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Last Updated: April 15, 2021

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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

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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
Drug patent expirations by year for NEXLETOL
Drug Prices for NEXLETOL

See drug prices for NEXLETOL

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

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

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