BEMPEDOIC ACID - Generic Drug Details

What are the generic sources for bempedoic acid and what is the scope of freedom to operate?

Bempedoic acid is the generic ingredient in two branded drugs marketed by Esperion Theraps Inc and is included in two NDAs. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Bempedoic acid has seventy-seven patent family members in twenty-four countries.

One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for BEMPEDOIC ACID

International Patents:	77
US Patents:	8
Tradenames:	2
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	64
Clinical Trials:	26
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BEMPEDOIC ACID
What excipients (inactive ingredients) are in BEMPEDOIC ACID?	BEMPEDOIC ACID excipients list
DailyMed Link:	BEMPEDOIC ACID at DailyMed

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

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.

Recent Clinical Trials for BEMPEDOIC ACID

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Daiichi Sankyo	PHASE1
Daiichi Sankyo	PHASE4
Gan & Lee Pharmaceuticals.	PHASE3

See all BEMPEDOIC ACID clinical trials

Generic filers with tentative approvals for BEMPEDOIC ACID

Applicant	Application No.	Strength	Dosage Form
		180MG	TABLET

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for BEMPEDOIC ACID

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

Anatomical Therapeutic Chemical (ATC) Classes for BEMPEDOIC ACID

C10AX	Other lipid modifying agents
C10A	LIPID MODIFYING AGENTS, PLAIN
C10	LIPID MODIFYING AGENTS
C	Cardiovascular system

Paragraph IV (Patent) Challenges for BEMPEDOIC ACID

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 BEMPEDOIC ACID

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	NEXLIZET	bempedoic acid; ezetimibe	TABLET;ORAL	211617-001	Feb 26, 2020		RX	Yes	Yes			Y
Esperion Theraps Inc	NEXLIZET	bempedoic acid; ezetimibe	TABLET;ORAL	211617-001	Feb 26, 2020		RX	Yes	Yes			Y	Y
Esperion Theraps Inc	NEXLETOL	bempedoic acid	TABLET;ORAL	211616-001	Feb 21, 2020		RX	Yes	Yes
Esperion Theraps Inc	NEXLETOL	bempedoic acid	TABLET;ORAL	211616-001	Feb 21, 2020		RX	Yes	Yes				Y
Esperion Theraps Inc	NEXLETOL	bempedoic acid	TABLET;ORAL	211616-001	Feb 21, 2020		RX	Yes	Yes			Y
Esperion Theraps Inc	NEXLIZET	bempedoic acid; ezetimibe	TABLET;ORAL	211617-001	Feb 26, 2020		RX	Yes	Yes
Esperion Theraps Inc	NEXLIZET	bempedoic acid; ezetimibe	TABLET;ORAL	211617-001	Feb 26, 2020		RX	Yes	Yes

Expired US Patents for BEMPEDOIC ACID

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
Esperion Theraps Inc	NEXLETOL	bempedoic acid	TABLET;ORAL	211616-001	Feb 21, 2020
Esperion Theraps Inc	NEXLETOL	bempedoic acid	TABLET;ORAL	211616-001	Feb 21, 2020
Esperion Theraps Inc	NEXLETOL	bempedoic acid	TABLET;ORAL	211616-001	Feb 21, 2020
Esperion Theraps Inc	NEXLETOL	bempedoic acid	TABLET;ORAL	211616-001	Feb 21, 2020

EU/EMA Drug Approvals for BEMPEDOIC ACID

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 BEMPEDOIC ACID

Country	Patent Number	Title	Estimated Expiration
Japan	2021193105	ＥＴＣ１００２及びエゼチミブを含む固定用量組合せ物及び製剤並びに心血管疾患を処置するか又は心血管疾患のリスクを低減させる方法 (FIXED DOSE COMBINATIONS AND FORMULATIONS COMPRISING ETC1002 AND EZETIMIBE, AND METHODS OF TREATING OR REDUCING RISK OF CARDIOVASCULAR DISEASE)
China	107530307
China	112437765	贝派地酸的盐形式及其使用方法 (SALT FORMS OF BEMPEDOIC ACID AND METHODS FOR USING THE SAME)
Israel	288909	שיטות להכנה של חומצה במפדואית ותכשירים המכילים אותה (Methods of making bempedoic acid and compositions of the same)
Japan	2022536979	塩形態のベンペド酸及びそれを使用する方法
South Africa	201706919	FIXED DOSE COMBINATIONS AND FORMULATIONS COMPRISING ETC1002 AND EZETIMIBE AND METHODS OF TREATING OR REDUCING THE RISK OF CARDIOVASCULAR DISEASE
Morocco	42616	COMBINAISONS ET FORMULATIONS DE DOSES FIXES COMPRENANT ETC1002 ET ÉZÉTIMIBE, ET PROCÉDÉS DE TRAITEMENT OU DE RÉDUCTION DU RISQUE DE MALADIE CARDIO-VASCULAIRE

