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GLYXAMBI Drug Profile

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Which patents cover Glyxambi, 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 forty-six patent family members in forty-six countries.

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

Summary for GLYXAMBI

International Patents:	446
US Patents:	13
Applicants:	1
NDAs:	1
Suppliers / Packagers:	2
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
Prior Art and Litigation Support	Order Prior Art and Litigation support 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

Synonyms for GLYXAMBI

Empagliflozin / Linagliptin

Empagliflozin and Linagliptin

Empagliflozin mixture with Linagliptin

Linagliptin and Empagliflozin

S900006430

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	Y
Boehringer Ingelheim	GLYXAMBI	empagliflozin; linagliptin	TABLET;ORAL	206073-002	Jan 30, 2015		RX	Yes	Yes			Y
Boehringer Ingelheim	GLYXAMBI	empagliflozin; linagliptin	TABLET;ORAL	206073-001	Jan 30, 2015		RX	Yes	No			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	206073-001	Jan 30, 2015
Boehringer Ingelheim	GLYXAMBI	empagliflozin; linagliptin	TABLET;ORAL	206073-002	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	Patent Number	Estimated Expiration
South Africa	200500087
European Patent Office	1532149
Norway	20140127
World Intellectual Property Organization (WIPO)	2005092877

Supplementary Protection Certificates for GLYXAMBI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1730131	14C0074	France		PRODUCT NAME: EMPAGLIFLOZINE ET SES SELS, EN PARTICULIER L'EMPAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/14/930 20140527
1730131	PA2014035,C1730131	Lithuania		PRODUCT NAME: EMPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/14/930 20140522
1532149	11C0052	France		PRODUCT NAME: LINAGLIPTINE SES ENANTIOMERES ET SELS; REGISTRATION NO/DATE: EU/1/11/707/001 20110824
2187879	276 10-2017	Slovakia		PRODUCT NAME: EMPAGLIFLOZIN/LINAGLIPTIN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/16/1146 20161115