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 three suppliers. There are nine 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 nineteen drug master file entries for this compound. Three 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:	9

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	0597-0140-30	30 TABLET, FILM COATED in 1 BOTTLE (0597-0140-30)
TRADJENTA	linagliptin	TABLET;ORAL	201280	NDA	Boehringer Ingelheim Pharmaceuticals, Inc.	0597-0140	0597-0140-61	100 BLISTER PACK in 1 CARTON (0597-0140-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	May 2, 2011	TE:	AB	RLD:	Yes
Regulatory Exclusivity Expiration:	Dec 20, 2026
Regulatory Exclusivity Use:	PEDIATRIC EXCLUSIVITY
Regulatory Exclusivity Expiration:	Jun 20, 2026
Regulatory Exclusivity Use:	REVISIONS TO THE PEDIATRIC USE SUBSECTION OF LABELING TO INCLUDE THE RESULTS FROM CLINICAL STUDY 1218-0091, CONDUCTED TO FULFILL A PEDIATRIC WRITTEN REQUEST
Patent:	⤷ Sign Up	Patent Expiration:	Feb 5, 2030	Product Flag?		Substance Flag?		Delist Request?	Y

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
Boehringer Ingelheim	TRADJENTA	linagliptin	TABLET;ORAL	201280-001	May 2, 2011	⤷ Sign Up	⤷ Sign Up
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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