Question 1

Is there a generic for Canagliflozin?

Accepted Answer

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.

Question 2

What is the reference-listed drug for Canagliflozin?

Accepted Answer

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

Question 3

What patents protect Canagliflozin?

Accepted Answer

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.

Question 4

Does Canagliflozin have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 4 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.

Question 5

What dosage forms of Canagliflozin are approved?

Accepted Answer

Canagliflozin is approved in the following dosage form: tablet.

Product	Applicant	Application	TE	Approved
CANAGLIFLOZIN×2	AUROBINDO PHARMA LTD	ANDA 210386	—	Apr 20, 2026
CANAGLIFLOZIN×2	APOTEX	ANDA 210449	AB	Apr 14, 2026

Patent	Expires	In	Type
7943788	Jul 14, 2027	in 1 yr 1 mo	SubstanceProduct
8513202	Dec 03, 2027	in 1 yr 6 mo	SubstanceProductU-493
7943788*PED	Jan 14, 2028	in 1 yr 7 mo
8513202*PED	Jun 03, 2028	in 2 yr
7943582	Feb 26, 2029	in 2 yr 9 mo	SubstanceProductU-2441
7943582*PED	Aug 26, 2029	in 3 yr 3 mo

Canagliflozin

Brand (NDA) products · tablet

Generic (ANDA) products (2)

Marketing exclusivity (4)

Listed patents (6)

Canagliflozin — frequently asked questions

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