Bempedoic acid; ezetimibe - Generic Drug Details

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

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

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

One supplier is listed for this compound.

Summary for bempedoic acid; ezetimibe

International Patents:	77
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	14
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for bempedoic acid; ezetimibe
DailyMed Link:	bempedoic acid; ezetimibe at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for bempedoic acid; ezetimibe

Constraining patent/regulatory exclusivity:

7,335,799

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; ezetimibe

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

Sponsor	Phase
Daiichi Sankyo	PHASE1
Daiichi Sankyo	PHASE4
AstraZeneca	PHASE1

See all bempedoic acid; ezetimibe clinical trials

Pharmacology for bempedoic acid; ezetimibe

Drug Class	Adenosine Triphosphate-Citrate Lyase Inhibitor Dietary Cholesterol Absorption Inhibitor
Mechanism of Action	Adenosine Triphosphate-Citrate Lyase Inhibitors
Physiological Effect	Decreased Cholesterol Absorption

Anatomical Therapeutic Chemical (ATC) Classes for bempedoic acid; ezetimibe

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

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

C10BA	Combinations of various lipid modifying agents
C10B	LIPID MODIFYING AGENTS, COMBINATIONS
C10	LIPID MODIFYING AGENTS
C	Cardiovascular system

Paragraph IV (Patent) Challenges for BEMPEDOIC ACID; EZETIMIBE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NEXLIZET	Tablets	bempedoic acid; ezetimibe	180 mg/10 mg	211617	3	2024-02-21

US Patents and Regulatory Information for bempedoic acid; ezetimibe

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	10,912,751
Esperion Theraps Inc	NEXLIZET	bempedoic acid; ezetimibe	TABLET;ORAL	211617-001	Feb 26, 2020		RX	Yes	Yes	7,335,799			Y
Esperion Theraps Inc	NEXLIZET	bempedoic acid; ezetimibe	TABLET;ORAL	211617-001	Feb 26, 2020		RX	Yes	Yes	11,926,584
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	11,744,816

Expired US Patents for bempedoic acid; ezetimibe

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Esperion Theraps Inc	NEXLIZET	bempedoic acid; ezetimibe	TABLET;ORAL	211617-001	Feb 26, 2020	10,118,881
Esperion Theraps Inc	NEXLIZET	bempedoic acid; ezetimibe	TABLET;ORAL	211617-001	Feb 26, 2020	9,000,041
Esperion Theraps Inc	NEXLIZET	bempedoic acid; ezetimibe	TABLET;ORAL	211617-001	Feb 26, 2020	9,624,152
Esperion Theraps Inc	NEXLIZET	bempedoic acid; ezetimibe	TABLET;ORAL	211617-001	Feb 26, 2020	8,497,301
Esperion Theraps Inc	NEXLIZET	bempedoic acid; ezetimibe	TABLET;ORAL	211617-001	Feb 26, 2020	10,941,095

EU/EMA Drug Approvals for bempedoic acid; ezetimibe

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Daiichi Sankyo Europe GmbH	Nustendi	bempedoic acid, ezetimibe	EMEA/H/C/004959Nustendi 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 in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin in addition to ezetimibealone in patients who are either statin-intolerant or for whom a statin is contraindicated, and are unable to reach LDL-C goals with ezetimibe alone,in patients already being treated with the combination of bempedoic acid and ezetimibe as separate tablets with or without statin	Authorised	no	no	no	2020-03-27

International Patents for bempedoic acid; ezetimibe

Country	Patent Number	Title	Estimated Expiration
Israel	288997	צורות מלח של חומצה במפדואית ושיטות לשימוש בהם (Salt forms of bempedoic acid and methods for using the same)
Canada	2978204
Philippines	12017501625
European Patent Office	3986860	FORMES SALINES D'ACIDE BEMPEDOÏQUE ET LEURS PROCÉDÉS D'UTILISATION (SALT FORMS OF BEMPEDOIC ACID AND METHODS FOR USING THE SAME)
South Korea	20180006887	ＥＴＣ1002 및 에제티미브를 포함하는 고정 용량 조합 및 제형 및 심혈관 질환의 치료 또는 이의 위험의 감소 방법

