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 |
---|---|
Medanta, The Medicity, India | N/A |
Diabetes & Endocrinology Foundation | N/A |
Priscilla Hsue, MD | 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
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 | NEXLETOL | bempedoic acid | TABLET;ORAL | 211616-001 | Feb 21, 2020 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
Esperion Theraps Inc | NEXLIZET | bempedoic acid; ezetimibe | TABLET;ORAL | 211617-001 | Feb 26, 2020 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | Y | ⤷ Subscribe | |||
Esperion Theraps Inc | NEXLETOL | bempedoic acid | TABLET;ORAL | 211616-001 | Feb 21, 2020 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
Esperion Theraps Inc | NEXLETOL | bempedoic acid | TABLET;ORAL | 211616-001 | Feb 21, 2020 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | Y | ⤷ Subscribe | |||
>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 | ⤷ Subscribe | ⤷ Subscribe |
Esperion Theraps Inc | NEXLETOL | bempedoic acid | TABLET;ORAL | 211616-001 | Feb 21, 2020 | ⤷ Subscribe | ⤷ Subscribe |
Esperion Theraps Inc | NEXLETOL | bempedoic acid | TABLET;ORAL | 211616-001 | Feb 21, 2020 | ⤷ Subscribe | ⤷ Subscribe |
Esperion Theraps Inc | NEXLETOL | bempedoic acid | TABLET;ORAL | 211616-001 | Feb 21, 2020 | ⤷ Subscribe | ⤷ Subscribe |
>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 |
---|---|---|---|
Brazil | 0318046 | Compostos de hidroxila e composições para controle de colesterol e empregos relacionados | ⤷ Subscribe |
Canada | 3144372 | FORMES SALINES D'ACIDE BEMPEDOIQUE ET LEURS PROCEDES D'UTILISATION (SALT FORMS OF BEMPEDOIC ACID AND METHODS FOR USING THE SAME) | ⤷ Subscribe |
European Patent Office | 2404890 | Composés hydroxyle et compositions pour la gestion du cholestérol et utilisations associées (Hydroxyl compounds and compositions for cholesterol management and related uses) | ⤷ Subscribe |
Israel | 288997 | צורות מלח של חומצה במפדואית ושיטות לשימוש בהם (Salt forms of bempedoic acid and methods for using the same) | ⤷ Subscribe |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for BEMPEDOIC ACID
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2404890 | CA 2020 00041 | Denmark | ⤷ Subscribe | PRODUCT NAME: BEMPEDOINSYRE ELLER ET/EN FARMACEUTISK ACCEPTABEL(T) SALT, HYDRAT, SOLVAT ELLER BLANDING DERAF; REG. NO/DATE: EU/1/20/1424 20200331 |
2404890 | 2020/037 | Ireland | ⤷ Subscribe | PRODUCT NAME: BEMPEDOIC ACID, OR A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE, SOLVATE, OR MIXTURE THEREOF; REGISTRATION NO/DATE: EU/1/20/1424 20200331 |
2404890 | C202030044 | Spain | ⤷ Subscribe | PRODUCT NAME: ACIDO BEMPEDOICO, O UNA SAL FARMACEUTICAMENTE ACEPTABLE, HIDRATO, SOLVATO O MEZCLA DE LOS MISMOS; NATIONAL AUTHORISATION NUMBER: EU/1/20/1424; DATE OF AUTHORISATION: 20200327; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1424; DATE OF FIRST AUTHORISATION IN EEA: 20200327 |
2404890 | LUC00174 | Luxembourg | ⤷ Subscribe | PRODUCT NAME: BEMPEDOIC ACID, OR A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE, SOLVATE, OR MIXTURE THEREOF; AUTHORISATION NUMBER AND DATE: EU/1/20/1424 20200331 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
BEMPEDOIC ACID Market Analysis and Financial Projection Experimental
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