FDA Orange Book · active-ingredient family
Canagliflozin
Canagliflozin: 1 brand, 2 generics; first approved Mar 29, 2013; generic available.
Generic available4 exclusivity periodsHas discontinued products
Generic status & protection
Generic available: 2 ANDA applications approved.
Earliest patent expiry Latest exclusivity ends
Brands (NDA)
1
Generics (ANDA)
2
Listed patents
6
Next patent expiry
Jul 14, 2027
in 9 mo
Brand (NDA) products
Originator applications
- INVOKANARLDJANSSEN PHARMSNDA 20404220132 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Rx AB 300MG TABLET ORAL Rx AB
Generic (ANDA) products (2)
Abbreviated applications
- CANAGLIFLOZINAUROBINDO PHARMA LTDANDA 21038620262 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — 300MG TABLET ORAL Discontinued — - CANAGLIFLOZINAPOTEXANDA 21044920262 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Rx AB 300MG TABLET ORAL Rx AB
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Marketing exclusivity
Hatch-Waxman
- NPPNew patient population exclusivity (3 years)
in 1 yr 2 mo
- PEDPediatric exclusivity (adds 6 months)
in 1 yr 9 mo
- NPPNew patient population exclusivity (3 years)
in 1 yr 2 mo
- PEDPediatric exclusivity (adds 6 months)
in 1 yr 9 mo
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 7943788 | in 9 mo | SubstanceProduct | |
| 8513202 | in 1 yr 2 mo | SubstanceProductU-493 | |
| 7943788*PED | in 1 yr 3 mo | ||
| 8513202*PED | in 1 yr 8 mo | ||
| 7943582 | in 2 yr 5 mo | SubstanceProductU-2441 | |
| 7943582*PED | in 2 yr 11 mo |
Approval history
FDA approval span
First approval
13 yr 9 mo ago
Most recent approval
6 mo ago
Approvals span 2013–2026 across 3 FDA applications.
Brand (NDA) 133%
Generic (ANDA) 267%
Canagliflozin: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
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