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Generated: December 15, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204042

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NDA 204042 describes INVOKANA, which is a drug marketed by Janssen Pharms and is included in one NDA. It is available from one supplier. There are four patents protecting this drug and one Paragraph IV challenge. Additional details are available on the INVOKANA profile page.

The generic ingredient in INVOKANA is canagliflozin. There are nineteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the canagliflozin profile page.

Summary for 204042

Tradename:1
Applicant:1
Ingredient:1
Patents:4
Formulation / Manufacturing:see details

Pharmacology for NDA: 204042

Medical Subject Heading (MeSH) Categories for 204042

Suppliers and Packaging for NDA: 204042

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INVOKANA canagliflozin TABLET;ORAL 204042 NDA Janssen Pharmaceuticals, Inc. 50458-140 50458-140-30 30 TABLET, FILM COATED in 1 BOTTLE (50458-140-30)
INVOKANA canagliflozin TABLET;ORAL 204042 NDA Janssen Pharmaceuticals, Inc. 50458-140 50458-140-50 500 TABLET, FILM COATED in 1 BOTTLE (50458-140-50)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Mar 29, 2013TE:RLD:Yes
Regulatory Exclusivity Expiration:Feb 1, 2020
Regulatory Exclusivity Use:
Regulatory Exclusivity Expiration:Mar 29, 2018
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:May 20, 2019
Regulatory Exclusivity Use:USE OF CANAGLIFLOZIN FOR INITIAL THERAPY IN COMBINATION WITH METFORMIN


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Serving leading biopharmaceutical companies globally:

Deloitte
Queensland Health
US Army
Teva
AstraZeneca
Boehringer Ingelheim
Novartis
Medtronic
Express Scripts
US Department of Justice

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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