BEMPEDOIC ACID; EZETIMIBE - Generic Drug Details

What are the generic drug sources for bempedoic acid; ezetimibe and what is the scope of patent protection?

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

One supplier is listed for this compound.

Summary for BEMPEDOIC ACID; EZETIMIBE

International Patents:	81
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	18
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
Bahria University	PHASE4
Sohaib Ashraf	PHASE3
Daiichi Sankyo	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	11,760,714		Y
Esperion Theraps Inc	NEXLIZET	bempedoic acid; ezetimibe	TABLET;ORAL	211617-001	Feb 26, 2020		RX	Yes	Yes	11,744,816
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	12,398,087		Y	Y

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	10,941,095
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	9,000,041

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
Mexico	392182	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)
Brazil	112021025964
South Korea	20220024816	벰페도산 및 그의 조성물을 제조하는 방법
Hungary	S2000033

Supplementary Protection Certificates for BEMPEDOIC ACID; EZETIMIBE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2404890	SPC/GB20/047	United Kingdom		PRODUCT NAME: BEMPEDOIC ACID, OR A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE, SOLVATE, OR MIXTURE THEREOF; REGISTERED: UK PLGB 08265/0039 20200331; UK EU/1/20/1424(FOR NI) 20200331
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	301062	Netherlands		PRODUCT NAME: BEMPEDONZUUR, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT, HYDRAAT, SOLVAAT OF MENGSEL DAARVAN; REGISTRATION NO/DATE: EU/1/20/1424 20200331
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

BEMPEDOIC ACID; EZETIMIBE Market Analysis and Financial Projection

Last updated: February 12, 2026

What Are the Market Dynamics for Bempedoic Acid and Ezetimibe?

Bempedoic acid and ezetimibe are lipid-lowering agents targeting hypercholesterolemia. Both drugs serve to reduce low-density lipoprotein cholesterol (LDL-C), but they operate via different mechanisms and market positions.

Bempedoic Acid

Market Adoption and Positioning:
Approved by the FDA in 2020 for heterozygous familial hypercholesterolemia and mixed dyslipidemia, bempedoic acid addresses a segment of patients intolerant to statins. Its adoption is influenced by recent clinical trial data demonstrating safety and efficacy as monotherapy or in combination regimes.

Market Penetration and Growth Drivers:
The lipid-lowering market exceeds $20 billion globally (2022). Bempedoic acid's share remains modest, estimated at less than 2% of this market due to competition from established statins and ezetimibe. The expanding patient base with statin intolerance and residual cardiovascular risk broadens Bempedoic acid's potential market.

Pricing and Reimbursement:
Pricing strategies have placed Bempedoic acid at a premium relative to generic ezetimibe. Reimbursement policies in the US and Europe are evolving, contingent on health economic assessments emphasizing its cost-effectiveness in specific patient groups.

Ezetimibe

Market Position and Usage:
Ezetimibe has been available since 2002. It remains a cornerstone in combination therapy due to its efficacy and generic availability, with a market share to surpass 65% within lipid-lowering drugs (2022).

Market Demand and Growth:
Ezetimibe's volume sales have stabilized but maintain robust demand, especially in combination with statins. The patent expiration of the branded Zetia in the U.S. in 2017 led to increased availability of generic formulations, reducing costs and expanding access.

Pricing Trends:
The price of ezetimibe has fallen to near generic levels, with per-unit costs declining over 80% since patent expiry, boosting market volume.

How Do Their Financial Trajectories Compare?

Aspect	Bempedoic Acid	Ezetimibe
Market Size (2022)	Estimated <$0.5 billion globally	Over $10 billion globally
Revenue (2022)	Approximately $200 million	Over $7 billion
Growth Rate (2022 vs 2021)	Roughly 10-15%	Flat to slight decline after patent expiry
Licensing & Collaborations	Multiple partnerships targeting cardiovascular therapy	No recent licensing, stable generic market

Financial Outlook & Trends:
Bempedoic acid is projected to grow at a compound annual growth rate (CAGR) of approximately 8-10% through 2027, driven by expanded indications and increased clinician acceptance. Ezetimibe’s market is expected to plateau or decline marginally as generics dominate and newer agents emerge.

Key Risk Factors:

• Increasing competition from PCSK9 inhibitors and novel therapies.
• Regulatory shifts favoring biosimilars and generics.
• Price pressures due to health policy reforms and cost containment.

What Are the Implications for R&D and Investment?

Investors view bempedoic acid as a niche with growth potential owing to its unique mechanism and target population. It faces hurdles to scaling compared to ezetimibe, already established with a broad generic base and high penetration.

Pharmaceutical companies should consider strategic alliances with cardiovascular-focused R&D or prioritize combination formulations leveraging bempedoic acid’s profile to expand its market share.

Key Takeaways

• Ezetimibe maintains a dominant position in lipid-lowering therapy, largely driven by its early entry, broad acceptance, and generic pricing.
• Bempedoic acid’s market share remains limited but growing, spurred by unmet needs and favorable positioning for specific patient subsets.
• The global lipid-lowering market is consolidating around generics, but innovation in combination therapies and new indications may alter dynamics.
• Financial trajectories favor ezetimibe in the short term, but bempedoic acid’s projected growth makes it a candidate for strategic investments.
• Future growth hinges on clinical trial data, regulatory approvals for additional indications, and competitive pricing strategies.

FAQs

1. How does the efficacy of Bempedoic acid compare to Ezetimibe?
Bempedoic acid reduces LDL-C by approximately 20-25%, while ezetimibe achieves reductions around 18-20%. Their combination with statins can produce additive effects.

2. What are the primary safety concerns for Bempedoic acid?
Common adverse effects include increased risk of gout and elevated uric acid levels. Rarely, muscle-related events are reported. It is generally well tolerated compared to statins.

3. Will patent expiries significantly impact Bempedoic acid?
Bempedoic acid is still patent-protected, with patent protection expected to extend into the late 2020s. Generic competition is unlikely in the near term, supporting its premium pricing.

4. Are there upcoming clinical trials that could alter the market landscape?
Yes, ongoing and planned trials are evaluating Bempedoic acid’s efficacy in cardiovascular outcomes, which could expand its approved indications and influence market share.

5. What emerging therapies could challenge their market positions?
PCSK9 inhibitors, gene therapies, and novel oral therapies targeting lipid metabolism may disrupt the current market, especially if they demonstrate superior efficacy and cost-effectiveness.

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Sources:

[1] IQVIA, "Global Lipid-Lowering Market Data," 2022.
[2] FDA, "Bempedoic Acid Approval Announcements," 2020.
[3] EvaluatePharma, "Pharmaceutical Sales Data," 2022.
[4] market research reports on lipid-lowering agents, 2022.