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BioPharmaceutical Business Intelligence

  • Analyze global market entry opportunities
  • Identify first generic entrants
  • Obtain formulation and manufacturing information

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Serving leading biopharmaceutical companies globally:

Queensland Health
US Department of Justice
Chinese Patent Office
Cantor Fitzgerald
QuintilesIMS
Colorcon
AstraZeneca
McKesson
Farmers Insurance
Express Scripts

Generated: November 18, 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 204353

Tradename:
1
Applicant:
1
Ingredient:
1
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 50458-540-60 60 TABLET, FILM COATED in 1 BOTTLE (50458-540-60)
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)

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:
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:

Accenture
Queensland Health
Dow
McKesson
Cipla
Express Scripts
Merck
Mallinckrodt
UBS
Novartis

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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