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 nineteen patent family members in thirty-seven countries.
The generic ingredient in XPOVIO is selinexor. One supplier is listed for this compound. Additional details are available on the selinexor profile page.
DrugPatentWatch® Generic Entry Outlook for Xpovio
Xpovio was eligible for patent challenges on July 3, 2023.
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
Summary for XPOVIO
| International Patents: | 119 |
| US Patents: | 6 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 42 |
| Clinical Trials: | 23 |
| 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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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
| Sponsor | Phase |
|---|---|
| University of Miami | Phase 2 |
| Xia Zhongjun | Phase 1/Phase 2 |
| Li Zhiming | Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes for XPOVIO
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 ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Hydrazide containing nuclear transport modulators and uses thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
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: ⤷ Try a Trial
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: ⤷ Try a Trial
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: ⤷ Try a Trial
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: ⤷ Try a Trial
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: ⤷ Try a Trial
| 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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Karyopharm Theraps | XPOVIO | selinexor | TABLET;ORAL | 212306-002 | Apr 15, 2021 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Karyopharm Theraps | XPOVIO | selinexor | TABLET;ORAL | 212306-004 | Apr 15, 2021 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Karyopharm Theraps | XPOVIO | selinexor | TABLET;ORAL | 212306-003 | Apr 15, 2021 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Karyopharm Theraps | XPOVIO | selinexor | TABLET;ORAL | 212306-004 | Apr 15, 2021 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Karyopharm Theraps | XPOVIO | selinexor | TABLET;ORAL | 212306-004 | Apr 15, 2021 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Karyopharm Theraps | XPOVIO | selinexor | TABLET;ORAL | 212306-002 | Apr 15, 2021 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
EU/EMA Drug Approvals for XPOVIO
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Stemline Therapeutics B.V. | Nexpovio | selinexor | EMEA/H/C/005127 NEXPOVIO is indicatedin combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.in combination with dexamethasone for the treatment of multiple myeloma in adult patients who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, two immunomodulatory agents and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy. |
Authorised | no | no | no | 2021-03-26 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
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: ⤷ Try a Trial
Patent: 20203246
Estimated Expiration: ⤷ Try a Trial
Patent: 21286266
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 57266
Estimated Expiration: ⤷ Try a Trial
China
Patent: 7072992
Estimated Expiration: ⤷ Try a Trial
Patent: 1481553
Estimated Expiration: ⤷ Try a Trial
Patent: 1484483
Estimated Expiration: ⤷ Try a Trial
Colombia
Patent: 17001884
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 80331
Estimated Expiration: ⤷ Try a Trial
Eurasian Patent Organization
Patent: 1790384
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 80331
Estimated Expiration: ⤷ Try a Trial
Patent: 12615
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 0328
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 77626
Estimated Expiration: ⤷ Try a Trial
Patent: 18323
Estimated Expiration: ⤷ Try a Trial
Patent: 17527549
Estimated Expiration: ⤷ Try a Trial
Patent: 20143144
Estimated Expiration: ⤷ Try a Trial
Patent: 23052622
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 17002013
Estimated Expiration: ⤷ Try a Trial
Patent: 21014128
Estimated Expiration: ⤷ Try a Trial
Morocco
Patent: 254
Estimated Expiration: ⤷ Try a Trial
Singapore
Patent: 201808624V
Estimated Expiration: ⤷ Try a Trial
Patent: 201700789S
Estimated Expiration: ⤷ Try a Trial
South Africa
Patent: 1700880
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 170043561
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 26377
Estimated Expiration: ⤷ Try a Trial
Ukraine
Patent: 3535
Estimated Expiration: ⤷ Try a Trial
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 |
|---|---|---|---|
| Japan | 2014521653 | ⤷ Try a Trial | |
| Argentina | 087342 | MODULADORES DEL TRANSPORTE NUCLEAR QUE CONTIENEN HIDRAZIDA Y SUS USOS | ⤷ Try a Trial |
| Peru | 20141003 | MODULADORES DEL TRANSPORTE NUCLEAR Y USOS DE LOS MISMOS | ⤷ Try a Trial |
| European Patent Office | 3180331 | FORMES POLYMORPHES DE SELINEXOR (POLYMORPHS OF SELINEXOR) | ⤷ Try a Trial |
| Japan | 6675431 | ⤷ Try a Trial | |
| Denmark | 3180331 | ⤷ Try a Trial | |
| South Korea | 20200088518 | 하이드라지드 함유 핵 수송 조절인자 및 이의 용도 (HYDRAZIDE CONTAINING NUCLEAR TRANSPORT MODULATORS AND USES THEREOF) | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for XPOVIO
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2736887 | 2021033 | Norway | ⤷ Try a Trial | PRODUCT NAME: SELINEKSOR ELLER ET FARMASOEYTISK AKSEPTABELT SALT DERAV; REG. NO/DATE: EU/1/21/1537 20210408 |
| 2736887 | 2021C/532 | Belgium | ⤷ Try a Trial | PRODUCT NAME: SELINEXOR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN; AUTHORISATION NUMBER AND DATE: EU/1/21/1537 20210329 |
| 2736887 | LUC00219 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: SELINEXOR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/21/1537 20210329 |
| 2736887 | 132021000000143 | Italy | ⤷ Try a Trial | PRODUCT NAME: SELIXENOR O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(NEXPOVIO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/21/1537, 20210329 |
| 2736887 | 29/2021 | Austria | ⤷ Try a Trial | PRODUCT NAME: SELINEXOR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1537 (MITTEILUNG) 20210329 |
| 2736887 | PA2021007 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: SELINEKSORAS; REGISTRATION NO/DATE: EU/1/21/1537 20210326 |
| 2736887 | PA2021007,C2736887 | Lithuania | ⤷ Try a Trial | 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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