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Generated: September 21, 2017

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 five 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 NDA: 204629

Tradename:
1
Applicant:
1
Ingredient:
1
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 0597-0152-07 1 BOTTLE in 1 CARTON (0597-0152-07) > 7 TABLET, FILM COATED in 1 BOTTLE
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)

Summary 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 500+ biopharmaceutical companies globally:

UBS
Dow
Harvard Business School
Julphar
Express Scripts
Argus Health
Cipla
Colorcon
Queensland Health
US Army

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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