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Canagliflozin - Generic Drug Details

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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 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 sixteen patent family members in forty-four countries.

There are twenty-one drug master file entries for canagliflozin. Three suppliers are listed for this compound.

Summary for canagliflozin

International Patents:	216
US Patents:	6
Tradenames:	3
Applicants:	1
NDAs:	3
Drug Master File Entries:	21
Suppliers / Packagers:	3
Bulk Api Vendors:	65
Clinical Trials:	110
Patent Applications:	165
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for canagliflozin
DailyMed Link:	canagliflozin at DailyMed

Recent Clinical Trials for canagliflozin

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

Sponsor	Phase
Petra Pharma	Phase 1/Phase 2
Zhongshan Hospital Xiamen University	Phase 4
Peking Union Medical College Hospital	Phase 4

See all canagliflozin clinical trials

Recent Litigation for canagliflozin

Identify potential future generic entrants

District Court Litigation

Case Name	Date
MITSUBISHI TANABE PHARMA CORPORATION v. MSN LABORATORIES PRIVATE LTD.	2019-10-14
MITSUBISHI TANABE PHARMA CORPORATION v. LUPIN LIMITED	2019-02-27
MITSUBISHI TANABE PHARMA CORPORATION v. LUPIN LIMITED	2018-01-09

See all canagliflozin litigation

Pharmacology for canagliflozin

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

Medical Subject Heading (MeSH) Categories for canagliflozin

Hypoglycemic Agents

Synonyms for canagliflozin

(1S)-1,5-Anhydro-1-(3-((5-(4-fluorophenyl)-2-thienyl)methyl)-4-methylphenyl)-D-glucitol

(1S)-1,5-anhydro-1-(3-{[5-(4-fluorophenyl)-2-thienyl]methyl}-4-methyl-phenyl)-D-glucitol

(1S)-1,5-anhydro-1-(3-{[5-(4-fluorophenyl)-2-thienyl]methyl}-4-methylphenyl)-D-glucitol

(1s)-1,5-anhydro-1-c-(3-((5-(4-fluorophenyl)-2-thienyl)methyl)-4-methylphenyl)-d-glucitol

(1S)-1,5-Anhydro-1-c-(3-((5-(4-fluorophenyl)thiophen-2-yl)methyl)-4-methylphenyl)-D-glucitol

(1S)-1,5-Anhydro-1-C-[3-[[5-(4-fluorophenyl)-2-thienyl]methyl]-4-methylphenyl]-D-glucitol

(2S,3R,4R,5S,6R)-2-(3-((5-(4-FLUOROPHENYL)THIOPHEN-2-YL)METHYL)-4-METHYLPHENYL)-6-(HYDROXYMETHYL)TETRAHYDRO-2H-PYRAN-3,4,5-TRIOL

(2S,3R,4R,5S,6R)-2-(3-{[5-(4-fluorophenyl)thiophen-2-yl]methyl}-4-methylphenyl)-6-(hydroxymethyl)oxane-3,4,5-triol

1-(Glucopyranosyl)-4-methyl-3-(5-(4-fluorophenyl)-2-thienylmethyl)benzene

6S49DGR869

842133-18-0

928672-86-0

ABP000358

AC-26303

ACN-034470

AJ-108287

AKOS025401827

API0013707

BC638828

BCP9000477

BCPP000303

BDBM50386885

C24H25FO5S

Canagliflozin [INN]

Canagliflozin anhydrous

canagliflozin hemihydrate

Canagliflozin hydrate

Canagliflozin/

CC0249

CCG-229581

CHEBI:73274

CHEMBL2048484

CS-0522

D-Glucitol, 1,5-anhydro-1-C-(3-((5-(4-fluorophenyl)-2-thienyl)methyl)-4- methylphenyl)-, (1S)-

D-glucitol, 1,5-anhydro-1-c-(3-((5-(4-fluorophenyl)-2-thienyl)methyl)-4- methylphenyl)-, (1s)-

D-Glucitol, 1,5-anhydro-1-C-[3-[[5-(4-fluorophenyl)-2-thienyl]methyl]-4-methylphenyl]-, (1S)-

DB08907

FT-0664217

GLU008

GTPL4582

HSDB 8284

HY-10451

Invokana

J-500391

JNJ 24831754

JNJ 24831754AAA

JNJ 24831754ZAE

JNJ-28431754

KB-271653

KB-75871

KS-1443

MLS006011126

MolPort-021-804-941

PB22925

Q-4516

RL05180

s2760

SCHEMBL157162

SMR004702906

SW219119-1

TA 7284

TA-7284

Tube102

UNII-6S49DGR869

XTNGUQKDFGDXSJ-ZXGKGEBGSA-N

Y0287

ZINC43207238

Paragraph IV (Patent) Challenges for CANAGLIFLOZIN

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

International Patents for canagliflozin

Country	Patent Number	Estimated Expiration
Taiwan	200637852
Norway	2014009
Eurasian Patent Organization	009768
Australia	2004260761
Argentina	048376
Eurasian Patent Organization	011515
China	104109155

Supplementary Protection Certificates for canagliflozin

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1651658	1490027-8	Sweden		PERIOD OF VALIDITY (FROM - UNTIL): 20240731 - 20281118
1651658	164 1-2014	Slovakia		PRODUCT NAME: KANAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/13/884/001 - EU/1/13/884/008 20131115
1651658	2014/029	Ireland		PRODUCT NAME: CANAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/13/884/001-004 20131119
1651658	300670	Netherlands		PRODUCT NAME: CANAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/13/884/001-008 20131119
1651658	C300670	Netherlands		PRODUCT NAME: CANAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/13/884/001-008 20131118
1651658	PA2014008,C1651658	Lithuania		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		PRODUCT NAME: CANAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/13/884/001-008 20131115