Orange Book product · Brand (NDA)
CABOMETYX
CABOZANTINIB S-MALATE
At a glance
Apr 25, 2016
Approved
Brand (NDA)
Application
Not listed
TE code
20
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 25, 2016
10 yr 4 mo ago
Exclusivity ends · ODE-227
Orphan-drug exclusivity (7 years)
Jan 14, 2026
5 mo ago
Today
Patent 7579473 expires
Listed drug substance patent expiration.
Aug 14, 2026
in 2 mo
Exclusivity ends · ODE-375
Orphan-drug exclusivity (7 years)
Sep 17, 2028
in 2 yr 3 mo
Patent 11091439 expires
Listed drug substance patent expiration.
Jan 15, 2030
in 3 yr 8 mo
Patent 11091440 expires
Listed drug product patent expiration.
Jan 15, 2030
in 3 yr 8 mo
Patent 11098015 expires
Listed method-of-use patent (U-4131) expiration.
Jan 15, 2030
in 3 yr 8 mo
Patent 11098015 expires
Listed method-of-use patent (U-4156) expiration.
Jan 15, 2030
in 3 yr 8 mo
Patent 11098015 expires
Listed method-of-use patent (U-2488) expiration.
Jan 15, 2030
in 3 yr 8 mo
Patent 11098015 expires
Listed method-of-use patent (U-1220) expiration.
Jan 15, 2030
in 3 yr 8 mo
Patent 11098015 expires
Listed method-of-use patent (U-1480) expiration.
Jan 15, 2030
in 3 yr 8 mo
Patent 11098015 expires
Listed method-of-use patent (U-3225) expiration.
Jan 15, 2030
in 3 yr 8 mo
Patent 8877776 expires
Listed drug substance patent expiration.
Oct 08, 2030
in 4 yr 4 mo
Patent 10034873 expires
Listed method-of-use patent (U-2488) expiration.
Jul 18, 2031
in 5 yr 2 mo
Patent 10039757 expires
Listed method-of-use patent (U-1480) expiration.
Jul 18, 2031
in 5 yr 2 mo
Patent 11298349 expires
Listed drug product patent expiration.
Feb 10, 2032
in 5 yr 9 mo
Patent 12128039 expires
Listed drug product patent expiration.
Feb 10, 2032
in 5 yr 9 mo
Patent 12128039 expires
Listed drug product patent expiration.
Feb 10, 2032
in 5 yr 9 mo
Patent 12128039 expires
Listed drug product patent expiration.
Feb 10, 2032
in 5 yr 9 mo
Patent 12128039 expires
Listed drug product patent expiration.
Feb 10, 2032
in 5 yr 9 mo
Patent 12128039 expires
Listed drug product patent expiration.
Feb 10, 2032
in 5 yr 9 mo
Patent 12128039 expires
Listed drug product patent expiration.
Feb 10, 2032
in 5 yr 9 mo
Exclusivity ends · ODE-530
Orphan-drug exclusivity (7 years)
Mar 26, 2032
in 5 yr 10 mo
Patent 9724342 expires
Listed drug product patent expiration.
Jul 09, 2033
in 7 yr 2 mo
Pharmaceutical detail
Active ingredient
CABOZANTINIB S-MALATE
Strength
EQ 20MG BASE
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 208692
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Marketing exclusivity (3)
- ODE-227Orphan-drug exclusivity (7 years)
Jan 14, 2026
5 mo ago
- ODE-375Orphan-drug exclusivity (7 years)
Sep 17, 2028
in 2 yr 3 mo
- ODE-530Orphan-drug exclusivity (7 years)
Mar 26, 2032
in 5 yr 10 mo
Listed patents (20)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7579473 | Aug 14, 2026 | in 2 mo | SubstanceProduct |
| 11091439 | Jan 15, 2030 | in 3 yr 8 mo | Substance |
| 11091440 | Jan 15, 2030 | in 3 yr 8 mo | Product |
| 11098015 | Jan 15, 2030 | in 3 yr 8 mo | U-4131 |
| 11098015 | Jan 15, 2030 | in 3 yr 8 mo | U-4156 |
| 11098015 | Jan 15, 2030 | in 3 yr 8 mo | U-2488 |
| 11098015 | Jan 15, 2030 | in 3 yr 8 mo | U-1220 |
| 11098015 | Jan 15, 2030 | in 3 yr 8 mo | U-1480 |
| 11098015 | Jan 15, 2030 | in 3 yr 8 mo | U-3225 |
| 8877776 | Oct 08, 2030 | in 4 yr 4 mo | SubstanceProductU-3225 |
| 10034873 | Jul 18, 2031 | in 5 yr 2 mo | U-2488 |
| 10039757 | Jul 18, 2031 | in 5 yr 2 mo | U-1480 |
| 11298349 | Feb 10, 2032 | in 5 yr 9 mo | Product |
| 12128039 | Feb 10, 2032 | in 5 yr 9 mo | ProductU-1220 |
| 12128039 | Feb 10, 2032 | in 5 yr 9 mo | ProductU-1480 |
| 12128039 | Feb 10, 2032 | in 5 yr 9 mo | ProductU-2488 |
| 12128039 | Feb 10, 2032 | in 5 yr 9 mo | ProductU-3225 |
| 12128039 | Feb 10, 2032 | in 5 yr 9 mo | ProductU-4131 |
| 12128039 | Feb 10, 2032 | in 5 yr 9 mo | ProductU-4156 |
| 9724342 | Jul 09, 2033 | in 7 yr 2 mo | Product |
