NEXLETOL Drug Patent Profile

Which patents cover Nexletol, and what generic alternatives are available?

Nexletol is a drug marketed by Esperion Theraps Inc and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.

This drug has seventy-seven patent family members in twenty-four countries.

The generic ingredient in NEXLETOL is bempedoic acid. One supplier is listed for this compound. Additional details are available on the bempedoic acid profile page.

DrugPatentWatch^® Generic Entry Outlook for Nexletol

Nexletol was eligible for patent challenges on February 21, 2024.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 3, 2030. This may change due to patent challenges or generic licensing.

There have been five patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (bempedoic acid), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for NEXLETOL

International Patents:	77
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	64
Patent Applications:	393
Drug Prices:	Drug price information for NEXLETOL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NEXLETOL
What excipients (inactive ingredients) are in NEXLETOL?	NEXLETOL excipients list
DailyMed Link:	NEXLETOL at DailyMed

See drug prices for NEXLETOL

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for NEXLETOL

Constraining patent/regulatory exclusivity:

7,335,799

NDA:

211616

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for NEXLETOL

Drug Class	Adenosine Triphosphate-Citrate Lyase Inhibitor
Mechanism of Action	Adenosine Triphosphate-Citrate Lyase Inhibitors

Paragraph IV (Patent) Challenges for NEXLETOL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NEXLETOL	Tablets	bempedoic acid	180 mg	211616	9	2024-02-21

US Patents and Regulatory Information for NEXLETOL

NEXLETOL is protected by seven US patents and three FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 7,335,799.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Esperion Theraps Inc	NEXLETOL	bempedoic acid	TABLET;ORAL	211616-001	Feb 21, 2020		RX	Yes	Yes	11,744,816
Esperion Theraps Inc	NEXLETOL	bempedoic acid	TABLET;ORAL	211616-001	Feb 21, 2020		RX	Yes	Yes	11,613,511			Y
Esperion Theraps Inc	NEXLETOL	bempedoic acid	TABLET;ORAL	211616-001	Feb 21, 2020		RX	Yes	Yes	11,760,714		Y
Esperion Theraps Inc	NEXLETOL	bempedoic acid	TABLET;ORAL	211616-001	Feb 21, 2020		RX	Yes	Yes

Expired US Patents for NEXLETOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Esperion Theraps Inc	NEXLETOL	bempedoic acid	TABLET;ORAL	211616-001	Feb 21, 2020	9,624,152
Esperion Theraps Inc	NEXLETOL	bempedoic acid	TABLET;ORAL	211616-001	Feb 21, 2020	10,118,881
Esperion Theraps Inc	NEXLETOL	bempedoic acid	TABLET;ORAL	211616-001	Feb 21, 2020	9,000,041
Esperion Theraps Inc	NEXLETOL	bempedoic acid	TABLET;ORAL	211616-001	Feb 21, 2020	8,497,301

EU/EMA Drug Approvals for NEXLETOL

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Daiichi Sankyo Europe GmbH	Nilemdo	bempedoic acid	EMEA/H/C/004958Nilemdo is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non familial) or mixed dyslipidaemia, as an adjunct to diet:in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach LDL C goals with the maximum tolerated dose of a statin (see sections 4.2, 4.3, and 4.4) or,alone or in combination with other lipid-lowering therapies in patients who are statin intolerant, or for whom a statin is contraindicated.	Authorised	no	no	no	2020-04-01

International Patents for NEXLETOL

See the table below for patents covering NEXLETOL around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2020257573
Russian Federation	2022102472	ФИКСИРОВАННЫЕ КОМБИНАЦИИ И СОСТАВЫ, СОДЕРЖАЩИЕ ETC-1002 И ЭЗЕТИМИБ, И СПОСОБЫ ЛЕЧЕНИЯ ИЛИ УМЕНЬШЕНИЯ РИСКА РАЗВИТИЯ СЕРДЕЧНО-СОСУДИСТОГО ЗАБОЛЕВАНИЯ
Mexico	2021015935	FORMAS DE SAL DE ACIDO BEMPEDOICO Y METODOS PARA UTILIZAR EL MISMO. (SALT FORMS OF BEMPEDOIC ACID AND METHODS FOR USING THE SAME.)
Brazil	PI0318046	compostos de hidroxila, seu usos, e composições farmacêuticas

