NEXLIZET Drug Patent Profile
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When do Nexlizet patents expire, 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 and one Paragraph IV challenge.
This drug has seventy-one patent family members in twenty-three 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 is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.
Indicators of Generic Entry
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Summary for NEXLIZET
| International Patents: | 71 |
| US Patents: | 6 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 1 |
| Drug Prices: | Drug price information for NEXLIZET |
| What excipients (inactive ingredients) are in NEXLIZET? | NEXLIZET excipients list |
| DailyMed Link: | NEXLIZET at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for NEXLIZET
*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.
Recent Clinical Trials for NEXLIZET
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Kaiser Permanente | Phase 4 |
| Esperion Therapeutics, Inc. | Phase 4 |
Pharmacology for NEXLIZET
| Drug Class | Adenosine Triphosphate-Citrate Lyase Inhibitor Dietary Cholesterol Absorption Inhibitor |
| Mechanism of Action | Adenosine Triphosphate-Citrate Lyase Inhibitors |
| Physiological Effect | Decreased Cholesterol Absorption |
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 eight US patents and three FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of NEXLIZET is ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting NEXLIZET
Fixed dose combinations and formulations comprising ETC1002 and ezetimibe and methods of treating or reducing the risk of cardiovascular disease
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: A METHOD OF LOWERING LDL-C OR REDUCING THE RISK OF CARDIOVASCULAR DISEASE IN PATIENTS WITH FAMILIAL HYPERCHOLESTEROLEMIA USING A FIXED-DOSE COMBINATION OF 180 MG BEMPEDOIC ACID AND 10 MG EZETIMIBE
Fixed dose combinations and formulations comprising ETC1002 and ezetimibe and methods of treating or reducing the risk of cardiovascular disease
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: A METHOD OF TREATING HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA OR ESTABLISHED ATHEROSCLEROTIC CARDIOVASCULAR DISEASE BY DECREASING THE LEVEL OF LDL-C USING A FIXED DOSE COMBINATION OF 180 MG BEMPEDOIC ACID AND 10 MG EZETIMIBE
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: A METHOD OF LOWERING LDL-C OR REDUCING THE RISK OF CARDIOVASCULAR DISEASE IN PATIENTS WITH FAMILIAL HYPERCHOLESTEROLEMIA USING 180 MG BEMPEDOIC ACID AND 10 MG EZETIMIBE
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: A METHOD OF TREATING HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA OR ESTABLISHED ATHEROSCLEROTIC CARDIOVASCULAR DISEASE BY DECREASING THE LEVEL OF LDL-C USING 180 MG BEMPEDOIC ACID AND 10 MG EZETIMIBE
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: A METHOD OF LOWERING LOW-DENSITY LIPOPROTEIN CHOLESTEROL (LDL-C) IN A HUMAN PATIENT IN NEED THEREOF COMPRISING ADMINISTRATION OF BEMPEDOIC ACID ALONE OR IN COMBINATION WITH OTHER LIPID LOWERING THERAPIES
Hydroxyl compounds and compositions for cholesterol management and related uses
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
FDA Regulatory Exclusivity protecting NEXLIZET
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up
TO REDUCE THE RISK OF MYOCARDIAL INFARCTION AND CORONARY REVASCULARIZATION IN ADULTS WHO ARE UNABLE TO TAKE RECOMMENDED STATIN THERAPY (INCLUDING THOSE NOT TAKING A STATIN) WITH ESTABLISHED CARDIOVASCULAR DISEASE (CVD), OR AT HIGH RISK FOR A CVD EVENT BUT WITHOUT ESTABLISHED CVD
Exclusivity Expiration: ⤷ Sign Up
EXPANDED INDICATION FOR USE AS AN ADJUNCT TO DIET, ALONE OR IN COMBINATION WITH OTHER LDL-C LOWERING THERAPIES, TO REDUCE LDL-C IN ADULTS WITH PRIMARY HYPERLIPIDEMIA, INCLUDING HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (HEFH)
Exclusivity Expiration: ⤷ Sign Up
