Last Updated: October 1, 2026

canagliflozin - Profile

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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 four branded drugs marketed by Apotex, Aurobindo Pharma Ltd, and Janssen Pharms, and is included in five NDAs. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are five tentative approvals for this compound.

Summary for canagliflozin

International Patents:	220
US Patents:	4
Tradenames:	4
Applicants:	3
NDAs:	5
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for canagliflozin

Generic filers with tentative approvals for CANAGLIFLOZIN

Applicant	Application No.	Strength	Dosage Form
⤷ Start Trial	⤷ Start Trial	100MG	TABLET; ORAL
⤷ Start Trial	⤷ Start Trial	300mg	TABLET; ORAL
⤷ Start Trial	⤷ Start Trial	300MG	TABLET;ORAL

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

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Apotex	CANAGLIFLOZIN	canagliflozin	TABLET;ORAL	210449-001	Apr 14, 2026	AB	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Apotex	CANAGLIFLOZIN	canagliflozin	TABLET;ORAL	210449-002	Apr 14, 2026	AB	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Aurobindo Pharma Ltd	CANAGLIFLOZIN	canagliflozin	TABLET;ORAL	210386-001	Apr 20, 2026		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
>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

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Janssen-Cilag International NV	Invokana	canagliflozin	EMEA/H/C/002649Invokana 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

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Country	Patent Number	Title	Estimated Expiration
Argentina	064099		⤷ Start Trial
Argentina	107510		⤷ Start Trial
Argentina	118450		⤷ Start Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for canagliflozin

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1651658	PA2014008	Lithuania	⤷ Start 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	14C0034	France	⤷ Start Trial	PRODUCT NAME: CANAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/13/884/001-008 20131119
1651658	300670	Netherlands	⤷ Start Trial	PRODUCT NAME: CANAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/13/884/001-008 20131119
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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