Details for New Drug Application (NDA): 201281

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NDA 201281 describes JENTADUETO, which is a drug marketed by Boehringer Ingelheim and is included in two NDAs. It is available from one supplier. There are eleven patents protecting this drug and two Paragraph IV challenges. Additional details are available on the JENTADUETO profile page.

The generic ingredient in JENTADUETO is linagliptin; metformin hydrochloride. There are nineteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the linagliptin; metformin hydrochloride profile page.

Summary for 201281

Tradename:	JENTADUETO
Applicant:	Boehringer Ingelheim
Ingredient:	linagliptin; metformin hydrochloride
Patents:	9

Pharmacology for NDA: 201281

Mechanism of Action	Dipeptidyl Peptidase 4 Inhibitors

Suppliers and Packaging for NDA: 201281

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
JENTADUETO	linagliptin; metformin hydrochloride	TABLET;ORAL	201281	NDA	Boehringer Ingelheim Pharmaceuticals, Inc.	0597-0146	0597-0146-18	180 TABLET, FILM COATED in 1 BOTTLE (0597-0146-18)
JENTADUETO	linagliptin; metformin hydrochloride	TABLET;ORAL	201281	NDA	Boehringer Ingelheim Pharmaceuticals, Inc.	0597-0146	0597-0146-60	60 TABLET, FILM COATED in 1 BOTTLE (0597-0146-60)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	2.5MG;500MG
Approval Date:	Jan 30, 2012	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:	Oct 2, 2029	Product Flag?		Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 201281

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	JENTADUETO	linagliptin; metformin hydrochloride	TABLET;ORAL	201281-001	Jan 30, 2012	⤷ Sign Up	⤷ Sign Up
Boehringer Ingelheim	JENTADUETO	linagliptin; metformin hydrochloride	TABLET;ORAL	201281-003	Jan 30, 2012	⤷ Sign Up	⤷ Sign Up
Boehringer Ingelheim	JENTADUETO	linagliptin; metformin hydrochloride	TABLET;ORAL	201281-002	Jan 30, 2012	⤷ Sign Up	⤷ Sign Up
Boehringer Ingelheim	JENTADUETO	linagliptin; metformin hydrochloride	TABLET;ORAL	201281-002	Jan 30, 2012	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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