Question 1

Is there a generic for Cabozantinib s-malate?

Accepted Answer

The FDA Orange Book does not currently list an approved generic (ANDA) for Cabozantinib s-malate. It is available as 2 brand (NDA) applications.

Question 2

What is the reference-listed drug for Cabozantinib s-malate?

Accepted Answer

CABOMETYX (NDA 208692, EXELIXIS INC) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Cabozantinib s-malate?

Accepted Answer

The Orange Book lists 11 patents against Cabozantinib s-malate products, with the earliest listed expiry in 2026. 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 Cabozantinib s-malate have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 9 marketing-exclusivity periods for Cabozantinib s-malate. 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 Cabozantinib s-malate are approved?

Accepted Answer

Cabozantinib s-malate is approved in the following dosage forms: capsule, tablet.

Product	Applicant	Application	TE	Approved
CABOMETYXRLD×3	EXELIXIS INC	NDA 208692	—	Apr 25, 2016
COMETRIQRLD×2	EXELIXIS	NDA 203756	—	Nov 29, 2012

Patent	Expires	In	Type
7579473	Aug 14, 2026	in 2 mo	SubstanceProduct
11098015	Jan 15, 2030	in 3 yr 8 mo	U-1617
11091440	Jan 15, 2030	in 3 yr 8 mo	Product
11091439	Jan 15, 2030	in 3 yr 8 mo	Substance
8877776	Oct 08, 2030	in 4 yr 4 mo	SubstanceProductU-1617
10039757	Jul 18, 2031	in 5 yr 2 mo	U-1480
10034873	Jul 18, 2031	in 5 yr 2 mo	U-2488
12128039	Feb 10, 2032	in 5 yr 9 mo	ProductU-1617
11298349	Feb 10, 2032	in 5 yr 9 mo	Product
9717720	Feb 10, 2032	in 5 yr 9 mo	Product
9724342	Jul 09, 2033	in 7 yr 2 mo	Product

Cabozantinib s-malate

Brand (NDA) products · capsule, tablet

Marketing exclusivity (9)

Listed patents (11)

Cabozantinib s-malate — frequently asked questions

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