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Last Updated: August 2, 2021

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CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE - Generic Drug Details

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What are the generic sources for canagliflozin; metformin hydrochloride and what is the scope of patent protection?

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

Canagliflozin; metformin hydrochloride has two hundred and thirty-one patent family members in forty-six countries.

There are twenty-one drug master file entries for canagliflozin; metformin hydrochloride. Two suppliers are listed for this compound.

Recent Clinical Trials for CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE

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

SponsorPhase
Johnson & Johnson Private LimitedPhase 4
Chang Gung Memorial HospitalPhase 2
Chiayi Christian HospitalPhase 2

See all CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE clinical trials

Pharmacology for CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Paragraph IV (Patent) Challenges for CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
INVOKAMET XR TABLET, EXTENDED RELEASE;ORAL canagliflozin; metformin hydrochloride 205879 2018-11-21
INVOKAMET TABLET;ORAL canagliflozin; metformin hydrochloride 204353 2017-03-29

US Patents and Regulatory Information for CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE

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 205879-002 Sep 20, 2016 RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Janssen Pharms INVOKAMET canagliflozin; metformin hydrochloride TABLET;ORAL 204353-004 Aug 8, 2014 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y Y ⤷  Free Forever Trial
Janssen Pharms INVOKAMET canagliflozin; metformin hydrochloride TABLET;ORAL 204353-001 Aug 8, 2014 RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Janssen Pharms INVOKAMET canagliflozin; metformin hydrochloride TABLET;ORAL 204353-004 Aug 8, 2014 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever 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; METFORMIN HYDROCHLORIDE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1651658 PA2014008 Lithuania ⤷  Free Forever 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 122014000050 Germany ⤷  Free Forever Trial PRODUCT NAME: CANAGLIFLOZIN; REGISTRATION NO/DATE: EU/1 /13/884/001-008 20131115
1651658 C01651658/01 Switzerland ⤷  Free Forever Trial PRODUCT NAME: CANAGLIFLOZIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 62956 29.01.2014
1651658 1490027-8 Sweden ⤷  Free Forever Trial PERIOD OF VALIDITY (FROM - UNTIL): 20240731 - 20281118
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Mallinckrodt
McKinsey
Moodys
Merck
Express Scripts

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