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Last Updated: May 24, 2022

XPOVIO Drug Patent Profile


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Which patents cover Xpovio, and what generic alternatives are available?

Xpovio is a drug marketed by Karyopharm Theraps and is included in one NDA. There are six patents protecting this drug.

This drug has one hundred and five patent family members in thirty-six countries.

The generic ingredient in XPOVIO is selinexor. Additional details are available on the selinexor profile page.

DrugPatentWatch® Generic Entry Outlook for Xpovio

Xpovio will be eligible for patent challenges on July 3, 2023. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 14, 2035. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for XPOVIO
International Patents:105
US Patents:6
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 37
Clinical Trials: 20
Patent Applications: 196
Drug Prices: Drug price information for XPOVIO
What excipients (inactive ingredients) are in XPOVIO?XPOVIO excipients list
DailyMed Link:XPOVIO at DailyMed
Drug patent expirations by year for XPOVIO
Drug Prices for XPOVIO

See drug prices for XPOVIO

DrugPatentWatch® Estimated Generic Entry Opportunity Date for XPOVIO
Generic Entry Date for XPOVIO*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for XPOVIO

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of Colorado, DenverPhase 2
H. Lee Moffitt Cancer Center and Research InstitutePhase 1
US Oncology ResearchPhase 2

See all XPOVIO clinical trials

US Patents and Regulatory Information for XPOVIO

XPOVIO is protected by twelve US patents and eight FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of XPOVIO is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting XPOVIO

Polymorphs of Selinexor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: XPOVIO IS INDICATED IN COMBINATION WITH DEXAMETHASONE TO TREAT RELAPSED OR REFRACTORY MULTIPLE MYELOMA (REFRACTORY TO AT LEAST AN ANTI-CD38 MAB, 2 PROTEASOME INHIBITORS AND 2 IMMUNOMODULATORY AGENTS) IN ADULTS WHO RECEIVED AT LEAST 4 PRIOR THERAPIES

Polymorphs of Selinexor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: XPOVIO IS INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL), NOT OTHERWISE SPECIFIED, INCLUDING DLBCL ARISING FROM FOLLICULAR LYMPHOMA, AFTER AT LEAST 2 LINES OF SYSTEMIC THERAPY

Polymorphs of Selinexor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: XPOVIO IS INDICATED IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE FOR THE TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY

Hydrazide containing nuclear transport modulators and uses thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: XPOVIO IS INDICATED IN COMBINATION WITH DEXAMETHASONE TO TREAT RELAPSED OR REFRACTORY MULTIPLE MYELOMA (REFRACTORY TO AT LEAST AN ANTI-CD38 MAB, 2 PROTEASOME INHIBITORS AND 2 IMMUNOMODULATORY AGENTS) IN ADULTS WHO RECEIVED AT LEAST 4 PRIOR THERAPIES

Hydrazide containing nuclear transport modulators and uses thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: XPOVIO IS INDICATED IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE FOR THE TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY

Hydrazide containing nuclear transport modulators and uses thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: XPOVIO IS INDICATED IN COMBINATION WITH DEXAMETHASONE TO TREAT RELAPSED OR REFRACTORY MULTIPLE MYELOMA (REFRACTORY TO AT LEAST AN ANTI-CD38 MAB, 2 PROTEASOME INHIBITORS AND 2 IMMUNOMODULATORY AGENTS) IN ADULTS WHO RECEIVED AT LEAST 4 PRIOR THERAPIES

Hydrazide containing nuclear transport modulators and uses thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: XPOVIO IS INDICATED IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE FOR THE TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY

Hydrazide containing nuclear transport modulators and uses thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Hydrazide containing nuclear transport modulators and uses thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: XPOVIO IS INDICATED IN COMBINATION WITH DEXAMETHASONE TO TREAT RELAPSED OR REFRACTORY MULTIPLE MYELOMA (REFRACTORY TO AT LEAST AN ANTI-CD38 MAB, 2 PROTEASOME INHIBITORS AND 2 IMMUNOMODULATORY AGENTS) IN ADULTS WHO RECEIVED AT LEAST 4 PRIOR THERAPIES

Hydrazide containing nuclear transport modulators and uses thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: XPOVIO IS INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL), NOT OTHERWISE SPECIFIED, INCLUDING DLBCL ARISING FROM FOLLICULAR LYMPHOMA, AFTER AT LEAST 2 LINES OF SYSTEMIC THERAPY

Hydrazide containing nuclear transport modulators and uses thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: XPOVIO IS INDICATED IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE FOR THE TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY

Hydrazide containing nuclear transport modulators and uses thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting XPOVIO

IN COMBO W/ DEXAMETHASONE FOR ADULTS W/ RELAPSED OR REFRACTORY MULTIPLE MYELOMA WHO RECEIVED AT LEAST 4 PRIOR THERAPIES AND REFRACTORY TO AT LEAST 2 PROTEASOME INHIBITORS, AT LEAST 2 IMMUNOMODULATORY AGENTS, AND AN ANTI-CD38 MONOCLONAL ANTIBODY
Exclusivity Expiration: See Plans and Pricing

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL), NOT OTHERWISE SPECIFIED, INCLUDING DLBCL ARISING FROM FOLLICULAR LYMPHOMA, AFTER AT LEAST 2 LINES OF SYSTEMIC THERAPY
Exclusivity Expiration: See Plans and Pricing

FOR THE TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY, EXCLUDING ADULT PATIENTS COVERED BY XPOVIO'S PREVIOUS INDICATION FOR MULTIPLE MYELOMA APPROVED ON JULY 3, 2019
Exclusivity Expiration: See Plans and Pricing

TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL), NOT OTHERWISE SPECIFIED, INCLUDING DLBCL ARISING FROM FOLLICULAR LYMPHOMA, AFTER AT LEAST 2 LINES OF SYSTEMIC THERAPY
Exclusivity Expiration: See Plans and Pricing

FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S).AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
Exclusivity Expiration: See Plans and Pricing

FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S).AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
Exclusivity Expiration: See Plans and Pricing

FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S).AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
Exclusivity Expiration: See Plans and Pricing

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Karyopharm Theraps XPOVIO selinexor TABLET;ORAL 212306-003 Apr 15, 2021 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Karyopharm Theraps XPOVIO selinexor TABLET;ORAL 212306-002 Apr 15, 2021 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Karyopharm Theraps XPOVIO selinexor TABLET;ORAL 212306-004 Apr 15, 2021 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Karyopharm Theraps XPOVIO selinexor TABLET;ORAL 212306-003 Apr 15, 2021 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for XPOVIO

When does loss-of-exclusivity occur for XPOVIO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 15301484
Estimated Expiration: See Plans and Pricing

Patent: 20203246
Estimated Expiration: See Plans and Pricing

Patent: 21286266
Estimated Expiration: See Plans and Pricing

Canada

Patent: 57266
Estimated Expiration: See Plans and Pricing

China

Patent: 7072992
Estimated Expiration: See Plans and Pricing

Patent: 1481553
Estimated Expiration: See Plans and Pricing

Patent: 1484483
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 17001884
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 1790384
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 80331
Estimated Expiration: See Plans and Pricing

Israel

Patent: 0328
Estimated Expiration: See Plans and Pricing

Japan

Patent: 77626
Estimated Expiration: See Plans and Pricing

Patent: 17527549
Estimated Expiration: See Plans and Pricing

Patent: 20143144
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 17002013
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 254
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 201808624V
Estimated Expiration: See Plans and Pricing

Patent: 201700789S
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1700880
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 170043561
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 3535
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering XPOVIO around the world.

Country Patent Number Title Estimated Expiration
Mexico 349712 MODULADORES DEL TRANSPORTE NUCLEAR QUE CONTIENEN HIDRAZIDA Y SUS USOS. (HYDRAZIDE CONTAINING NUCLEAR TRANSPORT MODULATORS AND USES THEREOF.) See Plans and Pricing
Norway 2021033 See Plans and Pricing
Chile 2015001259 Compuestos heterociclicos modulares del transporte nuclear; composicion farmaceutica; y usos de los mismos en enfermedades tales como cancer (div. sol. 224-14). See Plans and Pricing
Singapore 10201808624V POLYMORPHS OF SELINEXOR See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for XPOVIO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2736887 132021000000143 Italy See Plans and Pricing PRODUCT NAME: SELIXENOR O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(NEXPOVIO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/21/1537, 20210329
2736887 122021000055 Germany See Plans and Pricing PRODUCT NAME: SELINEXOR ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1537 20210326
2736887 29/2021 Austria See Plans and Pricing PRODUCT NAME: SELINEXOR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1537 (MITTEILUNG) 20210329
2736887 PA2021007 Lithuania See Plans and Pricing PRODUCT NAME: SELINEKSORAS; REGISTRATION NO/DATE: EU/1/21/1537 20210326
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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