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Last Updated: March 29, 2024

Bempedoic acid - Generic Drug Details


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What are the generic drug sources for bempedoic acid and what is the scope of patent protection?

Bempedoic acid is the generic ingredient in two branded drugs marketed by Esperion Theraps Inc and is included in two NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Bempedoic acid has forty-four patent family members in sixteen countries.

One supplier is listed for this compound.

Summary for bempedoic acid
International Patents:44
US Patents:5
Tradenames:2
Applicants:1
NDAs:2
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 64
Clinical Trials: 14
Patent Applications: 169
What excipients (inactive ingredients) are in bempedoic acid?bempedoic acid excipients list
DailyMed Link:bempedoic acid at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for bempedoic acid
Generic Entry Date for bempedoic acid*:
Constraining patent/regulatory exclusivity:
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 bempedoic acid

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

SponsorPhase
Priscilla Hsue, MDPhase 3
Massachusetts General HospitalPhase 3
University of UtahPhase 3

See all bempedoic acid clinical trials

Pharmacology for bempedoic acid

US Patents and Regulatory Information for bempedoic acid

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 ⤷  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
Esperion Theraps Inc NEXLIZET bempedoic acid; ezetimibe TABLET;ORAL 211617-001 Feb 26, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Esperion Theraps Inc NEXLIZET bempedoic acid; ezetimibe TABLET;ORAL 211617-001 Feb 26, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Esperion Theraps Inc NEXLIZET bempedoic acid; ezetimibe TABLET;ORAL 211617-001 Feb 26, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  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 bempedoic acid

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 bempedoic acid

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 bempedoic acid

Country Patent Number Title Estimated Expiration
Japan 2022536979 塩形態のベンペド酸及びそれを使用する方法 ⤷  Try a Trial
Mexico 2021015936 METODOS PARA PREPARAR ACIDO BEMPEDOICO Y COMPOSICIONES DEL MISMO. (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
Cyprus 1119404 ⤷  Try a Trial
China 115429784 制备贝派地酸及其组合物的方法 (Method for preparing bepiridic acid and composition thereof) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for bempedoic acid

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2404890 C202030044 Spain ⤷  Try a Trial 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 C02404890/01 Switzerland ⤷  Try a Trial PRODUCT NAME: BEMPEDOINSAEURE; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67583 14.12.2020
2404890 640 Finland ⤷  Try a Trial
2404890 301062 Netherlands ⤷  Try a Trial PRODUCT NAME: BEMPEDONZUUR, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT, HYDRAAT, SOLVAAT OF MENGSEL DAARVAN; REGISTRATION 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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