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Generated: April 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201280

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NDA 201280 describes TRADJENTA, which is a drug marketed by Boehringer Ingelheim and is included in one NDA. It is available from two suppliers. There are twelve patents protecting this drug and one Paragraph IV challenge. Additional details are available on the TRADJENTA profile page.

The generic ingredient in TRADJENTA is linagliptin. There are eighteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the linagliptin profile page.

Summary for 201280

Tradename:	TRADJENTA
Applicant:	Boehringer Ingelheim
Ingredient:	linagliptin
Patents:	12
Formulation / Manufacturing:	see details

Pharmacology for NDA: 201280

Mechanism of Action	Dipeptidyl Peptidase 4 Inhibitors

Medical Subject Heading (MeSH) Categories for 201280

Dipeptidyl-Peptidase IV Inhibitors
Hypoglycemic Agents
Incretins

Suppliers and Packaging for NDA: 201280

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TRADJENTA	linagliptin	TABLET;ORAL	201280	NDA	Boehringer Ingelheim Pharmaceuticals, Inc.	0597-0140	N	0597-0140-90
TRADJENTA	linagliptin	TABLET;ORAL	201280	NDA	Boehringer Ingelheim Pharmaceuticals, Inc.	0597-0140	N	0597-0140-30

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	May 2, 2011	TE:		RLD:	Yes
Patent:	➤ Sign Up	Patent Expiration:	Feb 2, 2019	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH INSULIN (WITH OR WITHOUT METFORMIN AND/OR PIOGLITAZONE)
Patent:	➤ Sign Up	Patent Expiration:	Feb 2, 2019	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF TYPE 2 DIABETES MELLITUS
Patent:	➤ Sign Up	Patent Expiration:	Feb 2, 2019	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH INSULIN (WITH OR WITHOUT METFORMIN AND/OR PIOGLITAZONE)

Expired US Patents for NDA 201280

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	TRADJENTA	linagliptin	TABLET;ORAL	201280-001	May 2, 2011	➤ Sign Up	➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

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