Esperion vs. Alkem: Bempedoic Acid Patent Dispute Dismissed in Landmark Hatch-Waxman Case
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📋 Case Summary
| Case Name | Esperion Therapeutics, Inc. v. Alkem Laboratories, Ltd. |
| Case Number | 2:24-cv-06263 (D.N.J.) |
| Court | U.S. District Court for the District of New Jersey |
| Duration | May 17, 2024 – Feb 18, 2026 642 days |
| Outcome | Dismissed Without Prejudice |
| Patents at Issue | |
| Accused Products | Alkem’s Generic Bempedoic Acid Products |
Case Overview
The Parties
⚖️ Plaintiff
Michigan-based biopharmaceutical company focused on developing and commercializing non-statin, oral therapies for LDL-cholesterol management. Its flagship products are NEXLETOL® and NEXLIZET®.
🛡️ Defendant
Multinational generic pharmaceutical manufacturer headquartered in Mumbai, India, with a significant U.S. market presence. Pursued an Abbreviated New Drug Application (ANDA) for generic bempedoic acid.
The Patents at Issue
This landmark case involved seven U.S. patents covering bempedoic acid formulations and methods, the active ingredient in Esperion’s branded cardiovascular therapies NEXLETOL® and NEXLIZET®. These patents represent a layered and strategically constructed IP portfolio.
- • US10912751B2 (App. No. 15/558,084)
- • US12398087B2 (App. No. 18/657,105)
- • US12404227B2 (App. No. 18/450,591)
- • US11760714B2 (App. No. 17/577,829)
- • US11926584B2 (App. No. 18/297,846)
- • US11744816B2 (App. No. 17/136,870)
- • US11613511B2 (App. No. 17/742,728)
Developing a similar drug?
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The Verdict & Legal Analysis
Outcome
Pursuant to Federal Rule of Civil Procedure 41(a)(1)(A)(ii), both parties executed a stipulated dismissal without prejudice of all claims and counterclaims. Each party agreed to bear its own costs, fees, and expenses. No damages were awarded, and no injunctive relief was issued.
A dismissal “without prejudice” is legally significant: Esperion retains the right to reassert these claims in the future, and Alkem receives no res judicata protection against re-litigation. This is a meaningful distinction from a dismissal with prejudice, which would have foreclosed future action on the same patents and products.
Key Legal Issues
The case was initiated as a standard Hatch-Waxman patent infringement action, triggered by Alkem’s filing of an ANDA with a Paragraph IV certification — asserting that Esperion’s listed patents were invalid, unenforceable, or would not be infringed by Alkem’s proposed generic product. The filing of such a certification constitutes a technical act of infringement under 35 U.S.C. § 271(e)(2), automatically conferring standing to sue.
Because the dismissal was stipulated and without a merits ruling, no formal findings on patent validity, claim construction, or infringement were issued by the court. The specific terms that precipitated the voluntary dismissal — whether a licensing agreement, covenant not to sue, commercial settlement, or Alkem’s withdrawal of its ANDA — were **not disclosed in the public record**. This is consistent with confidential resolution structures commonly employed in pharmaceutical IP disputes.
Freedom to Operate (FTO) Analysis in Pharmaceutical IP
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📋 Understand This Case’s Impact
Learn about the specific risks and implications from this litigation.
- View all 7 asserted patents and related families
- See which companies are active in bempedoic acid IP
- Understand claim construction patterns for pharmaceutical patents
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High Risk Area
Bempedoic acid formulations & methods
7 Asserted Patents
In bempedoic acid space
Design-Around Options
Available for specific claims
✅ Key Takeaways
Stipulated dismissals without prejudice in Hatch-Waxman cases preserve patent holder optionality across future generic challengers.
Search related case law →Multi-patent assertion strategies increase settlement leverage; monitor consolidation with related case No. 2:24-cv-05921.
Explore precedents →Esperion’s seven-patent assertion portfolio exemplifies layered pharmaceutical IP strategy — track these patents for potential IPR or PGR activity at the USPTO.
Monitor patent activity →Undisclosed resolution terms are common; monitor Orange Book listings for bempedoic acid for any patent delisting or licensing activity.
View Orange Book listings →Frequently Asked Questions
Seven U.S. patents were asserted, including US10912751B2, US11613511B2, US11744816B2, US11760714B2, US11926584B2, US12398087B2, and US12404227B2, all relating to bempedoic acid formulations and methods.
The parties filed a stipulated dismissal without prejudice under Fed. R. Civ. P. 41(a)(1)(A)(ii), with each party bearing its own costs. No merits ruling was issued.
The without-prejudice dismissal preserves Esperion’s right to reassert claims against future ANDA filers, maintaining its portfolio as an active enforcement tool in the cardiovascular generic drug market.
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References
- USPTO Patent Center
- PACER Case Locator
- FDA Orange Book (for bempedoic acid listings)
- Cornell Legal Information Institute — Fed. R. Civ. P. 41(a)(1)(A)(ii)
- Cornell Legal Information Institute — 35 U.S.C. § 271(e)(2)
This article is for informational purposes only and does not constitute legal advice. All case information is drawn from publicly available court records. For platform capabilities, visit PatSnap.