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 six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

One supplier is listed for this compound.

Summary for bempedoic acid; ezetimibe

International Patents:	73
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	6
DailyMed Link:	bempedoic acid; ezetimibe at DailyMed

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

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
Medanta, The Medicity, India	N/A
Diabetes & Endocrinology Foundation	N/A
Esperion Therapeutics, Inc.	Phase 4

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
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
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
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; 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
Esperion Theraps Inc	NEXLIZET	bempedoic acid; ezetimibe	TABLET;ORAL	211617-001	Feb 26, 2020
Esperion Theraps Inc	NEXLIZET	bempedoic acid; ezetimibe	TABLET;ORAL	211617-001	Feb 26, 2020
Esperion Theraps Inc	NEXLIZET	bempedoic acid; ezetimibe	TABLET;ORAL	211617-001	Feb 26, 2020
Esperion Theraps Inc	NEXLIZET	bempedoic acid; ezetimibe	TABLET;ORAL	211617-001	Feb 26, 2020

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/004959 Nustendi 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	2021015936	METODOS PARA PREPARAR ACIDO BEMPEDOICO Y COMPOSICIONES DEL MISMO. (METHODS OF MAKING BEMPEDOIC ACID AND COMPOSITIONS OF THE SAME.)
Brazil	112021025928	Métodos de preparação de ácido bempedoico e composições do mesmo
Singapore	11201707497U	FIXED DOSE COMBINATIONS AND FORMULATIONS COMPRISING ETC1002 AND EZETIMIBE AND METHODS OF TREATING OR REDUCING THE RISK OF CARDIOVASCULAR DISEASE
Singapore	10201908500U	FIXED DOSE COMBINATIONS AND FORMULATIONS COMPRISING ETC1002 AND EZETIMIBE AND METHODS OF TREATING OR REDUCING THE RISK OF CARDIOVASCULAR DISEASE
Spain	2642216
Russian Federation	2766085	ФИКСИРОВАННЫЕ КОМБИНАЦИИ И СОСТАВЫ, СОДЕРЖАЩИЕ ЕТС1002 И ЭЗЕТИМИБ, И СПОСОБЫ ЛЕЧЕНИЯ ИЛИ УМЕНЬШЕНИЯ РИСКА РАЗВИТИЯ СЕРДЕЧНО-СОСУДИСТОГО ЗАБОЛЕВАНИЯ (FIXED COMBINATIONS AND COMPOUNDS CONTAINING ETC-1002 AND EZETIMIBE, AND METHOD FOR TREATING OR REDUCING THE RISK OF DEVELOPING A CARDIOVASCULAR DISEASE)
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)

Supplementary Protection Certificates for bempedoic acid; ezetimibe

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2404890	C02404890/01	Switzerland		PRODUCT NAME: BEMPEDOINSAEURE; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67583 14.12.2020
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	2020C/534	Belgium		PRODUCT NAME: ACIDE BEMPEDOIQUE OU UN SEL, HYDRATE, PRODUIT DE SOLVATATION OU MELANGE DE CEUX-CI, PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: 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	301062	Netherlands		PRODUCT NAME: BEMPEDONZUUR, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT, HYDRAAT, SOLVAAT OF MENGSEL DAARVAN; 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
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

Market Dynamics and Financial Trajectory for Bempedoic Acid and Ezetimibe

Introduction to Bempedoic Acid and Ezetimibe

Bempedoic acid, often combined with ezetimibe, is a significant advancement in the treatment of hypercholesterolemia and cardiovascular risk reduction. Developed by Esperion Therapeutics, these medications have garnered substantial attention for their efficacy in lowering LDL-C (low-density lipoprotein cholesterol) levels, particularly in patients who are intolerant to statins.

Market Size and Growth

The market for pharma-grade bempedoic acid is experiencing robust growth. As of 2023, the market size was valued at $1.2 billion and is projected to reach $3.5 billion by 2031, growing at a CAGR of 14.33% during the forecast period of 2024-2031[3].

