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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 canagliflozin 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 ten patent family members in forty-three countries.

There are twenty drug master file entries for canagliflozin. One supplier is listed for this compound.

Summary for canagliflozin

International Patents:	210
US Patents:	6
Tradenames:	3
Applicants:	1
NDAs:	3
Drug Master File Entries:	20
Suppliers / Packagers:	1
Bulk Api Vendors:	52
Clinical Trials:	101
Patent Applications:	152
Formulation / Manufacturing:	see details
Drug Prices:	see low prices
DailyMed Link:	canagliflozin at DailyMed

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)-TETRAHYDRO-6-(HYDROXYMETHYL)-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/

Canagliflozin/metformin

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)-

D08DFX

D0S8XP

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

MFCD18251436

MLS006011126

MolPort-021-804-941

PB22925

Q-4516

RL05180

s2760

SCHEMBL157162

SMR004702906

TA 7284

TA-7284

Tube102

UNII-6S49DGR869

XTNGUQKDFGDXSJ-ZXGKGEBGSA-N

Y0287

ZINC43207238

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

Non-Orange Book US Patents for canagliflozin

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
7,521,430	N-glucoside compounds having an inhibitory activity against sodium-dependent glucose transporter
7,511,021	Substituted indazole-O-glucosides
7,094,764	Substituted benzimidazole-, Benztriazole-, and benzimidazolone-O-glucosides
8,202,984	Glucopyranoside compound

International Patents for canagliflozin

Country	Document Number	Estimated Expiration
Ukraine	93135
Serbia	20060079
South Africa	200700550
Taiwan	200510441

Supplementary Protection Certificates for canagliflozin

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
426	Luxembourg		PRODUCT NAME: CANAGLIFLOZINE
00670	Netherlands		PRODUCT NAME: CANAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/13/884/001-008 20131118
2014008,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
0140011 00102	Estonia		PRODUCT NAME: KANAGLIFLOSIIN;REG NO/DATE: K(2013)8171 (LOPLIK) 15.11.2013