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Serving leading biopharmaceutical companies globally:

Harvard Business School
Citi
Farmers Insurance
Mallinckrodt
UBS
US Army
Argus Health
Cipla
Fish and Richardson
Johnson and Johnson

Generated: January 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204629

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NDA 204629 describes JARDIANCE, which is a drug marketed by Boehringer Ingelheim and is included in one NDA. It is available from two suppliers. There are three patents protecting this drug. Additional details are available on the JARDIANCE profile page.

The generic ingredient in JARDIANCE is empagliflozin. There are eight drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the empagliflozin profile page.
Summary for 204629
Tradename:JARDIANCE
Applicant:Boehringer Ingelheim
Ingredient:empagliflozin
Patents:3
Formulation / Manufacturing:see details
Pharmacology for NDA: 204629
Suppliers and Packaging for NDA: 204629
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
JARDIANCE empagliflozin TABLET;ORAL 204629 NDA Boehringer Ingelheim Pharmaceuticals, Inc. 0597-0152 0597-0152-30 30 TABLET, FILM COATED in 1 BOTTLE (0597-0152-30)
JARDIANCE empagliflozin TABLET;ORAL 204629 NDA Boehringer Ingelheim Pharmaceuticals, Inc. 0597-0152 0597-0152-07 1 BOTTLE in 1 CARTON (0597-0152-07) > 7 TABLET, FILM COATED in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Aug 1, 2014TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 2, 2019
Regulatory Exclusivity Use:
Regulatory Exclusivity Expiration:Mar 18, 2019
Regulatory Exclusivity Use:INFORMATION ADDED TO CLINICAL STUDIES SECTION OF THE LABELING REGARDING INITIAL COMBINATION THERAPY OF EMPAGLIFLOZIN WITH METFORMIN
Regulatory Exclusivity Expiration:Aug 1, 2019
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY

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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Julphar
Federal Trade Commission
Mallinckrodt
Daiichi Sankyo
Johnson and Johnson
Novartis
Harvard Business School
US Department of Justice

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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