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Last Updated: November 22, 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
Ain Shams UniversityPhase 1/Phase 2
First Affiliated Hospital Xi'an Jiaotong UniversityN/A
Johnson & Johnson Private LimitedPhase 4

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 205879-002 Sep 20, 2016 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Janssen Pharms INVOKAMET canagliflozin; metformin hydrochloride TABLET;ORAL 204353-001 Aug 8, 2014 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 ⤷  Sign Up
Janssen Pharms INVOKAMET canagliflozin; metformin hydrochloride TABLET;ORAL 204353-001 Aug 8, 2014 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Janssen Pharms INVOKAMET canagliflozin; metformin hydrochloride TABLET;ORAL 204353-004 Aug 8, 2014 RX Yes Yes ⤷  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 205879-001 Sep 20, 2016 ⤷  Sign Up ⤷  Sign Up
Janssen Pharms INVOKAMET XR canagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205879-002 Sep 20, 2016 ⤷  Sign Up ⤷  Sign Up
Janssen Pharms INVOKAMET canagliflozin; metformin hydrochloride TABLET;ORAL 204353-003 Aug 8, 2014 ⤷  Sign Up ⤷  Sign Up
Janssen Pharms INVOKAMET XR canagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205879-004 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
Taiwan 200524950 Substituted indazole-O-glucosides ⤷  Sign Up
Ukraine 83377 N-ГЛИКОЗИД, СПОСОБ ЕГО ПОЛУЧЕНИЯ, ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ И СПОСОБ ЛЕЧЕНИЯ;N-ГЛІКОЗИД, СПОСІБ ЙОГО ОДЕРЖАННЯ, ФАРМАЦЕВТИЧНА КОМПОЗИЦІЯ ТА СПОСІБ ЛІКУВАННЯ (N- GLYCOSIDE, PROCESS FOR THE PREPARATION THEREOF, PHARMACEUTICAL COMPOSITION AND TREATMENT METHOD) ⤷  Sign Up
Japan 5317951 ⤷  Sign Up
Malaysia 143203 NOVEL COMPOUNDS HAVING INHIBITORY ACTIVITY AGAINST SODIUM-DEPENDENT TRANSPORTER ⤷  Sign Up
Eurasian Patent Organization 017103 КРИСТАЛЛИЧЕСКАЯ ФОРМА ГЕМИГИДРАТА 1-(β-D-ГЛЮКОПИРАНОЗИЛ)-4-МЕТИЛ-3-[5-(4-ФТОРФЕНИЛ)-2-ТИЕНИЛМЕТИЛ]БЕНЗОЛА (CRYSTALLINE FORM OF 1-(&bgr;-D-GLUCOPYRANOSYL)-4-METHYL-3-[5-(4-FLUOROPHENYL)-2-THIENYLMETHYL]BENZENE HEMIHYDRATE) ⤷  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 300670 Netherlands ⤷  Sign Up PRODUCT NAME: CANAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/13/884/001-008 20131119
1651658 CR 2014 00024 Denmark ⤷  Sign Up PRODUCT NAME: CANAGLIFLOZIN; REG. NO/DATE: EU/1/13/884/001-008 20131119
1651658 637 Finland ⤷  Sign Up
1651658 C300670 Netherlands ⤷  Sign Up PRODUCT NAME: CANAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/13/884/001-008 20131118
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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