NEXLIZET Drug Patent Profile
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Which patents cover Nexlizet, and when can generic versions of Nexlizet launch?
Nexlizet is a drug marketed by Esperion Theraps Inc and is included in one NDA. There are eight patents protecting this drug and one Paragraph IV challenge.
This drug has eighty-one patent family members in twenty-four countries.
The generic ingredient in NEXLIZET is bempedoic acid; ezetimibe. One supplier is listed for this compound. Additional details are available on the bempedoic acid; ezetimibe profile page.
DrugPatentWatch® Generic Entry Outlook for Nexlizet
Nexlizet was eligible for patent challenges on February 21, 2024.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be December 3, 2030. This may change due to patent challenges or generic licensing.
There have been five patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
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Questions you can ask:
- What is the 5 year forecast for NEXLIZET?
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Summary for NEXLIZET
| International Patents: | 81 |
| US Patents: | 8 |
| Applicants: | 1 |
| NDAs: | 1 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for NEXLIZET |
Paragraph IV (Patent) Challenges for NEXLIZET
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| NEXLIZET | Tablets | bempedoic acid; ezetimibe | 180 mg/10 mg | 211617 | 3 | 2024-02-21 |
US Patents and Regulatory Information for NEXLIZET
NEXLIZET is protected by ten US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of NEXLIZET is ⤷ Start Trial.
This potential generic entry date is based on patent ⤷ Start Trial.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
International Patents for NEXLIZET
See the table below for patents covering NEXLIZET around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Morocco | 42616 | ⤷ Start Trial | |
| Japan | 2018507901 | ⤷ Start Trial | |
| Singapore | 10201908500U | ⤷ Start Trial | |
| Mexico | 2022005469 | COMBINACIONES DE DOSIS FIJA Y FORMULACIONES QUE COMPRENDEN ACIDO 8-HIDROXI-2,2,14,14 TETRAMETILPENTADECANODIOICO (ETC1002) Y EZETIMIBA Y METODOS PARA TRATAR O REDUCIR EL RIESGO DE ENFERMEDAD CARDIOVASCULAR. (FIXED DOSE COMBINATIONS AND FORMULATIONS COMPRISING ETC1002 AND EZETIMIBE AND METHODS OF TREATING OR REDUCING THE RISK OF CARDIOVASCULAR DISEASE.) | ⤷ Start Trial |
| South Korea | 20220024815 | 벰페도산의 염 형태 및 그의 사용 방법 | ⤷ Start Trial |
| Brazil | PI0318046 | compostos de hidroxila, seu usos, e composições farmacêuticas | ⤷ Start Trial |
| Canada | 2978204 | ⤷ Start Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for NEXLIZET
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 | C202030044 | Spain | ⤷ Start Trial | PRODUCT NAME: ACIDO BEMPEDOICO, O UNA SAL FARMACEUTICAMENTE ACEPTABLE, HIDRATO, SOLVATO O MEZCLA DE LOS MISMOS; NATIONAL AUTHORISATION NUMBER: EU/1/20/1424; DATE OF AUTHORISATION: 20200327; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1424; DATE OF FIRST AUTHORISATION IN EEA: 20200327 |
| 2404890 | 2090035-3 | Sweden | ⤷ Start Trial | PRODUCT NAME: BEMPEDOIC ACID, OR A PHARMACEUTICALLY ACCEPTABLE SALT,HYDRATE,SOLVATE OR MIXTURE THEREOF; REG. NO/DATE: EU/1/20/1424 20200331 |
| 2404890 | C 2020 031 | Romania | ⤷ Start Trial | PRODUCT NAME: ACID BEMPEDOIC, SAU O SARE, HIDRAT, SOLVAT ACCEPTABILE FARMACEUTIC SAU AMESTECUL ACESTORA; NATIONAL AUTHORISATION NUMBER: EU/1/20/1424; DATE OF NATIONAL AUTHORISATION: 20200327; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1424; DATE OF FIRST AUTHORISATION IN EEA: 20200327 |
| 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 | C02404890/01 | Switzerland | ⤷ Start Trial | PRODUCT NAME: BEMPEDOINSAEURE; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67583 14.12.2020 |
| 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
NEXLIZET (Simeprevir/Velpatasvir): Investment Scenario, Market Dynamics, and Financial Trajectory
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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