Xpovio is a drug owned by Karyopharm Therapeutics Inc. It is protected by 10 US drug patents filed from 2021 to 2023 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.
| 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
(10 years from now) | Active |
| US11807629 | Polymorphs of Selinexor |
Aug, 2035
(10 years from now) | Active |
| US8999996 | Hydrazide containing nuclear transport modulators and uses thereof |
Jul, 2033
(8 years from now) | Active |
| US9714226 | Hydrazide containing nuclear transport modulators and uses thereof |
Jul, 2032
(7 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). | |||
| US11753401 | Polymorphs of Selinexor |
Aug, 2035
(10 years from now) | Active |
| US11746102 | Polymorphs of selinexor |
Aug, 2035
(10 years from now) | Active |
| US11034660 | Hydrazide containing nuclear transport modulators and uses thereof |
Jul, 2032
(7 years from now) | Active |
| US10544108 | Hydrazide containing nuclear transport modulators and uses thereof |
Jul, 2032
(7 years from now) | Active |
| US11787771 | Hydrazide containing nuclear transport modulators and uses thereof |
Jul, 2032
(7 years from now) | Active |
| US9079865 | Hydrazide containing nuclear transport modulators and uses thereof |
Jul, 2032
(7 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.
Latest 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 eGrant Notification | 07 Nov, 2023 | US11807629 |
| Mail Patent eGrant Notification | 07 Nov, 2023 | US11807629 |
| Recordation of Patent Grant Mailed Critical | 07 Nov, 2023 | US11807629 |
| Recordation of Patent eGrant | 07 Nov, 2023 | US11807629 |
| Email Notification Critical | 07 Nov, 2023 | US11807629 |
| Patent Issue Date Used in PTA Calculation Critical | 07 Nov, 2023 | US11807629 |
| Email Notification Critical | 19 Oct, 2023 | US11807629 |
| Issue Notification Mailed Critical | 18 Oct, 2023 | US11807629 |
| Email Notification Critical | 17 Oct, 2023 | US11787771 |
| Patent Issue Date Used in PTA Calculation Critical | 17 Oct, 2023 | US11787771 |
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 2 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*) | Jun 22, 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 |
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
Explore Our Curated Drug Screens
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 Theraps in 2019.
Approval Date:
Xpovio was approved by FDA for market use on 03 July, 2019.
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 03 July, 2019, 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 |
|---|---|---|---|
| 40MG | TABLET | Prescription | ORAL |
| 60MG | TABLET | Prescription | ORAL |
| 50MG | TABLET | Prescription | ORAL |
| 20MG | TABLET | Prescription | ORAL |