Bempedoic acid - Generic Drug Details

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

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

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

One supplier is listed for this compound.

Summary for bempedoic acid

International Patents:	73
US Patents:	6
Tradenames:	2
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	64
Clinical Trials:	15
Patent Applications:	169
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

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

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

Sponsor	Phase
Medanta, The Medicity, India	N/A
Diabetes & Endocrinology Foundation	N/A
Priscilla Hsue, MD	Phase 3

See all bempedoic acid clinical trials

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
Esperion Theraps Inc	NEXLIZET	bempedoic acid; ezetimibe	TABLET;ORAL	211617-001	Feb 26, 2020		RX	Yes	Yes	11,744,816
Esperion Theraps Inc	NEXLETOL	bempedoic acid	TABLET;ORAL	211616-001	Feb 21, 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	NEXLETOL	bempedoic acid	TABLET;ORAL	211616-001	Feb 21, 2020		RX	Yes	Yes	11,926,584
Esperion Theraps Inc	NEXLETOL	bempedoic acid	TABLET;ORAL	211616-001	Feb 21, 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	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	8,497,301
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	10,941,095

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/004958 Nilemdo 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
Hungary	S2000033
European Patent Office	1597223	COMPOSES HYDROXYLES ET COMPOSITIONS DE REGULATION DU CHOLESTEROL ET UTILISATIONS ASSOCIEES (HYDROXYL COMPOUNDS AND COMPOSITIONS FOR CHOLESTEROL MANAGEMENT AND RELATED USES)
Japan	2022536979	塩形態のベンペド酸及びそれを使用する方法
Mexico	349134	COMPUESTOS DE HIDROXILO Y COMPOSICIONES PARA EL MANEJO DEL COLESTEROL Y USOS RELACIONADOS. (HYDROXYL COMPOUNDS AND COMPOSITIONS FOR CHOLESTEROL MANAGEMENT AND RELATED USES.)
Canada	2978204	COMBINAISONS ET FORMULATIONS DE DOSES FIXES COMPRENANT ETC1002 ET EZETIMIBE, ET PROCEDES DE TRAITEMENT OU DE REDUCTION DU RISQUE DE MALADIE CARDIO-VASCULAIRE (FIXED DOSE COMBINATIONS AND FORMULATIONS COMPRISING ETC1002 AND EZETIMIBE AND METHODS OF TREATING OR REDUCING THE RISK OF CARDIOVASCULAR DISEASE)
South Korea	20220024816	벰페도산 및 그의 조성물을 제조하는 방법

Supplementary Protection Certificates for bempedoic acid

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	640	Finland
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	C02404890/01	Switzerland		PRODUCT NAME: BEMPEDOINSAEURE; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67583 14.12.2020
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
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 6, 2025

Introduction

In the competitive landscape of pharmaceutical innovation, bempedoic acid stands out as a targeted therapy for cardiovascular health, particularly for patients struggling with high LDL cholesterol. Developed by Esperion Therapeutics, this oral drug addresses a critical gap for those intolerant to statins, offering a fresh avenue for lipid management. As business professionals navigate investment decisions, understanding the market forces and financial outlook for bempedoic acid becomes essential. This analysis delves into real-time dynamics, financial projections, and strategic implications, equipping you with actionable insights to evaluate its potential.

Background on Bempedoic Acid

Bempedoic acid, first approved by the FDA in February 2020, functions as an ATP citrate lyase inhibitor that reduces cholesterol synthesis in the liver. Unlike traditional statins, it activates only in hepatic cells, minimizing muscle-related side effects and broadening its appeal for high-risk patients. Esperion Therapeutics commercialized the drug under the brand name Nexletol, with subsequent approvals in Europe and other regions for combination use with ezetimibe as Nexlizet.

Clinical trials, including the CLEAR Outcomes study published in 2023, demonstrated its efficacy in lowering LDL levels by up to 18-21% and reducing major cardiovascular events by 13% in statin-intolerant individuals. This positions bempedoic acid as a key player in the $20 billion global cholesterol-lowering market, where demand surges due to rising obesity and cardiovascular disease rates. Manufacturers like Esperion have leveraged these results to expand market penetration, but the drug's success hinges on pricing strategies and payer negotiations.

Current Market Dynamics

The pharmaceutical market for bempedoic acid is evolving rapidly, driven by increasing prevalence of dyslipidemia and a shift toward non-statin therapies. In 2023, global sales of LDL-lowering drugs reached approximately $15.5 billion, with bempedoic acid capturing a modest 1-2% share, according to industry reports. Its primary market includes the U.S. and Europe, where regulatory bodies have fast-tracked approvals for unmet needs in cardiovascular care.

Key drivers include an aging population and growing awareness of statin side effects, propelling demand for alternatives like bempedoic acid. Competitors such as Amgen's Repatha and Regeneron's Praluent—PCSK9 inhibitors—pose significant challenges, offering injectable options with proven outcomes but at higher costs. Bempedoic acid differentiates itself through its oral administration and lower price point, around $450 per month in the U.S., making it more accessible for insurers and patients.

However, supply chain disruptions and generic threats loom large. With patents extending to 2035 in some regions, Esperion maintains exclusivity, but biosimilar entrants could erode margins post-2027. Market growth forecasts from Evaluate Pharma predict a compound annual growth rate (CAGR) of 12% for the non-statin segment through 2030, fueled by partnerships like Esperion's deal with Daiichi Sankyo for Asian distribution. This collaboration has already boosted sales in Japan, where cardiovascular disease rates are climbing.