Supplementary Protection Certificates for bempedoic acid; ezetimibe

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2404890	CA 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	LUC00174	Luxembourg		PRODUCT NAME: BEMPEDOIC ACID, OR A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE, SOLVATE, OR MIXTURE THEREOF; AUTHORISATION NUMBER AND DATE: EU/1/20/1424 20200331
2404890	640	Finland
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	2020/037	Ireland		PRODUCT NAME: BEMPEDOIC ACID, OR A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE, SOLVATE, OR MIXTURE THEREOF; REGISTRATION NO/DATE: EU/1/20/1424 20200331

Market Dynamics and Financial Trajectory for Bempedoic Acid and Ezetimibe

Last updated: July 27, 2025

Introduction

The pharmaceutical landscape for cholesterol management has witnessed significant evolution over the last decade, driven by the increasing prevalence of cardiovascular disease (CVD), regulatory reforms, and advancements in lipid-lowering therapies. Among the prominent agents are Bempedoic Acid and Ezetimibe, both targeting low-density lipoprotein cholesterol (LDL-C) reduction but differing in mechanisms, market positioning, and financial potential. Analyzing their market dynamics and financial trajectories informs stakeholders—pharmaceutical firms, investors, and healthcare providers—about growth opportunities and competitive challenges.

Market Overview

Ezetimibe: A Pioneering Lipid-Lowering Agent

Ezetimibe, marketed notably as Zetia (Merck) and in combination with statins as Vytorin, debuted around 2002. It inhibits intestinal cholesterol absorption via the Niemann-Pick C1-Like 1 (NPC1L1) transporter, providing an adjunct or alternative to statin therapy. Its efficacy in reducing LDL-C, especially in patients intolerant or uncontrolled on statins, positions it as a staple in lipid management.

The global ezetimibe market is sizeable, driven by:

• High penetration in developed markets, particularly the U.S. and Europe.
• Guideline endorsements, including those from the American College of Cardiology/American Heart Association (ACC/AHA), recommending ezetimibe for particular patient subsets.
• Limited patent life: Originally patent-protected until late 2010s, with subsequent generics on the market, compressing profit margins.

The market's maturity has caused stagnation in revenue growth, yet demand remains steady due to its proven efficacy and safety.

Bempedoic Acid: A New Entrant with Growth Potential

Approved by the U.S. FDA in 2020 under the brand name Nexletol (and Nexlizet in combination with ezetimibe), Bempedoic acid is a first-in-class ATP citrate lyase (ACL) inhibitor. It functions upstream of statins, reducing LDL-C levels without some of the muscle-related adverse effects associated with statins.

Bempedoic acid targets:

• Patients statin-intolerant or inadequately controlled.
• A broader population seeking alternative or adjunct lipid-lowering options.

Its approval signaled a significant shift, introducing a novel mechanism that withstands patent exclusivity and addresses unmet clinical needs.

Market Dynamics

Competitive Landscape & Market Differentiation

Ezetimibe and bempedoic acid operate in partly overlapping spheres, but their strategic positioning varies:

• Ezetimibe’s dominance is challenged by generics, leading to declining revenues despite high use.
• Bempedoic acid's niche is in patients needing statin alternatives or combined therapy to achieve LDL-C targets, especially those intolerant to statins or on polypharmacy regimens.

Competition with emerging agents like PCSK9 inhibitors (evolocumab, alirocumab) remains intense, especially in high-risk CVD populations.

Pricing & Reimbursement Trends

• Ezetimibe’s pricing has plummeted post-patent expiration, with generics leading to lower costs and wider accessibility.
• Bempedoic acid initially commands premium pricing; however, reimbursement pressures and cost-effectiveness evaluations influence market penetration.

Regulatory and Clinical Influences

Updated clinical guidelines increasingly endorse ezetimibe and bempedoic acid as second-line or adjunct therapies to statins, emphasizing their role in LDL-C management. The CLEAR Outcomes trial (published 2021) demonstrated bempedoic acid’s efficacy in reducing cardiovascular events, bolstering its attractiveness for clinicians and investors.

Market Penetration and Adoption

Despite approval, bempedoic acid's adoption faces hurdles:

• Physician familiarity remains limited relative to ezetimibe.
• Long-term safety and real-world evidence are still accumulating.
• Pricing strategies influence formulary inclusion, especially as payers demand cost-effectiveness.

Ezetimibe maintains robust sales due to its established efficacy, broad prescriber base, and inclusion in combination therapies.

Financial Trajectory Analysis

Ezetimibe

• Revenue trends: Peaked around 2010-2015, with decline correlating with patent expiry and generics.
• Market share: Sustains because of its low cost and established use.
• Future outlook: Stable but stagnant; growth limited to niche populations.

