ERTUGLIFLOZIN; SITAGLIPTIN PHOSPHATE - Generic Drug Details

What are the generic sources for ertugliflozin; sitagliptin phosphate and what is the scope of patent protection?

Ertugliflozin; sitagliptin phosphate is the generic ingredient in one branded drug marketed by Msd Sub Merck and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ertugliflozin; sitagliptin phosphate has one hundred and thirty-eight patent family members in fifty-two countries.

One supplier is listed for this compound.

Summary for ERTUGLIFLOZIN; SITAGLIPTIN PHOSPHATE

International Patents:	138
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ERTUGLIFLOZIN; SITAGLIPTIN PHOSPHATE
DailyMed Link:	ERTUGLIFLOZIN; SITAGLIPTIN PHOSPHATE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ERTUGLIFLOZIN; SITAGLIPTIN PHOSPHATE

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 ERTUGLIFLOZIN; SITAGLIPTIN PHOSPHATE

Drug Class	Dipeptidyl Peptidase 4 Inhibitor
Mechanism of Action	Dipeptidyl Peptidase 4 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for ERTUGLIFLOZIN; SITAGLIPTIN PHOSPHATE

A10BH	Dipeptidyl peptidase 4 (DPP-4) inhibitors
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 ERTUGLIFLOZIN; SITAGLIPTIN PHOSPHATE

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	STEGLUJAN	ertugliflozin; sitagliptin phosphate	TABLET;ORAL	209805-002	Dec 19, 2017		RX	Yes	Yes
Msd Sub Merck	STEGLUJAN	ertugliflozin; sitagliptin phosphate	TABLET;ORAL	209805-001	Dec 19, 2017		RX	Yes	No			Y
Msd Sub Merck	STEGLUJAN	ertugliflozin; sitagliptin phosphate	TABLET;ORAL	209805-002	Dec 19, 2017		RX	Yes	Yes					Y

Expired US Patents for ERTUGLIFLOZIN; SITAGLIPTIN PHOSPHATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Msd Sub Merck	STEGLUJAN	ertugliflozin; sitagliptin phosphate	TABLET;ORAL	209805-002	Dec 19, 2017
Msd Sub Merck	STEGLUJAN	ertugliflozin; sitagliptin phosphate	TABLET;ORAL	209805-001	Dec 19, 2017
Msd Sub Merck	STEGLUJAN	ertugliflozin; sitagliptin phosphate	TABLET;ORAL	209805-001	Dec 19, 2017

International Patents for ERTUGLIFLOZIN; SITAGLIPTIN PHOSPHATE

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)
Mexico	PA05013931	SAL DE ACIDO FOSFORICO DE UN INHIBIDOR DE LA DIPEPTIDIL PEPTIDASA-IV. (PHOSPHORIC ACID SALT OF A DIPEPTIDYL PEPTIDASE-IV INHIBITOR.)
Lithuania	C2334687

Supplementary Protection Certificates for ERTUGLIFLOZIN; SITAGLIPTIN PHOSPHATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2334687	30/2018	Austria		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	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