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Last Updated: March 19, 2024

Canagliflozin - Generic Drug Details


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What are the generic drug sources for canagliflozin and what is the scope of freedom to operate?

Canagliflozin is the generic ingredient in three branded drugs marketed by Janssen Pharms and is included in three NDAs. There are seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Canagliflozin has two hundred and sixty-eight patent family members in forty-seven countries.

There are twenty-one drug master file entries for canagliflozin. Three suppliers are listed for this compound. There are five tentative approvals for this compound.

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for canagliflozin
Generic Entry Date for canagliflozin*:
Constraining patent/regulatory exclusivity:
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 canagliflozin

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

SponsorPhase
The Innovation Institute for Artificial Intelligence in Medicine, Zhejiang UniversityN/A
College of Pharmaceutical Sciences at Zhejiang UniversityN/A
Zhang Xiaofeng,MDN/A

See all canagliflozin clinical trials

Generic filers with tentative approvals for CANAGLIFLOZIN
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial100MGTABLET; ORAL
⤷  Try a Trial⤷  Try a Trial300mgTABLET; ORAL
⤷  Try a Trial⤷  Try a Trial300MGTABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Medical Subject Heading (MeSH) Categories for canagliflozin
Paragraph IV (Patent) Challenges for CANAGLIFLOZIN
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 canagliflozin

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Pharms INVOKAMET XR canagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205879-004 Sep 20, 2016 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Janssen Pharms INVOKAMET canagliflozin; metformin hydrochloride TABLET;ORAL 204353-001 Aug 8, 2014 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Janssen Pharms INVOKAMET canagliflozin; metformin hydrochloride TABLET;ORAL 204353-002 Aug 8, 2014 RX Yes No ⤷  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 canagliflozin

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 canagliflozin

Country Patent Number Title Estimated Expiration
Malaysia 153702 CRYSTALLINE FORM OF 1-(B-D-GLUCOPYRANOSYL)-4-METHYL-3-[5-(4-FLUOROPHENYL)-2-THIENYLMETHYL]BENZENE HEMIHYDRATE ⤷  Try a Trial
Uruguay 30730 FORMA CRISTALINA DEL HEMIHIDRATO DE 1-(B (BETA)-D-GLUCOPIRANOSIL) -4-METIL-3-[5-(4-FLUOROFENIL) -2-TIENILMETIL]BENCENO ⤷  Try a Trial
New Zealand 577545 CRYSTALLINE FORM OF 1- (BETA-D-GLUCOPYRANOSYL) -4 -METHYL- 3- [5- (4 -FLUOROPHENYL) -2-THIENYLMETHYL] BENZENE HEMIHYDRATE ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for canagliflozin

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 164 1-2014 Slovakia ⤷  Try a Trial PRODUCT NAME: KANAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/13/884/001 - EU/1/13/884/008 20131115
1651658 1490027-8 Sweden ⤷  Try a Trial PERIOD OF VALIDITY (FROM - UNTIL): 20240731 - 20281118
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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