Drivers of Market Growth

Rising Prevalence of Hypercholesterolemia

The increasing prevalence of hypercholesterolemia, driven by factors such as a lack of physical activity, poor lifestyle choices, and increased consumption of processed foods, is a major driver of the market. As more people are diagnosed with elevated cholesterol levels, the demand for effective cholesterol-lowering therapies like bempedoic acid increases[3].

Extending Development and Research

Continuous research and development in the pharmaceutical industry are expanding the therapeutic applications of bempedoic acid. Clinical trials examining its use in various patient populations and in combination with other lipid-lowering medications are enhancing its efficacy and safety profile. Regulatory approvals for new indications further boost market accessibility and reliability[3].

Growing Preventive Healthcare Adoption

The adoption of preventive healthcare measures, particularly in regions like North America, is driving the market. Early adoption of novel medications such as bempedoic acid, coupled with government programs aimed at reducing cardiovascular risks, contributes to the market's growth[3].

Competitive Landscape

The market for bempedoic acid and ezetimibe is highly competitive. Established pharmaceutical companies leverage their extensive distribution networks, marketing strategies, and brand reputation to maintain market share. New entrants face significant challenges, including price wars and competition from emerging breakthroughs and alternative medicines. To remain competitive, companies must invest heavily in marketing, R&D, and other areas[3].

Financial Performance of Esperion Therapeutics

Revenue and Sales

Esperion Therapeutics has seen notable financial growth driven by the success of bempedoic acid and the bempedoic acid/ezetimibe combination tablet. In the third quarter of 2022, U.S. net product revenue for NEXLETOL (bempedoic acid) and NEXLIZET (bempedoic acid and ezetimibe) grew 28% year-over-year to $14.0 million. Total revenue for the third quarter was $19.0 million, with a nine-month total of $56.7 million[5].

Collaboration Agreements

Esperion has secured significant financial support through collaboration agreements. For instance, the license and collaboration agreement with Daiichi Sankyo Europe included an upfront payment of $150 million, with potential additional regulatory and commercial milestone payments of up to $600 million, along with tiered royalties ranging from 15% to 25% on net territory sales[2].

Research and Development Expenses

The company's research and development expenses have been substantial, reflecting the ongoing clinical trials and regulatory submissions. In the first quarter of 2019, R&D expenses were $46.3 million, primarily due to the clinical development costs for bempedoic acid and the bempedoic acid/ezetimibe combination tablet[2].

Operational Costs and Losses

Despite revenue growth, Esperion has reported operational losses. In the third quarter of 2022, the company incurred a net loss of $55.1 million, largely due to high operating expenses, including R&D and selling, general, and administrative costs[5].

Regulatory Milestones and Approvals

FDA Approvals

On March 22, 2024, the FDA approved expanded labels for NEXLETOL (bempedoic acid) and NEXLIZET (bempedoic acid and ezetimibe), including indications for cardiovascular risk reduction and expanded LDL-C lowering to both primary and secondary prevention patients. These approvals were based on the CLEAR Outcomes data and marked a significant expansion of the drugs' indications[1].

European Regulatory Submissions

Esperion has also submitted a Type II(a) variation to the European Medicines Agency (EMA) seeking approval for NILEMDO (bempedoic acid) and NUSTENDI (bempedoic acid and ezetimibe) to reduce cardiovascular risk in patients with or at high risk for atherosclerotic cardiovascular disease[1].

Efficacy and Safety

Clinical Trial Results

Clinical trials have demonstrated the efficacy and safety of bempedoic acid when added to background lipid-modifying therapy, including ezetimibe. The CLEAR Tranquility trial showed that bempedoic acid reduced LDL-C by 28.5% more than placebo, with significant reductions in other lipid parameters and a favorable safety profile[4].

