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Last Updated: January 30, 2023

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 six 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 seventy-one 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 three tentative approvals for this compound.

Recent Clinical Trials for canagliflozin

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

SponsorPhase
Omar Tarek ElfarargiPhase 2/Phase 3
University of MichiganPhase 2
Brigham and Women's HospitalPhase 2

See all canagliflozin clinical trials

Generic filers with tentative approvals for CANAGLIFLOZIN
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing100MGTABLET; ORAL
See Plans and PricingSee Plans and Pricing300mgTABLET; ORAL
See Plans and PricingSee Plans and Pricing300MGTABLET;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 205879-003 Sep 20, 2016 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Janssen Pharms INVOKAMET canagliflozin; metformin hydrochloride TABLET;ORAL 204353-001 Aug 8, 2014 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Janssen Pharms INVOKAMET canagliflozin; metformin hydrochloride TABLET;ORAL 204353-004 Aug 8, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Janssen Pharms INVOKAMET XR canagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205879-004 Sep 20, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing 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 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
Janssen Pharms INVOKAMET canagliflozin; metformin hydrochloride TABLET;ORAL 204353-003 Aug 8, 2014 RX Yes No See Plans and Pricing See Plans and Pricing 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 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
Costa Rica 8402 INDAZOL-O-GLUCOSIDOS SUSTITUTOS See Plans and Pricing
Spain 2844401 See Plans and Pricing
Eurasian Patent Organization 200600351 НОВЫЕ СОЕДИНЕНИЯ, ОБЛАДАЮЩИЕ ИНГИБИРУЮЩЕЙ АКТИВНОСТЬЮ В ОТНОШЕНИИ НАТРИЙЗАВИСИМОГО ТРАНСПОРТЁРА See Plans and Pricing
Serbia 20060321 SUPSTITUISANI SPOJENI HETEROCIKLIČNI C-GLIKOZIDI (SUBSTITUTED FUSED HETEROCYCLIC C-GLYCOSIDES) See Plans and Pricing
Ukraine 93135 КРИСТАЛІЧНА ФОРМА ГЕМІГІДРАТУ 1-(β-D-ГЛЮКОПІРАНОЗИЛ)-4-МЕТИЛ-3-[5-(4-ФТОРФЕНІЛ)-2-ТІЕНІЛМЕТИЛ]БЕНЗОЛУ[КРИСТАЛЛИЧЕСКАЯ ФОРМА ГЕМИГИДРАТА 1-(b-D-ГЛЮКОПИРАНОЗИЛ)-4-МЕТИЛ-3-[5-(4-ФТОРФЕНИЛ)-2-ТИЭНИЛМЕТИЛ]БЕНЗОЛА (CRYSTALLINE FORM OF 1-(в-D-GLUCOPYRANOSYL)-4-METHYL-3-[5-(4-FLUOROPHENYL)-2-THIENYLMETHYL] BENZENE HEMIHYDRATE) See Plans and Pricing
Eurasian Patent Organization 201291217 ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ, СОДЕРЖАЩИЕ ПРОИЗВОДНЫЕ 1-(β-D-ГЛЮКОПИРАНОЗИЛ)-2-ТИЕНИЛМЕТИЛБЕНЗОЛА КАК ИНГИБИТОРЫ НЗПГ See Plans and Pricing
Malaysia 147375 INDOLE DERIVATIVES See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for canagliflozin

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1651658 637 Finland See Plans and Pricing
1651658 29/2014 Austria See Plans and Pricing PRODUCT NAME: CANAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/13/884 20131115
1651658 CA 2014 00024 Denmark See Plans and Pricing PRODUCT NAME: CANAGLIFLOZIN, HERUNDER CANAGLIFLOZINHEMIHYDRAT; REG. NO/DATE: EU/1/13/884/001-008 20131115
1651658 C01651658/01 Switzerland See Plans and Pricing PRODUCT NAME: CANAGLIFLOZIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 62956 29.01.2014
1651658 SPC/GB14/032 United Kingdom See Plans and Pricing PRODUCT NAME: CANAGLIFLOZIN; REGISTERED: UK EU/1/13/884/001 20131119; UK EU/1/13/884/002 20131119; UK EU/1/13/884/003 20131119; UK EU/1/13/884/004 20131119; UK EU/1/13/884/005 20131119; UK EU/1/13/884/006 20131119; UK EU/1/13/884/007 20131119; UK EU/1/13/884/008 20131119
1651658 2014/029 Ireland See Plans and Pricing PRODUCT NAME: CANAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/13/884/001-004 20131119
1651658 14C0034 France 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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