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Last Updated: October 25, 2021

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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-nine patent family members in forty-seven countries.

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

Recent Clinical Trials for canagliflozin

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

SponsorPhase
Center for Outcomes Research and Clinical Epidemiology, ItalyPhase 4
Italian Society of DiabetologyPhase 4
Shengjing HospitalPhase 1/Phase 2

See all canagliflozin clinical trials

Generic filers with tentative approvals for CANAGLIFLOZIN
Applicant Application No. Strength Dosage Form
⤷  Try it Free⤷  Try it Free100MGTABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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 204353-002 Aug 8, 2014 RX Yes No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Janssen Pharms INVOKAMET XR canagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205879-004 Sep 20, 2016 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y Y ⤷  Try it Free
Janssen Pharms INVOKAMET XR canagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205879-003 Sep 20, 2016 RX Yes No ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Janssen Pharms INVOKAMET XR canagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205879-003 Sep 20, 2016 RX Yes No ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Janssen Pharms INVOKAMET XR canagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205879-003 Sep 20, 2016 RX Yes No ⤷  Try it Free ⤷  Try it Free Y Y ⤷  Try it Free
Janssen Pharms INVOKANA canagliflozin TABLET;ORAL 204042-001 Mar 29, 2013 RX Yes No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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 C300670 Netherlands ⤷  Try it Free PRODUCT NAME: CANAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/13/884/001-008 20131118
1651658 C01651658/01 Switzerland ⤷  Try it Free PRODUCT NAME: CANAGLIFLOZIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 62956 29.01.2014
1651658 CA 2014 00024 Denmark ⤷  Try it Free PRODUCT NAME: CANAGLIFLOZIN, HERUNDER CANAGLIFLOZINHEMIHYDRAT; REG. NO/DATE: EU/1/13/884/001-008 20131115
1651658 92426 Luxembourg ⤷  Try it Free PRODUCT NAME: CANAGLIFLOZINE
1651658 PA2014008 Lithuania ⤷  Try it Free 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 C20140011 00102 Estonia ⤷  Try it Free PRODUCT NAME: KANAGLIFLOSIIN;REG NO/DATE: K(2013)8171 (LOPLIK) 15.11.2013
>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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