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NEXLETOL Drug Profile
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Which patents cover Nexletol, and what generic alternatives are available?
Nexletol is a drug marketed by Esperion Theraps Inc and is included in one NDA. There are five patents protecting this drug.
This drug has twenty-three patent family members in thirteen countries.
The generic ingredient in NEXLETOL is bempedoic acid. Additional details are available on the bempedoic acid profile page.
DrugPatentWatch® Generic Entry Outlook for Nexletol
Nexletol will be eligible for patent challenges on February 21, 2024. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be December 3, 2025. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for NEXLETOL
| International Patents: | 23 |
| US Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Bulk Api Vendors: | 45 |
| Patent Applications: | 132 |
| Drug Prices: | Drug price information for NEXLETOL |
| What excipients (inactive ingredients) are in NEXLETOL? | NEXLETOL excipients list |
| DailyMed Link: | NEXLETOL at DailyMed |
DrugPatentWatch® Estimated Generic Entry Opportunity Date for NEXLETOL
Generic Entry Date for NEXLETOL*:
Constraining patent/regulatory exclusivity:
NDA:
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.
US Patents and Regulatory Information for NEXLETOL
| 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 | Start Trial | Start Trial | Start Trial | ||||
| Esperion Theraps Inc | NEXLETOL | bempedoic acid | TABLET;ORAL | 211616-001 | Feb 21, 2020 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Esperion Theraps Inc | NEXLETOL | bempedoic acid | TABLET;ORAL | 211616-001 | Feb 21, 2020 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Esperion Theraps Inc | NEXLETOL | bempedoic acid | TABLET;ORAL | 211616-001 | Feb 21, 2020 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Esperion Theraps Inc | NEXLETOL | bempedoic acid | TABLET;ORAL | 211616-001 | Feb 21, 2020 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Esperion Theraps Inc | NEXLETOL | bempedoic acid | TABLET;ORAL | 211616-001 | Feb 21, 2020 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start 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 NEXLETOL
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Spain | 2625429 | Start Trial |
| Japan | 5593303 | Start Trial |
| Australia | 2003299993 | Start Trial |
| Mexico | PA05007674 | Start Trial |
| European Patent Office | 2404890 | Start Trial |
| Japan | 2012097105 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for NEXLETOL
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2404890 | 301062 | Netherlands | Start Trial | PRODUCT NAME: BEMPEDONZUUR, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT, HYDRAAT, SOLVAAT OF MENGSEL DAARVAN; REGISTRATION NO/DATE: EU/1/20/1424 20200331 |
| 2404890 | CA 2020 00041 | Denmark | Start 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 | LUC00174 | Luxembourg | Start 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 | Start 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 | 132020000000112 | Italy | Start 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 | 122020000048 | Germany | Start Trial | PRODUCT NAME: BEMPEDOINSAEURE ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ, HYDRAT, SOLVAT ODER EIN GEMISCH DAVON; REGISTRATION NO/DATE: EU/1/20/1424 20200327 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
