FDA Orange Book
Is there a generic for Xpovio?
Xpovio contains selinexor. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Xpovio (selinexor). The Orange Book shows its last listed patent expires August 14, 2035 and its last listed exclusivity ends December 18, 2027.
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Xpovio products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 10MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 20MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 40MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 50MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 60MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 80MG | Marketed (Rx) | None | 0 | None |
NDA 212306, held by KARYOPHARM THERAPEUTICS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Xpovio patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11787771 | July 26, 2032 | Method of use | U-3018 | 212306 |
| 11787771 | July 26, 2032 | Method of use | U-2584 | 212306 |
| 9079865 | July 26, 2032 | Method of use | U-3018 | 212306 |
| 9079865 | July 26, 2032 | Method of use | U-2584 | 212306 |
| 10544108 | July 26, 2032 | Method of use | U-3018 | 212306 |
| 10544108 | July 26, 2032 | Method of use | U-2584 | 212306 |
| 11034660 | July 26, 2032 | Method of use | U-2584 | 212306 |
| 11034660 | July 26, 2032 | Method of use | U-3018 | 212306 |
| 12291508 | July 26, 2032 | Method of use | U-2584 | 212306 |
| 12291508 | July 26, 2032 | Method of use | U-3018 | 212306 |
| 9714226 | July 26, 2032 | Drug substance, Drug product | None | 212306 |
| 11787771 | July 26, 2032 | Method of use | U-2855 | 212306 |
| 8999996 | July 3, 2033 | Drug substance, Drug product | None | 212306 |
| 10519139 | August 14, 2035 | Drug substance, Drug product | U-3018 | 212306 |
| 10519139 | August 14, 2035 | Drug substance, Drug product | U-2584 | 212306 |
| 11746102 | August 14, 2035 | Method of use | U-2584 | 212306 |
| 11746102 | August 14, 2035 | Method of use | U-3018 | 212306 |
| 11753401 | August 14, 2035 | Drug product | U-2584 | 212306 |
| 11753401 | August 14, 2035 | Drug product | U-3018 | 212306 |
| 11807629 | August 14, 2035 | Drug substance | None | 212306 |
Xpovio exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE* | See the Orange Book exclusivity code list | July 3, 2026 | 212306 |
| ODE-257 | Orphan drug exclusivity | July 3, 2026 | 212306 |
| ODE* | See the Orange Book exclusivity code list | June 22, 2027 | 212306 |
| ODE-310 | Orphan drug exclusivity | June 22, 2027 | 212306 |
| ODE* | See the Orange Book exclusivity code list | December 18, 2027 | 212306 |
| ODE-346 | Orphan drug exclusivity | December 18, 2027 | 212306 |
Xpovio NDC codes
Questions
Is there a generic for Xpovio?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Xpovio (selinexor). The Orange Book shows its last listed patent expires August 14, 2035 and its last listed exclusivity ends December 18, 2027.
What is the generic name for Xpovio?
The active ingredient in Xpovio is selinexor, per the FDA Orange Book.
When does the Xpovio patent expire?
The last patent listed for Xpovio in the Orange Book expires August 14, 2035. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.