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Serving hundreds of leading biopharmaceutical companies globally:

Teva
Federal Trade Commission
Merck
Colorcon
Farmers Insurance
Johnson and Johnson
Cipla
Fish and Richardson
US Army

Generated: April 25, 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 fourteen 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 N 0597-0152-30
JARDIANCE empagliflozin TABLET;ORAL 204629 NDA Boehringer Ingelheim Pharmaceuticals, Inc. 0597-0152 N 0597-0152-90

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Aug 1, 2014TE:RLD:Yes
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
Regulatory Exclusivity Expiration:Dec 2, 2019
Regulatory Exclusivity Use:TO REDUCE THE RISK OF CARDIOVASCULAR DEATH IN ADULT PATIENTS WITH TYPE 2 DIABETES MELLITUS AND ESTABLISHED CARDIOVASCULAR DISEASE

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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
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Healthtrust
Covington
McKinsey
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