Real-World Impact

The addition of bempedoic acid to ezetimibe has been shown to result in significantly more patients achieving target LDL-C levels, as indicated by simulation study results. This combination is particularly beneficial for patients who are intolerant to statins, providing an effective alternative for cardiovascular risk reduction[5].

Geographic Market Dynamics

North America

North America is leading the market growth due to improvements in the healthcare system, an increase in cardiovascular illnesses, and an aging population that increases the need for efficient cholesterol-lowering medications. Early adoption of novel medications like bempedoic acid aligns with rising healthcare costs and government initiatives to reduce cardiovascular risks[3].

Challenges and Opportunities

Competition and Market Penetration

The market faces challenges from fierce competition among pharmaceutical companies, which can lead to price wars and reduced profit margins. However, the unique positioning of bempedoic acid as an oral, non-statin option provides a significant opportunity for market penetration, especially in regions with high demand for alternative cholesterol-lowering therapies[3].

Regulatory and Market Access

The ability to comply with healthcare laws and regulations, as well as to obtain and maintain intellectual property protection, is crucial for the continued success of bempedoic acid and ezetimibe. Successful regulatory submissions and approvals in various territories will be key to expanding market access and driving revenue growth[1].

Key Takeaways

• The market for bempedoic acid and ezetimibe is growing rapidly, driven by increasing prevalence of hypercholesterolemia and ongoing R&D.
• Esperion Therapeutics has secured significant financial support through collaboration agreements and has seen revenue growth from product sales.
• Regulatory approvals, including recent FDA expansions, are critical for market growth.
• The combination of bempedoic acid and ezetimibe has shown strong efficacy and safety in clinical trials.
• North America is a leading market due to healthcare system improvements and an aging population.

Frequently Asked Questions (FAQs)

1. What is bempedoic acid, and how does it work?

Bempedoic acid is an oral, non-statin medication that inhibits the enzyme ATP-citrate lyase, preventing the liver from producing cholesterol. It is often combined with ezetimibe to enhance its cholesterol-lowering effects.

2. What are the key regulatory milestones for bempedoic acid and ezetimibe?

Recent regulatory milestones include the FDA's approval of expanded labels for NEXLETOL and NEXLIZET, and submissions to the EMA for approval in Europe.

3. How does the combination of bempedoic acid and ezetimibe compare to statins?

The combination is particularly beneficial for patients who are intolerant to statins, offering an effective alternative for reducing LDL-C levels and cardiovascular risk.

4. What are the financial projections for the bempedoic acid market?

The market is projected to grow from $1.2 billion in 2023 to $3.5 billion by 2031, with a CAGR of 14.33%.

5. What are the main challenges facing the market for bempedoic acid and ezetimibe?

Key challenges include fierce competition among pharmaceutical companies, potential price wars, and the need for significant investments in marketing and R&D to maintain market share.

Cited Sources:

1. Esperion Therapeutics. 2023 Annual Report. Retrieved from https://www.esperion.com/static-files/41d309fe-be54-497e-bb97-d5c4bb9f1730
2. Esperion Therapeutics. Esperion Provides Bempedoic Acid Franchise Development Program Updates and Financial Results for the First Quarter Ended March 31, 2019. Retrieved from https://www.esperion.com/news-releases/news-release-details/esperion-provides-bempedoic-acid-franchise-development-program-6
3. Verified Market Research. Pharma Grade Bempedoic Acid Market Size, Share, Trends. Retrieved from https://www.verifiedmarketresearch.com/product/pharma-grade-bempedoic-acid-market/
4. ScienceDirect. Efficacy and safety of bempedoic acid added to ezetimibe in statin-intolerant patients with hyperlipidemia: The CLEAR Tranquility study. Retrieved from https://www.sciencedirect.com/science/article/pii/S0021915018303095
5. Esperion Therapeutics. Esperion Reports Third Quarter 2022 Financial Results and Provides Company Update. Retrieved from https://www.esperion.com/news-releases/news-release-details/esperion-reports-third-quarter-2022-financial-results-and

Last updated: 2024-12-17