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Last Updated: March 3, 2024

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INVOKANA Drug Patent Profile


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Which patents cover Invokana, and when can generic versions of Invokana launch?

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

This drug has two hundred and sixty-eight patent family members in forty-seven 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.

DrugPatentWatch® 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 May 11, 2031. This may change due to patent challenges or generic licensing.

There have been seventeen 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.

There are five tentative approvals for the generic drug (canagliflozin), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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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

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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
Brigham and Women's HospitalPhase 2
University of Colorado, DenverPhase 2
Boston Medical CenterPhase 2

See all INVOKANA clinical trials

Paragraph IV (Patent) Challenges for INVOKANA
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 INVOKANA

INVOKANA is protected by nineteen US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of INVOKANA is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting INVOKANA

Pharmaceutical formulations
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF TYPE 2 DIABETES MELLITUS WITH 300 MG CANAGLIFLOZIN PER DAY

Pharmaceutical formulations
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: REDUCTION OF RISK OF END STAGE KIDNEY DISEASE, DOUBLING OF SERUM CREATININE, CARDIOVASCULAR DEATH, AND HOSPITALIZATION FOR HEART FAILURE IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS

Pharmaceutical formulations
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: REDUCTION OF RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS WITH 300 MG CANAGLIFLOZIN PER DAY

Pharmaceutical formulations
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: REDUCTION OF RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS WITH 100 MG CANAGLIFLOZIN PER DAY

Pharmaceutical formulations
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: REDUCTION OF RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS

Pharmaceutical formulations
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF TYPE 2 DIABETES MELLITUS WITH 100 MG CANAGLIFLOZIN PER DAY

Pharmaceutical formulations
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF TYPE 2 DIABETES MELLITUS

Pharmaceutical formulations
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: REDUCTION OF RISK OF END STAGE KIDNEY DISEASE, DOUBLING OF SERUM CREATININE, CARDIOVASCULAR DEATH, AND HOSPITALIZATION FOR HEART FAILURE IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS WITH 300 MG CANAGLIFLOZIN PER DAY

Pharmaceutical formulations
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: REDUCTION OF RISK OF END STAGE KIDNEY DISEASE, DOUBLING OF SERUM CREATININE, CARDIOVASCULAR DEATH, AND HOSPITALIZATION FOR HEART FAILURE IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS WITH 100 MG CANAGLIFLOZIN PER DAY

Crystalline form of 1-(.beta.-D-glucopyransoyl)-4-methyl-3-[5-(4-fluorophenyl)-2- thienylmethyl]benzene hemihydrate
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: REDUCTION OF RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS

Crystalline form of 1-(.beta.-D-glucopyransoyl)-4-methyl-3-[5-(4-fluorophenyl)-2- thienylmethyl]benzene hemihydrate
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: REDUCTION OF RISK OF END STAGE KIDNEY DISEASE, DOUBLING OF SERUM CREATININE, CARDIOVASCULAR DEATH, AND HOSPITALIZATION FOR HEART FAILURE IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS

Crystalline form of 1-(.beta.-D-glucopyransoyl)-4-methyl-3-[5-(4-fluorophenyl)-2- thienylmethyl]benzene hemihydrate
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF TYPE 2 DIABETES MELLITUS

Glucopyranoside compound
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Glucopyranoside compound
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF TYPE 2 DIABETES MELLITUS

Glucopyranoside compound
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: REDUCTION OF RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS

Glucopyranoside compound
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: REDUCTION OF RISK OF END STAGE KIDNEY DISEASE, DOUBLING OF SERUM CREATININE, CARDIOVASCULAR DEATH, AND HOSPITALIZATION FOR HEART FAILURE IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS

Crystalline form of 1-(.beta.-D-glucopyranosyl)-4-methyl-3-[5-(4-fluorophenyl)-2-thienylmethy- l]benzene hemihydrate
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF TYPE 2 DIABETES MELLITUS

Crystalline form of 1-(.beta.-D-glucopyranosyl)-4-methyl-3-[5-(4-fluorophenyl)-2-thienylmethy- l]benzene hemihydrate
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: REDUCTION OF RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS

Crystalline form of 1-(.beta.-D-glucopyranosyl)-4-methyl-3-[5-(4-fluorophenyl)-2-thienylmethy- l]benzene hemihydrate
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: REDUCTION OF RISK OF END STAGE KIDNEY DISEASE, DOUBLING OF SERUM CREATININE, CARDIOVASCULAR DEATH, AND HOSPITALIZATION FOR HEART FAILURE IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS

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

EU/EMA Drug Approvals for INVOKANA

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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for INVOKANA

When does loss-of-exclusivity occur for INVOKANA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 1036
Estimated Expiration: ⤷  Try a Trial

Australia

Patent: 11250909
Estimated Expiration: ⤷  Try a Trial

Patent: 15207823
Estimated Expiration: ⤷  Try a Trial

Patent: 17210661
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 2012028857
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 99204
Estimated Expiration: ⤷  Try a Trial

Chile

Patent: 12003162
Estimated Expiration: ⤷  Try a Trial

China

Patent: 2883726
Estimated Expiration: ⤷  Try a Trial

Patent: 8354930
Estimated Expiration: ⤷  Try a Trial

Colombia

Patent: 30184
Estimated Expiration: ⤷  Try a Trial

Costa Rica

Patent: 120626
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0161231
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 18093
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 68988
Estimated Expiration: ⤷  Try a Trial

Ecuador

Patent: 12012290
Estimated Expiration: ⤷  Try a Trial

Eurasian Patent Organization

Patent: 2365
Estimated Expiration: ⤷  Try a Trial

Patent: 1291217
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 68988
Estimated Expiration: ⤷  Try a Trial

Guatemala

Patent: 1200303
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 59250
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 29853
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 2858
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 27406
Estimated Expiration: ⤷  Try a Trial

Patent: 13526534
Estimated Expiration: ⤷  Try a Trial

Patent: 16147866
Estimated Expiration: ⤷  Try a Trial

Jordan

Patent: 77
Estimated Expiration: ⤷  Try a Trial

Lithuania

Patent: 68988
Estimated Expiration: ⤷  Try a Trial

Malaysia

Patent: 7718
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 9570
Estimated Expiration: ⤷  Try a Trial

Patent: 12013090
Estimated Expiration: ⤷  Try a Trial

Montenegro

Patent: 531
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 3128
Estimated Expiration: ⤷  Try a Trial

Nicaragua

Patent: 1200168
Estimated Expiration: ⤷  Try a Trial

Peru

Patent: 130227
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 68988
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 68988
Estimated Expiration: ⤷  Try a Trial

San Marino

Patent: 01600338
Estimated Expiration: ⤷  Try a Trial

Serbia

Patent: 202
Estimated Expiration: ⤷  Try a Trial

Singapore

Patent: 5525
Estimated Expiration: ⤷  Try a Trial

Patent: 201506114U
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 68988
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1931209
Estimated Expiration: ⤷  Try a Trial

Patent: 130062947
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 96291
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 99360
Estimated Expiration: ⤷  Try a Trial

Patent: 1206447
Estimated Expiration: ⤷  Try a Trial

Ukraine

Patent: 0207
Estimated Expiration: ⤷  Try a Trial

Uruguay

Patent: 380
Estimated Expiration: ⤷  Try a Trial

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering INVOKANA around the world.

Country Patent Number Title Estimated Expiration
Norway 20120585 ⤷  Try a Trial
Panama 8759401 ⤷  Try a Trial
Argentina 048376 C- GLICOSIDOS HETEROCICLOS FUSIONADOS SUSTITUIDOS ⤷  Try a Trial
Ecuador SP066623 BENCIMIDAZOL-, BENZTRIAZOL-, Y BENCIMIDAZOLONA-O-GLUCOSIDOS SUSTITUIDOS ⤷  Try a Trial
Brazil PI0606806 compostos indólicos, suas composições e seus usos ⤷  Try a Trial
Mexico 2007009178 DERIVADOS DE INDOL. (INDOLE DERIVATIVES.) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for INVOKANA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1651658 C20140011 00102 Estonia ⤷  Try a Trial PRODUCT NAME: KANAGLIFLOSIIN;REG NO/DATE: K(2013)8171 (LOPLIK) 15.11.2013
1651658 122014000050 Germany ⤷  Try a Trial PRODUCT NAME: CANAGLIFLOZIN; REGISTRATION NO/DATE: EU/1 /13/884/001-008 20131115
1651658 PA2014008 Lithuania ⤷  Try a 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 C01651658/01 Switzerland ⤷  Try a Trial PRODUCT NAME: CANAGLIFLOZIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 62956 29.01.2014
1651658 PA2014008,C1651658 Lithuania ⤷  Try a 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 29/2014 Austria ⤷  Try a Trial PRODUCT NAME: CANAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/13/884 20131115
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.