Supplementary Protection Certificates for NEXLETOL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2404890	132020000000112	Italy		PRODUCT NAME: ACIDO BEMPEDOICO, O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE, IDRATO, SOLVATO, O LORO MISCELA(NUSTENDI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1424, 20200331
2404890	20C1041	France		PRODUCT NAME: ACIDE BEMPEDOIQUE, OU UN SEL, HYDRATE, PRODUIT DE SOLVATATION OU MELANGE DE CEUX-CI, PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/20/1424 20200331
2404890	301062	Netherlands		PRODUCT NAME: BEMPEDONZUUR, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT, HYDRAAT, SOLVAAT OF MENGSEL DAARVAN; REGISTRATION NO/DATE: EU/1/20/1424 20200331
2404890	C 2020 031	Romania		PRODUCT NAME: ACID BEMPEDOIC, SAU O SARE, HIDRAT, SOLVAT ACCEPTABILE FARMACEUTIC SAU AMESTECUL ACESTORA; NATIONAL AUTHORISATION NUMBER: EU/1/20/1424; DATE OF NATIONAL AUTHORISATION: 20200327; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1424; DATE OF FIRST AUTHORISATION IN EEA: 20200327

Market Dynamics and Financial Trajectory for NEXLETOL (Bempedoic Acid)

Last updated: July 27, 2025

Introduction

NEXLETOL (bempedoic acid) emerged as a notable player in lipid management, targeting patients with hypercholesterolemia who are statin-intolerant or require adjunct therapy. Developed by Esperion Therapeutics, NEXLETOL fills a niche in cardiovascular risk reduction, driven by the increasing prevalence of hyperlipidemia and cardiovascular disease (CVD). Its market trajectory hinges on evolving clinical evidence, regulatory pathways, competition, and macroeconomic factors influencing pharmaceutical innovation.

Market Landscape and Demand Drivers

Rising Prevalence of Hypercholesterolemia and Cardiovascular Disease

The global burden of hypercholesterolemia and CVD underpins the potential for NEXLETOL’s market expansion. According to the World Health Organization, CVD accounts for approximately 17.9 million deaths annually, with hyperlipidemia recognized as a significant modifiable risk factor [1]. The escalating prevalence, particularly in aging populations and emerging markets, amplifies demand for lipid-lowering therapies.

Therapeutic Positioning and Unmet Needs

NEXLETOL offers a unique mechanism of action—activating adenosine triphosphate citrate lyase (ACL)—limiting cholesterol biosynthesis upstream of statins. This positions NEXLETOL as an alternative or adjunct for patients intolerant to statins, representing a substantial market segment. The need for novel therapies emerges as some patients experience adverse effects, such as myalgia, leading to statin discontinuation.

Market Penetration and Adoption

Initial launch strategies targeted high-risk, statin-intolerant patients, with subsequent broader approval extending its reach. The expansion into combination therapy with ezetimibe (as NEXLIZET) broadens its appeal by providing dual mechanisms in a single regimen. Data from pivotal clinical trials like CLEAR Outcomes suggest enhanced efficacy, bolstering clinician confidence and prescribing patterns.

Regulatory and Reimbursement Environment

Regulatory Milestones

Esperion secured FDA approval for NEXLETOL in 2019, followed by European approvals. Regulatory acceptance is driven by evidence from the CLEAR program, demonstrating reductions in LDL cholesterol and favorable safety profiles [2]. Ongoing post-marketing surveillance aims to reinforce its safety profile for broader approvals.

Market Access and Reimbursement Trends

Reimbursement policies significantly influence NEXLETOL’s financial trajectory. Managed care organizations assess cost-effectiveness, especially given the high prices typical of novel lipid agents. Pharmacoeconomic analyses demonstrating reduction in cardiovascular events could facilitate favorable formulary placements. However, pricing strategies and competition could impact revenue potential.

Competitive Landscape and Market Challenges

Key Competitors

The global lipid-lowering market includes traditional statins, PCSK9 inhibitors (e.g., evolocumab and alirocumab), and emerging therapies like inclisiran. While PCSK9 inhibitors have demonstrated superior LDL reduction, their high costs restrict widespread use, positioning NEXLETOL as a more accessible, oral alternative [3].

