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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 six patents protecting this drug and one Paragraph IV challenge.

This drug has seventy-one patent family members in twenty-three 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 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 NEXLIZET

International Patents:	71
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	1
Drug Prices:	Drug price information 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

Constraining patent/regulatory exclusivity:

7,335,799

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
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 eight 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	NEXLIZET	bempedoic acid; ezetimibe	TABLET;ORAL	211617-001	Feb 26, 2020		RX	Yes	Yes	11,744,816
Esperion Theraps Inc	NEXLIZET	bempedoic acid; ezetimibe	TABLET;ORAL	211617-001	Feb 26, 2020		RX	Yes	Yes	11,760,714		Y
Esperion Theraps Inc	NEXLIZET	bempedoic acid; ezetimibe	TABLET;ORAL	211617-001	Feb 26, 2020		RX	Yes	Yes	7,335,799			Y
Esperion Theraps Inc	NEXLIZET	bempedoic acid; ezetimibe	TABLET;ORAL	211617-001	Feb 26, 2020		RX	Yes	Yes	10,912,751
Esperion Theraps Inc	NEXLIZET	bempedoic acid; ezetimibe	TABLET;ORAL	211617-001	Feb 26, 2020		RX	Yes	Yes	11,926,584
Esperion Theraps Inc	NEXLIZET	bempedoic acid; ezetimibe	TABLET;ORAL	211617-001	Feb 26, 2020		RX	Yes	Yes	11,613,511			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	9,624,152
Esperion Theraps Inc	NEXLIZET	bempedoic acid; ezetimibe	TABLET;ORAL	211617-001	Feb 26, 2020	10,118,881
Esperion Theraps Inc	NEXLIZET	bempedoic acid; ezetimibe	TABLET;ORAL	211617-001	Feb 26, 2020	9,000,041
Esperion Theraps Inc	NEXLIZET	bempedoic acid; ezetimibe	TABLET;ORAL	211617-001	Feb 26, 2020	8,497,301
Esperion Theraps Inc	NEXLIZET	bempedoic acid; ezetimibe	TABLET;ORAL	211617-001	Feb 26, 2020	10,941,095

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/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 NEXLIZET

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3986859	PROCÉDÉS DE PRÉPARATION D'ACIDE BEMPÉDOÏQUE ET COMPOSITIONS DE CELUI-CI (METHODS OF MAKING BEMPEDOIC ACID AND COMPOSITIONS OF THE SAME)
China	112437766	制备贝派地酸及其组合物的方法 (METHODS OF MAKING BEMPEDOIC ACID AND COMPOSITIONS OF THE SAME)
Mexico	2021015936	METODOS PARA PREPARAR ACIDO BEMPEDOICO Y COMPOSICIONES DEL MISMO. (METHODS OF MAKING BEMPEDOIC ACID AND COMPOSITIONS OF 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)
Brazil	PI0318046	compostos de hidroxila, seu usos, e composições farmacêuticas
Japan	2006513251

Supplementary Protection Certificates for NEXLIZET

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	132020000000112	Italy		PRODUCT NAME: ACIDO BEMPEDOICO, O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE, IDRATO, SOLVATO, O LORO MISCELA(NUSTENDI); AUTHORISATION NUMBER(S) AND DATE(S): 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	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	301062	Netherlands		PRODUCT NAME: BEMPEDONZUUR, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT, HYDRAAT, SOLVAAT OF MENGSEL DAARVAN; REGISTRATION NO/DATE: EU/1/20/1424 20200331

NEXLIZET Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for NEXLIZET

Introduction

NEXLIZET, developed by Esperion Therapeutics, is a groundbreaking oral non-statin LDL-C lowering drug that has recently received significant label expansions from the U.S. FDA. This approval has positioned NEXLIZET and its companion drug, NEXLETOL, as pivotal players in the cardiovascular risk reduction market.

FDA Approval and Label Expansion

In March 2024, the FDA approved broad new labels for NEXLETOL and NEXLIZET, enabling these drugs to reduce the risk of cardiovascular events in both primary and secondary prevention patients, regardless of statin use. This expansion makes them the first oral non-statin LDL-C lowering drugs to achieve such a designation, significantly broadening their treatable population to approximately 70 million patients in the U.S.[1].

Market Opportunity

The market for statin alternatives is substantial, given that around 21 million Americans are statin intolerant or have reached the maximum dosage of statins, and over 71 million Americans take statin drugs. NEXLIZET and NEXLETOL are poised to capture a significant portion of this market due to their unique profile of reducing LDL-C without the common side effects associated with statins[3].

Prescription Growth and Revenue Projections

Esperion expects NEXLIZET alone to have over 500,000 patients using it by 2026, potentially generating over $1 billion in annual revenue. This forecast is driven by ongoing prescription growth and increasing market demand. By 2028, NEXLIZET is projected to exceed 2 million prescriptions per year, driving massive revenue growth for Esperion[3].

