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 eight patents protecting this drug.
This drug has sixty-seven 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 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: | 67 |
| US Patents: | 8 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 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 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 |
Anatomical Therapeutic Chemical (ATC) Classes for NEXLIZET
US Patents and Regulatory Information for NEXLIZET
NEXLIZET is protected by eight US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of NEXLIZET is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a 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.
Patents protecting NEXLIZET
Hydroxyl compounds and compositions for cholesterol management and related uses
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: USE OF NEXLIZET AS AN ADJUNCT TO DIET AND MAXIMALLY TOLERATED STATIN THERAPY TO LOWER LDL-C IN ADULTS WITH HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA OR ESTABLISHED ATHEROSCLEROTIC CARDIOVASCULAR DISEASE
Fixed dose combinations and formulations comprising ETC1002 and ezetimibe and methods of treating or reducing the risk of cardiovascular disease
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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
Hydroxyl compounds and compositions for cholesterol management and related uses
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: USE OF NEXLIZET AS AN ADJUNCT TO DIET AND MAXIMALLY TOLERATED STATIN THERAPY TO LOWER LDL-C IN ADULTS WITH HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA OR ESTABLISHED ATHEROSCLEROTIC CARDIOVASCULAR DISEASE
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Hydroxyl compounds and compositions for cholesterol management and related uses
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Hydroxyl compounds and compositions for cholesterol management and related uses
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: USE OF NEXLIZET AS AN ADJUNCT TO DIET AND MAXIMALLY TOLERATED STATIN THERAPY TO LOWER LDL-C IN ADULTS WITH HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA OR ESTABLISHED ATHEROSCLEROTIC CARDIOVASCULAR DISEASE
Hydroxyl compounds and compositions for cholesterol management and related uses
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: USE OF NEXLIZET AS AN ADJUNCT TO DIET AND MAXIMALLY TOLERATED STATIN THERAPY TO LOWER LDL-C IN ADULTS WITH HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA OR ESTABLISHED ATHEROSCLEROTIC CARDIOVASCULAR DISEASE
Hydroxyl compounds and compositions for cholesterol management and related uses
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: USE OF NEXLIZET AS AN ADJUNCT TO DIET AND MAXIMALLY TOLERATED STATIN THERAPY FOR INHIBITING CHOLESTEROL SYNTHESIS TO LOWER LDL-C IN ADULTS WITH HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA OR ESTABLISHED ATHEROSCLEROTIC CARDIOVASCULAR DISEASE
FDA Regulatory Exclusivity protecting NEXLIZET
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Try a Trial
NEW PRODUCT
Exclusivity Expiration: ⤷ Try a Trial
| 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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Esperion Theraps Inc | NEXLIZET | bempedoic acid; ezetimibe | TABLET;ORAL | 211617-001 | Feb 26, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Esperion Theraps Inc | NEXLIZET | bempedoic acid; ezetimibe | TABLET;ORAL | 211617-001 | Feb 26, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Esperion Theraps Inc | NEXLIZET | bempedoic acid; ezetimibe | TABLET;ORAL | 211617-001 | Feb 26, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Esperion Theraps Inc | NEXLIZET | bempedoic acid; ezetimibe | TABLET;ORAL | 211617-001 | Feb 26, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity 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 |
|---|---|---|---|
| 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) | ⤷ Try a Trial |
| Brazil | 112021025928 | Métodos de preparação de ácido bempedoico e composições do mesmo | ⤷ Try a Trial |
| European Patent Office | 1597223 | COMPOSES HYDROXYLES ET COMPOSITIONS DE REGULATION DU CHOLESTEROL ET UTILISATIONS ASSOCIEES (HYDROXYL COMPOUNDS AND COMPOSITIONS FOR CHOLESTEROL MANAGEMENT AND RELATED USES) | ⤷ Try a Trial |
| China | 115429784 | 制备贝派地酸及其组合物的方法 (Method for preparing bepiridic acid and composition thereof) | ⤷ Try a Trial |
| Russian Federation | 2766085 | ФИКСИРОВАННЫЕ КОМБИНАЦИИ И СОСТАВЫ, СОДЕРЖАЩИЕ ЕТС1002 И ЭЗЕТИМИБ, И СПОСОБЫ ЛЕЧЕНИЯ ИЛИ УМЕНЬШЕНИЯ РИСКА РАЗВИТИЯ СЕРДЕЧНО-СОСУДИСТОГО ЗАБОЛЕВАНИЯ (FIXED COMBINATIONS AND COMPOUNDS CONTAINING ETC-1002 AND EZETIMIBE, AND METHOD FOR TREATING OR REDUCING THE RISK OF DEVELOPING A CARDIOVASCULAR DISEASE) | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for NEXLIZET
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2404890 | 38/2020 | Austria | ⤷ Try a Trial | PRODUCT NAME: BEMPEDOINSAEURE ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ, HYDRAT, SOLVAT ODER EIN GEMISCH DAVON; REGISTRATION NO/DATE: EU/1/20/1424 (MITTEILUNG) 20200331 |
| 2404890 | 2090035-3 | Sweden | ⤷ Try a Trial | PRODUCT NAME: BEMPEDOIC ACID, OR A PHARMACEUTICALLY ACCEPTABLE SALT,HYDRATE,SOLVATE OR MIXTURE THEREOF; REG. NO/DATE: EU/1/20/1424 20200331 |
| 2404890 | C202030044 | Spain | ⤷ Try a 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 | LUC00174 | Luxembourg | ⤷ Try a 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 | 132020000000112 | Italy | ⤷ Try a 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 |
| >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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