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Last Updated: June 3, 2023

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-five patent family members in forty-eight countries.

The generic ingredient in SEGLUROMET is ertugliflozin; metformin hydrochloride. Two suppliers are 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

See drug prices for SEGLUROMET

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 two FDA Regulatory Exclusivities.

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

Dioxa-bicyclo[3.2.1]octane-2,3,4-triol derivatives
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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

FDA Regulatory Exclusivity protecting SEGLUROMET

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷  Try a Trial

REVISION TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY, MK-8835-004/B1521021, VERTIS CV
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
Msd Sub Merck SEGLUROMET ertugliflozin; metformin hydrochloride TABLET;ORAL 209806-002 Dec 19, 2017 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Msd Sub Merck SEGLUROMET ertugliflozin; metformin hydrochloride TABLET;ORAL 209806-003 Dec 19, 2017 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Msd Sub Merck SEGLUROMET ertugliflozin; metformin hydrochloride TABLET;ORAL 209806-001 Dec 19, 2017 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Msd Sub Merck SEGLUROMET ertugliflozin; metformin hydrochloride TABLET;ORAL 209806-002 Dec 19, 2017 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Msd Sub Merck SEGLUROMET ertugliflozin; metformin hydrochloride TABLET;ORAL 209806-004 Dec 19, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Msd Sub Merck SEGLUROMET ertugliflozin; metformin hydrochloride TABLET;ORAL 209806-003 Dec 19, 2017 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Msd Sub Merck SEGLUROMET ertugliflozin; metformin hydrochloride TABLET;ORAL 209806-001 Dec 19, 2017 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  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 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 alone, in patients on their maximally tolerated doses of metformin in addition to other medicinal products for the treatment of diabetes, in 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
Estimated Expiration: ⤷  Try a Trial

Australia

Patent: 10310956
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 77857
Estimated Expiration: ⤷  Try a Trial

Costa Rica

Patent: 120289
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0150107
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 15949
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 96583
Estimated Expiration: ⤷  Try a Trial

Ecuador

Patent: 12011946
Estimated Expiration: ⤷  Try a Trial

Eurasian Patent Organization

Patent: 1983
Estimated Expiration: ⤷  Try a Trial

Patent: 1290267
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 96583
Estimated Expiration: ⤷  Try a Trial

Georgia, Republic of

Patent: 0146104
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 96156
Estimated Expiration: ⤷  Try a Trial

Patent: 13509393
Estimated Expiration: ⤷  Try a Trial

Montenegro

Patent: 016
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 9945
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 96583
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 96583
Estimated Expiration: ⤷  Try a Trial

Serbia

Patent: 827
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 96583
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 1203486
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1426180
Estimated Expiration: ⤷  Try a Trial

Patent: 120093321
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 27179
Estimated Expiration: ⤷  Try a Trial

Ukraine

Patent: 3416
Estimated Expiration: ⤷  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.

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

Country Patent Number Title Estimated Expiration
Hong Kong 1193606 二氧雜-雙環 辛烷- -三醇衍生物 (DIOXA-BICYCLO[3.2.1.]OCTANE-2,3,4-TRIOL DERIVATIVES -[321]-234-) ⤷  Try a Trial
Japan 2012500842 ⤷  Try a Trial
Chile 2011000394 Compuestos derivados de 1-hidroximetil-6,8-dioxa-biciclo[3.2.1]octano-2,3,4-triol, inhibidores de sglt2; cocristal que comprende a dicho compuesto y l-prolina o acido l-piroglutamico; composicion farmaceutica que los comprende; utiles para el tratamiento de la obesidad y diabetes de tipo 2. ⤷  Try a Trial
Cuba 24003 DERIVADOS DE DIOXA-BICICLO(3.2.1)OCTANO-2,3,4-TRIOL ⤷  Try a Trial
South Korea 20110045093 ⤷  Try a Trial
Colombia 6341636 DERIVADOS DE DIOXA-BICICLO[3.2.1]OCTANO-2,3,4-TRIOL ⤷  Try a Trial
Australia 2009286380 Dioxa-bicyclo(3.2.1.)octane-2,3,4-triol derivatives ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for SEGLUROMET

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2334687 CR 2018 00025 Denmark ⤷  Try a 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 1890026-6 Sweden ⤷  Try a Trial PRODUCT NAME: ERTUGLIFLOZIN,OPTIONALLY IN THE FORM OF ERTUGLIFOZIN L- PYROGLUTAMIC ACID; REG. NO/DATE: EU/1/18/1267 20180323
2334687 392 18-2018 Slovakia ⤷  Try a Trial PRODUCT NAME: ERTUGLIFLOZIN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/18/1267 20180323
2334687 2018C/027 Belgium ⤷  Try a 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
2334687 716 Finland ⤷  Try a Trial
2334687 132018000000441 Italy ⤷  Try a Trial PRODUCT NAME: ERTUGLIFLOZIN(STEGLATRO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1267, 20180323
2334687 C20180023 00266 Estonia ⤷  Try a Trial PRODUCT NAME: ERTUGLIFLOSIIN;REG NO/DATE: EU/1/18/1267 23.03.2018
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Baxter
McKinsey
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.