| 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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Esperion Theraps Inc | NEXLIZET | bempedoic acid; ezetimibe | TABLET;ORAL | 211617-001 | Feb 26, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Esperion Theraps Inc | NEXLIZET | bempedoic acid; ezetimibe | TABLET;ORAL | 211617-001 | Feb 26, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Esperion Theraps Inc | NEXLIZET | bempedoic acid; ezetimibe | TABLET;ORAL | 211617-001 | Feb 26, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Esperion Theraps Inc | NEXLIZET | bempedoic acid; ezetimibe | TABLET;ORAL | 211617-001 | Feb 26, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Esperion Theraps Inc | NEXLIZET | bempedoic acid; ezetimibe | TABLET;ORAL | 211617-001 | Feb 26, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Esperion Theraps Inc | NEXLIZET | bempedoic acid; ezetimibe | TABLET;ORAL | 211617-001 | Feb 26, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for NEXLIZET
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Esperion Theraps Inc | NEXLIZET | bempedoic acid; ezetimibe | TABLET;ORAL | 211617-001 | Feb 26, 2020 | ⤷ Sign Up | ⤷ Sign Up |
| Esperion Theraps Inc | NEXLIZET | bempedoic acid; ezetimibe | TABLET;ORAL | 211617-001 | Feb 26, 2020 | ⤷ Sign Up | ⤷ Sign Up |
| Esperion Theraps Inc | NEXLIZET | bempedoic acid; ezetimibe | TABLET;ORAL | 211617-001 | Feb 26, 2020 | ⤷ Sign Up | ⤷ Sign Up |
| Esperion Theraps Inc | NEXLIZET | bempedoic acid; ezetimibe | TABLET;ORAL | 211617-001 | Feb 26, 2020 | ⤷ Sign Up | ⤷ Sign Up |
| Esperion Theraps Inc | NEXLIZET | bempedoic acid; ezetimibe | TABLET;ORAL | 211617-001 | Feb 26, 2020 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for NEXLIZET
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Daiichi Sankyo Europe GmbH | Nustendi | bempedoic acid, ezetimibe | EMEA/H/C/004959 Nustendi is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:in combination with a statin in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin in addition to ezetimibealone in patients who are either statin-intolerant or for whom a statin is contraindicated, and are unable to reach LDL-C goals with ezetimibe alone,in patients already being treated with the combination of bempedoic acid and ezetimibe as separate tablets with or without statin |
Authorised | no | no | no | 2020-03-27 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for NEXLIZET
See the table below for patents covering NEXLIZET around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| China | 112437765 | 贝派地酸的盐形式及其使用方法 (SALT FORMS OF BEMPEDOIC ACID AND METHODS FOR USING THE SAME) | ⤷ Sign Up |
| Spain | 2642216 | ⤷ Sign Up | |
| Japan | 2012097105 | HYDROXYL COMPOUND AND COMPOSITION FOR CHOLESTEROL MANAGEMENT AND RELATED USE | ⤷ Sign Up |
| World Intellectual Property Organization (WIPO) | 2020257571 | ⤷ Sign Up | |
| Spain | 2625429 | ⤷ Sign Up | |
| European Patent Office | 3267989 | COMBINAISONS ET FORMULATIONS DE DOSES FIXES COMPRENANT ETC1002 ET ÉZÉTIMIBE, ET PROCÉDÉS DE TRAITEMENT OU DE RÉDUCTION DU RISQUE DE MALADIE CARDIO-VASCULAIRE (FIXED DOSE COMBINATIONS AND FORMULATIONS COMPRISING ETC1002 AND EZETIMIBE AND METHODS OF TREATING OR REDUCING THE RISK OF CARDIOVASCULAR DISEASE) | ⤷ Sign Up |
| Canada | 3144371 | PROCEDES DE PREPARATION D'ACIDE BEMPEDOIQUE ET COMPOSITIONS DE CELUI-CI (METHODS OF MAKING BEMPEDOIC ACID AND COMPOSITIONS OF THE SAME) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for NEXLIZET
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2404890 | SPC/GB20/047 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: BEMPEDOIC ACID, OR A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE, SOLVATE, OR MIXTURE THEREOF; REGISTERED: UK PLGB 08265/0039 20200331; UK EU/1/20/1424(FOR NI) 20200331 |
| 2404890 | LUC00174 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: BEMPEDOIC ACID, OR A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE, SOLVATE, OR MIXTURE THEREOF; AUTHORISATION NUMBER AND DATE: EU/1/20/1424 20200331 |
| 2404890 | CA 2020 00041 | Denmark | ⤷ Sign Up | PRODUCT NAME: BEMPEDOINSYRE ELLER ET/EN FARMACEUTISK ACCEPTABEL(T) SALT, HYDRAT, SOLVAT ELLER BLANDING DERAF; REG. NO/DATE: EU/1/20/1424 20200331 |
| 2404890 | 122020000048 | Germany | ⤷ Sign Up | 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 | ⤷ Sign Up | PRODUCT NAME: BEMPEEDHAPE;REG NO/DATE: EU/1/20/1424 31.03.2020 |
| 2404890 | 640 | Finland | ⤷ Sign Up | |
| 2404890 | C 2020 031 | Romania | ⤷ Sign Up | 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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. 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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