Xpovio Patent Expiration

Xpovio is a drug owned by Karyopharm Therapeutics Inc. It is protected by 11 US drug patents filed from 2020 to 2025 out of which none have expired yet. Xpovio's patents have been open to challenges since 04 July, 2023. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 14, 2035. Details of Xpovio's patents and their expiration are given in the table below.

Patent strength
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Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire.
US10519139 Polymorphs of Selinexor
Aug, 2035

(8 years from now)

Active
US11807629 Polymorphs of Selinexor
Aug, 2035

(8 years from now)

Active
US8999996 Hydrazide containing nuclear transport modulators and uses thereof
Jul, 2033

(6 years from now)

Active
US9714226 Hydrazide containing nuclear transport modulators and uses thereof
Jul, 2032

(5 years from now)

Active
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11746102 Polymorphs of selinexor
Aug, 2035

(8 years from now)

Active
US11753401 Polymorphs of Selinexor
Aug, 2035

(8 years from now)

Active
US9079865 Hydrazide containing nuclear transport modulators and uses thereof
Jul, 2032

(5 years from now)

Active
US11787771 Hydrazide containing nuclear transport modulators and uses thereof
Jul, 2032

(5 years from now)

Active
US12291508 Hydrazide containing nuclear transport modulators and uses thereof
Jul, 2032

(5 years from now)

Active
US11034660 Hydrazide containing nuclear transport modulators and uses thereof
Jul, 2032

(5 years from now)

Active
US10544108 Hydrazide containing nuclear transport modulators and uses thereof
Jul, 2032

(5 years from now)

Active


A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Xpovio's patents.

Given below is the list of recent legal activities going on the following patents of Xpovio.

Activity Date Patent Number
Patent litigations
Email Notification 24 Jun, 2025 US12291508
Mail Patent eCofC Notification 24 Jun, 2025 US12291508
Patent eCofC Notification 24 Jun, 2025 US12291508
Recordation of Patent eCertificate of Correction 24 Jun, 2025 US12291508
Mail Certificate of Correction Memo 03 Jun, 2025 US12291508
Certificate of Correction Memo 31 May, 2025 US12291508
Patent eGrant Notification 06 May, 2025 US12291508
Email Notification 06 May, 2025 US12291508
Patent Issue Date Used in PTA Calculation 06 May, 2025 US12291508
Recordation of Patent Grant Mailed 06 May, 2025 US12291508


FDA has granted several exclusivities to Xpovio. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Xpovio, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Xpovio.

Exclusivity Information

Xpovio holds 6 exclusivities out of which 4 have expired. Its last outstanding exclusivity is set to expire in 2027. Details of Xpovio's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Indication(I-837) Jun 22, 2023
New Chemical Entity Exclusivity(NCE) Jul 03, 2024
ODE*(ODE*) Dec 18, 2027
Orphan Drug Exclusivity(ODE-257) Jul 03, 2026
Orphan Drug Exclusivity(ODE-310) Jun 22, 2027
Orphan Drug Exclusivity(ODE-346) Dec 18, 2027

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US patents provide insights into the exclusivity only within the United States, but Xpovio is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Xpovio's family patents as well as insights into ongoing legal events on those patents.

Xpovio's Family Patents

Xpovio has patent protection in a total of 37 countries. It's US patent count contributes only to 22.5% of its total global patent coverage. Click below to unlock the full patent family tree for Xpovio.

Family Patents

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Clinical Trials

Recent Clinical Trials on Xpovio:

Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
HCMT/MM2401: Ph2 Study of Selinexor + Bispecific Antibody for RRMM Duke University NA RECRUITING
(Sep 1, 2026)
PHASE2
Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment National Cancer Institute (NCI) NA RECRUITING
(Aug 1, 2026)
PHASE1, PHASE2
Selinexor in Maintenance Therapy After Systemic Therapy for Participants With p53 Wild-Type, Advanced or Recurrent Endometrial Carcinoma Karyopharm Therapeutics Inc NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE3
A Study of the Drug Selinexor With Radiation Therapy in Patients With Newly-Diagnosed Diffuse Intrinsic Pontine (DIPG) Glioma and High-Grade Glioma (HGG) National Cancer Institute (NCI) NA RECRUITING
(Jul 1, 2026)
PHASE1, PHASE2
Testing Atezolizumab With Selinexor in People ≥ 12 Years Old With Alveolar Soft Part Sarcoma, AXIOM Trial National Cancer Institute (NCI) NA RECRUITING
(Jul 1, 2026)
PHASE2
Selinexor (KPT-330) in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL) Karyopharm Therapeutics Inc NA ACTIVE NOT RECRUITING
(Jun 1, 2026)
PHASE2
A Study of Rituximab-Gemcitabine-Dexamethasone-Platinum (R-GDP) With or Without Selinexor in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma Karyopharm Therapeutics Inc NA ACTIVE NOT RECRUITING
(Jun 1, 2026)
PHASE2, PHASE3
Selinexor Maintenance Post CAR-T Cell Therapy for Multiple Myeloma Washington University School of Medicine NA RECRUITING
(Jun 1, 2026)
PHASE1
Selinexor in Myelofibrosis Refractory or Intolerant to JAK1/2 Inhibitors University of Utah NA TERMINATED
(May 1, 2026)
PHASE2
Low-Dose Selinexor and Choline Salicylate for Non-Hodgkin or Hodgkin Lymphoma, Histiocytic/Dendritic Cell Neoplasm, or Relapsed or Refractory Multiple Myeloma Mayo Clinic NA COMPLETED
(May 1, 2026)
PHASE1
A Study of Selinexor in People With Wilms Tumors and Other Solid Tumors Memorial Sloan Kettering Cancer Center NA RECRUITING
(May 1, 2026)
PHASE2
A Phase II Study of Sintilimab, Pegaspargase and Selinexor Followed by Radiotherapy in Newly Diagnosed Stage I/II Extranodal NK/T-Cell Lymphoma Sun Yat-sen University NA NOT YET RECRUITING
(May 1, 2026)
PHASE2
Maintenance With Selinexor/Placebo After Combination Chemotherapy in Participants With Endometrial Cancer [SIENDO] Karyopharm Therapeutics Inc NA COMPLETED
(Apr 1, 2026)
PHASE3
Study of Selinexor in Combination With Ruxolitinib in Myelofibrosis Karyopharm Therapeutics Inc NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE3
A Study to Evaluate Safety , Efficacy and Pharmacokinetics of WJ01024 Tablets Combined With Ruxolitinib in Patients With Myelofibrosis Suzhou Junjing BioSciences Co., Ltd. NA ACTIVE NOT RECRUITING
(Mar 1, 2026)
PHASE1, PHASE2
Selinexor and Pacritinib in JAK Inhibitor-naïve MF Patients With Cytopenias John Mascarenhas NA NOT YET RECRUITING
(Mar 1, 2026)
PHASE2




Generic Launch

Generic Release Date:

Xpovio's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Aug 14, 2035 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Xpovio Generics:

There are no approved generic versions for Xpovio as of now.





About Xpovio

Xpovio is a drug owned by Karyopharm Therapeutics Inc. It is used for treating relapsed or refractory Diffuse Large B-Cell Lymphoma (DLBCL) and Multiple Myeloma in adults. Xpovio uses Selinexor as an active ingredient. Xpovio was launched by Karyopharm in 2025.

Approval Date:

Xpovio was approved by FDA for market use on 10 March, 2025.

NCE-1 date:

NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Xpovio is 10 March, 2025, its NCE-1 date is estimated to be 04 July, 2023.

Active Ingredient:

Xpovio uses Selinexor as the active ingredient. Check out other Drugs and Companies using Selinexor ingredient

Treatment:

Xpovio is used for treating relapsed or refractory Diffuse Large B-Cell Lymphoma (DLBCL) and Multiple Myeloma in adults.

Dosage:

Xpovio is available in tablet form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
50MG TABLET Prescription ORAL
60MG TABLET Prescription ORAL
40MG TABLET Prescription ORAL
20MG TABLET Prescription ORAL
10MG TABLET Prescription ORAL
80MG TABLET Prescription ORAL