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Generated: October 20, 2018

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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 twenty 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:INVOKANA
Applicant:Janssen Pharms
Ingredient:canagliflozin
Patents:4
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 204042
Generic Entry Date for 204042*:
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: 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 50458-140-01 5 TABLET, FILM COATED in 1 BOTTLE (50458-140-01)
INVOKANA canagliflozin TABLET;ORAL 204042 NDA Janssen Pharmaceuticals, Inc. 50458-140 50458-140-10 10 BLISTER PACK in 1 CARTON (50458-140-10) > 10 TABLET, FILM COATED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Mar 29, 2013TE:RLD:Yes
Regulatory Exclusivity Expiration:Mar 29, 2018
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Feb 1, 2020
Regulatory Exclusivity Use:NEW CLINICAL DATA ADDED TO THE PRESCRIBING INFORMATION REGARDING CANAGLIFLOZIN ADD-ON COMBINATION THERAPY WITH METFORMIN AND A DIPEPTIDYL-PEPTIDASE-4 INHIBITOR
Regulatory Exclusivity Expiration:May 20, 2019
Regulatory Exclusivity Use:USE OF CANAGLIFLOZIN FOR INITIAL THERAPY IN COMBINATION WITH METFORMIN

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