Orange Book product · Brand (NDA)
XPOVIO
SELINEXOR
At a glance
Mar 10, 2025
Approved
Brand (NDA)
Application
Not listed
TE code
19
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 10, 2025
1 yr 4 mo ago
Today
Exclusivity ends · ODE*
FDA marketing exclusivity
Jul 03, 2026
in 14 d
Exclusivity ends · ODE*
FDA marketing exclusivity
Jun 22, 2027
in 1 yr
Exclusivity ends · ODE*
FDA marketing exclusivity
Dec 18, 2027
in 1 yr 6 mo
Patent 10544108 expires
Listed method-of-use patent (U-3018) expiration.
Jul 26, 2032
in 6 yr 2 mo
Patent 10544108 expires
Listed method-of-use patent (U-2584) expiration.
Jul 26, 2032
in 6 yr 2 mo
Patent 11034660 expires
Listed method-of-use patent (U-2584) expiration.
Jul 26, 2032
in 6 yr 2 mo
Patent 11034660 expires
Listed method-of-use patent (U-3018) expiration.
Jul 26, 2032
in 6 yr 2 mo
Patent 11787771 expires
Listed method-of-use patent (U-3018) expiration.
Jul 26, 2032
in 6 yr 2 mo
Patent 11787771 expires
Listed method-of-use patent (U-2584) expiration.
Jul 26, 2032
in 6 yr 2 mo
Patent 12291508 expires
Listed method-of-use patent (U-2584) expiration.
Jul 26, 2032
in 6 yr 2 mo
Patent 12291508 expires
Listed method-of-use patent (U-3018) expiration.
Jul 26, 2032
in 6 yr 2 mo
Patent 9079865 expires
Listed method-of-use patent (U-3018) expiration.
Jul 26, 2032
in 6 yr 2 mo
Patent 9079865 expires
Listed method-of-use patent (U-2584) expiration.
Jul 26, 2032
in 6 yr 2 mo
Patent 9714226 expires
Listed drug substance patent expiration.
Jul 26, 2032
in 6 yr 2 mo
Patent 8999996 expires
Listed drug substance patent expiration.
Jul 03, 2033
in 7 yr 2 mo
Patent 10519139 expires
Listed drug substance patent expiration.
Aug 14, 2035
in 9 yr 3 mo
Patent 10519139 expires
Listed drug substance patent expiration.
Aug 14, 2035
in 9 yr 3 mo
Patent 11746102 expires
Listed method-of-use patent (U-2584) expiration.
Aug 14, 2035
in 9 yr 3 mo
Patent 11746102 expires
Listed method-of-use patent (U-3018) expiration.
Aug 14, 2035
in 9 yr 3 mo
Patent 11753401 expires
Listed drug product patent expiration.
Aug 14, 2035
in 9 yr 3 mo
Patent 11753401 expires
Listed drug product patent expiration.
Aug 14, 2035
in 9 yr 3 mo
Patent 11807629 expires
Listed drug substance patent expiration.
Aug 14, 2035
in 9 yr 3 mo
Pharmaceutical detail
Active ingredient
SELINEXOR
Strength
10MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 212306
Product number
005
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*FDA marketing exclusivity
Jul 03, 2026
in 14 d
- ODE*FDA marketing exclusivity
Jun 22, 2027
in 1 yr
- ODE*FDA marketing exclusivity
Dec 18, 2027
in 1 yr 6 mo
Listed patents (19)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10544108 | Jul 26, 2032 | in 6 yr 2 mo | U-3018 |
| 10544108 | Jul 26, 2032 | in 6 yr 2 mo | U-2584 |
| 11034660 | Jul 26, 2032 | in 6 yr 2 mo | U-2584 |
| 11034660 | Jul 26, 2032 | in 6 yr 2 mo | U-3018 |
| 11787771 | Jul 26, 2032 | in 6 yr 2 mo | U-3018 |
| 11787771 | Jul 26, 2032 | in 6 yr 2 mo | U-2584 |
| 12291508 | Jul 26, 2032 | in 6 yr 2 mo | U-2584 |
| 12291508 | Jul 26, 2032 | in 6 yr 2 mo | U-3018 |
| 9079865 | Jul 26, 2032 | in 6 yr 2 mo | U-3018 |
| 9079865 | Jul 26, 2032 | in 6 yr 2 mo | U-2584 |
| 9714226 | Jul 26, 2032 | in 6 yr 2 mo | SubstanceProduct |
| 8999996 | Jul 03, 2033 | in 7 yr 2 mo | SubstanceProduct |
| 10519139 | Aug 14, 2035 | in 9 yr 3 mo | SubstanceProductU-3018 |
| 10519139 | Aug 14, 2035 | in 9 yr 3 mo | SubstanceProductU-2584 |
| 11746102 | Aug 14, 2035 | in 9 yr 3 mo | U-2584 |
| 11746102 | Aug 14, 2035 | in 9 yr 3 mo | U-3018 |
| 11753401 | Aug 14, 2035 | in 9 yr 3 mo | ProductU-2584 |
| 11753401 | Aug 14, 2035 | in 9 yr 3 mo | ProductU-3018 |
| 11807629 | Aug 14, 2035 | in 9 yr 3 mo | Substance |
