BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Argus Health
Chinese Patent Office
Cerilliant
Baxter
Colorcon
McKinsey
Federal Trade Commission
Daiichi Sankyo
Fish and Richardson
Boehringer Ingelheim

Generated: January 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204353

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NDA 204353 describes INVOKAMET, which is a drug marketed by Janssen Pharms and is included in two NDAs. It is available from one supplier. There are six patents protecting this drug and one Paragraph IV challenge. Additional details are available on the INVOKAMET profile page.

The generic ingredient in INVOKAMET is canagliflozin; metformin hydrochloride. There are twenty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the canagliflozin; metformin hydrochloride profile page.
Summary for 204353
Tradename:INVOKAMET
Applicant:Janssen Pharms
Ingredient:canagliflozin; metformin hydrochloride
Patents:5
Formulation / Manufacturing:see details
Pharmacology for NDA: 204353
Suppliers and Packaging for NDA: 204353
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INVOKAMET canagliflozin; metformin hydrochloride TABLET;ORAL 204353 NDA Janssen Pharmaceuticals, Inc. 50458-540 50458-540-91 10 TABLET, FILM COATED in 1 BOTTLE (50458-540-91)
INVOKAMET canagliflozin; metformin hydrochloride TABLET;ORAL 204353 NDA Janssen Pharmaceuticals, Inc. 50458-540 50458-540-60 60 TABLET, FILM COATED in 1 BOTTLE (50458-540-60)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG;500MG
Approval Date:Aug 8, 2014TE:RLD:Yes
Regulatory Exclusivity Expiration:Feb 1, 2020
Regulatory Exclusivity Use:
Regulatory Exclusivity Expiration:May 20, 2019
Regulatory Exclusivity Use:AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS WHEN TREATMENT WITH BOTH CANAGLIFLOZIN AND METFORMIN IS APPROPRIATE
Regulatory Exclusivity Expiration:Mar 29, 2018
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY

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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Deloitte
Moodys
Novartis
Dow
Accenture
McKesson
Healthtrust
Mallinckrodt

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