Bempedoic Acid

• Revenue expectations: Forecast to grow rapidly over the next five years, contingent on clinical adoption, rebate negotiations, and expanded indications.
• Sales projections: Industry estimates suggest global sales could reach $1.2–2.5 billion by 2027 (Industry sources, 2022), especially if combination regimens with ezetimibe or statins gain momentum.
• Pricing power: Expected to decline as generic competitors emerge or biosimilars are developed, unless patent protections are extended or new formulations approved.
• Profitability prospects: Dependent on market penetration, manufacturing costs, and reimbursement environment.

Key Financial Drivers

• Clinical efficacy and safety profile: As more data emerge, positive outcomes will drive prescriptions.
• Reimbursement policies: Value-based pricing models and payer negotiations affect margins.
• Market expansion: Entry into emerging markets like China and India offers volume growth but faces challenges due to price sensitivities.

Strategic Considerations for Stakeholders

• Pharmaceutical companies should prioritize differentiation of bempedoic acid via combination products, real-world evidence, and targeted marketing.
• Investors should monitor patent statuses, regulatory milestones, and competitive landscapes, especially shifts by PCSK9 inhibitors.
• Healthcare systems benefit from understanding the cost versus efficacy dynamics to optimize formulary decisions.

Conclusion

While ezetimibe remains a cornerstone in lipid management, its growth has stabilized amid generic competition. Bempedoic acid emerges as a promising player with significant potential to reshape the market, especially among statin-intolerant patients and those requiring intensified LDL-C reduction. Its financial trajectory hinges on clinical validation, regulatory support, and market adoption. Stakeholders must adapt strategies dynamically to capitalize on these evolving market forces.

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Key Takeaways

• Ezetimibe, after years of dominance, faces a mature, stagnant market due to patent expiry and generics.
• Bempedoic acid offers a novel mechanism with substantial growth prospects, especially in high-risk, treatment-resistant populations.
• Reimbursement strategies, clinical evidence, and formulary positioning will significantly influence its financial success.
• Competitive pressure from PCSK9 inhibitors and emerging therapies requires proactive differentiation.
• Global expansion into emerging markets could enhance volume but demands favorable pricing and regulatory strategies.

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FAQs

1. How does Bempedoic acid differ mechanistically from Ezetimibe?
Bempedoic acid inhibits ATP citrate lyase in the cholesterol biosynthesis pathway upstream of HMG-CoA reductase, reducing LDL-C via decreased hepatic cholesterol synthesis. Ezetimibe blocks intestinal cholesterol absorption via NPC1L1. These distinct mechanisms allow for combination therapy and tailored patient management.

2. What are the primary factors influencing Bempedoic acid’s market growth?
Market growth relies on clinical validation (e.g., outcomes from the CLEAR Outcomes trial), favorable reimbursement policies, clinician acceptance, and successful positioning against existing therapies. Long-term safety data and combination therapy approvals will further drive uptake.

3. Will the pharmaceutical market sustain high sales for Ezetimibe despite patent expiration?
Post-patent expiration, generic competition has significantly reduced ezetimibe’s price, constraining revenue growth. Its continued consumption depends on formulary inclusion, clinician familiarity, and combination therapy integration, but overall sales are expected to decline gradually.

4. How do regulatory approvals influence the financial trajectory of these agents?
Regulatory approvals, especially for new indications or combination therapies, can expand market size and sales volume. Conversely, delays or restrictions diminish financial prospects. The approval of bempedoic acid for cardiovascular outcomes enhances its market appeal.

5. What is the outlook for combination therapy involving Bempedoic acid?
Combination therapies (e.g., bempedoic acid with ezetimibe) are poised to gain acceptance, offering synergistic LDL-C reductions. Regulatory endorsements and positive clinical trial results will be critical in facilitating widespread adoption and maximizing market potential.

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References

[1] European Medicines Agency. “Ezetimibe: Summary of Product Characteristics.” 2015.
[2] U.S. Food and Drug Administration. “FDA approves new drug to treat high cholesterol” (Nexletol), 2020.
[3] Rosenson, R. S., et al. “Efficacy and safety of bempedoic acid in lowering LDL cholesterol,” Journal of the American College of Cardiology, 2021.
[4] Industry Reports. “Lipid-Lowering Drugs Market Analysis,” 2022.
[5] American College of Cardiology/American Heart Association Guidelines for Lipid Management, 2018.