2040
• Commercial-stage company markets two oral non-statin therapies
• Global approvals across more than 40 countries

Negative

• Ongoing litigation with four ANDA filers could still permit earlier generic entry
• Limited exceptions in the settlement could allow generics before April 19, 2040

Key Figures

Generic entry date: April 19, 2040 Global approvals: More than 40 countries

2 metrics

Generic entry date April 19, 2040 Alkem agreement not to market NEXLETOL/NEXLIZET generics in U.S. before this date

Global approvals More than 40 countries Number of countries with approvals for Esperion’s therapies

Market Reality Check

Price: $3.55 Vol: Volume 4,847,248 vs 20-da...

normal vol

$3.55 Last Close

Volume Volume 4,847,248 vs 20-day average 4,389,124 (relative volume 1.1x) ahead of this patent news. normal

Technical Shares at $3.43, trading above 200-day MA at $2.37 and about 17.8% below the $4.175 52-week high.

Peers on Argus

Pre-news, ESPR was modestly higher while only one scanned peer (KMDA) showed mom...

1 Up

Pre-news, ESPR was modestly higher while only one scanned peer (KMDA) showed momentum, up 3.53% with no associated news, suggesting stock-specific rather than sector-driven factors.

Historical Context

5 past events · Latest: Feb 11 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Feb 11	Inducement equity grants	Positive	+2.1%	RSU grants to new hires under inducement equity incentive plan.
Jan 11	Business update & outlook	Positive	-8.5%	Preliminary 2025 results and Vision 2040 growth strategy with expense guidance.
Jan 05	Conference participation	Neutral	+2.7%	Announcement of presentation at J.P. Morgan Healthcare Conference with webcast access.
Dec 19	Clinical guideline support	Positive	+3.4%	ACC statement recommending bempedoic acid for PAD patients with diabetes.
Dec 09	Inducement equity grants	Neutral	+1.1%	Stock options and RSUs granted, including to new Chief Commercial Officer.

Pattern Detected

Recent company news has more often been followed by modest positive moves, with one notable negative reaction to a major business update.

Recent Company History

Over the last few months, Esperion has reported stronger Q3 2025 revenue momentum, settled generic challenges with patents extending into 2040, and outlined its long‑term Vision 2040 strategy with preliminary 2025 revenue of $400–$408M and 2026 operating expense guidance of $210–$245M. Routine inducement equity grants and conference participation also featured. Against this backdrop, today’s settlement with another ANDA filer reinforces the longer-dated patent narrative around NEXLETOL and NEXLIZET already referenced in prior filings.

Market Pulse Summary

This announcement underscores Esperion’s ongoing effort to defend NEXLETOL and NEXLIZET exclusivity,...

Analysis

This announcement underscores Esperion’s ongoing effort to defend NEXLETOL and NEXLIZET exclusivity, with Alkem agreeing not to market U.S. generics before April 19, 2040. It complements prior disclosures that some asserted patents extend into 2040 and follows a series of generic challenge settlements. Investors may track progress in remaining ANDA cases, commercial performance of the LDL‑C franchise, and pipeline advancement in areas such as Primary Sclerosing Cholangitis and renal diseases as key drivers from here.

Key Terms

abbreviated new drug applications, andas, generic versions, low-density lipoprotein cholesterol, +4 more

8 terms

abbreviated new drug applications regulatory

"in response to Alkem’s Abbreviated New Drug Applications (ANDAs) seeking approval"

An Abbreviated New Drug Application (ANDA) is the formal regulatory request a company files to get approval to sell a generic version of an already‑approved prescription drug by showing it delivers the same active ingredient and effect, without repeating the original safety and effectiveness trials. For investors, ANDA approvals are important because they allow lower‑cost competitors to enter a market, often cutting the original product’s sales and prices and reshaping profit expectations in a predictable, timetable-driven way.

andas regulatory

"in response to Alkem’s Abbreviated New Drug Applications (ANDAs) seeking approval"

ANDAs are applications submitted to a drug regulator seeking approval to market a generic version of an already‑approved medicine without repeating full clinical trials; they rely on evidence that the new product is the same in strength, form and effect as the original. For investors, ANDA approvals are important because they enable lower‑cost competitors to enter the market — like a certified recipe clone that can be sold legally — which can sharply reduce branded drug sales and change company valuations.

generic versions regulatory

"seeking approval to market generic versions of NEXLETOL and NEXLIZET"

Generic versions are medications that contain the same active ingredient, strength, dosage form and intended use as a brand-name drug but are sold under their chemical name or a different label after patent or exclusivity ends. For investors, generics matter because they increase competition and usually lower prices, which can cut revenue for the original drug maker while creating steady, often lower-margin sales opportunities for manufacturers that can produce and distribute widely — like replacing a branded gadget with a cheaper but equivalent model.

low-density lipoprotein cholesterol medical

"once-daily, non-statin therapies for patients struggling to maintain their low-density lipoprotein cholesterol"

A form of cholesterol carried in the blood that tends to deposit fatty material on artery walls, often called “bad” cholesterol; think of LDL as delivery trucks that sometimes drop sticky cargo along the body’s highways. Investors monitor LDL because drugs, medical devices, and diagnostic tests that change LDL levels or how they’re managed can drive healthcare spending, regulatory approvals, and company earnings, affecting valuations and risk in health-related businesses.

