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Last Updated: September 25, 2022

NEXLIZET Drug Patent Profile


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

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

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

The generic ingredient in NEXLIZET is bempedoic acid; ezetimibe. Additional details are available on the bempedoic acid; ezetimibe profile page.

DrugPatentWatch® Generic Entry Outlook for Nexlizet

Nexlizet will be eligible for patent challenges on February 21, 2024. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 3, 2025. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for NEXLIZET
International Patents:48
US Patents:7
Applicants:1
NDAs:1
Clinical Trials: 1
Formulation / Manufacturing:see details
Drug Prices: Drug price information for NEXLIZET
What excipients (inactive ingredients) are in NEXLIZET?NEXLIZET excipients list
DailyMed Link:NEXLIZET at DailyMed
Drug patent expirations by year for NEXLIZET
Drug Prices for NEXLIZET

See drug prices for NEXLIZET

DrugPatentWatch® Estimated Generic Entry Opportunity Date for NEXLIZET
Generic Entry Date for NEXLIZET*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
Esperion Therapeutics, Inc.Phase 4
Kaiser PermanentePhase 4

See all NEXLIZET clinical trials

US Patents and Regulatory Information for NEXLIZET

NEXLIZET is protected by seven US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of NEXLIZET is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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

Patents protecting NEXLIZET

Hydroxyl compounds and compositions for cholesterol management and related uses
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF NEXLIZET AS AN ADJUNCT TO DIET AND MAXIMALLY TOLERATED STATIN THERAPY TO LOWER LDL-C IN ADULTS WITH HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA OR ESTABLISHED ATHEROSCLEROTIC CARDIOVASCULAR DISEASE

Fixed dose combinations and formulations comprising ETC1002 and ezetimibe and methods of treating or reducing the risk of cardiovascular disease
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: A METHOD OF TREATING HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA OR ESTABLISHED ATHEROSCLEROTIC CARDIOVASCULAR DISEASE BY DECREASING THE LEVEL OF LDL-C USING A FIXED DOSE COMBINATION OF 180 MG BEMPEDOIC ACID AND 10 MG EZETIMIBE

Hydroxyl compounds and compositions for cholesterol management and related uses
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF NEXLIZET AS AN ADJUNCT TO DIET AND MAXIMALLY TOLERATED STATIN THERAPY TO LOWER LDL-C IN ADULTS WITH HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA OR ESTABLISHED ATHEROSCLEROTIC CARDIOVASCULAR DISEASE

Hydroxyl compounds and compositions for cholesterol management and related uses
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Hydroxyl compounds and compositions for cholesterol management and related uses
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF NEXLIZET AS AN ADJUNCT TO DIET AND MAXIMALLY TOLERATED STATIN THERAPY TO LOWER LDL-C IN ADULTS WITH HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA OR ESTABLISHED ATHEROSCLEROTIC CARDIOVASCULAR DISEASE

Hydroxyl compounds and compositions for cholesterol management and related uses
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF NEXLIZET AS AN ADJUNCT TO DIET AND MAXIMALLY TOLERATED STATIN THERAPY TO LOWER LDL-C IN ADULTS WITH HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA OR ESTABLISHED ATHEROSCLEROTIC CARDIOVASCULAR DISEASE

Hydroxyl compounds and compositions for cholesterol management and related uses
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF NEXLIZET AS AN ADJUNCT TO DIET AND MAXIMALLY TOLERATED STATIN THERAPY FOR INHIBITING CHOLESTEROL SYNTHESIS TO LOWER LDL-C IN ADULTS WITH HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA OR ESTABLISHED ATHEROSCLEROTIC CARDIOVASCULAR DISEASE

FDA Regulatory Exclusivity protecting NEXLIZET

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

NEW PRODUCT
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Esperion Theraps Inc NEXLIZET bempedoic acid; ezetimibe TABLET;ORAL 211617-001 Feb 26, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Esperion Theraps Inc NEXLIZET bempedoic acid; ezetimibe TABLET;ORAL 211617-001 Feb 26, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Esperion Theraps Inc NEXLIZET bempedoic acid; ezetimibe TABLET;ORAL 211617-001 Feb 26, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for NEXLIZET

When does loss-of-exclusivity occur for NEXLIZET?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 03299993
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 18046
Estimated Expiration: See Plans and Pricing

Patent: 0318046
Estimated Expiration: See Plans and Pricing

Canada

Patent: 13660
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 19404
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 04890
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 97223
Estimated Expiration: See Plans and Pricing

Patent: 02300
Estimated Expiration: See Plans and Pricing

Patent: 04890
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 36646
Estimated Expiration: See Plans and Pricing

Patent: 000033
Estimated Expiration: See Plans and Pricing

Japan

Patent: 31349
Estimated Expiration: See Plans and Pricing

Patent: 93303
Estimated Expiration: See Plans and Pricing

Patent: 06513251
Estimated Expiration: See Plans and Pricing

Patent: 12097105
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 05007674
Estimated Expiration: See Plans and Pricing

Patent: 9134
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 04890
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 04890
Estimated Expiration: See Plans and Pricing

Spain

Patent: 94340
Estimated Expiration: See Plans and Pricing

Patent: 25429
Estimated Expiration: See Plans and Pricing

Patent: 42216
Estimated Expiration: See Plans and Pricing

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

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

Country Patent Number Title Estimated Expiration
Japan 5593303 See Plans and Pricing
Mexico 349134 COMPUESTOS DE HIDROXILO Y COMPOSICIONES PARA EL MANEJO DEL COLESTEROL Y USOS RELACIONADOS. (HYDROXYL COMPOUNDS AND COMPOSITIONS FOR CHOLESTEROL MANAGEMENT AND RELATED USES.) See Plans and Pricing
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) See Plans and Pricing
Singapore 10201908500U FIXED DOSE COMBINATIONS AND FORMULATIONS COMPRISING ETC1002 AND EZETIMIBE AND METHODS OF TREATING OR REDUCING THE RISK OF CARDIOVASCULAR DISEASE See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for NEXLIZET

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2404890 640 Finland See Plans and Pricing
2404890 132020000000112 Italy See Plans and Pricing 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 20C1041 France See Plans and Pricing 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
2404890 C20200030 00306 Estonia See Plans and Pricing PRODUCT NAME: BEMPEEDHAPE;REG NO/DATE: EU/1/20/1424 31.03.2020
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

AstraZeneca
McKinsey
Merck
Boehringer Ingelheim
Express Scripts
Harvard Business School

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.