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Bempedoic acid - Generic Drug Details
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
| Sponsor | Phase |
|---|---|
| Otsuka Pharmaceutical Co., Ltd. | Phase 2 |
| Esperion Therapeutics | Phase 2 |
| Esperion Therapeutics | Phase 3 |
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 |
International Patents for bempedoic acid
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Slovenia | 2404890 | ⤷ Free Forever Trial |
| Portugal | 2404890 | ⤷ Free Forever Trial |
| Brazil | PI0318046 | ⤷ Free Forever Trial |
| >Country | >Patent Number | >Estimated 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 |
