Canagliflozin - Generic Drug Details

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What are the generic 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.

Summary for canagliflozin

International Patents:	268
US Patents:	7
Tradenames:	3
Applicants:	1
NDAs:	3
Drug Master File Entries:	21
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	90
Clinical Trials:	144
Patent Applications:	355
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for canagliflozin
What excipients (inactive ingredients) are in canagliflozin?	canagliflozin excipients list
DailyMed Link:	canagliflozin at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for canagliflozin

Generic Entry Date for canagliflozin^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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

Sponsor	Phase
McGill University Health Centre/Research Institute of the McGill University Health Centre	Phase 2
Heart and Stroke Foundation of Canada	Phase 2
Ain Shams University	Phase 1/Phase 2

See all canagliflozin clinical trials

Generic filers with tentative approvals for CANAGLIFLOZIN

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	100MG	TABLET; ORAL
⤷ Sign Up	⤷ Sign Up	300mg	TABLET; ORAL
⤷ Sign Up	⤷ Sign Up	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.

Pharmacology for canagliflozin

Drug Class	Sodium-Glucose Cotransporter 2 Inhibitor
Mechanism of Action	P-Glycoprotein Inhibitors Sodium-Glucose Transporter 2 Inhibitors

Medical Subject Heading (MeSH) Categories for canagliflozin

Hypoglycemic Agents

Anatomical Therapeutic Chemical (ATC) Classes for canagliflozin

A10BK	Sodium-glucose co-transporter 2 (SGLT2) inhibitors
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

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
Janssen Pharms	INVOKAMET	canagliflozin; metformin hydrochloride	TABLET;ORAL	204353-004	Aug 8, 2014		RX	Yes	Yes	⤷ 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	INVOKANA	canagliflozin	TABLET;ORAL	204042-001	Mar 29, 2013		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			⤷ Sign Up
Janssen Pharms	INVOKAMET XR	canagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205879-004	Sep 20, 2016		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Janssen Pharms	INVOKANA	canagliflozin	TABLET;ORAL	204042-001	Mar 29, 2013		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

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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/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

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Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2005012318		⤷ Sign Up
Australia	2004261660	Substituted fused heterocyclic C-glycosides	⤷ Sign Up
China	104109155	Novel Compounds	⤷ Sign Up
South Korea	101101500		⤷ Sign Up
Portugal	2896397		⤷ Sign Up
Ecuador	SP066620	C-GLICOSIDOS HETEROCICLICOS FUSIONADOS SUSTITUIDOS	⤷ Sign Up
Japan	2008266328	NEW COMPOUND	⤷ Sign Up
>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,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	164 1-2014	Slovakia	⤷ Sign Up	PRODUCT NAME: KANAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/13/884/001 - EU/1/13/884/008 20131115
1651658	C20140011 00102	Estonia	⤷ Sign Up	PRODUCT NAME: KANAGLIFLOSIIN;REG NO/DATE: K(2013)8171 (LOPLIK) 15.11.2013
1651658	1490027-8	Sweden	⤷ Sign Up	PERIOD OF VALIDITY (FROM - UNTIL): 20240731 - 20281118
1651658	PA2014008	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	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	CA 2014 00024	Denmark	⤷ Sign Up	PRODUCT NAME: CANAGLIFLOZIN, HERUNDER CANAGLIFLOZINHEMIHYDRAT; REG. NO/DATE: EU/1/13/884/001-008 20131115
>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.