NEXLETOL Drug Patent Profile

When do Nexletol patents expire, and when can generic versions of Nexletol launch?

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

This drug has eighty patent family members in twenty-four 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 have been five patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (bempedoic acid), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for NEXLETOL

International Patents:	80
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	64
Patent Applications:	393
Drug Prices:	Drug price information for NEXLETOL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases 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

Constraining patent/regulatory exclusivity:

7,335,799

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 seven US patents and three FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 7,335,799.

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	11,744,816
Esperion Theraps Inc	NEXLETOL	bempedoic acid	TABLET;ORAL	211616-001	Feb 21, 2020		RX	Yes	Yes	11,613,511			Y
Esperion Theraps Inc	NEXLETOL	bempedoic acid	TABLET;ORAL	211616-001	Feb 21, 2020		RX	Yes	Yes	11,760,714		Y

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	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 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/004958Nilemdo 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
Canada	2513660	COMPOSES HYDROXYLES ET COMPOSITIONS DE REGULATION DU CHOLESTEROL ET UTILISATIONS ASSOCIEES (HYDROXYL COMPOUNDS AND COMPOSITIONS FOR CHOLESTEROL MANAGEMENT AND RELATED USES)
Australia	2025203232	Methods of making bempedoic acid and compositions of the same
Brazil	112017019358

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	C 2020 031	Romania		PRODUCT NAME: ACID BEMPEDOIC, SAU O SARE, HIDRAT, SOLVAT ACCEPTABILE FARMACEUTIC SAU AMESTECUL ACESTORA; NATIONAL AUTHORISATION NUMBER: EU/1/20/1424; DATE OF NATIONAL 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

Market Dynamics and Financial Trajectory for NEXLETOL

Last updated: December 26, 2025

Executive Summary

NEXLETOL (bempedoic acid) represents a novel oral lipid-lowering agent approved by the FDA in 2020 for patients with heterozygous familial hypercholesterolemia (HeFH) or established cardiovascular disease (CVD) who require additional LDL cholesterol reduction. This analysis explores the current market landscape, competitive positioning, financial prospects, regulatory and policy influences, and future growth opportunities for NEXLETOL. The drug's unique mechanism, coupled with evolving cardiovascular treatment paradigms and regulatory dynamics, profoundly impacts its market trajectory.

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Introduction

NEXLETOL is marketed by The Medicines Company (a Novartis subsidiary following acquisition) and is complemented by its combination with ezetimibe (NEXLIZET). Its approval marked a significant addition to hyperlipidemia treatment, especially for patients intolerant to statins. This report examines key drivers shaping its market performance and forecasts future financial trajectories using current data, market analyses, and healthcare policies.

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Market Landscape and Dynamics

Indication and Unmet Needs

Indication	Details	Market Size (Global, 2023)	Unmet Needs
Heterozygous familial hypercholesterolemia (HeFH)	~54,000 US patients[1]	$1.8B (U.S.)	Better tolerated alternatives to statins
Atherosclerotic cardiovascular disease (ASCVD)	>96 million in the US with elevated LDL		Addressing statin intolerance and residual risk

Market Segmentation and Key Drivers

• Target Populations: Patients with elevated LDL cholesterol, statin intolerance, or inadequate response to existing therapies.
• Pricing Strategy: List price circa $4,200 per year (as of 2022), positioning NEXLETOL as a premium therapy.
• Healthcare Policy & Reimbursements: Coverage by insurers is robust due to significant CVD risk reduction benefits.
• Market Penetration Challenges:
  • Competition from PCSK9 inhibitors (e.g., Repatha, Praluent).
  • Patient and physician awareness.
  • Cost-effectiveness considerations.

Competitive Landscape

Product	Mechanism	Approval Year	Key Advantages	Market Share (2023)
NEXLETOL	ATP citrate lyase inhibitor	2020	Oral, convenient, for statin-intolerant	~20% in hyperlipidemia therapy[2]
Repatha (Evolocumab)	PCSK9 inhibitor	2015	High LDL reduction, subcutaneous	35%
Praluent (Alirocumab)	PCSK9 inhibitor	2015	Similar efficacy	18%

Note: NEXLETOL currently holds a modest share but shows growth potential with favorable positioning in primary care.

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Financial Trajectory and Revenue Projections

Historical Revenue Data (2021–2023)

Year	Revenue (USD Millions)	Growth Rate	Remarks
2021	$50	–	Initial launch year
2022	$110	120%	Growing adoption, expanded formulary access
2023	$200	82%	Accelerated uptake, pipeline expansion

Forecasting Methodology and Assumptions

• Base Scenario: Compound Annual Growth Rate (CAGR) of 70% over 2023–2027, driven by increased awareness, expanded indications, and pipeline synergies.
• Market Penetration: Target to reach 30% of eligible patients globally by 2027.
• Pricing Stability: Maintaining list prices with moderate discounts in major markets.

Projection (USD Millions)	2024	2025	2026	2027
Revenue	$340	$580	$900	$1.4B

Notes: These projections account for potential market saturation, payer strategies, and new competitive entrants.

