INVOKANA Drug Patent 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 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
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: | 1,206 |
Formulation / Manufacturing: | see details |
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
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
Sponsor | Phase |
---|---|
Brigham and Women's Hospital | Phase 2 |
University of Colorado, Denver | Phase 2 |
Boston Medical Center | Phase 2 |
Pharmacology for INVOKANA
Drug Class | Sodium-Glucose Cotransporter 2 Inhibitor |
Mechanism of Action | P-Glycoprotein Inhibitors Sodium-Glucose Transporter 2 Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for INVOKANA
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 | |||
>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 |
---|---|---|---|
South Korea | 20070065454 | NOVEL COMPOUNDS HAVING INHIBITORY ACTIVITY AGAINST SODIUM-DEPENDENT TRANSPORTER | ⤷ Try a Trial |
Portugal | 1651658 | ⤷ Try a Trial | |
Singapore | 10201506114U | PHARMACEUTICAL FORMULATIONS COMPRISING 1 - (BETA-D-GLUCOPYRANOSYL) - 2 -THIENYLMETHYLBENZENE DERIVATIVES AS INHIBITORS OF SGLT | ⤷ Try a Trial |
European Patent Office | 1679966 | BENZIMIDAZOLE-, BENZTRIAZOLE- ET BENZIMIDAZOLONE-O-GLUCOSIDES SUBSTITUES (SUBSTITUTED BENZIMIDAZOLE-, BENZTRIAZOLE-, AND BENZIMIDAZOLONE-O-GLUCOSIDES) | ⤷ 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 | 637 | Finland | ⤷ Try a Trial | |
1651658 | 29/2014 | Austria | ⤷ Try a Trial | PRODUCT NAME: CANAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/13/884 20131115 |
1651658 | 92426 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: CANAGLIFLOZINE |
1651658 | C300670 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: CANAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/13/884/001-008 20131118 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |