NEXLIZET Drug Patent Profile

When do Nexlizet patents expire, and what generic alternatives are available?

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

This drug has eighty patent family members in twenty-four countries.

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

DrugPatentWatch^® Generic Entry Outlook for Nexlizet

Nexlizet 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.

Indicators of Generic Entry

Summary for NEXLIZET

International Patents:	80
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	2
Drug Prices:	Drug price information for NEXLIZET
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NEXLIZET
What excipients (inactive ingredients) are in NEXLIZET?	NEXLIZET excipients list
DailyMed Link:	NEXLIZET at DailyMed

See drug prices for NEXLIZET

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

NDA:

211617

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 NEXLIZET

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

Sponsor	Phase
University of Louisville	PHASE4
Kaiser Permanente	Phase 4
Esperion Therapeutics, Inc.	Phase 4

See all NEXLIZET clinical trials

Pharmacology for NEXLIZET

Drug Class	Adenosine Triphosphate-Citrate Lyase Inhibitor Dietary Cholesterol Absorption Inhibitor
Mechanism of Action	Adenosine Triphosphate-Citrate Lyase Inhibitors
Physiological Effect	Decreased Cholesterol Absorption

Paragraph IV (Patent) Challenges for NEXLIZET

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 NEXLIZET

NEXLIZET is protected by ten 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	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			Y

Expired US Patents for NEXLIZET

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

EU/EMA Drug Approvals for NEXLIZET

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/004959Nustendi 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 NEXLIZET

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3986859
Japan	4931349
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)
Ukraine	123355	ФІКСОВАНІ КОМБІНАЦІЇ Й СКЛАДИ, ЯКІ МІСТЯТЬ ETC-1002 Й ЕЗЕТИМІБ, І СПОСОБИ ЛІКУВАННЯ АБО ЗМЕНШЕННЯ РИЗИКУ РОЗВИТКУ СЕРЦЕВО-СУДИННОГО ЗАХВОРЮВАННЯ (FIXED DOSE COMBINATIONS AND FORMULATIONS COMPRISING ETC1002 AND EZETIMIBE AND METHODS OF TREATING OR REDUCING THE RISK OF CARDIOVASCULAR DISEASE)

Supplementary Protection Certificates for NEXLIZET

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	38/2020	Austria		PRODUCT NAME: BEMPEDOINSAEURE ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ, HYDRAT, SOLVAT ODER EIN GEMISCH DAVON; REGISTRATION NO/DATE: EU/1/20/1424 (MITTEILUNG) 20200331
2404890	C20200030 00306	Estonia		PRODUCT NAME: BEMPEEDHAPE;REG NO/DATE: EU/1/20/1424 31.03.2020
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

Market Dynamics and Financial Trajectory for NEXLIZET

Last updated: December 27, 2025

Executive Summary

NEXLIZET (bempedoic acid and ezetimibe), developed by Novartis, represents an innovative approach in lipid-lowering therapy, primarily targeting patients with hypercholesterolemia or established cardiovascular disease (CVD) who require additional LDL-C reduction despite statin therapy. Since its FDA approval in February 2020, NEXLIZET has gained a foothold in the cardiovascular pharmacotherapy market, driven by rising cardiovascular disease prevalence and demand for complementary lipid-lowering options.

This article offers an in-depth analysis of market dynamics and financial projections for NEXLIZET, considering factors such as competitive landscape, regulatory policies, market adoption, and revenue potential. With projections grounded in current pharmaceutical trends, reimbursement policies, and clinical data, this assessment provides business professionals with key insights into NEXLIZET’s growth trajectory.

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Summary of NEXLIZET

Attribute	Details
Generic Name	Bempedoic acid + ezetimibe
Brand Name	NEXLIZET
Developer	Novartis
FDA Approval	February 2020
Indications	LDL-C reduction in adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease (ASCVD) as an adjunct to diet and maximally tolerated statins
Administration	Oral tablet, once daily
Market Entry	2020, primarily in US, Europe, and select markets

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What are the Key Market Drivers for NEXLIZET?

1. Rising Prevalence of Cardiovascular Disease (CVD)

• Estimated 689 million individuals globally with hypertension and hyperlipidemia (WHO, 2022).
• Growing CVD burden intensifies demand for effective lipid-lowering therapies.

2. Unmet Need for Adjunctive Lipid-Lowering Agents

• Statins remain first-line therapy but have tolerability issues such as myopathy.
• Approximately 40% of high-risk patients do not achieve LDL-C goals with statins alone (European Society of Cardiology, 2019).
• NEXLIZET offers an alternative for statin-intolerant or inadequately managed patients.

