Canagliflozin - Generic Drug Details

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 six 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 seventy-one 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 three tentative approvals for this compound.

Summary for canagliflozin

International Patents:	271
US Patents:	6
Tradenames:	3
Applicants:	1
NDAs:	3
Drug Master File Entries:	21
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	83
Clinical Trials:	135
Patent Applications:	361
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

Recent Clinical Trials for canagliflozin

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

Sponsor	Phase
Omar Tarek Elfarargi	Phase 2/Phase 3
University of Michigan	Phase 2
Brigham and Women's Hospital	Phase 2

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	205879-003	Sep 20, 2016		RX	Yes	No			Y
Janssen Pharms	INVOKAMET	canagliflozin; metformin hydrochloride	TABLET;ORAL	204353-001	Aug 8, 2014		RX	Yes	No			Y
Janssen Pharms	INVOKAMET	canagliflozin; metformin hydrochloride	TABLET;ORAL	204353-004	Aug 8, 2014		RX	Yes	Yes			Y
Janssen Pharms	INVOKAMET XR	canagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205879-004	Sep 20, 2016		RX	Yes	Yes			Y
Janssen Pharms	INVOKANA	canagliflozin	TABLET;ORAL	204042-002	Mar 29, 2013		RX	Yes	Yes			Y
Janssen Pharms	INVOKANA	canagliflozin	TABLET;ORAL	204042-002	Mar 29, 2013		RX	Yes	Yes			Y	Y
Janssen Pharms	INVOKAMET	canagliflozin; metformin hydrochloride	TABLET;ORAL	204353-003	Aug 8, 2014		RX	Yes	No

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
Costa Rica	8402	INDAZOL-O-GLUCOSIDOS SUSTITUTOS
Spain	2844401
Eurasian Patent Organization	200600351	НОВЫЕ СОЕДИНЕНИЯ, ОБЛАДАЮЩИЕ ИНГИБИРУЮЩЕЙ АКТИВНОСТЬЮ В ОТНОШЕНИИ НАТРИЙЗАВИСИМОГО ТРАНСПОРТЁРА
Serbia	20060321	SUPSTITUISANI SPOJENI HETEROCIKLIČNI C-GLIKOZIDI (SUBSTITUTED FUSED HETEROCYCLIC C-GLYCOSIDES)
Ukraine	93135	КРИСТАЛІЧНА ФОРМА ГЕМІГІДРАТУ 1-(β-D-ГЛЮКОПІРАНОЗИЛ)-4-МЕТИЛ-3-[5-(4-ФТОРФЕНІЛ)-2-ТІЕНІЛМЕТИЛ]БЕНЗОЛУ[КРИСТАЛЛИЧЕСКАЯ ФОРМА ГЕМИГИДРАТА 1-(b-D-ГЛЮКОПИРАНОЗИЛ)-4-МЕТИЛ-3-[5-(4-ФТОРФЕНИЛ)-2-ТИЭНИЛМЕТИЛ]БЕНЗОЛА (CRYSTALLINE FORM OF 1-(в-D-GLUCOPYRANOSYL)-4-METHYL-3-[5-(4-FLUOROPHENYL)-2-THIENYLMETHYL] BENZENE HEMIHYDRATE)
Eurasian Patent Organization	201291217	ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ, СОДЕРЖАЩИЕ ПРОИЗВОДНЫЕ 1-(β-D-ГЛЮКОПИРАНОЗИЛ)-2-ТИЕНИЛМЕТИЛБЕНЗОЛА КАК ИНГИБИТОРЫ НЗПГ
Malaysia	147375	INDOLE DERIVATIVES

Supplementary Protection Certificates for canagliflozin

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1651658	637	Finland
1651658	29/2014	Austria		PRODUCT NAME: CANAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/13/884 20131115
1651658	CA 2014 00024	Denmark		PRODUCT NAME: CANAGLIFLOZIN, HERUNDER CANAGLIFLOZINHEMIHYDRAT; REG. NO/DATE: EU/1/13/884/001-008 20131115
1651658	C01651658/01	Switzerland		PRODUCT NAME: CANAGLIFLOZIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 62956 29.01.2014
1651658	SPC/GB14/032	United Kingdom		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
1651658	2014/029	Ireland		PRODUCT NAME: CANAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/13/884/001-004 20131119
1651658	14C0034	France		PRODUCT NAME: CANAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/13/884/001-008 20131119