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Last Updated: October 1, 2022

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 seventy-one 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.

Annual sales in 2019 were $1.2bn, indicating a strong incentive for generic entry (peak sales were $2.5bn in 2018).

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 three 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 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
University of MichiganPhase 2
Brigham and Women's HospitalPhase 2
University of Colorado, DenverPhase 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 and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of INVOKANA is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF TYPE 2 DIABETES MELLITUS WITH 300 MG CANAGLIFLOZIN PER DAY

Pharmaceutical formulations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: REDUCTION OF RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS

Pharmaceutical formulations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF TYPE 2 DIABETES MELLITUS WITH 100 MG CANAGLIFLOZIN PER DAY

Pharmaceutical formulations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF TYPE 2 DIABETES MELLITUS

Pharmaceutical formulations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF TYPE 2 DIABETES MELLITUS

Glucopyranoside compound
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Glucopyranoside compound
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF TYPE 2 DIABETES MELLITUS

Glucopyranoside compound
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: REDUCTION OF RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS

Glucopyranoside compound
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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

FDA Regulatory Exclusivity protecting INVOKANA

TO REDUCE THE RISK OF END-STAGE KIDNEY DISEASE, DOUBLING OF SERUM CREATININE, CARDIOVASCULAR DEATH, AND HOSPITALIZATION FOR HEART FAILURE IN ADULTS WITH TYPE 2 DIABETES MELLITUS AND DIABETIC NEPHROPATHY WITH ALBUMINURIA > 300 MG/DAY
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Janssen Pharms INVOKANA canagliflozin TABLET;ORAL 204042-001 Mar 29, 2013 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Janssen Pharms INVOKANA canagliflozin TABLET;ORAL 204042-002 Mar 29, 2013 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
>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: See Plans and Pricing

Australia

Patent: 11250909
Estimated Expiration: See Plans and Pricing

Patent: 15207823
Estimated Expiration: See Plans and Pricing

Patent: 17210661
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2012028857
Estimated Expiration: See Plans and Pricing

Canada

Patent: 99204
Estimated Expiration: See Plans and Pricing

Chile

Patent: 12003162
Estimated Expiration: See Plans and Pricing

China

Patent: 2883726
Estimated Expiration: See Plans and Pricing

Patent: 8354930
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 30184
Estimated Expiration: See Plans and Pricing

Costa Rica

Patent: 120626
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0161231
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 18093
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 68988
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 12012290
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 2365
Estimated Expiration: See Plans and Pricing

Patent: 1291217
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 68988
Estimated Expiration: See Plans and Pricing

Guatemala

Patent: 1200303
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 59250
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 29853
Estimated Expiration: See Plans and Pricing

Israel

Patent: 2858
Estimated Expiration: See Plans and Pricing

Japan

Patent: 27406
Estimated Expiration: See Plans and Pricing

Patent: 13526534
Estimated Expiration: See Plans and Pricing

Patent: 16147866
Estimated Expiration: See Plans and Pricing

Jordan

Patent: 77
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 68988
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 7718
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 9570
Estimated Expiration: See Plans and Pricing

Patent: 12013090
Estimated Expiration: See Plans and Pricing

Montenegro

Patent: 531
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 3128
Estimated Expiration: See Plans and Pricing

Nicaragua

Patent: 1200168
Estimated Expiration: See Plans and Pricing

Peru

Patent: 130227
Estimated Expiration: See Plans and Pricing

Poland

Patent: 68988
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 68988
Estimated Expiration: See Plans and Pricing

San Marino

Patent: 01600338
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 202
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 5525
Estimated Expiration: See Plans and Pricing

Patent: 201506114U
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 68988
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1931209
Estimated Expiration: See Plans and Pricing

Patent: 130062947
Estimated Expiration: See Plans and Pricing

Spain

Patent: 96291
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 99360
Estimated Expiration: See Plans and Pricing

Patent: 1206447
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 0207
Estimated Expiration: See Plans and Pricing

Uruguay

Patent: 380
Estimated Expiration: See Plans and Pricing

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
Croatia P20171838 See Plans and Pricing
South Korea 20060132539 NOVEL COMPOUNDS See Plans and Pricing
Norway 344354 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for INVOKANA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1651658 PA2014008 Lithuania See Plans and Pricing 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 See Plans and Pricing PRODUCT NAME: CANAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/13/884/001-008 20131119
1651658 300670 Netherlands See Plans and Pricing PRODUCT NAME: CANAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/13/884/001-008 20131119
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Harvard Business School
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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.