Ertugliflozin; metformin hydrochloride - Generic Drug Details

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 Msd Sub Merck 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-six patent family members in forty-nine countries.

One supplier is listed for this compound.

Summary for ertugliflozin; metformin hydrochloride

International Patents:	86
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	9
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ertugliflozin; metformin hydrochloride
DailyMed Link:	ertugliflozin; metformin hydrochloride at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ertugliflozin; metformin hydrochloride

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.

Recent Clinical Trials for ertugliflozin; metformin hydrochloride

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

Sponsor	Phase
Cedars-Sinai Medical Center	Phase 4
Merck Sharp & Dohme Corp.	Phase 4
Merck Sharp & Dohme Corp.	Phase 3

See all ertugliflozin; metformin hydrochloride clinical trials

Pharmacology for ertugliflozin; metformin hydrochloride

Drug Class

Biguanide

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

EU/EMA Drug Approvals for ertugliflozin; metformin hydrochloride

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

International Patents for ertugliflozin; metformin hydrochloride

Country	Patent Number	Title	Estimated Expiration
Japan	2013509393
Honduras	2009001652	DERIVADOS DE DIOXA- BICICLO [3.2.1] OCTANO -2,3,4-TRIOL
Poland	2334687
Portugal	2496583
Norway	2018019
Slovenia	2334687

Supplementary Protection Certificates for ertugliflozin; metformin hydrochloride

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	PA2018510	Lithuania		PRODUCT NAME: ERTUGLIFLOZINAS, PASIRINKTINAI KAIP KRISTALINE FORMA, YPAC KAIP KO-KRISTALAS SU L-PIROGLUTAMO RUGSTIMI, IR YPAC KAIP ERTUGLIFLOZINO L-PIROGLUTAMO RUGSTIS; REGISTRATION NO/DATE: EU/1/18/1267 20180321
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	122018000070	Germany		PRODUCT NAME: ERTUGLIFLOZIN, EINSCHLIESSLICH KRISTALL UMFASSEND ERTUGLIFLOZIN UND ERTUGLIFLOZIN UND L-PYROGLUTAMINSAEURE ALS CO-KRISTALL; REGISTRATION NO/DATE: EU/1/18/1267 20180321
2334687	392 18-2018	Slovakia		PRODUCT NAME: ERTUGLIFLOZIN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/18/1267 20180323
2334687	LUC00079	Luxembourg		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