selinexor · Karyopharm Theraps · NDA 212306
Xpovio
Earliest generic entry, as listed · earliest of 6 marketed strengths
14 Aug 2035
Blocked by patent: US 10519139, US 11746102, US 11753401, US 11807629.
Listed patents · 11 unexpired
20 Orange Book listing rows for 11 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 10519139 | drug substance, drug product, use U-2584, U-3018 | 14 Aug 2035 |
| US 10519139 listing row | drug substance, drug product, use U-2584 · sets the listed date | 14 Aug 2035 |
| US 10519139 listing row | drug substance, drug product, use U-3018 · sets the listed date | 14 Aug 2035 |
| US 11746102 | use U-2584, U-3018 | 14 Aug 2035 |
| US 11746102 listing row | use U-2584 · sets the listed date | 14 Aug 2035 |
| US 11746102 listing row | use U-3018 · sets the listed date | 14 Aug 2035 |
| US 11753401 | drug product, use U-2584, U-3018 | 14 Aug 2035 |
| US 11753401 listing row | drug product, use U-2584 · sets the listed date | 14 Aug 2035 |
| US 11753401 listing row | drug product, use U-3018 · sets the listed date | 14 Aug 2035 |
| US 11807629 | drug substance, drug product · sets the listed date | 14 Aug 2035 |
| US 8999996 | drug substance, drug product | 3 Jul 2033 |
| US 10544108 | use U-2584, U-3018 | 26 Jul 2032 |
| US 10544108 listing row | use U-2584 | 26 Jul 2032 |
| US 10544108 listing row | use U-3018 | 26 Jul 2032 |
| US 11034660 | use U-2584, U-3018 | 26 Jul 2032 |
| US 11034660 listing row | use U-2584 | 26 Jul 2032 |
| US 11034660 listing row | use U-3018 | 26 Jul 2032 |
| US 11787771 | use U-2584, U-2855, U-3018 | 26 Jul 2032 |
| US 11787771 listing row | use U-2584 | 26 Jul 2032 |
| US 11787771 listing row | use U-2855 | 26 Jul 2032 |
| US 11787771 listing row | use U-3018 | 26 Jul 2032 |
| US 12291508 | use U-2584, U-3018 | 26 Jul 2032 |
| US 12291508 listing row | use U-2584 | 26 Jul 2032 |
| US 12291508 listing row | use U-3018 | 26 Jul 2032 |
| US 9079865 | use U-2584, U-3018 | 26 Jul 2032 |
| US 9079865 listing row | use U-2584 | 26 Jul 2032 |
| US 9079865 listing row | use U-3018 | 26 Jul 2032 |
| US 9714226 | drug substance, drug product | 26 Jul 2032 |
Exclusivities · 3 unexpired
| ODE* | 18 Dec 2027 | |
| ODE-346 | orphan drug (7 years) | 18 Dec 2027 |
| ODE* | 22 Jun 2027 | |
| ODE-310 | orphan drug (7 years) | 22 Jun 2027 |
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 6
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 212306 · 001 · RLD | tablet, oral | 20MG | 14 Aug 2035 |
| 212306 · 002 · RLD | tablet, oral | 40MG | 14 Aug 2035 |
| 212306 · 003 · RLD | tablet, oral | 50MG | 14 Aug 2035 |
| 212306 · 004 · RLD | tablet, oral | 60MG | 14 Aug 2035 |
| 212306 · 005 · RLD | tablet, oral | 10MG | 14 Aug 2035 |
| 212306 · 006 · RLD | tablet, oral | 80MG | 14 Aug 2035 |
Expired or delisted (2)
- ODE-257 · 3 Jul 2026
- ODE* · 3 Jul 2026