Supplementary Protection Certificates for BEMPEDOIC ACID

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2404890	38/2020	Austria		PRODUCT NAME: BEMPEDOINSAEURE ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ, HYDRAT, SOLVAT ODER EIN GEMISCH DAVON; REGISTRATION NO/DATE: EU/1/20/1424 (MITTEILUNG) 20200331
2404890	122020000048	Germany		PRODUCT NAME: BEMPEDOINSAEURE ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ, HYDRAT, SOLVAT ODER EIN GEMISCH DAVON; REGISTRATION NO/DATE: EU/1/20/1424 20200327
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	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
2404890	CR 2020 00041	Denmark		PRODUCT NAME: BEMPEDOINSYRE ELLER ET/EN FARMACEUTISK ACCEPTABEL(T) SALT, HYDRAT, SOLVAT ELLER BLANDING DERAF; REG. NO/DATE: EU/1/20/1424 20200331
2404890	C02404890/01	Switzerland		PRODUCT NAME: BEMPEDOINSAEURE; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67583 14.12.2020
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

Market Dynamics and Financial Trajectory for Bempedoic Acid

Last updated: July 28, 2025

Introduction

Bempedoic acid represents a novel therapeutic agent targeting hypercholesterolemia, positioned to influence cardiovascular risk management significantly. Market potential hinges on its clinical profile, regulatory landscape, competitive positioning, and evolving healthcare paradigms. This analysis delineates the dynamic market environment and forecasts the drug’s financial trajectory based on recent developments, strategic factors, and industry trends.

Market Context and Clinical Significance

Cardiovascular disease (CVD) remains the leading cause of mortality worldwide, with elevated low-density lipoprotein cholesterol (LDL-C) as a major modifiable risk factor. Statins have long been the cornerstone of lipid management but face limitations due to statin intolerance and residual risk in some patient populations.

Bempedoic acid, approved by the U.S. FDA in 2020 under the brand name Nexletol, offers an alternative mechanism by inhibiting ATP citrate lyase (ACL), a key enzyme in cholesterol biosynthesis upstream of HMG-CoA reductase (statins) (1). Its oral administration, favorable safety profile, and efficacy in reducing LDL-C elevate its potential in lipid-lowering therapy, particularly for statin-intolerant patients or those inadequately controlled on existing regimens.

Market Drivers

1. Growing Cardiovascular Disease Burden

An escalation in global CVD prevalence, driven by aging populations and lifestyle factors, expands the potential patient base. According to the World Health Organization (WHO), cardiovascular diseases account for approximately 17.9 million deaths annually, with a significant subset exhibiting uncontrolled LDL-C despite standard therapy (2).

2. Unmet Medical Need

Approximately 10-15% of patients are statin-intolerant, creating a niche for non-statin lipid-lowering agents (3). Additionally, resistant hypercholesterolemia demands adjunct therapies, enabling expanded utilization of bempedoic acid.

3. Regulatory Approvals and Label Expansion

Post-approval, regulatory agencies are increasingly supportive of drugs with demonstrated safety and efficacy in specific patient populations. The submission and approval of bempedoic acid's combination with ezetimibe (brand name Nexlizet) further broaden its therapeutic scope (4). Future label extensions targeting broader indications could augment market penetration.

4. Competitive Landscape

Bempedoic acid faces competition from PCSK9 inhibitors (alirocumab, evolocumab), ezetimibe, and emerging therapies like inclisiran. While PCSK9 inhibitors demonstrate superior LDL-C reduction, their high costs and injectable administration limit adoption, favoring oral agents like bempedoic acid.

5. Strategic Collaborations and Market Penetration

Partnerships between pharmaceutical companies and payers are crucial to facilitate formulary acceptance. Novartis, which markets Nexletol, has engaged in marketing strategies emphasizing its role as an oral, convenient alternative to injectables, potentially increasing market share.

Market Challenges

1. Competitive Efficacy and Positioning

Bempedoic acid offers LDL-C reductions up to 20-25%, which is moderate compared to PCSK9 inhibitors (>50%). Its placement as an adjunct rather than primary therapy influences its adoption trajectory.

2. Safety and Tolerability Profile

While generally well tolerated, concerns regarding increased uric acid and gout risk and muscle-related adverse events need continuous monitoring and management to preserve market confidence.

