Is there a generic for Canagliflozin?

Yes. The FDA Orange Book lists 2 approved generic (ANDA) applications for Canagliflozin, referencing the brand INVOKANA. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Canagliflozin?

INVOKANA (NDA 204042, JANSSEN PHARMS) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Canagliflozin?

The Orange Book lists 6 patents against Canagliflozin products, with the earliest listed expiry in 2027. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Does Canagliflozin have FDA marketing exclusivity?

Yes. The Orange Book records 2 marketing-exclusivity periods for Canagliflozin. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

What dosage forms of Canagliflozin are approved?

Canagliflozin is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Canagliflozin

Canagliflozin: 1 brand, 2 generics; first approved Mar 29, 2013; generic available.

Generic available2 exclusivity periodsHas discontinued products

Generic status & protection

Generic available: 2 ANDA applications approved.

Earliest patent expiry Jul 14, 2027Latest exclusivity ends Jun 18, 2028

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Jul 14, 2027

in 9 mo

Brand (NDA) products

Originator applications

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INVOKANARLD
JANSSEN 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

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

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CANAGLIFLOZIN
AUROBINDO PHARMA LTDANDA 21038620262 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG TABLET ORAL Discontinued -
300MG TABLET ORAL Discontinued -
CANAGLIFLOZIN
APOTEXANDA 21044920262 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG TABLET ORAL Rx AB
300MG TABLET ORAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG	TABLET	ORAL	Discontinued	-
300MG	TABLET	ORAL	Discontinued	-

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

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Patent expiryExclusivity endToday

Marketing exclusivity

Hatch-Waxman

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NPPNew patient population exclusivity (3 years)
Dec 18, 2027
in 1 yr 2 mo
PEDPediatric exclusivity (adds 6 months)
Jun 18, 2028
in 1 yr 8 mo

Listed patents

Orange Book patent file

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Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
7943788	Jul 14, 2027	in 9 mo	SubstanceProduct
8513202	Dec 03, 2027	in 1 yr 2 mo	SubstanceProductU-493
7943788*PED	Jan 14, 2028	in 1 yr 3 mo
8513202*PED	Jun 03, 2028	in 1 yr 8 mo
7943582	Feb 26, 2029	in 2 yr 5 mo	SubstanceProductU-2441
7943582*PED	Aug 26, 2029	in 2 yr 11 mo

Approval history

FDA approval span

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First approval

Mar 29, 2013

13 yr 9 mo ago

Most recent approval

Apr 20, 2026

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

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