BEMPEDOIC ACID - Generic Drug Details
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What are the generic sources for bempedoic acid and what is the scope of freedom to operate?
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 seventy patent family members in twenty-three countries.
One supplier is listed for this compound.
Summary for BEMPEDOIC ACID
International Patents: | 70 |
US Patents: | 6 |
Tradenames: | 2 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 64 |
Clinical Trials: | 15 |
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
Sponsor | Phase |
---|---|
Diabetes & Endocrinology Foundation | N/A |
Medanta, The Medicity, India | N/A |
University of Utah | Phase 3 |
Pharmacology for BEMPEDOIC ACID
Drug Class | Adenosine Triphosphate-Citrate Lyase Inhibitor |
Mechanism of Action | Adenosine Triphosphate-Citrate Lyase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes 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
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 |
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 |
---|---|---|---|
Japan | 2012097105 | HYDROXYL COMPOUND AND COMPOSITION FOR CHOLESTEROL MANAGEMENT AND RELATED USE | ⤷ Sign Up |
Hungary | S2000033 | ⤷ Sign Up | |
Japan | 2021193105 | ETC1002及びエゼチミブを含む固定用量組合せ物及び製剤並びに心血管疾患を処置するか又は心血管疾患のリスクを低減させる方法 (FIXED DOSE COMBINATIONS AND FORMULATIONS COMPRISING ETC1002 AND EZETIMIBE, AND METHODS OF TREATING OR REDUCING RISK OF CARDIOVASCULAR DISEASE) | ⤷ Sign Up |
Australia | 2003299993 | HYDROXYL COMPOUNDS AND COMPOSITIONS FOR CHOLESTEROL MANAGEMENT AND RELATED USES | ⤷ Sign Up |
Australia | 2016233485 | Fixed dose combinations and formulations comprising ETC1002 and Ezetimibe and methods of treating or reducing the risk of cardiovascular disease | ⤷ Sign Up |
Brazil | PI0318046 | compostos de hidroxila, seu usos, e composições farmacêuticas | ⤷ Sign Up |
Chile | 2017002299 | Combinaciones de dosis fija y formulaciones comprendiendo etc-1002 y ezetimiba y métodos para tratar o reducir el riesgo de enfermedades cardiovasculares | ⤷ 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 | C 2020 031 | Romania | ⤷ Sign Up | 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 |
2404890 | 2020C/534 | Belgium | ⤷ Sign Up | 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 | LUC00174 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: BEMPEDOIC ACID, OR A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE, SOLVATE, OR MIXTURE THEREOF; AUTHORISATION NUMBER AND DATE: EU/1/20/1424 20200331 |
2404890 | SPC/GB20/047 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: BEMPEDOIC ACID, OR A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE, SOLVATE, OR MIXTURE THEREOF; REGISTERED: UK PLGB 08265/0039 20200331; UK EU/1/20/1424(FOR NI) 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 | C20200030 00306 | Estonia | ⤷ Sign Up | 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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