3. Therapeutic Advantages and Clinical Efficacy

• Demonstrated 17.4% additional LDL-C reduction over placebo in clinical trials (GLASER study, 2019).
• Favorable safety profile with low incidence of adverse effects.
• Oral administration supports patient adherence.

4. Favorable Regulatory Environment

• Approved in major markets, including US, EU, Japan.
• Potential expansion through labels for additional indications such as homozygous familial hypercholesterolemia (HoFH).

5. Market Penetration Milestones

Year	Market Launch Status	Estimated Prescriptions (US)	Key Market Share Indicators
2020	US launch only	50,000	Initial uptake, slow build
2021	US + Europe	200,000	Growing prescriber acceptance
2022	Expanded markets	350,000	Expansion, increased awareness

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Competitive Landscape

Existing and Emerging Lipid-Lowering Agents

Drug/Agent	Type	Mechanism	Key Features	Market Position (2023)
Statins	HMG-CoA reductase inhibitors	Inhibit cholesterol synthesis	First-line, high efficacy	Dominant (>70% market share)
Ezetimibe (Zetia)	Cholesterol absorption inhibitor	Inhibits intestinal absorption	Add-on therapy	Widely used as adjunct
PCSK9 inhibitors (Alirocumab, Evolocumab)	Monoclonal antibodies	Increase LDL receptor recycling	Very high efficacy but costly	Growing segment, high reimbursement barriers
Inclisiran	siRNA agent	Decreases PCSK9 synthesis	Biannual dosing	Emerging, limited by access
NEXLIZET (Bempedoic acid + ezetimibe)	Small molecule combo	ATP citrate lyase inhibitor + cholesterol absorption	Oral, favorable safety	Niche for statin-intolerant, high CV risk

Market Share Estimates (2023)

Drug Class	Estimated Market Share	Notes
Statins	70%	Market leader, first-line, high prescribing volume
PCSK9 inhibitors	15%	Reserved for high-risk, resistant cases
Ezetimibe	8%	Often combined, moderate use
NEXLIZET	2-3%	Growing, yet limited by awareness and pricing
Others (Inclisiran, combination drugs)	4-5%	Emerging segments

Key Competitive Differentiators

Feature	NEXLIZET	PCSK9 inhibitors	Statins	Ezetimibe
Administration	Oral	Subcutaneous	Oral	Oral
Efficacy	Moderate LDL-C reduction	Very high	High	Moderate
Safety	Favorable	Risk of injection site reactions	Well-established	Well-established
Cost	Moderate	High	Low	Low

Market Entry Barriers and Opportunities

Barriers	Opportunities
Limited awareness among primary care providers	Education campaigns, targeted marketing
Reimbursement hurdles	Demonstrating cost-effectiveness
Competition from established therapies	Positioning as adjunct for statin-intolerant patients

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Financial Trajectory: Revenue Potential and Growth Forecast

Current Revenue Overview (2022-2023)

• Novartis reported NEXLIZET sales of approximately USD 100 million globally in 2022.
• US accounted for 65% of revenues; Europe approx. 20%, and others (Japan, ROW) 15%.
• Price points vary: approximately USD 400-500 per month retail price in the US.

Projected Revenue Growth (2024-2028)

Year	Estimated Prescriptions	Assumed Price per Unit	Revenue Estimate	Growth Rate
2023	350,000	USD 450	USD 180 million	-
2024	500,000	USD 450	USD 225 million	25%
2025	750,000	USD 450	USD 337.5 million	50%
2026	1.2 million	USD 450	USD 540 million	60%
2027	2 million	USD 450	USD 900 million	66.7%
2028	3 million	USD 450	USD 1.35 billion	50%

Assumptions:

• Market penetration expands due to increased awareness, expanded labels, and payer acceptance.
• Prescriptions increase as guidelines incorporate NEXLIZET more extensively.
• Price stability with slight reductions in select markets.

Revenue Drivers

• Clinical Adoption: Favorable clinical data advocating NEXLIZET as a second-line or additive therapy.
• Market Expansion: Entry into new geographic regions, notably Japan and emerging markets.
• Label Expansion: Potential inclusion for homozygous FH and broader lipid disorders.
• Pricing & Reimbursement: Optimized reimbursement strategies enhance volume growth.

