CANAGLIFLOZIN - Generic Drug Details

What are the generic drug sources for canagliflozin and what is the scope of patent protection?

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:	140
Patent Applications:	355
Formulation / Manufacturing:	see details
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

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
College of Pharmaceutical Sciences at Zhejiang University	N/A
Zhang Xiaofeng,MD	N/A
The Innovation Institute for Artificial Intelligence in Medicine, Zhejiang University	N/A

See all CANAGLIFLOZIN clinical trials

Generic filers with tentative approvals for CANAGLIFLOZIN

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

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 XR	canagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205879-001	Sep 20, 2016		RX	Yes	No			Y
Janssen Pharms	INVOKANA	canagliflozin	TABLET;ORAL	204042-001	Mar 29, 2013		RX	Yes	No
Janssen Pharms	INVOKAMET XR	canagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205879-002	Sep 20, 2016		RX	Yes	No			Y	Y

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

International Patents for CANAGLIFLOZIN

Country	Patent Number	Title	Estimated Expiration
South Korea	101146095
Lithuania	2568988
Portugal	2896397

Supplementary Protection Certificates for CANAGLIFLOZIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1651658	CA 2014 00024	Denmark		PRODUCT NAME: CANAGLIFLOZIN, HERUNDER CANAGLIFLOZINHEMIHYDRAT; REG. NO/DATE: EU/1/13/884/001-008 20131115
1651658	164 1-2014	Slovakia		PRODUCT NAME: KANAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/13/884/001 - EU/1/13/884/008 20131115
1651658	122014000050	Germany		PRODUCT NAME: CANAGLIFLOZIN; REGISTRATION NO/DATE: EU/1 /13/884/001-008 20131115