Bempedoic acid; ezetimibe - Generic Drug Details
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What are the generic sources for bempedoic acid; ezetimibe and what is the scope of freedom to operate?
Bempedoic acid; ezetimibe
is the generic ingredient in one branded drug marketed by Esperion Theraps Inc and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.Bempedoic acid; ezetimibe has seventy-one patent family members in twenty-three countries.
One supplier is listed for this compound.
Summary for bempedoic acid; ezetimibe
International Patents: | 71 |
US Patents: | 6 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Clinical Trials: | 6 |
DailyMed Link: | bempedoic acid; ezetimibe at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for bempedoic acid; ezetimibe
Generic Entry Date for bempedoic acid; ezetimibe*:
Constraining patent/regulatory exclusivity:
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 bempedoic acid; ezetimibe
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Diabetes & Endocrinology Foundation | N/A |
Medanta, The Medicity, India | N/A |
Esperion Therapeutics, Inc. | Phase 4 |
Pharmacology for bempedoic acid; ezetimibe
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 bempedoic acid; ezetimibe
Paragraph IV (Patent) Challenges for BEMPEDOIC ACID; EZETIMIBE
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 bempedoic acid; ezetimibe
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 | 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 | ⤷ 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 bempedoic acid; ezetimibe
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 bempedoic acid; ezetimibe
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 bempedoic acid; ezetimibe
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Brazil | 112017019358 | combinações e formulações de dose fixa compreendendo etc1002 e ezetimiba e métodos de tratamento ou redução do risco de doença cardiovascular | ⤷ Sign Up |
Russian Federation | 2022102472 | ФИКСИРОВАННЫЕ КОМБИНАЦИИ И СОСТАВЫ, СОДЕРЖАЩИЕ ETC-1002 И ЭЗЕТИМИБ, И СПОСОБЫ ЛЕЧЕНИЯ ИЛИ УМЕНЬШЕНИЯ РИСКА РАЗВИТИЯ СЕРДЕЧНО-СОСУДИСТОГО ЗАБОЛЕВАНИЯ | ⤷ Sign Up |
China | 112437766 | 制备贝派地酸及其组合物的方法 (METHODS OF MAKING BEMPEDOIC ACID AND COMPOSITIONS OF THE SAME) | ⤷ Sign Up |
China | 107530307 | 包含ETC1002和依泽替米贝的固定剂量组合和制剂以及治疗心血管疾病或降低心血管疾病风险的方法 (Fixed dose combinations and formulations comprising etc1002 and ezetimibe and methods of treating or reducing the risk of cardiovascular disease) | ⤷ Sign Up |
Spain | 2625429 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for bempedoic acid; ezetimibe
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
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 | C02404890/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: BEMPEDOINSAEURE; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67583 14.12.2020 |
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 | 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 | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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