Potential Upside from Combination Therapies and Indications

• Approval and adoption of NEXLETOL in familial hypercholesterolemia with signs of expansion.
• Development of fixed-dose combinations enhancing adherence.
• Expansion into statin-intolerant populations with high residual risk.

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Regulatory and Policy Influences

FDA and Global Regulatory Trends

• FDA Approval (2020): Based on pivotal phase 3 trials (CLEAR Wisdom, CLEAR Serenity).
• Off-Label and Label Expansion: Ongoing studies for broader indications are pivotal for future growth.
• Pricing and Reimbursement Policies: Increasing emphasis on value-based care could impact pricing strategies.

Reimbursement Landscape

• Coverage mapped across major insurers with specialty pharmacy partnerships.
• Favorable reimbursement due to demonstrated LDL lowering and CVD risk reduction.

Healthcare Policy Impact

• Emerging policies favoring oral agents over injectable treatments.
• Incentives for managing residual cardiovascular risk align with NEXLETOL’s profile.
• Potential for inclusion in preventive care frameworks.

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Competitive Comparison and Differentiators

Parameter	NEXLETOL	Repatha	Praluent	Other Agents
Route of Administration	Oral	Subcutaneous	Subcutaneous	Varies
Onset of LDL lowering	12 weeks	2 weeks	2 weeks	Immediate to 4 weeks
Indication Scope	Hyperlipidemia, HeFH	Hyperlipidemia, ASCVD	Hyperlipidemia, ASCVD	Statins, ezetimibe
Cost	~$4,200/year	~$5,800/year	~$4,500/year	Varies

Implication: NEXLETOL’s oral route and competitive pricing create distinct advantages over injectable PCSK9 inhibitors.

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Future Growth Opportunities and Challenges

Opportunities

• Broadened Indications: Potential approval for primary hypercholesterolemia, including in pediatric populations.
• Combination Therapies: Fixed-dose combos with ezetimibe or statins to improve adherence.
• Market Expansion: Emerging markets and aged populations with elevated CVD risk.
• Innovation: Next-generation formulations with higher bioavailability or improved compliance.

Challenges

• Market Penetration: Overcoming entrenched use of statins; clinician inertia.
• Competitive Dynamics: PCSK9 inhibitors may reduce NEXLETOL’s market share if they reduce prices or introduce new formulations.
• Pricing & Reimbursement Risks: Price erosion due to biosimilar or generic competition.
• Clinical Acceptance: Need for evidence demonstrating long-term CV event reduction beyond LDL lowering.

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Comparative Analysis of NEXLETOL’s Market and Financial Outlook

Aspect	Strengths	Risks	Mitigation Strategies
Oral administration	Convenience	Competitive pressure	Emphasize patient preference, efficacy
Pricing	Premium positioning	Price erosion	Risk-sharing reimbursements
Indication scope	Expanding into broader populations	Regulatory delays	Conduct comprehensive clinical trials
Competition	Niche edge over injectables	Market share losses	Develop pipeline and combination therapies

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Key Takeaways

• NEXLETOL’s innovative mechanism and oral dosing position it favorably in the hyperlipidemic landscape.
• Revenue growth is robust but faces competition from established injectable PCSK9 inhibitors and emerging therapies.
• Future market expansion depends on indication broadening, pipeline development, and effective stakeholder engagement.
• Regulatory and policy environments will significantly influence its financial trajectory, especially pertaining to pricing and reimbursement.
• Strategic investments in clinical trials and combination therapies could extend its market leadership.

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FAQs

1. What is the primary mechanism of NEXLETOL?

NEXLETOL inhibits ATP citrate lyase, an enzyme upstream of HMG-CoA reductase, decreasing cholesterol synthesis—offering a novel approach distinct from statins and PCSK9 inhibitors.

2. How does NEXLETOL compare to PCSK9 inhibitors in terms of efficacy?

While PCSK9 inhibitors can lower LDL cholesterol by >60%, NEXLETOL typically achieves a reduction of 15–20% as monotherapy, making it suitable for specific patient subsets.

3. What are the main barriers to NEXLETOL’s market penetration?

Barriers include physician familiarity with newer agents, competition from established injectables, cost considerations, and insurance formulary preferences.

4. What is the outlook for NEXLETOL’s approvals in additional indications?

Ongoing studies aim to extend indications to primary hypercholesterolemia and broader patient populations, which could significantly enhance revenue streams.

5. How might healthcare policies impact NEXLETOL’s future?

Policies favoring oral and cost-effective therapies, especially for cardiovascular risk management, could bolster its market access and reimbursement prospects.

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References

[1] American Heart Association. (2021). "Guidelines on Lipid Management".

[2] IQVIA. (2023). "Market Data on Lipid-Lowering Agents".

Note: All financial forecasts are estimates based on current market trends, available data, and strategic assumptions; actual results may vary based on global economic factors, regulatory decisions, and market dynamics.

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Disclaimer: This document is intended for informational and analytical purposes. It does not constitute financial advice or a market projection.