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NEXLETOL Drug Patent Profile

Which patents cover Nexletol, and what generic alternatives are available?

Nexletol is a drug marketed by Esperion Theraps Inc and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has seventy patent family members in twenty-three countries.

The generic ingredient in NEXLETOL is bempedoic acid. One supplier is listed for this compound. Additional details are available on the bempedoic acid profile page.

DrugPatentWatch^® Generic Entry Outlook for Nexletol

Nexletol was eligible for patent challenges on February 21, 2024.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 3, 2030. This may change due to patent challenges or generic licensing.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for NEXLETOL

International Patents:	70
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	64
Patent Applications:	63
Drug Prices:	Drug price information for NEXLETOL
What excipients (inactive ingredients) are in NEXLETOL?	NEXLETOL excipients list
DailyMed Link:	NEXLETOL at DailyMed

See drug prices for NEXLETOL

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for NEXLETOL

NDA:

211616

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.

Pharmacology for NEXLETOL

Drug Class	Adenosine Triphosphate-Citrate Lyase Inhibitor
Mechanism of Action	Adenosine Triphosphate-Citrate Lyase Inhibitors

Paragraph IV (Patent) Challenges for NEXLETOL

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 NEXLETOL

NEXLETOL is protected by five US patents and three FDA Regulatory Exclusivities.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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
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

Expired US Patents for NEXLETOL

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 NEXLETOL

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 NEXLETOL

See the table below for patents covering NEXLETOL around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2021218120	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)
Canada	2513660	COMPOSES HYDROXYLES ET COMPOSITIONS DE REGULATION DU CHOLESTEROL ET UTILISATIONS ASSOCIEES (HYDROXYL COMPOUNDS AND COMPOSITIONS FOR CHOLESTEROL MANAGEMENT AND RELATED USES)
Russian Federation	2022102472	ФИКСИРОВАННЫЕ КОМБИНАЦИИ И СОСТАВЫ, СОДЕРЖАЩИЕ ETC-1002 И ЭЗЕТИМИБ, И СПОСОБЫ ЛЕЧЕНИЯ ИЛИ УМЕНЬШЕНИЯ РИСКА РАЗВИТИЯ СЕРДЕЧНО-СОСУДИСТОГО ЗАБОЛЕВАНИЯ
Japan	7295179
Hungary	E036646

Supplementary Protection Certificates for NEXLETOL

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
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	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	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

NEXLETOL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for NEXLETOL

Introduction to NEXLETOL

NEXLETOL, also known as bempedoic acid, is a medication developed by Esperion Therapeutics, Inc. It is primarily used to lower low-density lipoprotein cholesterol (LDL-C) in patients with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who are on a maximally tolerated statin therapy.

Market Drivers

Increasing Prevalence of Chronic Diseases

The global NEXLETOL market is driven significantly by the rising incidence of chronic diseases such as cardiovascular diseases, hypertension, heart failure, and diabetic kidney disease. These conditions increase the risk of heart attacks and strokes, thereby boosting the demand for effective cholesterol-lowering medications like NEXLETOL[1].

Rising Geriatric Population

The expanding geriatric population worldwide is another key driver. Older individuals are more prone to chronic diseases, including cardiovascular and endovascular diseases, which increases the demand for NEXLETOL[1].

Increasing Research and Development Activities

Continued research and clinical trials demonstrating the benefits of NEXLETOL, especially in comparison to existing treatments or in specific patient populations, are expected to strengthen its market position. Positive outcomes from these studies can lead to increased clinical approvals and broader adoption[1].

Growing Healthcare Expenditure and Awareness

Rising healthcare expenditure and increasing awareness towards health and better hygiene are also contributing factors. As more people become aware of the importance of managing cholesterol levels, the demand for NEXLETOL is likely to increase[1].

Market Segmentation

By Type

The NEXLETOL market is segmented by type, with the primary form being the 180mg tablet. Other forms may also be available, but the 180mg tablet is the most prevalent[4].

By Drug Class

NEXLETOL belongs to the adenosine triphosphate-citrate lyase (ACL) inhibitor class. This classification is crucial as it differentiates NEXLETOL from other cholesterol-lowering medications like statins[4].

By Application

The market is segmented by application, with key areas including familial heterozygous hypercholesterolemia and high cholesterol. NEXLETOL is particularly effective for patients who cannot tolerate statins or require additional LDL-C reduction[4].

By Dosage and Route of Administration

NEXLETOL is primarily administered orally in tablet form. This ease of administration contributes to its market appeal[4].

