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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Summary for INVOKANA
| International Patents: | 268 |
| US Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 128 |
| Clinical Trials: | 23 |
| Patent Applications: | 978 |
| Drug Prices: | Drug price information for INVOKANA |
| Drug Sales Revenues: | Drug sales revenues for INVOKANA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for INVOKANA |
| What excipients (inactive ingredients) are in INVOKANA? | INVOKANA excipients list |
| DailyMed Link: | INVOKANA at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for INVOKANA
*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
| Sponsor | Phase |
|---|---|
| University of Michigan | Phase 2 |
| Brigham and Women's Hospital | Phase 2 |
| University of Colorado, Denver | Phase 2 |
Pharmacology for INVOKANA
| Drug Class | Sodium-Glucose Cotransporter 2 Inhibitor |
| Mechanism of Action | P-Glycoprotein Inhibitors Sodium-Glucose Transporter 2 Inhibitors |
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 ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF TYPE 2 DIABETES MELLITUS WITH 300 MG CANAGLIFLOZIN PER DAY
Pharmaceutical formulations
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: REDUCTION OF RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
Pharmaceutical formulations
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF TYPE 2 DIABETES MELLITUS WITH 100 MG CANAGLIFLOZIN PER DAY
Pharmaceutical formulations
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF TYPE 2 DIABETES MELLITUS
Pharmaceutical formulations
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF TYPE 2 DIABETES MELLITUS
Glucopyranoside compound
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Glucopyranoside compound
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF TYPE 2 DIABETES MELLITUS
Glucopyranoside compound
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: REDUCTION OF RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
Glucopyranoside compound
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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 | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Janssen Pharms | INVOKANA | canagliflozin | TABLET;ORAL | 204042-002 | Mar 29, 2013 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Janssen Pharms | INVOKANA | canagliflozin | TABLET;ORAL | 204042-001 | Mar 29, 2013 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Janssen Pharms | INVOKANA | canagliflozin | TABLET;ORAL | 204042-002 | Mar 29, 2013 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Janssen Pharms | INVOKANA | canagliflozin | TABLET;ORAL | 204042-002 | Mar 29, 2013 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Janssen Pharms | INVOKANA | canagliflozin | TABLET;ORAL | 204042-001 | Mar 29, 2013 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Janssen Pharms | INVOKANA | canagliflozin | TABLET;ORAL | 204042-002 | Mar 29, 2013 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| >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: ⤷ Sign Up
Australia
Patent: 11250909
Estimated Expiration: ⤷ Sign Up
Patent: 15207823
Estimated Expiration: ⤷ Sign Up
Patent: 17210661
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 2012028857
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 99204
Estimated Expiration: ⤷ Sign Up
Chile
Patent: 12003162
Estimated Expiration: ⤷ Sign Up
China
Patent: 2883726
Estimated Expiration: ⤷ Sign Up
Patent: 8354930
Estimated Expiration: ⤷ Sign Up
Colombia
Patent: 30184
Estimated Expiration: ⤷ Sign Up
Costa Rica
Patent: 120626
Estimated Expiration: ⤷ Sign Up
Croatia
Patent: 0161231
Estimated Expiration: ⤷ Sign Up
Cyprus
Patent: 18093
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 68988
Estimated Expiration: ⤷ Sign Up
Ecuador
Patent: 12012290
Estimated Expiration: ⤷ Sign Up
Eurasian Patent Organization
Patent: 2365
Estimated Expiration: ⤷ Sign Up
Patent: 1291217
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 68988
Estimated Expiration: ⤷ Sign Up
Guatemala
Patent: 1200303
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 59250
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 29853
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 2858
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 27406
Estimated Expiration: ⤷ Sign Up
Patent: 13526534
Estimated Expiration: ⤷ Sign Up
Patent: 16147866
Estimated Expiration: ⤷ Sign Up
Jordan
Patent: 77
Estimated Expiration: ⤷ Sign Up
Lithuania
Patent: 68988
Estimated Expiration: ⤷ Sign Up
Malaysia
Patent: 7718
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 9570
Estimated Expiration: ⤷ Sign Up
Patent: 12013090
Estimated Expiration: ⤷ Sign Up
Montenegro
Patent: 531
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 3128
Estimated Expiration: ⤷ Sign Up
Nicaragua
Patent: 1200168
Estimated Expiration: ⤷ Sign Up
Peru
Patent: 130227
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 68988
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 68988
Estimated Expiration: ⤷ Sign Up
San Marino
Patent: 01600338
Estimated Expiration: ⤷ Sign Up
Serbia
Patent: 202
Estimated Expiration: ⤷ Sign Up
Singapore
Patent: 5525
Estimated Expiration: ⤷ Sign Up
Patent: 201506114U
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 68988
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 1931209
Estimated Expiration: ⤷ Sign Up
Patent: 130062947
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 96291
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 99360
Estimated Expiration: ⤷ Sign Up
Patent: 1206447
Estimated Expiration: ⤷ Sign Up
Ukraine
Patent: 0207
Estimated Expiration: ⤷ Sign Up
Uruguay
Patent: 380
Estimated Expiration: ⤷ Sign Up
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 |
|---|---|---|---|
| World Intellectual Property Organization (WIPO) | 2005012318 | ⤷ Sign Up | |
| Australia | 2004261660 | Substituted fused heterocyclic C-glycosides | ⤷ Sign Up |
| China | 104109155 | Novel Compounds | ⤷ Sign Up |
| South Korea | 101101500 | ⤷ Sign Up | |
| Portugal | 2896397 | ⤷ Sign Up | |
| Ecuador | SP066620 | C-GLICOSIDOS HETEROCICLICOS FUSIONADOS SUSTITUIDOS | ⤷ Sign Up |
| Japan | 2008266328 | NEW COMPOUND | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for INVOKANA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1651658 | PA2014008,C1651658 | Lithuania | ⤷ Sign Up | 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 | 164 1-2014 | Slovakia | ⤷ Sign Up | PRODUCT NAME: KANAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/13/884/001 - EU/1/13/884/008 20131115 |
| 1651658 | C20140011 00102 | Estonia | ⤷ Sign Up | PRODUCT NAME: KANAGLIFLOSIIN;REG NO/DATE: K(2013)8171 (LOPLIK) 15.11.2013 |
| 1651658 | 1490027-8 | Sweden | ⤷ Sign Up | PERIOD OF VALIDITY (FROM - UNTIL): 20240731 - 20281118 |
| 1651658 | PA2014008 | Lithuania | ⤷ Sign Up | 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 | C 2014 017 | Romania | ⤷ Sign Up | PRODUCT NAME: CANAGLIFLOZIN; NATIONAL AUTHORISATION NUMBER: EU/1/13/884; DATE OF NATIONAL AUTHORISATION: 20131115; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/884; DATE OF FIRST AUTHORISATION IN EEA: 20131115 |
| 1651658 | CA 2014 00024 | Denmark | ⤷ Sign Up | PRODUCT NAME: CANAGLIFLOZIN, HERUNDER CANAGLIFLOZINHEMIHYDRAT; REG. NO/DATE: EU/1/13/884/001-008 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.
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