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Last Updated: March 7, 2021

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INVOKAMET XR Drug Profile

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When do Invokamet Xr patents expire, and what generic alternatives are available?

Invokamet Xr is a drug marketed by Janssen Pharms and is included in one NDA. There are six patents protecting this drug.

This drug has two hundred and thirty-one patent family members in forty-six countries.

The generic ingredient in INVOKAMET XR 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 Xr

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

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 26, 2029. This may change due to patent challenges or generic licensing.

There have been twenty-two 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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Drug patent expirations by year for INVOKAMET XR
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Generic Entry Opportunity Date for INVOKAMET XR
Generic Entry Date for INVOKAMET XR*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET, EXTENDED RELEASE;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.

Paragraph IV (Patent) Challenges for INVOKAMET XR
Tradename Dosage Ingredient NDA Submissiondate
INVOKAMET XR TABLET, EXTENDED RELEASE;ORAL canagliflozin; metformin hydrochloride 205879 2018-11-21

US Patents and Regulatory Information for INVOKAMET XR

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 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 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 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 205879-001 Sep 20, 2016 RX Yes No   Start Trial   Start Trial 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 XR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 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 C01651658/01 Switzerland   Start Trial PRODUCT NAME: CANAGLIFLOZIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 62956 29.01.2014
1651658 1490027-8 Sweden   Start Trial PERIOD OF VALIDITY (FROM - UNTIL): 20240731 - 20281118
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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McKinsey

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