Details for New Drug Application (NDA): 212614

NDA 212614 describes TRIJARDY XR, which is a drug marketed by Boehringer Ingelheim and is included in one NDA. It is available from one supplier. There are fifteen patents protecting this drug. Additional details are available on the TRIJARDY XR profile page.

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

Summary for 212614

Tradename:	TRIJARDY XR
Applicant:	Boehringer Ingelheim
Ingredient:	empagliflozin; linagliptin; metformin hydrochloride
Patents:	15

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 212614

Constraining patent/regulatory exclusivity:

9,155,705

Dosage:

TABLET, EXTENDED RELEASE;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 NDA: 212614

Mechanism of Action

Dipeptidyl Peptidase 4 Inhibitors Sodium-Glucose Transporter 2 Inhibitors

Suppliers and Packaging for NDA: 212614

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TRIJARDY XR	empagliflozin; linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	212614	NDA	Boehringer Ingelheim Pharmaceuticals, Inc.	0597-0380	0597-0380-13	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0597-0380-13)
TRIJARDY XR	empagliflozin; linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	212614	NDA	Boehringer Ingelheim Pharmaceuticals, Inc.	0597-0380	0597-0380-68	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (0597-0380-68)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	5MG;2.5MG;1GM
Approval Date:	Jan 27, 2020	TE:		RLD:	Yes
Patent:	10,022,379	Patent Expiration:	Apr 2, 2029	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	METHOD OF TREATING TYPE 2 DIABETES USING A PHARMACEUTICAL COMPOSITION COMPRISING LINAGLIPTIN, METFORMIN, EMPAGLIFLOZIN AND A BASIC AMINO ACID
Patent:	10,258,637*PED	Patent Expiration:	Oct 3, 2034	Product Flag?		Substance Flag?		Delist Request?	Y
Patent:	10,406,172	Patent Expiration:	Jun 15, 2030	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	METHOD OF TREATING A TYPE 2 DIABETES MELLITUS PATIENT WITH INSUFFICIENT GLYCEMIC CONTROL DESPITE THERAPY WITH METFORMIN USING A PHARMACEUTICAL COMPOSITION COMPRISING EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN

Expired US Patents for NDA 212614

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	TRIJARDY XR	empagliflozin; linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	212614-003	Jan 27, 2020	6,488,962
Boehringer Ingelheim	TRIJARDY XR	empagliflozin; linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	212614-001	Jan 27, 2020	6,488,962
Boehringer Ingelheim	TRIJARDY XR	empagliflozin; linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	212614-002	Jan 27, 2020	6,488,962
Boehringer Ingelheim	TRIJARDY XR	empagliflozin; linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	212614-002	Jan 27, 2020	8,178,541
Boehringer Ingelheim	TRIJARDY XR	empagliflozin; linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	212614-002	Jan 27, 2020	8,119,648
Boehringer Ingelheim	TRIJARDY XR	empagliflozin; linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	212614-003	Jan 27, 2020	8,119,648
Boehringer Ingelheim	TRIJARDY XR	empagliflozin; linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	212614-004	Jan 27, 2020	8,178,541

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