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Orange Book drug · Brand (NDA)

Xpovio

Selinexor

RLDNDA 212306 6 strengths Karyopharm Theraps
Approved
Jul 03, 2019
Strengths
6
Listed patents
11

What does the FDA Orange Book show for Xpovio?

Xpovio contains Selinexor and is the new drug FDA Orange Book record for NDA 212306. The application has 6 presentations with strength, dosage-form, route, status, RLD/RS, TE, patent, and exclusivity context. Current inventory and clinical labeling are not established without an application-matched source.

FDA application
NDA 212306

New drug application identity from the Orange Book snapshot.

Application holder
Karyopharm Therapeutics Inc

The listed applicant holds the FDA application; this field does not establish the product manufacturer.

Product presentations
6

Each FDA product number remains tied to its own strength, dosage form, route, and status.

Marketing categories
Prescription

Orange Book marketing categories do not establish real-time inventory or commercial availability.

Reference roles
RLD / RS

RLD and RS designations are presentation-specific, not inferred from the trade name.

TE codes
None posted

Therapeutic-equivalence codes apply only within the matching Orange Book product heading.

Listed patents
11

A zero means none appear in this snapshot, not that no patent rights exist.

Exclusivity records
6

FDA exclusivity and listed patent protection are distinct regulatory concepts.

Sourced from the official FDA Orange Book data file · snapshot refreshed

FDA product-presentation matrix

Every product number in this exact application
Every FDA product presentation under this application, with strength, dosage form and route, marketing status, therapeutic-equivalence code, and reference role.
ProductStrengthDosage form / routeMarketing statusTE codeReference role
00120MGTABLETORALPrescriptionNone posted
RLD
00240MGTABLETORALPrescriptionNone posted
RLD
00350MGTABLETORALPrescriptionNone posted
RLD
00460MGTABLETORALPrescriptionNone posted
RLDRS
00510MGTABLETORALPrescriptionNone posted
RLD
00680MGTABLETORALPrescriptionNone posted
RLD

Marketing status, TE code, RLD, and RS are presentation-level fields. Never transfer one product number's designation to another presentation.

Who is responsible for this application?

Application holder is not the same as manufacturer

FDA application holder

Karyopharm Therapeutics Inc

The Orange Book identifies this organization as the applicant responsible for NDA 212306.

Manufacturer status

Not established by the Orange Book

A product-specific FDA label or NDC source must independently identify a manufacturer, labeler, distributor, packager, repackager, or relabeler. The applicant name is not used as a substitute for that evidence.

Regulatory interpretation

What the record means, and what it does not
FDA marketing status

6 presentations listed as prescription

RX and OTC are Orange Book marketing categories, not real-time inventory signals. Confirm current commercial availability with labeling, the application holder, or an authoritative drug listing.

Therapeutic equivalence

No TE code is posted for this application

No TE code does not mean FDA found the product ineffective or non-equivalent. FDA generally publishes TE evaluations for multisource prescription products; single-source and some other products may have no code.

Patent & exclusivity record

11 listed patent expirations and 4 exclusivity dates remain on or after Jul 26, 2026

The latest future date recorded across those files is Aug 14, 2035. Patent and FDA exclusivity operate independently, can overlap, and do not by themselves predict a generic launch date.

Same-ingredient landscape

0 other ANDAs and 0 other NDAs found

0 of the related ANDA applications are not marked discontinued. Sharing an ingredient does not establish pharmaceutical or therapeutic equivalence; strength, dosage form, route, and TE group still matter.

Which products are meaningfully comparable?

Exact ingredient + dosage form + route cohorts

NDA 212306 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.

Tablet · Oral

Selinexor

1 application
Product rows
6
Active applications
1
Active with AB row
0

Why are clinical sections unavailable?

Exact application-label matching status
Exact source match queuedQueue NDA-212306

No exact application-level FDA or DailyMed label match has been reviewed for this application. Approved uses, dosing, warnings, adverse reactions, and clinical evidence remain unavailable rather than being inherited from a related brand, generic, or ingredient record.

Until an exact application match passes human review, this page intentionally omits approved uses, dosing, warnings, adverse reactions, mechanism, and clinical-study summaries. It never inherits those claims from an RLD, brand, generic, or same-ingredient product.

Strengths & dosage forms

6 approved presentations · NDA 212306
RLD
Strength
20MG
Dosage form
TABLET
Route
ORAL
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    7 yr 2 mo ago

  2. Exclusivity ends · ODE-257

    Orphan-drug exclusivity (7 years)

    23 d ago

  3. Today

  4. Exclusivity ends · ODE-310

    Orphan-drug exclusivity (7 years)

    in 11 mo

  5. Exclusivity ends · ODE-346

    Orphan-drug exclusivity (7 years)

    in 1 yr 5 mo

  6. Patent 10544108 expires

    Listed method-of-use patent (U-2584) expiration.

    in 6 yr 1 mo

  7. Patent 10544108 expires

    Listed method-of-use patent (U-3018) expiration.

    in 6 yr 1 mo

  8. Patent 11034660 expires

    Listed method-of-use patent (U-2584) expiration.

    in 6 yr 1 mo

  9. Patent 11034660 expires

    Listed method-of-use patent (U-3018) expiration.

    in 6 yr 1 mo

  10. Patent 11787771 expires

    Listed method-of-use patent (U-2855) expiration.

    in 6 yr 1 mo

  11. Patent 11787771 expires

    Listed method-of-use patent (U-2584) expiration.

    in 6 yr 1 mo

  12. Patent 11787771 expires

    Listed method-of-use patent (U-3018) expiration.

    in 6 yr 1 mo

  13. Patent 12291508 expires

    Listed method-of-use patent (U-3018) expiration.

