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Last Updated: July 10, 2020

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INVOKAMET Drug Profile


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Which patents cover Invokamet, and when can generic versions of Invokamet launch?

Invokamet is a drug marketed by Janssen Pharms and is included in two NDAs. There are six patents protecting this drug and two Paragraph IV challenges.

This drug has two hundred and twenty patent family members in forty-five countries.

The generic ingredient in INVOKAMET is canagliflozin; metformin hydrochloride. There are twenty-one 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.

US ANDA Litigation and Generic Entry Outlook for Invokamet

Invokamet was eligible for patent challenges on March 29, 2017.

There have been eleven patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Paragraph IV (Patent) Challenges for INVOKAMET
Tradename Dosage Ingredient NDA Submissiondate
INVOKAMET TABLET;ORAL canagliflozin; metformin hydrochloride 204353 2017-03-29

US Patents and Regulatory Information for INVOKAMET

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Pharms INVOKAMET XR canagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205879-003 Sep 20, 2016 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Janssen Pharms INVOKAMET canagliflozin; metformin hydrochloride TABLET;ORAL 204353-004 Aug 8, 2014 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Janssen Pharms INVOKAMET canagliflozin; metformin hydrochloride TABLET;ORAL 204353-004 Aug 8, 2014 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Janssen Pharms INVOKAMET XR canagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205879-003 Sep 20, 2016 RX Yes No   Start Trial   Start Trial   Start Trial
Janssen Pharms INVOKAMET canagliflozin; metformin hydrochloride TABLET;ORAL 204353-004 Aug 8, 2014 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Janssen Pharms INVOKAMET XR canagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205879-002 Sep 20, 2016 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Janssen Pharms INVOKAMET XR canagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205879-004 Sep 20, 2016 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for INVOKAMET

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1651658 C300670 Netherlands   Start Trial PRODUCT NAME: CANAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/13/884/001-008 20131118
1651658 2014C/027 Belgium   Start Trial PRODUCT NAME: CANAGLIFLOZINE; AUTHORISATION NUMBER AND DATE: EU/1/13/884 20131119
1651658 29/2014 Austria   Start Trial PRODUCT NAME: CANAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/13/884 20131115
1651658 14C0034 France   Start Trial PRODUCT NAME: CANAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/13/884/001-008 20131115
1651658 PA2014008,C1651658 Lithuania   Start Trial PRODUCT NAME: CANAGLIFOZINUM; REGISTRATION NO/DATE: EU/1/13/884/001 - EU/1/13/884/004, 2013- 11-15 EU/1/13/884/005 - EU/1/13/884/008 20131115
1651658 164 1-2014 Slovakia   Start Trial PRODUCT NAME: KANAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/13/884/001 - EU/1/13/884/008 20131115
1651658 92426 Luxembourg   Start Trial PRODUCT NAME: CANAGLIFLOZINE
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Merck
Moodys
Baxter
McKesson
Express Scripts
Mallinckrodt

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