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 five 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: | 5 |
| 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
| Sponsor | Phase |
|---|---|
| University of Utah | Phase 3 |
| University of California, Los Angeles | Phase 3 |
| Priscilla Hsue, MD | Phase 3 |
Pharmacology for BEMPEDOIC ACID
| Drug Class | Adenosine Triphosphate-Citrate Lyase Inhibitor |
| Mechanism of Action | Adenosine Triphosphate-Citrate Lyase Inhibitors |
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 | 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 | |||
| >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 |
| >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 |
|---|---|---|---|
| World Intellectual Property Organization (WIPO) | 2020257571 | ⤷ Try a Trial | |
| European Patent Office | 3986859 | PROCÉDÉS DE PRÉPARATION D'ACIDE BEMPÉDOÏQUE ET COMPOSITIONS DE CELUI-CI (METHODS OF MAKING BEMPEDOIC ACID AND COMPOSITIONS OF THE SAME) | ⤷ Try a Trial |
| Mexico | PA05007674 | COMPUESTOS DE HIDROXILO Y COMPOSICIONES PARA EL MANEJO DEL COLESTEROL Y USOS RELACIONADOS. (HYDROXYL COMPOUNDS AND COMPOSITIONS FOR CHOLESTEROL MANAGEMENT AND RELATED USES.) | ⤷ 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 | 38/2020 | Austria | ⤷ Try a Trial | PRODUCT NAME: BEMPEDOINSAEURE ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ, HYDRAT, SOLVAT ODER EIN GEMISCH DAVON; REGISTRATION NO/DATE: EU/1/20/1424 (MITTEILUNG) 20200331 |
| 2404890 | C202030044 | Spain | ⤷ Try a Trial | 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 | 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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