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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
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 |
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
International Patents for NEXLIZET
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Hungary | S2000033 | Get Started Free |
| Mexico | 349134 | Get Started Free |
| Canada | 2513660 | Get Started Free |
| Hungary | E036646 | Get Started Free |
| Spain | 2594340 | Get Started Free |
| Portugal | 2404890 | Get Started Free |
| >Country | >Patent Number | >Estimated 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 |
