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Last Updated: June 21, 2024

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 sixty-nine patent family members in forty-seven countries.

One supplier is listed for this compound.

Summary for canagliflozin; metformin hydrochloride
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for canagliflozin; metformin hydrochloride
Generic Entry Dates for canagliflozin; metformin hydrochloride*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET, EXTENDED RELEASE;ORAL
Generic Entry Dates for canagliflozin; metformin hydrochloride*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;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.

Recent Clinical Trials for canagliflozin; metformin hydrochloride

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

SponsorPhase
First Affiliated Hospital Xi'an Jiaotong UniversityN/A
Johnson & Johnson Private LimitedPhase 4
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 Strength NDA ANDAs Submitted Submissiondate
INVOKAMET XR Extended-release Tablets canagliflozin; metformin hydrochloride 50 mg/500 mg 50 mg/1000 mg 150 mg/500 mg 150 mg/1000 mg 205879 1 2018-11-21
INVOKAMET Tablets canagliflozin; metformin hydrochloride 50 mg/500 mg 50 mg/1000 mg 150 mg/500 mg 150 mg/1000 mg 204353 6 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 205879-001 Sep 20, 2016 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Janssen Pharms INVOKAMET XR canagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205879-002 Sep 20, 2016 RX Yes No ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Janssen Pharms INVOKAMET XR canagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205879-001 Sep 20, 2016 RX Yes No ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Janssen Pharms INVOKAMET XR canagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205879-003 Sep 20, 2016 RX Yes No ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Janssen Pharms INVOKAMET canagliflozin; metformin hydrochloride TABLET;ORAL 204353-002 Aug 8, 2014 RX Yes No ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Janssen Pharms INVOKAMET XR canagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205879-002 Sep 20, 2016 RX Yes No ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for canagliflozin; metformin hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms INVOKAMET XR canagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205879-001 Sep 20, 2016 ⤷  Sign Up ⤷  Sign Up
Janssen Pharms INVOKAMET XR canagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205879-003 Sep 20, 2016 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for canagliflozin; metformin hydrochloride

Country Patent Number Title Estimated Expiration
New Zealand 545304 Novel compounds having inhibitory activity against sodium-dependant transporter ⤷  Sign Up
Iceland 8445 Staðgengin, brædd heteróhringuð c-glýkósíð ⤷  Sign Up
Slovenia 2102224 ⤷  Sign Up
Japan 2008528441 ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2005012326 ⤷  Sign Up
Denmark 2896397 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for canagliflozin; metformin hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1651658 PA2014008,C1651658 Lithuania ⤷  Sign Up 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 SPC/GB14/032 United Kingdom ⤷  Sign Up PRODUCT NAME: CANAGLIFLOZIN; REGISTERED: UK EU/1/13/884/001 20131119; UK EU/1/13/884/002 20131119; UK EU/1/13/884/003 20131119; UK EU/1/13/884/004 20131119; UK EU/1/13/884/005 20131119; UK EU/1/13/884/006 20131119; UK EU/1/13/884/007 20131119; UK EU/1/13/884/008 20131119
1651658 1490027-8 Sweden ⤷  Sign Up PERIOD OF VALIDITY (FROM - UNTIL): 20240731 - 20281118
1651658 CA 2014 00024 Denmark ⤷  Sign Up PRODUCT NAME: CANAGLIFLOZIN, HERUNDER CANAGLIFLOZINHEMIHYDRAT; REG. NO/DATE: EU/1/13/884/001-008 20131115
1651658 2014/029 Ireland ⤷  Sign Up PRODUCT NAME: CANAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/13/884/001-004 20131119
1651658 29/2014 Austria ⤷  Sign Up PRODUCT NAME: CANAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/13/884 20131115
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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