    in 6 yr 1 mo

  14. Patent 12291508 expires

    Listed method-of-use patent (U-2584) expiration.

    in 6 yr 1 mo

  15. Patent 9079865 expires

    Listed method-of-use patent (U-2584) expiration.

    in 6 yr 1 mo

  16. Patent 9079865 expires

    Listed method-of-use patent (U-3018) expiration.

    in 6 yr 1 mo

  17. Patent 9714226 expires

    Listed drug substance patent expiration.

    in 6 yr 1 mo

  18. Patent 8999996 expires

    Listed drug substance patent expiration.

    in 7 yr

  19. Patent 10519139 expires

    Listed drug substance patent expiration.

    in 9 yr 2 mo

  20. Patent 10519139 expires

    Listed drug substance patent expiration.

    in 9 yr 2 mo

  21. Patent 11746102 expires

    Listed method-of-use patent (U-2584) expiration.

    in 9 yr 2 mo

  22. Patent 11746102 expires

    Listed method-of-use patent (U-3018) expiration.

    in 9 yr 2 mo

  23. Patent 11753401 expires

    Listed drug product patent expiration.

    in 9 yr 2 mo

  24. Patent 11753401 expires

    Listed drug product patent expiration.

    in 9 yr 2 mo

  25. Patent 11807629 expires

    Listed drug substance patent expiration.

    in 9 yr 2 mo

Patent & exclusivity timeline

Protection horizon
20262027202820292030203120322033203420352036TodayExclusivity ODE-257: 2026-07-03Exclusivity ODE-257Exclusivity ODE-310: 2027-06-22Exclusivity ODE-310Exclusivity ODE-346: 2027-12-18Exclusivity ODE-346Patent 10544108: 2032-07-26Patent 10544108Patent 10544108: 2032-07-26Patent 10544108Patent 11034660: 2032-07-26Patent 11034660Patent 11034660: 2032-07-26Patent 11034660Patent 11787771: 2032-07-26Patent 11787771Patent 11787771: 2032-07-26Patent 11787771Patent 11787771: 2032-07-26Patent 11787771Patent 12291508: 2032-07-26Patent 12291508Patent 12291508: 2032-07-26Patent 12291508Patent 9079865: 2032-07-26Patent 9079865Patent 9079865: 2032-07-26Patent 9079865Patent 9714226: 2032-07-26Patent 9714226Patent 8999996: 2033-07-03Patent 8999996Patent 10519139: 2035-08-14Patent 10519139Patent 10519139: 2035-08-14Patent 10519139Patent 11746102: 2035-08-14Patent 11746102Patent 11746102: 2035-08-14Patent 11746102Patent 11753401: 2035-08-14Patent 11753401Patent 11753401: 2035-08-14Patent 11753401Patent 11807629: 2035-08-14Patent 11807629
Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

SELINEXOR

Strength

20MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 212306

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

Marketing exclusivity

Hatch-Waxman
  • ODE-257Orphan-drug exclusivity (7 years)

    23 d ago

  • ODE-310Orphan-drug exclusivity (7 years)

    in 11 mo

  • ODE-346Orphan-drug exclusivity (7 years)

    in 1 yr 5 mo

Listed patents

Orange Book patent file
Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10544108in 6 yr 1 mo
U-2584
10544108in 6 yr 1 mo
U-3018
11034660in 6 yr 1 mo
U-2584
11034660in 6 yr 1 mo
U-3018
11787771in 6 yr 1 mo
U-2855
11787771in 6 yr 1 mo
U-2584
11787771in 6 yr 1 mo
U-3018
12291508in 6 yr 1 mo
U-3018
12291508in 6 yr 1 mo
U-2584
9079865in 6 yr 1 mo
U-2584
9079865in 6 yr 1 mo
U-3018
9714226in 6 yr 1 mo
SubstanceProduct
8999996in 7 yr
SubstanceProduct
10519139in 9 yr 2 mo
SubstanceProductU-2584
10519139in 9 yr 2 mo
SubstanceProductU-3018
11746102in 9 yr 2 mo
U-2584
11746102in 9 yr 2 mo
U-3018
11753401in 9 yr 2 mo
ProductU-2584
11753401in 9 yr 2 mo
ProductU-3018
11807629in 9 yr 2 mo
SubstanceProduct

Active-ingredient family

Brand + generics

This is a reference-listed drug (RLD), the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

No other applications share this active ingredient.

View full Selinexor family

How to use this record responsibly

Scope, limitations, and primary sources

What to verify before making a decision

  • The applicant is the holder of legal responsibility for the application; the Orange Book does not establish that the applicant manufactured or currently markets every listed product.
  • RX, OTC, and discontinued are FDA listing categories, not real-time pharmacy inventory or commercial-availability data.
  • Therapeutic equivalence applies only within the matching ingredient, dosage form, route, strength, and TE-code group; same ingredient alone is insufficient.
  • Listed patent and exclusivity dates are regulatory intelligence, not legal advice, a freedom-to-operate analysis, or a reliable generic-launch forecast.
  • The Orange Book is not prescribing information and does not provide indications, dosing, contraindications, adverse reactions, recalls, or current safety communications.

Official FDA references

Data shown here is normalized for search and comparison. When a regulatory, substitution, launch, or legal decision turns on a field, verify it against the current FDA record and the relevant source document.

Xpovio: frequently asked questions

Approval, therapeutic equivalence, patents, and exclusivity for this drug, from the FDA Orange Book.

Built directly from the FDA Orange Book product, patent, and exclusivity files refreshed Jul 02, 2026, 06:34 PM. Every strength of NDA 212306 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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