Esperion Reaches Settlement Agreement with ANDA Filer, Dr. Reddy’s Laboratories, Not to Market Generic Versions of NEXLETOL® (bempedoic acid) and NEXLIZET® (bempedoic acid and ezetimibe) Prior to April 19, 2040

Rhea-AI Summary

Esperion (NASDAQ: ESPR) announced a settlement with Dr. Reddy’s Laboratories resolving ANDA litigation over NEXLETOL and NEXLIZET. Under the agreement, Dr. Reddy’s will not market generic versions in the U.S. before April 19, 2040, except for customary limited exceptions. Esperion previously settled with Micro Labs, Hetero and Accord earlier in 2025. Esperion’s U.S. Patent No. 7,335,799 (bempedoic acid) expires December 2030; with this settlement there are no remaining challenges to that patent’s validity or infringement in the pending litigation. Other Esperion patents at issue expire March 2036 and June 2040. Litigation continues against several other ANDA filers, and there is no assurance those cases won’t permit earlier generic entry.

Positive

• Dr. Reddy’s agrees no U.S. generic sales before April 19, 2040
• No remaining challenges to U.S. Patent 7,335,799 in this litigation
• Settlements reached with Micro Labs, Hetero, and Accord in 2025

Negative

• Pending litigation continues with multiple ANDA defendants (ongoing)
• Certain Esperion patents expire earlier: Dec 2030 and Mar 2036
• Agreement allows limited circumstances for earlier generic entry

Insights

Patent and IP Strategist

Settlement preserves U.S. exclusivity for NEXLETOL and NEXLIZET through April 19, 2040.

What it means: Esperion and Dr. Reddy’s Laboratories agreed that Dr. Reddy’s will not market generics of NEXLETOL or NEXLIZET in the U.S. before April 19, 2040, subject to customary exceptions.

Why it matters: This settlement resolves the specific ANDA challenge and eliminates one litigation front, removing uncertainty tied to U.S. Patent No. 7,335,799 and related patents that extend through March 2036 and June 2040. The agreement narrows ongoing litigation to other defendants and consolidates Esperion’s patent enforcement position.

Monitor: The agreed date April 19, 2040 is the clear milestone to track for potential generic entry.

Commercial Market Analyst

Deal delays generic competition in the U.S., maintaining branded market control for Esperion until April 19, 2040.

What it means: With Dr. Reddy’s barred from marketing generics before April 19, 2040, Esperion retains a clearer branded market window for NEXLETOL and NEXLIZET in the U.S., reducing near-term sales risk from that ANDA filer.

Why it matters: The settlement removes one immediate source of downward pricing and share loss. Remaining ANDA defendants still face litigation, so competitive risk is reduced but not eliminated; this preserves the commercial upside tied to continued branded availability under the stated patent framework.

Monitor: Track the remaining litigation outcomes and the April 19, 2040 date as the primary market-exposure milestone.

ANN ARBOR, Mich., Oct. 03, 2025 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today announced that it has entered into a settlement agreement with Dr. Reddy’s Laboratories, Inc. and its affiliate Dr. Reddy’s Laboratories Ltd. (together, Dr. Reddy’s Laboratories). This agreement resolves the patent litigation brought by Esperion against Dr. Reddy’s Laboratories in response to Dr. Reddy’s Laboratories’ Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of each of NEXLETOL and NEXLIZET prior to the expiration of the applicable patents. Pursuant to the agreement, Dr. Reddy’s Laboratories 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.

As previously disclosed, Esperion reached settlement agreements with Micro Labs USA, Inc. and its affiliate; Hetero USA Inc. and its affiliates; and Accord Healthcare Inc. earlier this year with respect to their generic versions of NEXLETOL. Bempedoic acid is claimed in Esperion’s U.S Patent No. 7,335,799, which is scheduled to expire in December 2030. With this latest settlement with Dr. Reddy’s Laboratories, there are no remaining challenges regarding the validity or infringement of U.S Patent No. 7,335,799 in the pending patent litigation. Certain of Esperion’s patents that remain subject to the pending patent litigation are scheduled to expire in March 2036, while others are scheduled to expire in June 2040.

The pending patent litigation against the remaining defendants (Alkem Laboratories Ltd.; Aurobindo Pharma Limited (along with an affiliate); MSN Pharmaceuticals Inc. (along with an affiliate); Renata Limited (along with an affiliate); 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, patent expiration 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 did Esperion (ESPR) announce on October 3, 2025 regarding Dr. Reddy’s ANDA?

Esperion announced a settlement where Dr. Reddy’s agreed not to market generics of NEXLETOL or NEXLIZET in the U.S. before April 19, 2040.

How does the Dr. Reddy’s settlement affect Esperion’s patent U.S. Patent No. 7,335,799?

With the settlement, there are no remaining challenges to the validity or infringement of U.S. Patent No. 7,335,799 in the pending litigation.

When do Esperion’s key patents for NEXLETOL/NEXLIZET expire?

Patent No. 7,335,799 expires in December 2030; other patents at issue expire in March 2036 and June 2040.

Are there other generic challengers after the Dr. Reddy’s settlement for ESPR?

Yes. Litigation is ongoing against Alkem, Aurobindo, MSN, Renata and Sandoz, and outcomes remain uncertain.

Does the April 19, 2040 date guarantee no earlier generics for ESPR products?

No. The agreement excludes certain customary limited circumstances that could permit earlier generic entry.

Did Esperion settle similar ANDA challenges earlier in 2025 for ESPR products?

Yes. Esperion previously reached settlements with Micro Labs USA, Hetero USA, and Accord Healthcare earlier in 2025.