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.
Summary for canagliflozin
International Patents: | 271 |
US Patents: | 6 |
Tradenames: | 3 |
Applicants: | 1 |
NDAs: | 3 |
Drug Master File Entries: | 21 |
Finished Product Suppliers / Packagers: | 3 |
Raw Ingredient (Bulk) Api Vendors: | 83 |
Clinical Trials: | 135 |
Patent Applications: | 361 |
Formulation / Manufacturing: | see details |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for canagliflozin |
What excipients (inactive ingredients) are in canagliflozin? | canagliflozin excipients list |
DailyMed Link: | canagliflozin at DailyMed |
Recent Clinical Trials for canagliflozin
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Omar Tarek Elfarargi | Phase 2/Phase 3 |
University of Michigan | Phase 2 |
Brigham and Women's Hospital | Phase 2 |
Generic filers with tentative approvals for CANAGLIFLOZIN
Applicant | Application No. | Strength | Dosage Form |
See Plans and Pricing | See Plans and Pricing | 100MG | TABLET; ORAL |
See Plans and Pricing | See Plans and Pricing | 300mg | TABLET; ORAL |
See Plans and Pricing | See Plans and Pricing | 300MG | TABLET;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for canagliflozin
Drug Class | Sodium-Glucose Cotransporter 2 Inhibitor |
Mechanism of Action | P-Glycoprotein Inhibitors Sodium-Glucose Transporter 2 Inhibitors |
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
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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