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Last Updated: January 22, 2020

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INVOKANA Drug Profile

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When do Invokana patents expire, and when can generic versions of Invokana launch?

Invokana is a drug marketed by Janssen Pharms and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and nineteen patent family members in forty-four countries.

The generic ingredient in INVOKANA is canagliflozin. There are twenty-one drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the canagliflozin profile page.

US ANDA Litigation and Generic Entry Outlook for Invokana

Invokana was eligible for patent challenges on March 29, 2017.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 26, 2029. This may change due to patent challenges or generic licensing.

Annual sales in 2017 were $1.9bn, indicating a strong incentive for generic entry (peak sales were $2.0bn in 2015).

There have been seven patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Very High

  Start Trial

Drug patent expirations by year for INVOKANA
Drug Prices for INVOKANA

See drug prices for INVOKANA

Drug Sales Revenue Trends for INVOKANA

See drug sales revenues for INVOKANA

Generic Entry Opportunity Date for INVOKANA
Generic Entry Date for INVOKANA*:
Constraining patent/regulatory exclusivity:
NDA:
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 INVOKANA

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

SponsorPhase
Petra PharmaPhase 1/Phase 2
Janssen Inc.N/A
Université de SherbrookeN/A

See all INVOKANA clinical trials

Recent Litigation for INVOKANA

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 INVOKANA litigation

Synonyms for INVOKANA
(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-methylphenyl)-D-glucitol hemihydrate
(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-(3-{[5-(4-fluorophenyl)-2-thienyl]methyl}-4-methylphenyl)-D-glucitol--water (2/1)
(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 hemihydrate
(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
(1S)-1,5-Anhydro-1-C-[3-[[5-(4-fluorophenyl)-2-thienyl]methyl]-4-methylphenyl]-D-glucitol hydrate (2:1)
(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)tetrahydro-2H-pyran-3,4,5-triol hemihydrate
(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 hydrate(2:1)
(2S,3R,4R,5S,6R)-2-(3-{[5-(4-fluorophenyl)thiophen-2-yl]methyl}-4-methylphenyl)-6-(hydroxymethyl)oxane-3,4,5-triol
0SAC974Z85
1-(beta-D-glucopyranosyl)-4-methyl-3-[5-(4-fluorophenyl)-2-thienylmethyl]benzene hemihydrate
1-(Glucopyranosyl)-4-methyl-3-(5-(4-fluorophenyl)-2-thienylmethyl)benzene
6S49DGR869
842133-18-0
928672-86-0
ABP000358
AC-26303
AC-29556
ACN-034470
AJ-108287
AK198969
AKOS025401827
AKOS026674130
API0013707
BC638828
BCP9000477
BCPP000303
BDBM50386885
C24H25FO5S
Cagliflozin hemihydrate
Canagliflozin
Canagliflozin (USAN/INN)
Canagliflozin [INN]
Canagliflozin [USAN:INN]
Canagliflozin anhydrous
canagliflozin hemihydrate
Canagliflozin hydrate
Canagliflozin hydrate (JAN)
Canagliflozin/
CC0249
CCG-229581
CHEBI:73272
CHEBI:73274
CHEMBL2048484
CHEMBL2103841
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)-, hydrate (2:1), (1S)-
D-Glucitol, 1,5-anhydro-1-C-[3-[[5-(4-fluorophenyl)-2-thienyl]methyl]-4-methylphenyl]-, (1S)-
D09592
DB08907
FT-0664217
FT-0699228
GLU008
GTPL4582
HSDB 8284
HY-10451
Invokana (TN)
J-500391
JNJ 24831754
JNJ 24831754AAA
JNJ 24831754ZAE
JNJ 28431754
JNJ-24831754-ZAE
JNJ-28431754
JNJ-28431754-AAA
KB-271653
KB-75871
KS-1443
MLS006011126
MolPort-021-804-941
MolPort-042-663-494
PB22925
Q-4516
RL05180
s2760
SCHEMBL157162
SCHEMBL681039
SMR004702906
SW219119-1
TA 7284
TA-7284
Tube102
UNII-0SAC974Z85
UNII-6S49DGR869
VHOFTEAWFCUTOS-TUGBYPPCSA-N
XTNGUQKDFGDXSJ-ZXGKGEBGSA-N
Y0287
ZINC43207238
Paragraph IV (Patent) Challenges for INVOKANA
Tradename Dosage Ingredient NDA Submissiondate
INVOKANA TABLET;ORAL canagliflozin 204042 2017-03-29

US Patents and Regulatory Information for INVOKANA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Pharms INVOKANA canagliflozin TABLET;ORAL 204042-002 Mar 29, 2013 RX Yes Yes   Start Trial   Start Trial   Start Trial
Janssen Pharms INVOKANA canagliflozin TABLET;ORAL 204042-001 Mar 29, 2013 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 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 INVOKANA canagliflozin TABLET;ORAL 204042-002 Mar 29, 2013 RX Yes Yes   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
Janssen Pharms INVOKANA canagliflozin TABLET;ORAL 204042-001 Mar 29, 2013 RX Yes No   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 INVOKANA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 92426 Luxembourg   Start Trial PRODUCT NAME: CANAGLIFLOZINE
1651658 CA 2014 00024 Denmark   Start Trial PRODUCT NAME: CANAGLIFLOZIN, HERUNDER CANAGLIFLOZINHEMIHYDRAT; REG. NO/DATE: EU/1/13/884/001-008 20131115
1651658 2014C/027 Belgium   Start Trial PRODUCT NAME: CANAGLIFLOZINE; AUTHORISATION NUMBER AND DATE: EU/1/13/884 20131119
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 C300670 Netherlands   Start Trial PRODUCT NAME: CANAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/13/884/001-008 20131118
1651658 2014/029 Ireland   Start Trial PRODUCT NAME: CANAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/13/884/001-004 20131119
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

McKesson
Express Scripts
Merck
Mallinckrodt
AstraZeneca
Medtronic

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