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Last Updated: October 23, 2020

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Canagliflozin - Generic Drug Details

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What are the generic drug sources for canagliflozin and what is the scope of freedom to operate?

Canagliflozin is the generic ingredient in three branded drugs marketed by Janssen Pharms and is included in three NDAs. There are seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Canagliflozin has two hundred and sixty-six patent family members in forty-six countries.

There are twenty-one drug master file entries for canagliflozin. Three suppliers are listed for this compound.

Recent Clinical Trials for canagliflozin

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Canadian Medical and Surgical Knowledge Translation Research GroupPhase 4
Applied Health Research CentrePhase 4
St. Michael's Hospital, TorontoPhase 4

See all canagliflozin clinical trials

Medical Subject Heading (MeSH) Categories for canagliflozin
Paragraph IV (Patent) Challenges for CANAGLIFLOZIN
Tradename Dosage Ingredient NDA Submissiondate
INVOKANA TABLET;ORAL canagliflozin 204042 2017-03-29

US Patents and Regulatory Information for canagliflozin

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 canagliflozin; metformin hydrochloride TABLET;ORAL 204353-001 Aug 8, 2014 RX Yes No   Start Trial   Start Trial   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   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   Start Trial
Janssen Pharms INVOKANA canagliflozin TABLET;ORAL 204042-001 Mar 29, 2013 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Janssen Pharms INVOKAMET canagliflozin; metformin hydrochloride TABLET;ORAL 204353-001 Aug 8, 2014 RX Yes No   Start Trial   Start Trial   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
>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 canagliflozin

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1651658 1490027-8 Sweden   Start Trial PERIOD OF VALIDITY (FROM - UNTIL): 20240731 - 20281118
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 2014/029 Ireland   Start Trial PRODUCT NAME: CANAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/13/884/001-004 20131119
1651658 300670 Netherlands   Start Trial PRODUCT NAME: CANAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/13/884/001-008 20131119
1651658 C300670 Netherlands   Start Trial PRODUCT NAME: CANAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/13/884/001-008 20131118
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Colorcon
AstraZeneca
Boehringer Ingelheim
Baxter
Express Scripts
Dow

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