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BioPharmaceutical Business Intelligence

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Serving 500+ biopharmaceutical companies globally:

Mallinckrodt
Harvard Business School
Express Scripts
Dow
McKesson
McKinsey
Chinese Patent Office
US Army
Johnson and Johnson
US Department of Justice

Generated: September 25, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205879

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NDA 205879 describes INVOKAMET XR, which is a drug marketed by Janssen Pharms and is included in one NDA. It is available from one supplier. There are six patents protecting this drug. Additional details are available on the INVOKAMET XR profile page.

The generic ingredient in INVOKAMET XR 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: 205879

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:6
Formulation / Manufacturing:see details

Pharmacology for NDA: 205879

Suppliers and Packaging for NDA: 205879

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INVOKAMET XR
canagliflozin; metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL 205879 NDA Janssen Pharmaceuticals, Inc. 50458-940 50458-940-01 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50458-940-01)
INVOKAMET XR
canagliflozin; metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL 205879 NDA Janssen Pharmaceuticals, Inc. 50458-940 50458-940-02 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50458-940-02)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength50MG;500MG
Approval Date:Sep 20, 2016TE:RLD:Yes
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
Regulatory Exclusivity Expiration:Aug 8, 2017
Regulatory Exclusivity Use:NEW COMBINATION


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Serving 500+ biopharmaceutical companies globally:

Fuji
Covington
Chubb
McKinsey
Cipla
Cerilliant
Chinese Patent Office
Colorcon
Teva
Harvard Business School

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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