FDA Orange Book

Generic for Cabometyx

Cabometyx contains cabozantinib s-malate. 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 Cabometyx is cabozantinib s-malate. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Cabometyx products in the Orange Book

Cabometyx products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
tablet, oral	EQ 20MG BASE	Marketed (Rx)	AB	1	AB
tablet, oral	EQ 40MG BASE	Marketed (Rx)	AB	1	AB
tablet, oral	EQ 60MG BASE	Marketed (Rx)	AB	1	AB

NDA 208692, held by EXELIXIS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic cabozantinib s-malate

Approved generic versions of Cabometyx
Company	ANDA	TE code	Approved	Strengths
MSN LABORATORIES PRIVATE LTD	213878	AB (A-rated, therapeutically equivalent)	August 14, 2026	EQ 20MG BASE, EQ 40MG BASE, EQ 60MG BASE

Cabometyx patents

Patents listed for Cabometyx
Patent	Expires	Covers	Use code	NDA
7579473	August 14, 2026	Drug substance, Drug product	None	208692
11098015	January 15, 2030	Method of use	U-4131	208692
11098015	January 15, 2030	Method of use	U-4156	208692
11098015	January 15, 2030	Method of use	U-2488	208692
11098015	January 15, 2030	Method of use	U-1220	208692
11098015	January 15, 2030	Method of use	U-1480	208692
11098015	January 15, 2030	Method of use	U-3225	208692
11091440	January 15, 2030	Drug product	None	208692
11091439	January 15, 2030	Drug substance	None	208692
8877776	October 8, 2030	Drug substance, Drug product	U-3225	208692
10039757	July 18, 2031	Method of use	U-1480	208692
10034873	July 18, 2031	Method of use	U-2488	208692
12128039	February 10, 2032	Drug product	U-1220	208692
12128039	February 10, 2032	Drug product	U-1480	208692
12128039	February 10, 2032	Drug product	U-2488	208692
12128039	February 10, 2032	Drug product	U-3225	208692
12128039	February 10, 2032	Drug product	U-4131	208692
12128039	February 10, 2032	Drug product	U-4156	208692
11298349	February 10, 2032	Drug product	None	208692
9724342	July 9, 2033	Drug product	None	208692

Cabometyx exclusivity

Exclusivity listed for Cabometyx
Code	Meaning	Expires	NDA
ODE-227	Orphan drug exclusivity	January 14, 2026	208692
ODE-375	Orphan drug exclusivity	September 17, 2028	208692
ODE-530	Orphan drug exclusivity	March 26, 2032	208692

Cabometyx NDC codes

Questions

Is there a generic for Cabometyx?

Yes. The generic name for Cabometyx is cabozantinib s-malate. 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 Cabometyx?

The active ingredient in Cabometyx is cabozantinib s-malate, per the FDA Orange Book.

When does the Cabometyx patent expire?

The last patent listed for Cabometyx in the Orange Book expires July 9, 2033. 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.