FDA Orange Book · active-ingredient family
Selinexor
Selinexor is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:XPOVIO · NDA 212306
1
Brand (NDA)
0
Generics (ANDA)
11
Listed patents
17
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| XPOVIORLD×6 | KARYOPHARM THERAPS | NDA 212306 | — | Mar 10, 2025 |
Marketing exclusivity (17)
- 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
- ODE-257Orphan-drug exclusivity (7 years)
Jul 03, 2026
in 14 d
- ODE-310Orphan-drug exclusivity (7 years)
Jun 22, 2027
in 1 yr
- ODE-346Orphan-drug exclusivity (7 years)
Dec 18, 2027
in 1 yr 6 mo
- ODE*FDA marketing exclusivity
Jun 22, 2027
in 1 yr
- ODE*FDA marketing exclusivity
Dec 18, 2027
in 1 yr 6 mo
- ODE*FDA marketing exclusivity
Jul 03, 2026
in 14 d
- ODE*FDA marketing exclusivity
Dec 18, 2027
in 1 yr 6 mo
- ODE*FDA marketing exclusivity
Jul 03, 2026
in 14 d
- ODE*FDA marketing exclusivity
Jun 22, 2027
in 1 yr
- 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
- ODE*FDA marketing exclusivity
Jul 03, 2026
in 14 d
- ODE*FDA marketing exclusivity
Dec 18, 2027
in 1 yr 6 mo
Listed patents (11)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11787771 | Jul 26, 2032 | in 6 yr 2 mo | U-3018 |
| 9079865 | Jul 26, 2032 | in 6 yr 2 mo | U-3018 |
| 10544108 | Jul 26, 2032 | in 6 yr 2 mo | U-3018 |
| 11034660 | Jul 26, 2032 | in 6 yr 2 mo | U-2584 |
| 12291508 | 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 |
| 11746102 | Aug 14, 2035 | in 9 yr 3 mo | U-2584 |
| 11753401 | Aug 14, 2035 | in 9 yr 3 mo | ProductU-2584 |
| 11807629 | Aug 14, 2035 | in 9 yr 3 mo | Substance |
Selinexor — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