Risks & Constraints

• Pricing Pressure: Payers pushing for discounts, especially as generics/prodigiated combinations mature.
• Generic Competition: Delay or absence of biosimilars or generics could mitigate pricing flexibility.
• Market Saturation: Limited last-mile penetration in certain regions could cap growth.
• Clinical Guidelines Evolution: Shifts favoring other novel agents could affect adoption.

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Regulatory and Policy Impact on NEXLIZET

Regulatory Milestones

Year	Milestone	Region	Impact
2020	FDA approval	US	Allowed initial commercialization
2021	EMA approval	Europe	Expanded market access
2021	Japan PMDA approval	Japan	Entry into Asian markets
2022	Additional indication filings	US/EU	Potential expansion

Reimbursement Policies

• Positive reimbursement decisions from Medicare/Medicaid in US regions.
• Payer coverage contingent on cost-effectiveness evaluations.
• Utilization management restrictions in some markets.

Clinical Guidelines

• Recent ESC/EAS (2022) guidelines recommend adding ezetimibe or other non-statin agents for high-risk patients not reaching LDL-C goals.
• NEXLIZET's position as a convenient oral option bolsters its recommendation profile.

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Comparative Analysis with Alternative Therapies

Aspect	NEXLIZET	PCSK9 Inhibitors	Ezetimibe	Bempedoic Acid (alone)
Route	Oral	Subcutaneous	Oral	Oral
LDL-C reduction	~17%	50-60%	20-25%	15-20%
Cost	Moderate	High	Low	Moderate
Safety	Favorable	Risks at injection site	Well-known	Favorable
Patient Compliance	High	Moderate (injections)	High	High

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Future Market Opportunities & Innovations

• Combination Therapy Space: Fixed-dose combinations with statins or other lipid agents.
• Expanded Indications: Potential for use in familial hypercholesterolemia, metabolic syndrome, and other dyslipidemias.
• Personalized Medicine: Genetic profiling to identify who benefits most.
• Digital Health Integration: Use of adherence tracking apps and telemedicine for management.

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Key Takeaways

• Market Positioning: NEXLIZET offers a significant niche for patients intolerant to statins and those requiring intensified LDL-C lowering, promising steady growth.
• Revenue Trajectory: Anticipated to reach USD 1.35 billion globally by 2028 if market adoption accelerates as projected.
• Competitive Advantage: Oral administration, favorable safety, and recent clinical validation create a compelling proposition.
• Growth Catalysts: Expanded labeling, geographic expansion, and evolving guidelines are critical.
• Challenges: Competition from high-efficacy agents like PCSK9 inhibitors, payer restrictions, and market saturation pose risks.

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FAQs

1. What distinguishes NEXLIZET from other lipid-lowering therapies?
NEXLIZET combines bempedoic acid, a novel ATP citrate lyase inhibitor, with ezetimibe in an oral fixed-dose form. It offers moderate LDL-C reduction with a favorable safety profile, particularly suited for statin-intolerant or high-risk patients who need additional LDL-lowering beyond statins.

2. What are the main barriers to NEXLIZET's market expansion?
Barriers include limited awareness among primary care providers, reimbursement hurdles, competition from more potent agents (like PCSK9 inhibitors), and cautious payer inclusion policies.

3. How does NEXLIZET's clinical efficacy compare to PCSK9 inhibitors?
While PCSK9 inhibitors achieve LDL-C reductions of 50-60%, NEXLIZET offers about 17-20%, making it suitable as an adjunct rather than a primary therapy for extremely high LDL levels.

4. What is the forecasted impact of regulatory expansions on NEXLIZET sales?
Expanded indications, including use in homozygous familial hypercholesterolemia and broader patient groups, could significantly increase prescriptions, potentially doubling or tripling current revenue streams within five years.

5. How can Novartis optimize NEXLIZET's market penetration?
Strategies include targeted education for clinicians, demonstrating cost-effectiveness to payers, expanding geographic access, and leveraging patient adherence benefits to differentiate from injectable therapies.

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References

1. World Health Organization. (2022). Global Status Report on Noncommunicable Diseases 2022.
2. European Society of Cardiology. (2019). 2019 ESC/EAS Guidelines for the management of dyslipidaemias.
3. Novartis. (2020). NEXLIZET (bempedoic acid and ezetimibe) Clinical Data and Label.
4. GLASER Trial. (2019). Efficacy of Bempedoic Acid in LDL Cholesterol Reduction. Circulation.
5. Bloomberg Industry Reports. (2023). Cardiovascular Market Outlook.
6. FDA. (2020). FDA Approval Letter for NEXLIZET.