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Last Updated: November 24, 2020

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Ertugliflozin; metformin hydrochloride - Generic Drug Details

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What are the generic sources for ertugliflozin; metformin hydrochloride and what is the scope of freedom to operate?

Ertugliflozin; metformin hydrochloride is the generic ingredient in one branded drug marketed by Merck Sharp Dohme and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ertugliflozin; metformin hydrochloride has eighty-four patent family members in forty-eight countries.

One supplier is listed for this compound.

Summary for ertugliflozin; metformin hydrochloride
International Patents:84
US Patents:3
Tradenames:1
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Clinical Trials: 9
DailyMed Link:ertugliflozin; metformin hydrochloride at DailyMed
Recent Clinical Trials for ertugliflozin; metformin hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Merck Sharp & Dohme Corp.Phase 4
Cedars-Sinai Medical CenterPhase 4
Merck Sharp & Dohme Corp.Phase 3

See all ertugliflozin; metformin hydrochloride clinical trials

Pharmacology for ertugliflozin; metformin hydrochloride
Drug ClassBiguanide

US Patents and Regulatory Information for ertugliflozin; metformin hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck Sharp Dohme SEGLUROMET ertugliflozin; metformin hydrochloride TABLET;ORAL 209806-003 Dec 19, 2017 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Merck Sharp Dohme SEGLUROMET ertugliflozin; metformin hydrochloride TABLET;ORAL 209806-004 Dec 19, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
Merck Sharp Dohme SEGLUROMET ertugliflozin; metformin hydrochloride TABLET;ORAL 209806-003 Dec 19, 2017 RX Yes No   Start Trial   Start Trial   Start Trial
Merck Sharp Dohme SEGLUROMET ertugliflozin; metformin hydrochloride TABLET;ORAL 209806-003 Dec 19, 2017 RX Yes No   Start Trial   Start Trial   Start Trial
Merck Sharp Dohme SEGLUROMET ertugliflozin; metformin hydrochloride TABLET;ORAL 209806-002 Dec 19, 2017 RX Yes No   Start Trial   Start Trial   Start Trial
Merck Sharp Dohme SEGLUROMET ertugliflozin; metformin hydrochloride TABLET;ORAL 209806-004 Dec 19, 2017 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Merck Sharp Dohme SEGLUROMET ertugliflozin; metformin hydrochloride TABLET;ORAL 209806-001 Dec 19, 2017 RX Yes No   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for ertugliflozin; metformin hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2334687 132018000000441 Italy   Start Trial PRODUCT NAME: ERTUGLIFLOZIN(STEGLATRO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1267, 20180323
2334687 1890026-6 Sweden   Start Trial PRODUCT NAME: ERTUGLIFLOZIN,OPTIONALLY IN THE FORM OF ERTUGLIFOZIN L- PYROGLUTAMIC ACID; REG. NO/DATE: EU/1/18/1267 20180323
2334687 C02334687/01 Switzerland   Start Trial PRODUCT NAME: ERTUGLIFLOZIN; REGISTRATION NO/DATE: SWISSMEDIC AUTHORISATION 66577 18.10.2018
2334687 18C1036 France   Start Trial PRODUCT NAME: ERTUGLIFLOZINE,OPTIONNELLEMENT SOUS FORME CRISTALLINE,EN PARTICULIER EN TANT QUE CO-CRISTAL AVEC L'ACIDE L-PYROGLUTANIQUE,ET PARTICULIEREMENT ERTUGLIFOZINE ACIDE L-PYROGLUTANIQUE.; REGISTRATION NO/DATE: EU/1/18/1267 20180323
2334687 122018000070 Germany   Start Trial PRODUCT NAME: ERTUGLIFLOZIN, EINSCHLIESSLICH KRISTALL UMFASSEND ERTUGLIFLOZIN UND ERTUGLIFLOZIN UND L-PYROGLUTAMINSAEURE ALS CO-KRISTALL; REGISTRATION NO/DATE: EU/1/18/1267 20180321
2334687 CR 2018 00025 Denmark   Start Trial PRODUCT NAME: ERTUGLIFLOZIN, EVENTUELT SOM EN KRYSTALFORM, SAERLIGT SOM ET CO-KRYSTAL MED L-PYROGLUTAMINSYRE OG SPECIFIKT SOM ERTUGLIFLOZIN-L-PYROGLUTAMINSYRE; NAT. REG. NO/DATE: EU/1/18/1267/001-012 20180323; FIRST REG. NO/DATE: EU EU/1/18/1267/001/012 20180323
2334687 30/2018 Austria   Start Trial PRODUCT NAME: ERTUGLIFLOZIN, GEGEBENENFALLS ALS KRISTALLFORM, INSBESONDERE ALS CO-KRISTALL MIT L-PYROGLUTAMINSAEURE, UND INSBESONDERE ALS ERTUGLIFLOZIN L-PYROGLUTAMINSAEURE; REGISTRATION NO/DATE: EU/1/18/1267 (MITTEILUNG) 20180323
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Baxter
Boehringer Ingelheim
Mallinckrodt
Dow
Johnson and Johnson
AstraZeneca

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