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Last Updated: May 22, 2022

NEXLETOL Drug Patent Profile


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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 six patents protecting this drug.

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

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

DrugPatentWatch® Generic Entry Outlook for Nexletol

Nexletol 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 NEXLETOL
International Patents:23
US Patents:6
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 54
Patent Applications: 95
Drug Prices: Drug price information for NEXLETOL
What excipients (inactive ingredients) are in NEXLETOL?NEXLETOL excipients list
DailyMed Link:NEXLETOL at DailyMed
Drug patent expirations by year for NEXLETOL
Drug Prices for NEXLETOL

See drug prices for NEXLETOL

DrugPatentWatch® Estimated Generic Entry Opportunity Date for NEXLETOL
Generic Entry Date for NEXLETOL*:
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.

US Patents and Regulatory Information for NEXLETOL

NEXLETOL is protected by six US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of NEXLETOL 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 NEXLETOL

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 NEXLETOL 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 NEXLETOL 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 NEXLETOL 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 NEXLETOL 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 NEXLETOL 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 NEXLETOL

NEW CHEMICAL ENTITY
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 NEXLETOL bempedoic acid TABLET;ORAL 211616-001 Feb 21, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Esperion Theraps Inc NEXLETOL bempedoic acid TABLET;ORAL 211616-001 Feb 21, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Esperion Theraps Inc NEXLETOL bempedoic acid TABLET;ORAL 211616-001 Feb 21, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Esperion Theraps Inc NEXLETOL bempedoic acid TABLET;ORAL 211616-001 Feb 21, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Esperion Theraps Inc NEXLETOL bempedoic acid TABLET;ORAL 211616-001 Feb 21, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Esperion Theraps Inc NEXLETOL bempedoic acid TABLET;ORAL 211616-001 Feb 21, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Esperion Theraps Inc NEXLETOL bempedoic acid TABLET;ORAL 211616-001 Feb 21, 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

International Patents for NEXLETOL

When does loss-of-exclusivity occur for NEXLETOL?

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 NEXLETOL around the world.

Country Patent Number Title Estimated Expiration
European Patent Office 2402300 Composés d'hydroxyle et compositions pour gestion du cholestérol et utilisations associées (Hydroxyl compounds and compositions for cholesterol management and related uses) See Plans and Pricing
Denmark 2404890 See Plans and Pricing
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) See Plans and Pricing
Spain 2642216 See Plans and Pricing
Japan 4931349 See Plans and Pricing
European Patent Office 1597223 COMPOSES HYDROXYLES ET COMPOSITIONS DE REGULATION DU CHOLESTEROL ET UTILISATIONS ASSOCIEES (HYDROXYL COMPOUNDS AND COMPOSITIONS FOR CHOLESTEROL MANAGEMENT AND RELATED USES) See Plans and Pricing
Portugal 2404890 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for NEXLETOL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 640 Finland See Plans and Pricing
2404890 2020C/534 Belgium See Plans and Pricing 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 C202030044 Spain See Plans and Pricing 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 C 2020 031 Romania See Plans and Pricing 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 38/2020 Austria See Plans and Pricing PRODUCT NAME: BEMPEDOINSAEURE ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ, HYDRAT, SOLVAT ODER EIN GEMISCH DAVON; REGISTRATION NO/DATE: EU/1/20/1424 (MITTEILUNG) 20200331
2404890 2090035-3 Sweden See Plans and Pricing PRODUCT NAME: BEMPEDOIC ACID, OR A PHARMACEUTICALLY ACCEPTABLE SALT,HYDRATE,SOLVATE OR MIXTURE THEREOF; REG. NO/DATE: EU/1/20/1424 20200331
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.