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SEGLUROMET Drug Profile

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

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

This drug has eighty-four patent family members in forty-eight countries.

The generic ingredient in SEGLUROMET is ertugliflozin; metformin hydrochloride. Additional details are available on the ertugliflozin; metformin hydrochloride profile page.

US ANDA Litigation and Generic Entry Outlook for Segluromet

Segluromet will be eligible for patent challenges on December 19, 2021. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

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.

Indicators of Generic Entry

Summary for SEGLUROMET

International Patents:	84
US Patents:	3
Applicants:	1
NDAs:	1
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for SEGLUROMET
DailyMed Link:	SEGLUROMET at DailyMed

See drug prices for SEGLUROMET

Generic Entry Opportunity 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.

US Patents and Regulatory Information for SEGLUROMET

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Merck Sharp Dohme	SEGLUROMET	ertugliflozin; metformin hydrochloride	TABLET;ORAL	209806-002	Dec 19, 2017		RX	Yes	No			Y	Y
Merck Sharp Dohme	SEGLUROMET	ertugliflozin; metformin hydrochloride	TABLET;ORAL	209806-001	Dec 19, 2017		RX	Yes	No
Merck Sharp Dohme	SEGLUROMET	ertugliflozin; metformin hydrochloride	TABLET;ORAL	209806-002	Dec 19, 2017		RX	Yes	No
Merck Sharp Dohme	SEGLUROMET	ertugliflozin; metformin hydrochloride	TABLET;ORAL	209806-004	Dec 19, 2017		RX	Yes	Yes
Merck Sharp Dohme	SEGLUROMET	ertugliflozin; metformin hydrochloride	TABLET;ORAL	209806-001	Dec 19, 2017		RX	Yes	No
Merck Sharp Dohme	SEGLUROMET	ertugliflozin; metformin hydrochloride	TABLET;ORAL	209806-003	Dec 19, 2017		RX	Yes	No

International Patents for SEGLUROMET

Country	Patent Number	Estimated Expiration
Cuba	24003
Eurasian Patent Organization	201290267
China	102149717
Nicaragua	201100043
Ukraine	103416
Norway	2018019

Supplementary Protection Certificates for SEGLUROMET

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	C201830047	Spain		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	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	2018/028	Ireland		PRODUCT NAME: ERTUGLIFLOZIN, OPTIONALLY AS A CRYSTAL FORM, PARTICULARLY AS A CO-CRYSTAL WITH L-PYROGLUTAMIC ACID, AND SPECIFICALLY AS ERTUGLIFLOZIN L-PYROGLUTAMIC ACID; REGISTRATION NO/DATE: EU/1/18/1267/001 EU/1/18/1267/012 20180321
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	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