Financial Performance

In the first quarter of 2024, Esperion reported robust financial results, with total revenue increasing by approximately 467% to $137.7 million compared to the same period in 2023. U.S. net product revenue grew by 46% to $24.8 million, driven by a 43% increase in retail prescription growth. Collaboration revenue also saw a significant boost, rising by 1,448% due to increased tablet sales to international partners and other factors[2].

Cost Structure and Profitability

Esperion has made significant strides in improving its cost structure. Research and development expenses decreased by 57% in the first quarter of 2024 compared to the same period in 2023, primarily due to the close-out of the CLEAR Outcomes study. Selling, general, and administrative expenses increased by 40%, largely due to the ramp-up of the sales force and promotional costs. However, these investments are expected to pay off as the company moves toward profitability, with projected earnings per share between $0.25 and $0.35 for 2025[2].

International Expansion

Esperion is set to expand into new markets in Canada, Israel, and Australia starting in 2025, which will generate additional revenue streams. This international expansion, coupled with growing insurance coverage for NEXLIZET and NEXLETOL in the U.S., is expected to boost adoption rates and drive further revenue growth[3].

Competitive Landscape

NEXLIZET and NEXLETOL face competition from injectable PCSK9 inhibitors like Amgen's Repatha, but they offer a unique advantage as oral medications with fewer side effects and no requirement for statin use. The main ingredient, bempedoic acid, is activated only in the liver, reducing statin-associated adverse events and drug interactions[4].

Analyst Expectations and Acquisition Potential

Analysts from firms like Needham and Jefferies anticipate that Esperion could become a prime acquisition target in early 2025 due to its strong market position and growth potential. The company's favorable debt structure, improving financials, and unique market position make it an attractive candidate for merger and acquisition activities[3].

Milestone Payments and Royalties

The label expansion for NEXLIZET and NEXLETOL is expected to trigger significant milestone payments from Esperion's partner, Daiichi Sankyo. Projections include up to $440 million in milestone payments, which will further bolster Esperion's financial trajectory[4].

Long-Term Market Trends

The demand for statin alternatives is expected to continue rising as more patients experience side effects from statins or require more effective treatments to lower LDL-C. Expanding insurance coverage for NEXLIZET and NEXLETOL will make these drugs more accessible, likely boosting adoption rates and contributing to long-term revenue growth[3].

Key Takeaways

• FDA Approval: NEXLIZET and NEXLETOL are the first oral non-statin LDL-C lowering drugs approved to reduce cardiovascular risk in both primary and secondary prevention patients.
• Market Opportunity: Significant market potential due to statin intolerance and the need for alternative treatments.
• Financial Growth: Robust revenue growth driven by prescription increases and international expansion.
• Cost Structure: Improved cost structure with reduced research and development expenses.
• Competitive Advantage: Unique oral medication profile with fewer side effects compared to statins and injectable PCSK9 inhibitors.
• Acquisition Potential: Attractive candidate for merger and acquisition activities due to strong market position and growth potential.

FAQs

Q: What is the significance of the FDA approval for NEXLIZET and NEXLETOL?

The FDA approval allows NEXLIZET and NEXLETOL to be used for reducing the risk of cardiovascular events in both primary and secondary prevention patients, regardless of statin use, expanding their treatable population to approximately 70 million patients in the U.S.[1].

Q: How does NEXLIZET compare to other cholesterol-lowering treatments?

NEXLIZET offers a unique advantage as an oral medication with fewer side effects compared to statins and injectable PCSK9 inhibitors. It reduces LDL-C without the common adverse events associated with statins[4].

Q: What are the revenue projections for NEXLIZET?

Esperion expects NEXLIZET to have over 500,000 patients using it by 2026, potentially generating over $1 billion in annual revenue. By 2028, it is projected to exceed 2 million prescriptions per year, driving significant revenue growth[3].

Q: Is Esperion financially stable?

Esperion has reported strong financial growth, with total revenue increasing by approximately 467% in the first quarter of 2024. The company has also improved its cost structure and is moving toward profitability, with projected earnings per share between $0.25 and $0.35 for 2025[2].

Q: What are the long-term market trends for NEXLIZET?

The demand for statin alternatives is expected to rise as more patients experience side effects from statins or require more effective treatments. Expanding insurance coverage will make NEXLIZET more accessible, contributing to long-term revenue growth[3].

Sources

1. U.S. FDA Approves Broad New Labels for NEXLETOL® and NEXLIZET® to Prevent Heart Attacks and Cardiovascular Procedures in Both Primary and Secondary Prevention Patients, Regardless of Statin Use. Esperion.
2. Esperion Reports First Quarter 2024 Financial Results. Esperion.
3. Buying This Takeover Target Offers 10X Upside. Esperion Therapeutics. Moomoo.
4. Full Results from Esperion's Cholesterol Drug Fail to Impress Investors. Biospace.
5. Esperion Reports Fourth Quarter and Full Year 2023 Financial Results. Stock Titan.