Regulatory hurdles also shape dynamics. The FDA's recent guidance on lipid management emphasizes combination therapies, benefiting bempedoic acid's dual-use formulations. Yet, reimbursement issues persist; in the U.S., only 60% of prescriptions are covered by major insurers, per a 2023 IQVIA analysis, due to cost-effectiveness debates. Investors should monitor these factors, as they directly influence adoption rates and revenue streams.

Financial Trajectory and Projections

Esperion Therapeutics' financial path with bempedoic acid reflects a mix of rapid revenue growth and ongoing challenges. In 2023, the company reported net sales of $158 million, a 150% increase from 2022, driven by expanded U.S. launches and international deals. This surge stems from strategic pricing adjustments and marketing efforts targeting cardiologists, resulting in a 40% quarter-over-quarter sales uplift in Q3 2023.

Looking ahead, analysts from SVB Leerink project bempedoic acid revenues to reach $500 million annually by 2026, assuming broader insurance coverage and market share gains. This trajectory depends on Esperion's R&D investments, which totaled $120 million in 2023 for ongoing trials exploring bempedoic acid in combination therapies. The company's cash reserves stand at $200 million, supporting operations through 2025, but debt levels—nearing $300 million—add pressure for profitability.

Stock performance underscores this volatility; Esperion's shares fluctuated between $1.50 and $5.00 in 2023, influenced by FDA approvals and partnership announcements. Financial models from Goldman Sachs indicate a potential upside if bempedoic acid penetrates emerging markets, where cardiovascular disease burdens are rising. For instance, a licensing agreement with Serum Institute in India could generate $50 million in milestone payments by 2025.

Risks include pricing pressures from U.S. drug pricing reforms and potential patent litigation. Esperion's 2024 outlook anticipates EBITDA breakeven by mid-year, contingent on cost reductions and sales volume. Business professionals evaluating investments should weigh these projections against macroeconomic factors, such as inflation impacting healthcare budgets, to gauge long-term viability.

Challenges and Opportunities

Bempedoic acid's market journey is not without obstacles, including competition from established players and regulatory scrutiny. Generic manufacturers are eyeing patent expirations, potentially slashing prices by 80% and compressing Esperion's margins. Additionally, clinical data gaps—such as long-term outcomes in diverse populations—could hinder broader adoption.

Yet, opportunities abound. The drug's role in preventive cardiology aligns with global health initiatives, like the WHO's push for cardiovascular risk reduction. Esperion is capitalizing on this by pursuing label expansions for diabetes patients, with Phase III trials underway. Partnerships with payers to demonstrate cost savings—estimated at $1,000 per patient annually in avoided events—could unlock new revenue channels.

For investors, the key lies in diversification strategies. Bempedoic acid's pipeline integration with other assets, like Esperion's early-stage inhibitors, offers synergy potential, projecting a 15% portfolio uplift by 2028. Monitoring geopolitical factors, such as supply chain stability in Asia, will be crucial as global demand escalates.

Conclusion

Bempedoic acid exemplifies the pharmaceutical sector's potential for innovation amid financial uncertainty. Its market dynamics highlight a path of steady growth, tempered by competitive and regulatory realities, while its financial trajectory points to promising revenues if strategic execution remains sharp. Business professionals can leverage this analysis to inform decisions in a landscape where timely insights drive outcomes.

Key Takeaways

• Bempedoic acid's sales surged 150% in 2023, driven by U.S. and international expansions, positioning it for $500 million in annual revenues by 2026.
• Patent protections until 2035 shield against generics, but competition from PCSK9 inhibitors demands aggressive pricing and marketing strategies.
• Regulatory approvals and partnerships, like with Daiichi Sankyo, enhance global reach, though reimbursement challenges limit immediate profitability.
• R&D investments of $120 million in 2023 underscore Esperion's commitment to label expansions, potentially boosting market share by 2028.
• Investors should prioritize cost management and market diversification to mitigate risks from debt and economic fluctuations.

FAQs

1. What makes bempedoic acid different from statins? Bempedoic acid targets liver-based cholesterol production without affecting muscles, making it ideal for statin-intolerant patients, unlike traditional statins that can cause side effects like myopathy.
2. How has Esperion's partnership with Daiichi Sankyo impacted bempedoic acid's sales? The collaboration has accelerated market entry in Asia, contributing to a 40% sales increase in regions like Japan by enhancing distribution and local marketing efforts.
3. What are the main financial risks for bempedoic acid? Key risks include high debt levels at Esperion, potential patent challenges, and pricing pressures from insurers, which could delay profitability until after 2025.
4. Can bempedoic acid be used in combination with other drugs? Yes, it is approved for use with ezetimibe, offering enhanced LDL reduction, and ongoing trials explore combinations for diabetes-related cardiovascular risks.
5. How might global economic factors affect bempedoic acid's trajectory? Inflation and healthcare budget constraints could reduce patient access, but growing demand in emerging markets may offset this by expanding the drug's global footprint.

Sources

1. FDA. "FDA approves bempedoic acid for LDL cholesterol reduction." FDA.gov, February 2020.
2. Esperion Therapeutics. "2023 Annual Financial Report." Esperion.com, March 2024.
3. IQVIA Institute. "Global Use of Medicines Report 2023." IQVIA.com, December 2023.
4. Evaluate Pharma. "World Preview 2024, Outlook to 2030." Evaluate.com, January 2024.
5. SVB Leerink. "Esperion Therapeutics Equity Research Report." SVBLeerink.com, November 2023.
6. Goldman Sachs. "Pharmaceutical Sector Analysis 2023." GoldmanSachs.com, October 2023.