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Last Updated: June 17, 2021

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NEXLIZET Drug Profile


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Which patents cover Nexlizet, and what generic alternatives are available?

Nexlizet is a drug marketed by Esperion Theraps Inc and is included in one NDA. There are six patents protecting this drug.

This drug has twenty-three patent family members in thirteen countries.

The generic ingredient in NEXLIZET is bempedoic acid; ezetimibe. Additional details are available on the bempedoic acid; ezetimibe profile page.

DrugPatentWatch® Generic Entry Outlook for Nexlizet

Nexlizet 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 NEXLIZET
International Patents:23
US Patents:6
Applicants:1
NDAs:1
Formulation / Manufacturing:see details
Drug Prices: Drug price information for NEXLIZET
What excipients (inactive ingredients) are in NEXLIZET?NEXLIZET excipients list
DailyMed Link:NEXLIZET at DailyMed
Drug patent expirations by year for NEXLIZET
Drug Prices for NEXLIZET

See drug prices for NEXLIZET

DrugPatentWatch® Estimated Generic Entry Opportunity Date for NEXLIZET
Generic Entry Date for NEXLIZET*:
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 NEXLIZET

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   Get Started Free   Get Started Free   Get Started Free
Esperion Theraps Inc NEXLIZET bempedoic acid; ezetimibe TABLET;ORAL 211617-001 Feb 26, 2020 RX Yes Yes   Get Started Free   Get Started Free   Get Started Free
Esperion Theraps Inc NEXLIZET bempedoic acid; ezetimibe TABLET;ORAL 211617-001 Feb 26, 2020 RX Yes Yes   Get Started Free   Get Started Free   Get Started Free
Esperion Theraps Inc NEXLIZET bempedoic acid; ezetimibe TABLET;ORAL 211617-001 Feb 26, 2020 RX Yes Yes   Get Started Free   Get Started Free   Get Started Free
Esperion Theraps Inc NEXLIZET bempedoic acid; ezetimibe TABLET;ORAL 211617-001 Feb 26, 2020 RX Yes Yes   Get Started Free   Get Started Free   Get Started Free
Esperion Theraps Inc NEXLIZET bempedoic acid; ezetimibe TABLET;ORAL 211617-001 Feb 26, 2020 RX Yes Yes   Get Started Free   Get Started Free   Get Started Free
>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 NEXLIZET

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2404890 CA 2020 00041 Denmark   Get Started Free PRODUCT NAME: BEMPEDOINSYRE ELLER ET/EN FARMACEUTISK ACCEPTABEL(T) SALT, HYDRAT, SOLVAT ELLER BLANDING DERAF; REG. NO/DATE: EU/1/20/1424 20200331
2404890 2020C/534 Belgium   Get Started Free 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 LUC00174 Luxembourg   Get Started Free PRODUCT NAME: BEMPEDOIC ACID, OR A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE, SOLVATE, OR MIXTURE THEREOF; AUTHORISATION NUMBER AND DATE: EU/1/20/1424 20200331
2404890 122020000048 Germany   Get Started Free PRODUCT NAME: BEMPEDOINSAEURE ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ, HYDRAT, SOLVAT ODER EIN GEMISCH DAVON; REGISTRATION NO/DATE: EU/1/20/1424 20200327
2404890 C20200030 00306 Estonia   Get Started Free PRODUCT NAME: BEMPEEDHAPE;REG NO/DATE: EU/1/20/1424 31.03.2020
2404890 132020000000112 Italy   Get Started Free 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

AstraZeneca
McKinsey
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Boehringer Ingelheim
Express Scripts
Harvard Business School

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