Is Exelixis, Inc. FDA approved?

Exelixis, Inc. holds no registered establishment of its own; 6 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does Exelixis, Inc. make?

6 products are listed under Exelixis, Inc. in the openFDA NDC Directory, most often as tablet; kit; capsule. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Exelixis, Inc.

Data as of 24 Sept 2026 · How to read this entry

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Registered sites: 0
Active NDC listings: 6
Live patents: 41
Exclusivities: 1
Countries: 0

Catalogue

Drug listings by form and route

6 active NDC listings: 6 human prescription drug. By marketing category: NDA 6.

Dosage form	NDCs
tablet	3
kit	2
capsule	1

Route	NDCs
oral	4

Labeller name on the listing	NDCs
exelixis, inc.	6

Exclusivity

Patents and exclusivities

Patent	Product	Covers	Expiry
11091439	CABOMETYX, COMETRIQcabozantinib s-malate	substance	Jan 2030
11091440	CABOMETYX, COMETRIQcabozantinib s-malate	product	Jan 2030
11098015	CABOMETYX, COMETRIQcabozantinib s-malate	use	Jan 2030
8877776	CABOMETYX, COMETRIQcabozantinib s-malate	substance, product	Oct 2030
10034873	CABOMETYXcabozantinib s-malate	use	Jul 2031
10039757	CABOMETYXcabozantinib s-malate	use	Jul 2031
11298349	CABOMETYX, COMETRIQcabozantinib s-malate	product	Feb 2032
12128039	CABOMETYX, COMETRIQcabozantinib s-malate	product	Feb 2032
9717720	COMETRIQcabozantinib s-malate	product	Feb 2032
9724342	CABOMETYXcabozantinib s-malate	product	Jul 2033

Product	Exclusivity	Until
CABOMETYXCABOZANTINIB S-MALATE	ODE-530 Orphan drug	Mar 2032

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
CABOMETYX	cabozantinib	tablet, oral	42388-023NDA
CABOMETYX	cabozantinib	tablet, oral	42388-024NDA
CABOMETYX	cabozantinib	tablet, oral	42388-025NDA
COMETRIQ	cabozantinib	kit	42388-011NDA
COMETRIQ	cabozantinib	kit	42388-012NDA
COMETRIQ	cabozantinib	capsule, oral	42388-013NDA

Enquiry

Common questions

Is Exelixis, Inc. FDA approved?: Exelixis, Inc. holds no registered establishment of its own; 6 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does Exelixis, Inc. make?: 6 products are listed under Exelixis, Inc. in the openFDA NDC Directory, most often as tablet; kit; capsule. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.