Market Barriers

Challenges encompass physician familiarity, cost considerations, and patient adherence. Additionally, the ongoing development of novel therapies targeting different pathways may introduce competition, limiting NEXLETOL’s growth. Nevertheless, its oral administration and safety profile serve as competitive advantages.

Financial Trajectory and Revenue Outlook

Sales Performance and Growth Projections

NEXLETOL’s initial sales, launched in the US, reached approximately $70 million in 2021 and exceeded $100 million in 2022, according to Esperion’s financial reports [4]. Growth is anticipated to accelerate as awareness increases, especially with expanded indications and combination formulations.

Strategic Initiatives and Pipeline Development

Esperion’s ongoing efforts to enhance market penetration include branch-out into additional markets, robust physician education programs, and development of combination therapies like NEXLIZET, which amalgamate NEXLETOL with ezetimibe. The ongoing CLEAR Outcomes trial aims to demonstrate cardiovascular event reduction, pivotal for payer reimbursement and clinician adoption.

Potential Risks Impacting Financial Trajectory

Factors such as regulatory delays, label restrictions, competitive innovations, or patent challenges could impede growth. Price erosion through negotiated discounts or market saturation may also curtail revenue expansion.

Market Outlook and Future Trends

The global cardiovascular drugs market is projected to grow at a CAGR of over 6% through 2030, driven by aging populations and rising chronic disease prevalence [5]. NEXLETOL is poised to capture a segment within this expanding market, especially if key trials confirm cardiovascular benefits.

Emerging formulations, such as fixed-dose combinations, will likely enhance adherence and market share. Furthermore, real-world evidence on long-term safety and efficacy will bolster confidence among prescribers and payers.

Conclusion

NEXLETOL’s market dynamics revolve around its innovative mechanism, positioning as an alternative for statin-intolerant patients, and strategic expansion into combination therapies. Financial prospects are promising, contingent on ongoing clinical validation, effective market access strategies, and competitive landscape navigation. As cardiovascular disease remains a global health priority, NEXLETOL’s trajectory reflects the broader shift towards personalized, patient-centered lipid management.

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Key Takeaways

• Growing CVD and hyperlipidemia prevalence underpin expanding demand for NEXLETOL.
• Its unique mechanism positions NEXLETOL as an alternative and adjunct therapy, especially for statin-intolerant patients.
• Regulatory approvals and ongoing trials, such as CLEAR Outcomes, are critical to affirming cardiovascular benefits and securing reimbursement.
• Competition from PCSK9 inhibitors emphasizes the need for NEXLETOL to differentiate through cost, ease of use, and safety.
• The market’s growth potential relies on successful commercialization, favorable pricing strategies, and robust clinical validation.

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FAQs

1. What is NEXLETOL and how does it work?

NEXLETOL (bempedoic acid) is an oral lipid-lowering drug that inhibits adenosine triphosphate citrate lyase (ACL), an enzyme upstream of HMG-CoA reductase in cholesterol biosynthesis, leading to reduced LDL cholesterol levels.

2. Who are the primary target patients for NEXLETOL?

Patients with heterozygous familial hypercholesterolemia or those with atherosclerotic cardiovascular disease who are statin-intolerant or require additional LDL reduction.

3. What are the main advantages of NEXLETOL over existing therapies?

Compared to injectable PCSK9 inhibitors, NEXLETOL offers oral administration, potentially lower cost, and a favorable safety profile, broadening accessibility.

4. What is the significance of the CLEAR Outcomes trial?

This ongoing cardiovascular outcomes trial aims to demonstrate whether NEXLETOL reduces major adverse cardiovascular events, a key factor for clinician confidence and payer reimbursement.

5. What are the potential challenges faced by NEXLETOL in the market?

Challenges include intense competition from high-efficacy injectables, pricing pressures, regulatory hurdles, and the need for long-term outcome data to justify widespread adoption.

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Sources

[1] World Health Organization. (2021). Cardiovascular diseases (CVDs).
[2] Esperion Therapeutics. (2022). NEXLETOL (bempedoic acid) prescribing information.
[3] GlobalData. (2022). Lipid-Lowering Drugs Market Analysis.
[4] Esperion Therapeutics. (2022). Quarterly Financial Reports.
[5] Grand View Research. (2021). Cardiovascular Drugs Market Size, Share & Trends.