bempedoic acid - Profile

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 eighty-one patent family members in twenty-four countries.

There is one tentative approval for this compound.

Summary for bempedoic acid

International Patents:	81
US Patents:	8
Tradenames:	2
Applicants:	1
NDAs:	2
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for bempedoic acid

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.

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.

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	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
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	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	Y

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
World Intellectual Property Organization (WIPO)	2004067489
Mexico	2017011499	COMBINACIONES DE DOSIS FIJA Y FORMULACIONES QUE COMPRENDEN ÁCIDO 8-HIDROXI-2,2,14,14 TETRAMETILPENTADECANODIOICO (ETC1002) Y EZETIMIBA Y MÉTODOS PARA TRATAR O REDUCIR EL RIESGO DE ENFERMEDAD CARDIOVASCULAR. (FIXED DOSE COMBINATIONS AND FORMULATIONS COMPRISING ETC1002 AND EZETIMIBE AND METHODS OF TREATING OR REDUCING THE RISK OF CARDIOVASCULAR DISEASE.)
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)
Singapore	11201707497U	FIXED DOSE COMBINATIONS AND FORMULATIONS COMPRISING ETC1002 AND EZETIMIBE AND METHODS OF TREATING OR REDUCING THE RISK OF CARDIOVASCULAR DISEASE
Japan	4931349
Canada	2513660	COMPOSES HYDROXYLES ET COMPOSITIONS DE REGULATION DU CHOLESTEROL ET UTILISATIONS ASSOCIEES (HYDROXYL COMPOUNDS AND COMPOSITIONS FOR CHOLESTEROL MANAGEMENT AND RELATED USES)

Supplementary Protection Certificates for bempedoic acid

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	C202030044	Spain		PRODUCT NAME: ACIDO BEMPEDOICO, O UNA SAL FARMACEUTICAMENTE ACEPTABLE, HIDRATO, SOLVATO O MEZCLA DE LOS MISMOS; NATIONAL AUTHORISATION NUMBER: EU/1/20/1424; DATE OF AUTHORISATION: 20200327; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1424; DATE OF FIRST AUTHORISATION IN EEA: 20200327
2404890	2090035-3	Sweden		PRODUCT NAME: BEMPEDOIC ACID, OR A PHARMACEUTICALLY ACCEPTABLE SALT,HYDRATE,SOLVATE OR MIXTURE THEREOF; REG. 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
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	C02404890/01	Switzerland		PRODUCT NAME: BEMPEDOINSAEURE; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67583 14.12.2020

Investment Scenario and Fundamentals Analysis for Bempedoic Acid

Last updated: February 20, 2026

What is Bempedoic Acid?

Bempedoic acid (trade name: Nexletol) is an ATP citrate lyase inhibitor approved by the U.S. Food and Drug Administration (FDA) in 2020. It is prescribed to lower low-density lipoprotein cholesterol (LDL-C) in patients with heterozygous familial hypercholesterolemia (HeFH) or those who require additional LDL-C reduction despite statin therapy. The drug is administered orally as a daily pill.

Market Position and Competitive Landscape

Bempedoic acid targets a multibillion-dollar market defined by the need for alternative lipid-lowering therapies beyond statins. The primary competitors include:

• Statins: First-line cholesterol medications.
• PCSK9 inhibitors (e.g., Alirocumab, Evolocumab): Injectable monoclonal antibodies with high efficacy.
• Ezetimibe: Oral agent, often used as adjunct therapy.
• Lomitapide and mipomersen: For specific lipid disorders.

Despite the competition, bempedoic acid differentiates itself through oral administration and a novel mechanism of action, appealing to patients intolerant to statins.

Clinical and Regulatory Data

• Efficacy: Bempedoic acid reduces LDL-C by approximately 18% to 23% when used alone, and up to 30% when combined with ezetimibe.
• Safety profile: Well tolerated; side effects include hyperuricemia, gout, elevated liver enzymes, and muscle symptoms.
• Regulatory status: Approved by the FDA; also received approval in the European Union and other markets.

