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Last Updated: February 25, 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 ten 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:10
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

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 ⤷  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
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 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 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
China 112437766 制备贝派地酸及其组合物的方法 (METHODS OF MAKING BEMPEDOIC ACID AND COMPOSITIONS OF THE SAME) ⤷  Try a Trial
Cyprus 1119404 ⤷  Try a Trial
South Korea 20220024816 벰페도산 및 그의 조성물을 제조하는 방법 ⤷  Try a Trial
Japan 5593303 ⤷  Try a Trial
Spain 2642216 ⤷  Try a Trial
Japan 4931349 ⤷  Try a Trial
Portugal 2404890 ⤷  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 C02404890/01 Switzerland ⤷  Try a Trial PRODUCT NAME: BEMPEDOINSAEURE; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67583 14.12.2020
2404890 2090035-3 Sweden ⤷  Try a Trial PRODUCT NAME: BEMPEDOIC ACID, OR A PHARMACEUTICALLY ACCEPTABLE SALT,HYDRATE,SOLVATE OR MIXTURE THEREOF; REG. NO/DATE: EU/1/20/1424 20200331
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 20C1041 France ⤷  Try a Trial 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 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
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 122020000048 Germany ⤷  Try a Trial PRODUCT NAME: BEMPEDOINSAEURE ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ, HYDRAT, SOLVAT ODER EIN GEMISCH DAVON; REGISTRATION NO/DATE: EU/1/20/1424 20200327
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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