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Last Updated: April 13, 2024

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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 three patents protecting this drug.

This drug has forty-four patent family members in sixteen 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, 2025. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for NEXLETOL
International Patents:44
US Patents:3
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 64
Patent Applications: 91
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 Loss of Exclusivity (LOE) 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 three US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of NEXLETOL is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

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


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Hydroxyl compounds and compositions for cholesterol management and related uses
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

FDA Regulatory Exclusivity protecting NEXLETOL

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷  Try a Trial

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 ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Esperion Theraps Inc NEXLETOL bempedoic acid TABLET;ORAL 211616-001 Feb 21, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Esperion Theraps Inc NEXLETOL bempedoic acid TABLET;ORAL 211616-001 Feb 21, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Esperion Theraps Inc NEXLETOL bempedoic acid TABLET;ORAL 211616-001 Feb 21, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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 ⤷  Try a Trial ⤷  Try a Trial
Esperion Theraps Inc NEXLETOL bempedoic acid TABLET;ORAL 211616-001 Feb 21, 2020 ⤷  Try a Trial ⤷  Try a Trial
Esperion Theraps Inc NEXLETOL bempedoic acid TABLET;ORAL 211616-001 Feb 21, 2020 ⤷  Try a Trial ⤷  Try a Trial
Esperion Theraps Inc NEXLETOL bempedoic acid TABLET;ORAL 211616-001 Feb 21, 2020 ⤷  Try a Trial ⤷  Try a Trial
Esperion Theraps Inc NEXLETOL bempedoic acid TABLET;ORAL 211616-001 Feb 21, 2020 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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/004958
Nilemdo 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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for NEXLETOL

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

Country Patent Number Title Estimated Expiration
Israel 288909 שיטות להכנה של חומצה במפדואית ותכשירים המכילים אותה (Methods of making bempedoic acid and compositions of the same) ⤷  Try a Trial
European Patent Office 3986860 FORMES SALINES D'ACIDE BEMPEDOÏQUE ET LEURS PROCÉDÉS D'UTILISATION (SALT FORMS OF BEMPEDOIC ACID AND METHODS FOR USING THE SAME) ⤷  Try a Trial
Japan 2012097105 HYDROXYL COMPOUND AND COMPOSITION FOR CHOLESTEROL MANAGEMENT AND RELATED USE ⤷  Try a Trial
Spain 2594340 ⤷  Try a Trial
South Korea 20220024816 벰페도산 및 그의 조성물을 제조하는 방법 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for NEXLETOL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2404890 CR 2020 00041 Denmark ⤷  Try a Trial PRODUCT NAME: BEMPEDOINSYRE ELLER ET/EN FARMACEUTISK ACCEPTABEL(T) SALT, HYDRAT, SOLVAT ELLER BLANDING DERAF; REG. NO/DATE: EU/1/20/1424 20200331
2404890 CA 2020 00041 Denmark ⤷  Try a Trial 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 ⤷  Try a Trial 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 640 Finland ⤷  Try a Trial
2404890 2020/037 Ireland ⤷  Try a Trial PRODUCT NAME: BEMPEDOIC ACID, OR A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE, SOLVATE, OR MIXTURE THEREOF; REGISTRATION 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.