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Last Updated: March 28, 2024

BEMPEDOIC ACID; EZETIMIBE - Generic Drug Details


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

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

Bempedoic acid; ezetimibe has seventy patent family members in twenty-three countries.

One supplier is listed for this compound.

Summary for BEMPEDOIC ACID; EZETIMIBE
International Patents:70
US Patents:5
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Clinical Trials: 5
DailyMed Link:BEMPEDOIC ACID; EZETIMIBE at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for BEMPEDOIC ACID; EZETIMIBE
Generic Entry Date for BEMPEDOIC ACID; EZETIMIBE*:
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; EZETIMIBE

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

SponsorPhase
Kaiser PermanentePhase 4
Esperion Therapeutics, Inc.Phase 4
Esperion TherapeuticsPhase 2

See all BEMPEDOIC ACID; EZETIMIBE clinical trials

US Patents and Regulatory Information for BEMPEDOIC ACID; EZETIMIBE

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 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 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
>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; EZETIMIBE

EU/EMA Drug Approvals for BEMPEDOIC ACID; EZETIMIBE

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Daiichi Sankyo Europe GmbH Nustendi bempedoic acid, ezetimibe EMEA/H/C/004959
Nustendi 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 in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin in addition to ezetimibealone in patients who are either statin-intolerant or for whom a statin is contraindicated, and are unable to reach LDL-C goals with ezetimibe alone,in patients already being treated with the combination of bempedoic acid and ezetimibe as separate tablets with or without statin
Authorised no no no 2020-03-27
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for BEMPEDOIC ACID; EZETIMIBE

Country Patent Number Title Estimated Expiration
Australia 2020295503 Salt forms of bempedoic acid and methods for using the same ⤷  Try a Trial
Singapore 11201707497U FIXED DOSE COMBINATIONS AND FORMULATIONS COMPRISING ETC1002 AND EZETIMIBE AND METHODS OF TREATING OR REDUCING THE RISK OF CARDIOVASCULAR DISEASE ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2016149191 ⤷  Try a Trial
Philippines 12017501625 FIXED DOSE COMBINATIONS AND FORMULATIONS COMPRISING ETC1002 AND EZETIMIBE AND METHODS OF TREATING OR REDUCING THE RISK OF CARDIOVASCULAR DISEASE ⤷  Try a Trial
Russian Federation 2022102472 ФИКСИРОВАННЫЕ КОМБИНАЦИИ И СОСТАВЫ, СОДЕРЖАЩИЕ ETC-1002 И ЭЗЕТИМИБ, И СПОСОБЫ ЛЕЧЕНИЯ ИЛИ УМЕНЬШЕНИЯ РИСКА РАЗВИТИЯ СЕРДЕЧНО-СОСУДИСТОГО ЗАБОЛЕВАНИЯ ⤷  Try a Trial
Japan 5593303 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for BEMPEDOIC ACID; EZETIMIBE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
2404890 LUC00174 Luxembourg ⤷  Try a Trial PRODUCT NAME: BEMPEDOIC ACID, OR A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE, SOLVATE, OR MIXTURE THEREOF; AUTHORISATION NUMBER AND DATE: EU/1/20/1424 20200331
2404890 2020C/534 Belgium ⤷  Try a Trial PRODUCT NAME: ACIDE BEMPEDOIQUE OU UN SEL, HYDRATE, PRODUIT DE SOLVATATION OU MELANGE DE CEUX-CI, PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/20/1424 20200331
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 C20200030 00306 Estonia ⤷  Try a Trial PRODUCT NAME: BEMPEEDHAPE;REG NO/DATE: EU/1/20/1424 31.03.2020
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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