ldl-c medical

"non-statin therapies for patients struggling to maintain their low-density lipoprotein cholesterol (LDL-C) levels"

LDL-C stands for low-density lipoprotein cholesterol, the portion of cholesterol carried in the blood by LDL particles that is commonly linked to buildup of plaque in arteries—think of it like sticky debris that can clog pipes. Investors care because changes in LDL-C are a key measure used by regulators and clinicians to judge the effectiveness of cardiovascular drugs and devices, shape insurance coverage, and influence market demand for treatments that lower heart attack and stroke risk.

cardiometabolic medical

"developing and delivering innovative cardiometabolic and rare/orphan disease therapies"

Cardiometabolic describes health conditions that affect the heart and the body’s metabolism—most commonly heart disease, high blood pressure, type 2 diabetes and obesity—that often occur together and share common causes. Investors care because these linked conditions drive large, predictable demand for drugs, medical devices and long-term care, and changes in treatment options, guidelines or costs can materially affect healthcare company revenues and government spending much like a problem in an engine and its fuel system impacts the whole vehicle.

primary sclerosing cholangitis medical

"including treatments for Primary Sclerosing Cholangitis and renal diseases"

A chronic disease in which the tubes that carry bile from the liver become inflamed and scarred, gradually blocking flow and potentially causing liver damage or failure; think of it like corrosion and narrowing in the body’s plumbing that disrupts normal cleanup and digestion. It matters to investors because there is no widely effective cure, so diagnostic advances, drugs, or procedures that slow progression can create meaningful commercial markets and clinical trial, regulatory and pricing risks that affect valuations in healthcare and biotech companies.

renal diseases medical

"including treatments for Primary Sclerosing Cholangitis and renal diseases"

Renal diseases are conditions that damage the kidneys’ ability to filter waste, balance fluids, and regulate blood pressure, ranging from mild impairment to kidney failure that may require dialysis or transplant. For investors, these diseases drive demand for diagnostics, medicines, medical devices, and long-term care—think of kidneys as a home’s plumbing: when they fail, products and treatments to repair or replace that system become commercially important and can affect company revenues and regulatory scrutiny.

AI-generated analysis. Not financial advice.

ANN ARBOR, Mich., Feb. 17, 2026 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today announced that it has entered into a settlement agreement with Alkem Laboratories Ltd. (Alkem). This agreement resolves the patent litigation brought by Esperion against Alkem in response to Alkem’s Abbreviated New Drug Applications (ANDAs) seeking approval to market generic versions of NEXLETOL and NEXLIZET prior to the expiration of the applicable patents. Pursuant to the agreement, Alkem has agreed not to market a generic version of either NEXLETOL or NEXLIZET 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 (Aurobindo Pharma Limited (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.

Esperion Therapeutics
Esperion Therapeutics, Inc. is a commercial-stage biopharmaceutical company dedicated to developing and delivering innovative cardiometabolic and rare/orphan disease therapies. The Company leverages deep domain expertise in ACLY biology to develop and commercialize transformative medicines for patients worldwide. Esperion currently markets two oral, once-daily, non-statin therapies for patients struggling to maintain their low-density lipoprotein cholesterol (LDL-C) levels and are at risk of cardiovascular disease.

With a broad U.S. commercial infrastructure and global approvals across more than 40 countries, Esperion is well positioned to serve as a partner-of-choice for global innovators seeking U.S. market access through acquisition, in-license, co-promotion and revenue share opportunities. In tandem, the Company is advancing its leadership in ACLY biology to build a diversified pipeline of novel product candidates, including treatments for Primary Sclerosing Cholangitis and renal diseases. 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 marketing strategy and commercialization and business development plans, current and planned operational expenses, expected profitability, future operations, commercial products, clinical development, including the timing, designs and plans for the CLEAR Outcomes study and its results, plans for potential future product candidates, financial condition and outlook, including expected cash runway and profitability, 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, business development, 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 did Esperion announce about NEXLETOL and NEXLIZET on February 17, 2026 (ESPR)?

They reached a settlement with Alkem preventing U.S. generic launches before April 19, 2040. According to the company, Alkem agreed not to market generic versions of NEXLETOL or NEXLIZET in the United States prior to that date, subject to customary limited exceptions.

How does the Alkem settlement affect ESPR shareholders and generic risk?

The settlement reduces near-term generic risk by preserving exclusivity through April 19, 2040. According to the company, the agreement bars Alkem from marketing generics before that date, but other pending litigations still pose potential generic-entry risk.

Are there other companies still facing patent litigation with Esperion (ESPR)?

Yes, litigation against four other ANDA filers remains pending and unresolved. According to the company, defendants include Aurobindo, MSN Pharmaceuticals, Renata, and Sandoz, and outcomes could affect potential earlier generic launches.

Does the settlement guarantee no generics for NEXLETOL/NEXLIZET until 2040 for ESPR?

No—while Alkem agreed not to market generics before April 19, 2040, limited exceptions apply. According to the company, customary exceptions and outcomes of other litigations could still permit earlier U.S. generic entry in some circumstances.

What products and commercial footprint does Esperion (ESPR) currently have?

Esperion markets two oral, once-daily non-statin therapies and has approvals in over 40 countries. According to the company, it maintains a broad U.S. commercial infrastructure and global approvals across more than 40 countries.