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Last Updated: May 28, 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 six 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:6
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
University of California, Los AngelesPhase 3
Priscilla Hsue, MDPhase 3
Massachusetts General HospitalPhase 3

See all bempedoic acid clinical trials

Pharmacology for bempedoic acid
Paragraph IV (Patent) Challenges for BEMPEDOIC ACID
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
NEXLETOL Tablets bempedoic acid 180 mg 211616 9 2024-02-21

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 ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Esperion Theraps Inc NEXLETOL bempedoic acid TABLET;ORAL 211616-001 Feb 21, 2020 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Esperion Theraps Inc NEXLETOL bempedoic acid TABLET;ORAL 211616-001 Feb 21, 2020 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Esperion Theraps Inc NEXLIZET bempedoic acid; ezetimibe TABLET;ORAL 211617-001 Feb 26, 2020 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 ⤷  Sign Up ⤷  Sign Up
Esperion Theraps Inc NEXLETOL bempedoic acid TABLET;ORAL 211616-001 Feb 21, 2020 ⤷  Sign Up ⤷  Sign Up
Esperion Theraps Inc NEXLETOL bempedoic acid TABLET;ORAL 211616-001 Feb 21, 2020 ⤷  Sign Up ⤷  Sign Up
Esperion Theraps Inc NEXLETOL bempedoic acid TABLET;ORAL 211616-001 Feb 21, 2020 ⤷  Sign Up ⤷  Sign Up
>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
South Korea 20220024815 벰페도산의 염 형태 및 그의 사용 방법 ⤷  Sign Up
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) ⤷  Sign Up
Brazil 112021025928 Métodos de preparação de ácido bempedoico e composições do mesmo ⤷  Sign Up
Japan 4931349 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for bempedoic acid

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2404890 CR 2020 00041 Denmark ⤷  Sign Up PRODUCT NAME: BEMPEDOINSYRE ELLER ET/EN FARMACEUTISK ACCEPTABEL(T) SALT, HYDRAT, SOLVAT ELLER BLANDING DERAF; REG. NO/DATE: EU/1/20/1424 20200331
2404890 38/2020 Austria ⤷  Sign Up PRODUCT NAME: BEMPEDOINSAEURE ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ, HYDRAT, SOLVAT ODER EIN GEMISCH DAVON; REGISTRATION NO/DATE: EU/1/20/1424 (MITTEILUNG) 20200331
2404890 122020000048 Germany ⤷  Sign Up PRODUCT NAME: BEMPEDOINSAEURE ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ, HYDRAT, SOLVAT ODER EIN GEMISCH DAVON; REGISTRATION NO/DATE: EU/1/20/1424 20200327
2404890 301062 Netherlands ⤷  Sign Up PRODUCT NAME: BEMPEDONZUUR, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT, HYDRAAT, SOLVAAT OF MENGSEL DAARVAN; REGISTRATION NO/DATE: EU/1/20/1424 20200331
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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