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Last Updated: October 16, 2021

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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 twenty-three patent family members in thirteen countries.

Summary for bempedoic acid
International Patents:23
US Patents:6
Tradenames:2
Applicants:1
NDAs:2
Raw Ingredient (Bulk) Api Vendors: 52
Clinical Trials: 11
Patent Applications: 296
What excipients (inactive ingredients) are in bempedoic acid?bempedoic acid excipients list
DailyMed Link:bempedoic acid at DailyMed
Recent Clinical Trials for bempedoic acid

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

SponsorPhase
Otsuka Pharmaceutical Co., Ltd.Phase 2
Esperion TherapeuticsPhase 2
Esperion TherapeuticsPhase 3

See all bempedoic acid clinical trials

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

Supplementary Protection Certificates for bempedoic acid

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2404890 2020/037 Ireland ⤷  Free Forever Trial PRODUCT NAME: BEMPEDOIC ACID, OR A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE, SOLVATE, OR MIXTURE THEREOF; REGISTRATION NO/DATE: EU/1/20/1424 20200331
2404890 132020000000112 Italy ⤷  Free Forever Trial PRODUCT NAME: ACIDO BEMPEDOICO, O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE, IDRATO, SOLVATO, O LORO MISCELA(NUSTENDI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1424, 20200331
2404890 301062 Netherlands ⤷  Free Forever Trial 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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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
AstraZeneca
Merck
Express Scripts
Mallinckrodt
Dow

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