By End-Users and Distribution Channel

The end-users include clinics, hospitals, and other healthcare facilities. Distribution channels encompass hospital pharmacies, retail pharmacies, and online pharmacies. Hospitals dominate the end-user segment due to the high demand for NEXLETOL in these settings[1].

Financial Trajectory

Revenue Growth

Esperion Therapeutics, the company behind NEXLETOL, has seen significant revenue growth. For the full year 2023, total revenue grew by 54% to $116.3 million compared to $75.5 million in 2022. U.S. net product revenue specifically grew by 40% to $78.3 million in 2023 from $55.9 million in 2022[2][5].

Quarterly Performance

In the fourth quarter of 2023, U.S. net product revenue increased by 39% to $20.8 million, and total revenue grew by 72% to $32.3 million compared to the same period in 2022. Retail prescription equivalents also saw a 44% year-over-year growth and an 8% quarter-over-quarter growth, indicating strong market momentum[5].

Collaboration Revenue

Collaboration revenue, which includes royalty revenues and tablet shipments to international partners, increased by 195% in the fourth quarter of 2023 and by 94% for the full year 2023 compared to the corresponding periods in 2022[5].

Research and Development Expenses

Research and development expenses decreased by 46% in the fourth quarter of 2023 and by 28% for the full year 2023, primarily due to the close-out of the CLEAR Outcomes study. This reduction in expenses is expected to improve the company's financial health[5].

Cash Position and Funding

As of December 31, 2023, Esperion had $82.2 million in cash, cash equivalents, and investment securities. The company further strengthened its cash position in January 2024 through a follow-on equity offering that raised approximately $97.8 million and a joint settlement agreement that resulted in a $100 million cash payment[2][5].

Market Opportunities

Increasing Clinical Approvals

Positive interactions with regulatory bodies such as the FDA and EMA, along with proposed indications for primary and secondary prevention of cardiovascular risk, are expected to expand NEXLETOL's market reach. The FDA PDUFA date of March 31, 2024, for these indications is a significant milestone[5].

Expanding into Emerging Markets

The demand for NEXLETOL is expected to rise in emerging economies, driven by increasing healthcare expenditure and growing awareness of cardiovascular health. This presents a lucrative opportunity for Esperion to expand its market presence[1].

Challenges

Lack of Awareness and Access

In developing countries, there is a lack of awareness and access to NEXLETOL programs, which can hinder market growth. Additionally, resistance from traditional healthcare providers and unstable payment models can pose challenges[4].

Key Takeaways

• Market Growth: The global NEXLETOL market is expected to grow at a CAGR of 7.3% from 2023 to 2030.
• Revenue Increase: Esperion's revenue from NEXLETOL has seen significant growth, with a 54% increase in total revenue and a 40% increase in U.S. net product revenue for 2023.
• Clinical Approvals: Ongoing research and positive clinical trials are expected to strengthen NEXLETOL's market position.
• Financial Health: Esperion has improved its cash position through equity offerings and settlement agreements, enabling further commercialization and research efforts.
• Market Segmentation: The market is segmented by type, drug class, application, dosage, route of administration, end-users, and distribution channels.

FAQs

What is NEXLETOL used for?

NEXLETOL (bempedoic acid) is used to lower LDL-C in patients with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who are on a maximally tolerated statin therapy.

Who is the primary manufacturer of NEXLETOL?

The primary manufacturer of NEXLETOL is Esperion Therapeutics, Inc.

What is the expected market growth for NEXLETOL?

The global NEXLETOL market is expected to grow at a CAGR of 7.3% from 2023 to 2030.

What are the key drivers of the NEXLETOL market?

Key drivers include the increasing prevalence of chronic diseases, rising geriatric population, growing healthcare expenditure, and increasing awareness towards health.

How has Esperion's revenue from NEXLETOL performed in recent years?

Esperion's revenue from NEXLETOL has seen significant growth, with a 54% increase in total revenue and a 40% increase in U.S. net product revenue for 2023 compared to 2022.

Sources

1. Data Bridge Market Research: Global Nexletol Market – Industry Trends and Forecast to 2030.
2. Esperion: Esperion Reports Fourth Quarter and Full Year 2023 Financial Results.
3. Annual Reports: 2020 - Annual Reports.
4. PharmiWeb: Nexletol Market Analysis By Type, Top Vendors, Size, Revenue and Growth Rate Through 2028.
5. GlobeNewswire: Esperion Reports Fourth Quarter and Full Year 2023 Financial Results.