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Serving 500+ biopharmaceutical companies globally:

US Department of Justice
Boehringer Ingelheim
Argus Health
Harvard Business School
Queensland Health
Federal Trade Commission

Generated: July 25, 2017

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 nineteen 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 NDA: 204353

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
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)
canagliflozin; metformin hydrochloride
TABLET;ORAL 204353 NDA Janssen Pharmaceuticals, Inc. 50458-541 50458-541-60 60 TABLET, FILM COATED in 1 BOTTLE (50458-541-60)

Summary 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:
Patent:► SubscribePatent Expiration:Jul 14, 2027Product Flag?YSubstance Flag?YDelist Request?
Patent:► SubscribePatent Expiration:Jul 30, 2024Product Flag?YSubstance Flag?Delist Request?

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Serving 500+ biopharmaceutical companies globally:

US Army
Argus Health
Cantor Fitzgerald
Johnson and Johnson

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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