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Serving leading biopharmaceutical companies globally:

QuintilesIMS
Fish and Richardson
US Department of Justice
UBS
Daiichi Sankyo
Harvard Business School
AstraZeneca
McKinsey
Baxter
Healthtrust

Generated: November 18, 2017

DrugPatentWatch Database Preview

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 three suppliers. There are seventeen patents protecting this drug and one Paragraph IV challenge. Additional details are available on the JENTADUETO profile page.

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

Summary for 201281

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:13
Formulation / Manufacturing:see details

Pharmacology for NDA: 201281

Ingredient-typeBiguanides
Mechanism of ActionDipeptidyl 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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG;500MG
Approval Date:Jan 30, 2012TE:RLD:Yes
Regulatory Exclusivity Expiration:Jul 30, 2017
Regulatory Exclusivity Use:INFORMATION ADDED TO THE CLINICAL STUDIES SECTION ON INITIAL COMBINATION THERAPY WITH LINAGLIPTIN AND METFORMIN VS. LINAGLIPTIN MONOTHERAPY IN TREATMENT NAIVE PATIENTS
Patent:► SubscribePatent Expiration:Apr 24, 2017Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR
Patent:► SubscribePatent Expiration:Feb 2, 2019Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-4 INHIBITOR IN COMBINATION WITH METFORMIN

Expired Orange Book Patents for NDA: 201281

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim
JENTADUETO
linagliptin; metformin hydrochloride
TABLET;ORAL201281-003Jan 30, 2012► Subscribe► Subscribe
Boehringer Ingelheim
JENTADUETO
linagliptin; metformin hydrochloride
TABLET;ORAL201281-002Jan 30, 2012► Subscribe► Subscribe
Boehringer Ingelheim
JENTADUETO
linagliptin; metformin hydrochloride
TABLET;ORAL201281-001Jan 30, 2012► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

McKinsey
Colorcon
UBS
Baxter
Johnson and Johnson
QuintilesIMS
Merck
Chubb
AstraZeneca
Teva

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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