SEGLUROMET Drug Patent Profile

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

Summary for SEGLUROMET

International Patents:	85
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for SEGLUROMET
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SEGLUROMET
What excipients (inactive ingredients) are in SEGLUROMET?	SEGLUROMET excipients list
DailyMed Link:	SEGLUROMET at DailyMed

See drug prices for SEGLUROMET

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for SEGLUROMET

NDA:

209806

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 Class

Biguanide

Anatomical Therapeutic Chemical (ATC) Classes for SEGLUROMET

A10BA	Biguanides
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

A10BK	Sodium-glucose co-transporter 2 (SGLT2) inhibitors
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

US Patents and Regulatory Information for SEGLUROMET

SEGLUROMET is protected by three US patents and two FDA Regulatory Exclusivities.

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

FDA Regulatory Exclusivity protecting SEGLUROMET

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
Msd Sub Merck	SEGLUROMET	ertugliflozin; metformin hydrochloride	TABLET;ORAL	209806-003	Dec 19, 2017		RX	Yes	No			Y
Msd Sub Merck	SEGLUROMET	ertugliflozin; metformin hydrochloride	TABLET;ORAL	209806-001	Dec 19, 2017		RX	Yes	No			Y	Y
Msd Sub Merck	SEGLUROMET	ertugliflozin; metformin hydrochloride	TABLET;ORAL	209806-002	Dec 19, 2017		RX	Yes	No
Msd Sub Merck	SEGLUROMET	ertugliflozin; metformin hydrochloride	TABLET;ORAL	209806-004	Dec 19, 2017		RX	Yes	Yes
Msd Sub Merck	SEGLUROMET	ertugliflozin; metformin hydrochloride	TABLET;ORAL	209806-003	Dec 19, 2017		RX	Yes	No
Msd Sub Merck	SEGLUROMET	ertugliflozin; metformin hydrochloride	TABLET;ORAL	209806-001	Dec 19, 2017		RX	Yes	No			Y

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

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)

Australia

Canada

Costa Rica

Croatia

Cyprus

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Georgia, Republic of

Japan

Montenegro

New Zealand

Poland

Portugal

Serbia

Slovenia

South Africa

South Korea

Spain

Ukraine

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-)
Japan	2012500842
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.
Cuba	24003	DERIVADOS DE DIOXA-BICICLO(3.2.1)OCTANO-2,3,4-TRIOL
South Korea	20110045093
Colombia	6341636	DERIVADOS DE DIOXA-BICICLO[3.2.1]OCTANO-2,3,4-TRIOL
Australia	2009286380	Dioxa-bicyclo(3.2.1.)octane-2,3,4-triol derivatives

Supplementary Protection Certificates for SEGLUROMET

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2334687	CR 2018 00025	Denmark		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		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		PRODUCT NAME: ERTUGLIFLOZIN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/18/1267 20180323
2334687	2018C/027	Belgium		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
2334687	132018000000441	Italy		PRODUCT NAME: ERTUGLIFLOZIN(STEGLATRO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1267, 20180323
2334687	C20180023 00266	Estonia		PRODUCT NAME: ERTUGLIFLOSIIN;REG NO/DATE: EU/1/18/1267 23.03.2018