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Last Updated: July 10, 2020

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 four suppliers. There are six patents protecting this drug and one Paragraph IV challenge. Additional details are available on the JARDIANCE profile page.

The generic ingredient in JARDIANCE is empagliflozin. There are twenty-two drug master file entries for this compound. Four 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:6
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 204629
Generic Entry Date for 204629*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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)
Paragraph IV (Patent) Challenges for 204629
Tradename Dosage Ingredient NDA Submissiondate
JARDIANCE TABLET;ORAL empagliflozin 204629 2018-08-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Aug 1, 2014TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Apr 3, 2034Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2
Patent:  Start TrialPatent Expiration:Nov 5, 2025Product Flag?Substance Flag?YDelist Request?
Patent:  Start TrialPatent Expiration:Apr 15, 2027Product Flag?YSubstance Flag?YDelist Request?

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