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Last Updated: July 13, 2024

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SEGLUROMET Drug Patent Profile


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

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

This drug has eighty-six patent family members in forty-nine countries.

The generic ingredient in SEGLUROMET is ertugliflozin; metformin hydrochloride. One supplier is listed for this compound. Additional details are available on the ertugliflozin; metformin hydrochloride profile page.

DrugPatentWatch® Generic Entry Outlook for Segluromet

Segluromet was eligible for patent challenges on December 19, 2021.

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.

There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for SEGLUROMET
Drug Prices for SEGLUROMET

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DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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.

Pharmacology for SEGLUROMET
Drug ClassBiguanide

US Patents and Regulatory Information for SEGLUROMET

SEGLUROMET is protected by three US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of SEGLUROMET 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 SEGLUROMET

Dioxa-bicyclo[3.2.1]octane-2,3,4-triol derivatives
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES

Dioxa-bicyclo[3.2.1]octane-2,3,4-triol derivatives
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Dioxa-bicyclo[3.2.1]octane-2,3,4-triol derivatives
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES

FDA Regulatory Exclusivity protecting SEGLUROMET

REVISION TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY, MK-8835-004/B1521021, VERTIS CV
Exclusivity Expiration: ⤷  Sign Up

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Msd Sub Merck SEGLUROMET ertugliflozin; metformin hydrochloride TABLET;ORAL 209806-002 Dec 19, 2017 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Msd Sub Merck SEGLUROMET ertugliflozin; metformin hydrochloride TABLET;ORAL 209806-001 Dec 19, 2017 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Msd Sub Merck SEGLUROMET ertugliflozin; metformin hydrochloride TABLET;ORAL 209806-002 Dec 19, 2017 RX Yes No ⤷  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

EU/EMA Drug Approvals for SEGLUROMET

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Merck Sharp & Dohme B.V. Segluromet ertugliflozin, metformin hydrochloride EMEA/H/C/004314
Segluromet is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control:in patients not adequately controlled on their maximally tolerated dose of metformin alonein patients on their maximally tolerated doses of metformin in addition to other medicinal products for the treatment of diabetesin patients already being treated with the combination of ertugliflozin and metformin as separate tablets.
Authorised no no no 2018-03-23
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for SEGLUROMET

When does loss-of-exclusivity occur for SEGLUROMET?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

African Regional IP Organization (ARIPO)

Patent: 99
Patent: Dioxa-bicyclo[3.2.1]octane-2,3,4-triol de derivatives
Estimated Expiration: ⤷  Sign Up

Australia

Patent: 10310956
Patent: Dioxa-bicyclo[3.2.1]octane-2,3,4-triol derivatives
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 77857
Patent: DERIVES DIOXA-BICYCLO[3.2.1]OCTANE-2,3,4-TRIOL (DIOXA-BICYCLO[3.2.1]OCTANE-2,3,4-TRIOL DERIVATIVES)
Estimated Expiration: ⤷  Sign Up

Costa Rica

Patent: 120289
Patent: DERIVADOS DE DIOXA-BICICLO[3.2.1]OCTANO-2,3,4-TRIOL
Estimated Expiration: ⤷  Sign Up

Croatia

Patent: 0150107
Estimated Expiration: ⤷  Sign Up

Cyprus

Patent: 15949
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 96583
Estimated Expiration: ⤷  Sign Up

Ecuador

Patent: 12011946
Patent: DERIVADOS DE DIOXA- BICICLO [3.2.1] OCTANO- 2 ,3,4- TRIOL
Estimated Expiration: ⤷  Sign Up

Eurasian Patent Organization

Patent: 1983
Patent: ПРОИЗВОДНЫЕ ДИОКСАБИЦИКЛО[3.2.1]ОКТАН-2,3,4-ТРИОЛА (DIOXA-BICYCLO[3.2.1]OCTANE-2,3,4-TRIOL DERIVATIVES)
Estimated Expiration: ⤷  Sign Up

Patent: 1290267
Patent: ПРОИЗВОДНЫЕ ДИОКСАБИЦИКЛО[3.2.1]ОКТАН-2,3,4-ТРИОЛА
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 96583
Patent: DERIVES DE DIOXA-BICYCLO[3.2.1]OCTANE-2,3,4-TRIOL (DIOXA-BICYCLO[3.2.1]OCTANE-2,3,4-TRIOL DERIVATIVES)
Estimated Expiration: ⤷  Sign Up