3. Cost and Reimbursement

Pricing strategies and insurance coverage significantly influence utilization. As a newer drug, initial reimbursement hurdles could temper rapid market expansion.

4. Market Penetration in Emerging Economies

Despite growth prospects, cost barriers, regulatory variations, and healthcare infrastructure limit access in certain regions, affecting global market size.

Financial Trajectory and Forecasting

1. Revenue Projections

Based on current prescriptions, sales data, and market penetration rates, Novartis projected revenues from Nexletol to reach approximately $600 million to $800 million globally by 2025 (5). A compound annual growth rate (CAGR) of around 15-20% is anticipated, driven by expanding indications, combination therapies, and increased awareness.

2. Market Share Evolution

In the broader hypercholesterolemia therapy landscape, bempedoic acid's share is expected to grow incrementally, potentially capturing 10-15% of LDL-C lowering treatment prescriptions in its class within five years. The combination with ezetimibe and upcoming fixed-dose formulations could accelerate this trajectory.

3. Impact of Clinical Outcomes Data

Ongoing trials, including the CLEAR Outcomes study evaluating cardiovascular event reduction, could substantiate additional value propositions, elevating prescribing rates and bolstering revenue forecasts (6). Positive results may catalyze label extensions and higher dosing approvals, further enhancing financial prospects.

4. Patent Life and Market Exclusivity

Patent protections extending into the late 2020s or early 2030s, along with exclusivity periods, underpin revenue stability. Patent cliffs or biosimilar challenges are less relevant, given the small-molecule nature and existing patents.

5. Cost-Effectiveness and Payer Acceptance

As healthcare systems increasingly emphasize value-based care, demonstrating cost-effectiveness relative to existing therapies will be pivotal. Favorable pharmacoeconomic analyses could secure wider formulary inclusion, positively influencing revenues.

Future Outlook

The market dynamics for bempedoic acid are favorable, especially considering the unmet needs in hypercholesterolemia management. Anticipated regulatory milestones, evolving clinical evidence, and strategic positioning will shape its financial trajectory. While it may not threaten the dominance of PCSK9 inhibitors in LDL-C reduction, its role as an accessible, orally administered adjunct provides a significant niche, with predictable revenue escalations aligned with global cardiovascular health initiatives.

Key Takeaways

• Expanding indications and combination therapies will be primary drivers for bempedoic acid’s growth.
• Competitive positioning as an oral, moderate LDL-C reducer makes it an attractive choice, especially for statin-intolerant patients.
• Clinical trial outcomes (e.g., the CLEAR Outcomes study) are critical to establishing its cardiovascular benefit, influencing market confidence.
• Pricing strategies and payer negotiations will directly impact revenue potential, particularly in emerging markets.
• Innovation and regulatory support will remain essential in extending the drug’s market penetration and sustaining financial growth.

FAQs

Q1: How does bempedoic acid compare to other lipid-lowering agents in efficacy?
Bempedoic acid reduces LDL-C by approximately 20-25%, which is moderate relative to PCSK9 inhibitors (>50%) but superior to ezetimibe alone. Its role is primarily as an adjunct in patients requiring additional LDL-C reduction or those intolerant to statins.

Q2: What are the primary safety concerns associated with bempedoic acid?
Most adverse events are mild, but notable issues include increased serum uric acid levels, raising gout risk, and muscle-related symptoms, especially when combined with statins.

Q3: Will upcoming clinical trial results impact bempedoic acid’s market potential?
Yes. The CLEAR Outcomes trial results, assessing cardiovascular event reduction, could significantly reinforce its clinical value, driving increased adoption and revenue.

Q4: What is the expected market share of bempedoic acid in hypercholesterolemia management?
Within five years, it is projected to hold a 10-15% share of the oral LDL-C lowering segment, with growth contingent on clinical data, pricing, and competitive dynamics.

Q5: Could biosimilar or generic alternatives threaten bempedoic acid’s market?
Given its small-molecule nature and patent protections, generic or biosimilar competition risks are limited until patent expirations in the late 2020s or early 2030s.

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Sources
[1] FDA Approval of Nexletol. U.S. Food and Drug Administration. 2020.
[2] WHO Cardiovascular Disease Fact Sheet. World Health Organization. 2022.
[3] Statin Intolerance and Management. Journal of Clinical Lipidology. 2021.
[4] EZetimibe and Bempedoic Acid Combination Approvals. Novartis Press Releases. 2021.
[5] MarketResearch.com. Bempedoic Acid Market Forecast. 2022.
[6] CLEAR Outcomes Clinical Trial Registry. Novartis. 2022.