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Last Updated: October 24, 2019

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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.

Recent Clinical Trials for canagliflozin

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

SponsorPhase
Petra PharmaPhase 1/Phase 2
Zhongshan Hospital Xiamen UniversityPhase 4
Peking Union Medical College HospitalPhase 4

See all canagliflozin clinical trials

Recent Litigation for canagliflozin

Identify potential future generic entrants

District Court Litigation
Case NameDate
MITSUBISHI TANABE PHARMA CORPORATION v. MSN LABORATORIES PRIVATE LTD.2019-10-14
MITSUBISHI TANABE PHARMA CORPORATION v. LUPIN LIMITED2019-02-27
MITSUBISHI TANABE PHARMA CORPORATION v. LUPIN LIMITED2018-01-09

See all canagliflozin litigation

Medical Subject Heading (MeSH) Categories for canagliflozin
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   Start Trial   Start Trial Y   Start Trial
Janssen Pharms INVOKAMET XR canagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205879-003 Sep 20, 2016 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Janssen Pharms INVOKAMET canagliflozin; metformin hydrochloride TABLET;ORAL 204353-004 Aug 8, 2014 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Janssen Pharms INVOKAMET canagliflozin; metformin hydrochloride TABLET;ORAL 204353-003 Aug 8, 2014 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Janssen Pharms INVOKANA canagliflozin TABLET;ORAL 204042-001 Mar 29, 2013 RX Yes No   Start Trial   Start Trial   Start Trial
Janssen Pharms INVOKAMET canagliflozin; metformin hydrochloride TABLET;ORAL 204353-003 Aug 8, 2014 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Janssen Pharms INVOKANA canagliflozin TABLET;ORAL 204042-002 Mar 29, 2013 RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for canagliflozin

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

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Merck
Moodys
Medtronic
McKinsey
Johnson and Johnson

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