Georgia, Republic of

Patent: 0146104
Patent: DIOXA-BICYCLO[3.2.1]OCTANE-2,3,4-TRIOL DERIVATIVES
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 96156
Estimated Expiration: ⤷  Sign Up

Patent: 13509393
Estimated Expiration: ⤷  Sign Up

Montenegro

Patent: 016
Patent: DERIVATI DIOKSABICIKLO[3.2.1]OKTAN-2,3,4-TRIOLA (DIOXA-BICYCLO[3.2.1]OCTANE-2,3,4-TRIOL DERIVATIVES)
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 9945
Patent: Dioxa-bicyclo[3.2.1]octane-2,3,4-triol derivatives
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 96583
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 96583
Estimated Expiration: ⤷  Sign Up

Serbia

Patent: 827
Patent: DERIVATI DIOKSA-BICIKLO[3.2.1]OKTAN-2,3,4-TRIOLA (DIOXA-BICYCLO[3.2.1]OCTANE-2,3,4-TRIOL DERIVATIVES)
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 96583
Estimated Expiration: ⤷  Sign Up

South Africa

Patent: 1203486
Patent: DIOXA-BICYCLO[3.2.1]OCTANE-2,3,4-TRIOL DERIVATIVES
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 1426180
Estimated Expiration: ⤷  Sign Up

Patent: 120093321
Patent: DIOXA-BICYCLO [3.2.1] OCTANE-2,3,4-TRIOL DERIVATIVES
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 27179
Estimated Expiration: ⤷  Sign Up

Ukraine

Patent: 3416
Patent: ПОХІДНІ ДІОКСАБІЦИКЛО[3.2.1]ОКТАН-2,3,4-ТРІОЛУ[ПРОИЗВОДНЫЕ ДИОКСАБИЦИКЛО[3.2.1]ОКТАН-2,3,4-ТРИОЛА (Normal;heading 1;heading 2;heading 3;DIOXA-BICYCLO[3.2.1]OCTANE-2,3,4-TRIOL DERIVATIVES)
Estimated Expiration: ⤷  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.

See the table below for additional patents covering SEGLUROMET around the world.

Country Patent Number Title Estimated Expiration
Eurasian Patent Organization 018492 ДИОКСАБИЦИКЛО[3.2.1]ОКТАН-2,3,4-ТРИОЛЬНЫЕ ПРОИЗВОДНЫЕ (DIOXA-BICYCLO[3.2.1.]OCTANE-2,3,4-TRIOL DERIVATIVES) ⤷  Sign Up
Montenegro 02016 DERIVATI DIOKSABICIKLO[3.2.1]OKTAN-2,3,4-TRIOLA (DIOXA-BICYCLO[3.2.1]OCTANE-2,3,4-TRIOL DERIVATIVES) ⤷  Sign Up
South Africa 201101341 DIOXA-BICYCLO[3.2.1.]OCTANE-2,3,4-TRIOL DERIVATIVES ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for SEGLUROMET

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2334687 C201830047 Spain ⤷  Sign Up 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 LUC00079 Luxembourg ⤷  Sign Up PRODUCT NAME: ERTUGLIFLOZINE, EVENTUELLEMENT SOUS FORME CRISTALLINE, EN PARTICULIER EN TANT QUE CO-CRISTAL AVEC L'ACIDE L-PYROGLUTAMIQUE, ET PLUS SPECIFIQUEMENT EN TANT QU'ACIDE ERTUGLIFLOZINE L-PYROGLUTAMIQUE; AUTHORISATION NUMBER AND DATE: EU/1/18/1267 20180323
2334687 300943 Netherlands ⤷  Sign Up PRODUCT NAME: ERTUGLIFLOZINE, DESGEWENST IN KRISTALVORM, MET NAME ALS CO-KRISTAL MET L-PYROGLUTAMINEZUUR, MET NAME ERTUGLIFLOZIN L-PYROGLUTAMINE ZUUR; REGISTRATION NO/DATE: EU/1/18/1267 20180323
>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.