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 patent family members in twenty-three countries.

One supplier is listed for this compound.

Summary for bempedoic acid

International Patents:	70
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	NEXLETOL	bempedoic acid	TABLET;ORAL	211616-001	Feb 21, 2020		RX	Yes	Yes
Esperion Theraps Inc	NEXLIZET	bempedoic acid; ezetimibe	TABLET;ORAL	211617-001	Feb 26, 2020		RX	Yes	Yes	11,613,511			Y
Esperion Theraps Inc	NEXLETOL	bempedoic acid	TABLET;ORAL	211616-001	Feb 21, 2020		RX	Yes	Yes	11,926,584

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	10,118,881
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	9,000,041

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
Brazil	0318046	Compostos de hidroxila e composições para controle de colesterol e empregos relacionados
Canada	3144372	FORMES SALINES D'ACIDE BEMPEDOIQUE ET LEURS PROCEDES D'UTILISATION (SALT FORMS OF BEMPEDOIC ACID AND METHODS FOR USING THE SAME)
European Patent Office	2404890	Composés hydroxyle et compositions pour la gestion du cholestérol et utilisations associées (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	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	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	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

Bempedoic acid Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Bempedoic Acid

Introduction to Bempedoic Acid

Bempedoic acid, a novel oral non-statin lipid-lowering therapy, has been gaining significant attention in the pharmaceutical industry due to its efficacy in reducing low-density lipoprotein cholesterol (LDL-C) levels. This drug is particularly important for patients with atherosclerotic cardiovascular disease (ASCVD) and those who are unable to achieve adequate LDL-C lowering with statins alone.

Market Size and Growth Projections

The global market for bempedoic acid is poised for substantial growth. The bempedoic acid API market, for instance, was valued at USD 0.06 billion in 2024 and is projected to reach USD 0.32 billion by 2032, exhibiting a Compound Annual Growth Rate (CAGR) of 23% during this period[1].

On a broader scale, the pharma-grade bempedoic acid market was valued at approximately USD 1.2 billion in 2023 and is expected to reach USD 3.5 billion by 2031, growing at a CAGR of 14.33%[3].

Driving Factors

Several factors are driving the growth of the bempedoic acid market:

Rising Prevalence of Hypercholesterolemia

The increasing prevalence of hypercholesterolemia, a condition marked by elevated cholesterol levels, is a significant driver. As more people are diagnosed with this condition, the demand for effective cholesterol-lowering therapies like bempedoic acid increases[3].

Advancements in Technology and R&D

Ongoing research and development in the pharmaceutical industry are crucial. Clinical trials and studies aimed at enhancing the efficacy and safety profile of bempedoic acid, as well as exploring its use in various patient populations and in combination with other lipid-lowering medications, are driving market growth[3].

Growing Preventive Healthcare Adoption

There is a growing focus on preventive healthcare, which includes the use of pharmaceuticals to manage and prevent cardiovascular diseases. This trend is expected to boost the adoption of bempedoic acid[3].

Key Players and Market Competition

The bempedoic acid market is dominated by several key players:

• Esperion: As the primary developer of bempedoic acid, Esperion has seen significant growth in its product revenue and collaboration agreements. The company has expanded its product labels, scaled up its commercial team, and launched new indications, driving double-digit prescription growth[2].
• Metrochem API Pvt Ltd, Lee Pharma, Conscientia Industrial Co., Ltd, Sun Pharmaceutical, China Fortune Way Company, Shanghai Yingrui Biopharma Co., Ltd., and Viruj Pharma: These companies are also major players in the bempedoic acid API market, contributing to the overall market growth[1].

Financial Performance and Trajectory

Esperion, the leading company in this market, has reported impressive financial results:

Revenue Growth

In the third quarter of 2024, Esperion's total revenue increased by 52% year-over-year to $51.6 million, with U.S. net product revenue growing by 53% to $31.1 million. Collaboration revenue also saw a significant increase of 50% to $20.5 million[2].

Expanding Commercial Initiatives

The company has successfully expanded its commercialization initiatives, including the launch of new indications and the strengthening of its balance sheet by monetizing European royalties and paying off a revenue interest facility[2].

International Market Expansion

Esperion's European partner, Daichi Sankyo Europe, has generated substantial revenue across Europe, and the company is also advancing towards regulatory approval in Japan through its partner, Otsuka Pharmaceutical[2].

Challenges and Regulatory Environment

Despite the positive growth trajectory, the bempedoic acid market faces several challenges:

Regulatory Difficulties

Navigating the regulatory environment is complex and costly. Different regions have varying regulations, such as those set by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA), which can delay product availability and increase research expenses[3].

High Development Costs

The development, production, and marketing of pharmaceutical-grade bempedoic acid are expensive. High costs associated with clinical trials, laboratory research, and factory scale-up can deter small and medium-sized businesses from entering the market[3].

Competitive Market

The market is highly competitive, with established companies using their distribution networks, marketing strategies, and brand reputation to maintain market share. This competition can lead to price wars and lower profit margins[3].

Clinical Trials and Research

Bempedoic acid has been the subject of several significant clinical trials, including the CLEAR Outcomes trial. This trial aimed to assess the cardiovascular risk reduction capabilities of bempedoic acid and was completed in October 2022, with topline results expected to be reported in early 2023[5].

Market Adoption and Awareness

Despite the promising clinical data, the market still faces challenges related to adoption and awareness. The lack of widespread recognition and adoption among healthcare providers and patients can slow down market growth. However, recommendations from prestigious medical organizations, such as the American College of Cardiology, can significantly boost adoption rates[5].

Key Takeaways

• The bempedoic acid market is projected to grow significantly, driven by increasing prevalence of hypercholesterolemia and advancements in R&D.
• Key players like Esperion are driving market growth through expanded commercial initiatives and international partnerships.
• Regulatory challenges, high development costs, and competitive market dynamics are significant hurdles.
• Clinical trials and recommendations from medical organizations are crucial for market adoption.

Frequently Asked Questions (FAQs)

1. What is the projected market size of the bempedoic acid API market by 2032? The global bempedoic acid API market is projected to reach USD 0.32 billion by 2032[1].

2. What is the CAGR expected for the bempedoic acid API market from 2024 to 2032? The bempedoic acid API market is expected to exhibit a CAGR of 23% from 2024 to 2032[1].

3. Which companies are the top players in the bempedoic acid API market? Top players include Esperion, Metrochem API Pvt Ltd, Lee Pharma, Conscientia Industrial Co., Ltd, Sun Pharmaceutical, China Fortune Way Company, Shanghai Yingrui Biopharma Co., Ltd., and Viruj Pharma[1].

4. How has Esperion's revenue grown in recent years? Esperion's total revenue increased by 52% year-over-year to $51.6 million in the third quarter of 2024, with U.S. net product revenue growing by 53% to $31.1 million[2].

5. What are the main challenges facing the bempedoic acid market? The main challenges include regulatory difficulties, high development costs, and a highly competitive market environment[3].

Cited Sources:

1. Business Research Insights - Bempedoic Acid API Market Report | Global Forecast To 2032
2. Esperion - Esperion Reports Third Quarter 2024 Financial Results and ...
3. Verified Market Research - Pharma Grade Bempedoic Acid Market Size, Share, Trends
4. DataIntelo - Pharma Grade Bempedoic Acid Market Research Report 2032
5. Esperion - Esperion Reports Third Quarter 2022 Financial Results and ...