NEXLIZET Drug Patent 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 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
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.
Recent Clinical Trials for NEXLIZET
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Esperion Therapeutics, Inc. | Phase 4 |
Kaiser Permanente | 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
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 |
---|---|---|---|
Australia | 2016233485 | Fixed dose combinations and formulations comprising ETC1002 and Ezetimibe and methods of treating or reducing the risk of cardiovascular disease | ⤷ Sign Up |
World Intellectual Property Organization (WIPO) | 2004067489 | ⤷ Sign Up | |
Japan | 2022537049 | ベンペド酸の製造方法及びその組成物 | ⤷ Sign Up |
Morocco | 42616 | COMBINAISONS ET FORMULATIONS DE DOSES FIXES COMPRENANT ETC1002 ET ÉZÉTIMIBE, ET PROCÉDÉS DE TRAITEMENT OU DE RÉDUCTION DU RISQUE DE MALADIE CARDIO-VASCULAIRE | ⤷ Sign Up |
Canada | 2978204 | COMBINAISONS ET FORMULATIONS DE DOSES FIXES COMPRENANT ETC1002 ET EZETIMIBE, ET PROCEDES DE TRAITEMENT OU DE REDUCTION 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 |
Japan | 2018507901 | ETC1002及びエゼチミブを含む固定用量配合剤及び製剤並びに心血管疾患を処置するか又は心血管疾患のリスクを低減させる方法 | ⤷ 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 | C02404890/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: BEMPEDOINSAEURE; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67583 14.12.2020 |
2404890 | 2020C/534 | Belgium | ⤷ Sign Up | 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 | 38/2020 | Austria | ⤷ Sign Up | PRODUCT NAME: BEMPEDOINSAEURE ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ, HYDRAT, SOLVAT ODER EIN GEMISCH DAVON; REGISTRATION NO/DATE: EU/1/20/1424 (MITTEILUNG) 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 | 2090035-3 | Sweden | ⤷ Sign Up | PRODUCT NAME: BEMPEDOIC ACID, OR A PHARMACEUTICALLY ACCEPTABLE SALT,HYDRATE,SOLVATE OR MIXTURE THEREOF; REG. NO/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 | C202030044 | Spain | ⤷ Sign Up | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |