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GLYXAMBI Drug Profile

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When do Glyxambi patents expire, and what generic alternatives are available?

Glyxambi is a drug marketed by Boehringer Ingelheim and is included in one NDA. There are thirteen patents protecting this drug and one Paragraph IV challenge.

This drug has four hundred and twenty-three patent family members in forty-six countries.

The generic ingredient in GLYXAMBI is empagliflozin; linagliptin. There are twenty-one drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the empagliflozin; linagliptin profile page.

Summary for GLYXAMBI

International Patents:	423
US Patents:	13
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	1
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for GLYXAMBI
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for GLYXAMBI
DailyMed Link:	GLYXAMBI at DailyMed

Generic Entry Opportunity Date for GLYXAMBI

NDA:

206073

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 GLYXAMBI

Drug Class	Sodium-Glucose Cotransporter 2 Inhibitor Dipeptidyl Peptidase 4 Inhibitor
Mechanism of Action	Sodium-Glucose Transporter 2 Inhibitors Dipeptidyl Peptidase 4 Inhibitors

US Patents and Regulatory Information for GLYXAMBI

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Boehringer Ingelheim	GLYXAMBI	empagliflozin; linagliptin	TABLET;ORAL	206073-002	Jan 30, 2015		RX	Yes	Yes
Boehringer Ingelheim	GLYXAMBI	empagliflozin; linagliptin	TABLET;ORAL	206073-002	Jan 30, 2015		RX	Yes	Yes				Y
Boehringer Ingelheim	GLYXAMBI	empagliflozin; linagliptin	TABLET;ORAL	206073-002	Jan 30, 2015		RX	Yes	Yes
Boehringer Ingelheim	GLYXAMBI	empagliflozin; linagliptin	TABLET;ORAL	206073-002	Jan 30, 2015		RX	Yes	Yes			Y	Y
Boehringer Ingelheim	GLYXAMBI	empagliflozin; linagliptin	TABLET;ORAL	206073-001	Jan 30, 2015		RX	Yes	No			Y
Boehringer Ingelheim	GLYXAMBI	empagliflozin; linagliptin	TABLET;ORAL	206073-002	Jan 30, 2015		RX	Yes	Yes			Y

Expired US Patents for GLYXAMBI

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	GLYXAMBI	empagliflozin; linagliptin	TABLET;ORAL	206073-001	Jan 30, 2015
Boehringer Ingelheim	GLYXAMBI	empagliflozin; linagliptin	TABLET;ORAL	206073-002	Jan 30, 2015

Paragraph IV (Patent) Challenges for GLYXAMBI

Drugname	Dosage	Strength	RLD	Date
	Tablets	10 mg/5 mg and 25 mg/5 mg

International Patents for GLYXAMBI

Country	Document Number	Estimated Expiration
Croatia	P20140373
New Zealand	609765
Eurasian Patent Organization	201000321
Denmark	1888552
Eurasian Patent Organization	012163
Philippines	12013501791

Supplementary Protection Certificates for GLYXAMBI

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C0052	France		PRODUCT NAME: LINAGLIPTINE SES ENANTIOMERES ET SELS; REGISTRATION NO/DATE: EU/1/11/707/001 20110824
00569	Netherlands		PRODUCT NAME: LINAGLIPTINE, DESGEWENST IN DE VORM VAN EEN ZOUT, IN COMBINATIE MET METFORMINEHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/12/780/001-028 20120720
2011013,C1532149	Lithuania		PRODUCT NAME: LINAGLIPTINUM; REGISTRATION NO/DATE: EU/1/11/707/001, 2011-08-24 EU/1/11/707/002, 2011-08-24 EU/1/11/707/003, 2011-08-24 EU/1/11/707/004, 2011-08-24 EU/1/11/707/005, 2011-08-24 EU/1/11/707/006, 2011-08-24 EU/1/11/707/007, 2011-08-24 EU/1/11/707/008, 2011-08-24 EU/1/11/707/00 2011082
2011 00030	Denmark
2012022	Lithuania		PRODUCT NAME: LINAGLIPTINUM + METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/12/780/001 - EU/1/12/780/034 20120720
889	Luxembourg		91889, EXPIRES: 20260824