Is there a generic for Cabozantinib s-malate?

Yes. The FDA Orange Book lists 1 approved generic (ANDA) application for Cabozantinib s-malate, referencing the brand CABOMETYX. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

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

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

What patents protect Cabozantinib s-malate?

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.

Does Cabozantinib s-malate have FDA marketing exclusivity?

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.

What dosage forms of Cabozantinib s-malate are approved?

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

FDA Orange Book · active-ingredient family

Cabozantinib s-malate

Cabozantinib s-malate: 2 brands, 1 generic; first approved Nov 29, 2012; generic available.

Generic available9 exclusivity periods

Generic status & protection

Generic available: 1 ANDA application approved.

Earliest patent expiry Aug 14, 2026Latest exclusivity ends Mar 26, 2032

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Aug 14, 2026

2 mo ago

Brand (NDA) products

Originator applications

CABOMETYXRLD
EXELIXIS INCNDA 20869220163 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 20MG BASE TABLET ORAL Rx AB
EQ 40MG BASE TABLET ORAL Rx AB
EQ 60MG BASE TABLET ORAL Rx AB
COMETRIQRLD
EXELIXISNDA 20375620122 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 20MG BASE CAPSULE ORAL Rx —
EQ 80MG BASE CAPSULE ORAL Rx —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 20MG BASE	TABLET	ORAL	Rx	AB
EQ 40MG BASE	TABLET	ORAL	Rx	AB
EQ 60MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 20MG BASE	CAPSULE	ORAL	Rx	—
EQ 80MG BASE	CAPSULE	ORAL	Rx	—

Generic (ANDA) products (1)

Abbreviated applications

CABOZANTINIB S-MALATE
MSNANDA 21387820263 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 20MG BASE TABLET ORAL Rx AB
EQ 40MG BASE TABLET ORAL Rx AB
EQ 60MG BASE TABLET ORAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 20MG BASE	TABLET	ORAL	Rx	AB
EQ 40MG BASE	TABLET	ORAL	Rx	AB
EQ 60MG BASE	TABLET	ORAL	Rx	AB

Patent & exclusivity timeline

Protection horizon

Patent expiryExclusivity endToday

Marketing exclusivity

Hatch-Waxman

ODE-227Orphan-drug exclusivity (7 years)
Jan 14, 2026
9 mo ago
ODE-375Orphan-drug exclusivity (7 years)
Sep 17, 2028
in 2 yr
ODE-530Orphan-drug exclusivity (7 years)
Mar 26, 2032
in 5 yr 6 mo
ODE-227Orphan-drug exclusivity (7 years)
Jan 14, 2026
9 mo ago
ODE-375Orphan-drug exclusivity (7 years)
Sep 17, 2028
in 2 yr
ODE-530Orphan-drug exclusivity (7 years)
Mar 26, 2032
in 5 yr 6 mo
ODE-227Orphan-drug exclusivity (7 years)
Jan 14, 2026
9 mo ago
ODE-375Orphan-drug exclusivity (7 years)
Sep 17, 2028
in 2 yr
ODE-530Orphan-drug exclusivity (7 years)
Mar 26, 2032
in 5 yr 6 mo

Listed patents

Orange Book patent file

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
7579473	Aug 14, 2026	2 mo ago	SubstanceProduct
11098015	Jan 15, 2030	in 3 yr 4 mo	U-1617
11091440	Jan 15, 2030	in 3 yr 4 mo	Product
11091439	Jan 15, 2030	in 3 yr 4 mo	Substance
8877776	Oct 08, 2030	in 4 yr 1 mo	SubstanceProductU-1617
10039757	Jul 18, 2031	in 4 yr 10 mo	U-1480
10034873	Jul 18, 2031	in 4 yr 10 mo	U-2488
12128039	Feb 10, 2032	in 5 yr 5 mo	ProductU-1617
11298349	Feb 10, 2032	in 5 yr 5 mo	Product
9717720	Feb 10, 2032	in 5 yr 5 mo	Product
9724342	Jul 09, 2033	in 6 yr 10 mo	Product

Approval history

FDA approval span

First approval

Nov 29, 2012

14 yr 1 mo ago

Most recent approval

Aug 14, 2026

2 mo ago

Approvals span 2012–2026 across 3 FDA applications.

Brand (NDA) 267%

Generic (ANDA) 133%

Cabozantinib s-malate: 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.

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