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Last Updated: January 21, 2021

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SEGLUROMET Drug Profile

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Which patents cover Segluromet, and what generic alternatives are available?

Segluromet is a drug marketed by Merck Sharp Dohme and is included in one NDA. There are three patents protecting this drug.

This drug has eighty-four patent family members in forty-eight countries.

The generic ingredient in SEGLUROMET is ertugliflozin; metformin hydrochloride. Additional details are available on the ertugliflozin; metformin hydrochloride profile page.

US ANDA Litigation and Generic Entry Outlook for Segluromet

Segluromet will be eligible for patent challenges on December 19, 2021. 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 October 21, 2030. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for SEGLUROMET
International Patents:84
US Patents:3
Applicants:1
NDAs:1
Formulation / Manufacturing:see details
Drug Prices: Drug price information for SEGLUROMET
DailyMed Link:SEGLUROMET at DailyMed
Drug patent expirations by year for SEGLUROMET
Drug Prices for SEGLUROMET

See drug prices for SEGLUROMET

Generic Entry Opportunity Date for SEGLUROMET
Generic Entry Date for SEGLUROMET*:
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.

US Patents and Regulatory Information for SEGLUROMET

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 209806-002 Dec 19, 2017 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Merck Sharp Dohme SEGLUROMET ertugliflozin; metformin hydrochloride TABLET;ORAL 209806-001 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   Start Trial
Merck Sharp Dohme SEGLUROMET ertugliflozin; metformin hydrochloride TABLET;ORAL 209806-001 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
>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 SEGLUROMET

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 C201830047 Spain   Start Trial PRODUCT NAME: ERTUGLIFLOZINA, OPICIONALMENTE EN FORMA CRISTALINA, PARTICULARMENTE COMO UN CO-CRISTAL CON ACIDO L-PIROGLUTAMICO, Y ESPECIFICAMENTE COMO ACIDO L-PIROGLUTAMICO DE ERTUGLIFLOZINA; NATIONAL AUTHORISATION NUMBER: EU/1/18/1267; DATE OF AUTHORISATION: 20180321; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1267; DATE OF FIRST AUTHORISATION IN EEA: 20180321
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 2018/028 Ireland   Start Trial PRODUCT NAME: ERTUGLIFLOZIN, OPTIONALLY AS A CRYSTAL FORM, PARTICULARLY AS A CO-CRYSTAL WITH L-PYROGLUTAMIC ACID, AND SPECIFICALLY AS ERTUGLIFLOZIN L-PYROGLUTAMIC ACID; REGISTRATION NO/DATE: EU/1/18/1267/001 EU/1/18/1267/012 20180321
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
2334687 2018C/027 Belgium   Start Trial PRODUCT NAME: ERTUGLIFLOZINE, DESGEWENST IN KRISTALVORM, MET NAME ALS CO-KRISTAL MET L-PYROGLUTAMINEZUUR, EN SPECIFIEK ALS ERTUGLIFLOZIN L-PYROGLUTAMINE ZUUR; AUTHORISATION NUMBER AND DATE: EU/1/18/1267 20180323
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Merck
McKesson
Express Scripts

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.