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Last Updated: July 22, 2024

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-eight 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 are five tentative approvals for this compound.

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for canagliflozin
Generic Entry Date for canagliflozin*:
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

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

SponsorPhase
Heart and Stroke Foundation of CanadaPhase 2
McGill University Health Centre/Research Institute of the McGill University Health CentrePhase 2
Ain Shams UniversityPhase 1/Phase 2

See all canagliflozin clinical trials

Generic filers with tentative approvals for CANAGLIFLOZIN
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up100MGTABLET; ORAL
⤷  Sign Up⤷  Sign Up300mgTABLET; ORAL
⤷  Sign Up⤷  Sign Up300MGTABLET;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 Strength NDA ANDAs Submitted Submissiondate
INVOKANA Tablets canagliflozin 100 mg and 300 mg 204042 10 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 204353-004 Aug 8, 2014 RX Yes Yes ⤷  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 204353-001 Aug 8, 2014 RX Yes No ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Janssen Pharms INVOKAMET canagliflozin; metformin hydrochloride TABLET;ORAL 204353-003 Aug 8, 2014 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

EU/EMA Drug Approvals for canagliflozin

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Janssen-Cilag International NV Invokana canagliflozin EMEA/H/C/002649
Invokana is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise:as monotherapy when metformin is considered inappropriate due to intolerance or contraindicationsin addition to other medicinal products for the treatment of diabetes.For study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4.4, 4.5 and 5.1.
Authorised no no no 2013-11-15
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for canagliflozin

Country Patent Number Title Estimated Expiration
Japan 2008266328 NEW COMPOUND ⤷  Sign Up
Israel 206831 GLUCOPYRANOSYL DERIVATIVES AND PHARMACEUTICAL COMPOSITIONS CONTAINING THE SAME AND USES THEREOF ⤷  Sign Up
Australia 2004261664 Substituted indole-O-glucosides ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2005012326 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for canagliflozin

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1651658 29/2014 Austria ⤷  Sign Up PRODUCT NAME: CANAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/13/884 20131115
1651658 C 2014 017 Romania ⤷  Sign Up PRODUCT NAME: CANAGLIFLOZIN; NATIONAL AUTHORISATION NUMBER: EU/1/13/884; DATE OF NATIONAL AUTHORISATION: 20131115; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/884; DATE OF FIRST AUTHORISATION IN EEA: 20131115
1651658 14C0034 France ⤷  Sign Up PRODUCT NAME: CANAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/13/884/001-008 20131119
1651658 92426 Luxembourg ⤷  Sign Up PRODUCT NAME: CANAGLIFLOZINE
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.