FDA Orange Book

Generic for Invokana

Invokana contains canagliflozin. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.

Source: FDA Orange Book data file dated 2026-10-09. Publisher page

Yes. The generic name for Invokana is canagliflozin. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Invokana products in the Orange Book

Invokana products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
tablet, oral	100MG	Marketed (Rx)	AB	1	AB
tablet, oral	300MG	Marketed (Rx)	AB	1	AB

NDA 204042, held by JANSSEN PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic canagliflozin

Approved generic versions of Invokana
Company	ANDA	TE code	Approved	Strengths
APOTEX INC	210449	AB (A-rated, therapeutically equivalent)	April 14, 2026	100MG, 300MG

Invokana patents

Patents listed for Invokana
Patent	Expires	Covers	Use code	NDA
7943788	July 14, 2027	Drug substance, Drug product	None	204042
8513202	December 3, 2027	Drug substance, Drug product	U-493	204042
8513202	December 3, 2027	Drug substance, Drug product	U-2441	204042
8513202	December 3, 2027	Drug substance, Drug product	U-2632	204042
7943788*PED	January 14, 2028	Method of use	None	204042
8513202*PED	June 3, 2028	Method of use	None	204042
7943582	February 26, 2029	Drug substance, Drug product	U-2441	204042
7943582	February 26, 2029	Drug substance, Drug product	U-2632	204042
7943582	February 26, 2029	Drug substance, Drug product	U-493	204042
7943582*PED	August 26, 2029	Method of use	None	204042

Invokana exclusivity

Exclusivity listed for Invokana
Code	Meaning	Expires	NDA
NPP	New patient population	December 18, 2027	204042
PED	Pediatric exclusivity	June 18, 2028	204042

Invokana NDC codes

Questions

Is there a generic for Invokana?

Yes. The generic name for Invokana is canagliflozin. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

What is the generic name for Invokana?

The active ingredient in Invokana is canagliflozin, per the FDA Orange Book.

When does the Invokana patent expire?

The last patent listed for Invokana in the Orange Book expires August 26, 2029. A listed patent expiry date is not a generic launch date.

What does a therapeutic equivalence code mean?

In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.