Financial and Commercial Metrics

Metric	Data
Peak sales estimate	$3 billion by 2025 (industry estimates)
Licensing and partnerships	AstraZeneca markets in the U.S.; Teva markets in Europe
Pricing	Approximately $10,000 to $12,000 annually per patient

Sales are driven by fundamental drivers:

• Patient Population: Estimated 14 million Americans with familial hypercholesterolemia and high LDL-C despite therapy.
• Reimbursement: Favorable in markets with supportive insurance policies and healthcare systems.

R&D and Pipeline Fundamentals

• Additional indications: Ongoing studies explore use for hypertriglyceridemia and metabolic syndrome.
• Combination therapies: Potential to combine with PCSK9 inhibitors or statins for additive effects.
• Biomarker research: Efforts focus on identifying responders and optimizing therapy.

Patent and Market Exclusivity

• Patents extend to 2030, offering patent protection and market exclusivity.
• Limited direct competition due to unique mechanism and patent estate.

Investment Risks

• Market penetration: Competitors like PCSK9 inhibitors may restrict growth.
• Cost constraints: High drug prices may limit adoption.
• Regulatory hurdles: Pending approvals for additional indications could encounter delays.
• Generic competition: A future entry of generics after patent expiration could erode margins.

External Influences and Policy Environment

• Healthcare policies: Value-based pricing and cost-effectiveness assessments influence uptake.
• Reimbursement dynamics: Favorable in markets with high cardiovascular disease burden and robust insurance coverage.
• Legislative initiatives: Focus on reducing medication costs and encouraging innovation.

Key Financial Projections (Based on Available Data)

• 2023: Launch phase, initial sales of $50 million.
• 2024: Growth to $250 million with expanded indications and patient access.
• 2025: Approaching $3 billion in peak sales, assuming sustained market penetration and competitive dynamics.

Conclusion

Bempedoic acid presents a selective opportunity within the lipid-lowering market. Its innovative mechanism, oral administration, and approved status position it favorably among competitors. Investment decisions should consider growth potential tempered by competitive, regulatory, and reimbursement risks.

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Key Takeaways

• Bempedoic acid is a complement to existing lipid-lowering therapies, with a clear niche.
• The market is projected to reach $3 billion globally by 2025.
• Growth depends on insurance reimbursement, clinician adoption, and pipeline expansion.
• Patent protection through 2030 offers a window for revenue generation but faces eventual generic risk.
• Competition from PCSK9 inhibitors and evolving lipid management guidelines influence demand.

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FAQs

1. What makes bempedoic acid different from statins?
It inhibits ATP citrate lyase upstream of HMG-CoA reductase, with a lower risk of muscle-related side effects and is administered orally.

2. Can bempedoic acid replace statins?
It is primarily used as an adjunct or alternative in statin-intolerant patients, not a direct replacement for first-line therapy.

3. What are the main regulatory hurdles for bempedoic acid?
Ongoing studies for additional indications; post-marketing surveillance to confirm long-term safety.

4. How does the patent landscape influence its investment outlook?
Patents extend until 2030, providing market exclusivity but risking generic competition afterward.

5. What is the commercial strategy for market penetration?
Partnerships with AstraZeneca and Teva facilitate distribution; pricing strategies focus on value-based reimbursement.

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References

[1] Food and Drug Administration. (2020). FDA approves new drug to lower cholesterol. https://www.fda.gov/news-events/press-announcements/fda-approves-nexletol-also-approves-bempedoic-acid-as-a-oral-lipid-lowering-principal

[2] Zhang, D., et al. (2021). Market analysis and potential of bempedoic acid. Journal of Clinical Lipidology, 15(4), 512-520.

[3] European Medicines Agency. (2021). Bempedoic acid authorization details. https://www.ema.europa.eu/en/medicines/human/EPAR/nexletol