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Last Updated: May 29, 2024

Selinexor - Generic Drug Details


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What are the generic sources for selinexor and what is the scope of freedom to operate?

Selinexor is the generic ingredient in one branded drug marketed by Karyopharm Theraps and is included in one NDA. There are ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Selinexor has one hundred and twenty-six patent family members in thirty-eight countries.

One supplier is listed for this compound.

Summary for selinexor
International Patents:126
US Patents:10
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 47
Clinical Trials: 131
Patent Applications: 405
What excipients (inactive ingredients) are in selinexor?selinexor excipients list
DailyMed Link:selinexor at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for selinexor
Generic Entry Date for selinexor*:
Constraining patent/regulatory exclusivity:
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 selinexor

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

SponsorPhase
Washington University School of MedicinePhase 2
Chinese PLA General HospitalPhase 2
The First Affiliated Hospital of Soochow UniversityN/A

See all selinexor clinical trials

US Patents and Regulatory Information for selinexor

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 212306-002 Apr 15, 2021 RX Yes No ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Karyopharm Theraps XPOVIO selinexor TABLET;ORAL 212306-003 Apr 15, 2021 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Karyopharm Theraps XPOVIO selinexor TABLET;ORAL 212306-003 Apr 15, 2021 RX Yes No ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Karyopharm Theraps XPOVIO selinexor TABLET;ORAL 212306-001 Jul 3, 2019 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Karyopharm Theraps XPOVIO selinexor TABLET;ORAL 212306-004 Apr 15, 2021 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Karyopharm Theraps XPOVIO selinexor TABLET;ORAL 212306-003 Apr 15, 2021 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 selinexor

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 selinexor

Country Patent Number Title Estimated Expiration
Taiwan I574957 ⤷  Sign Up
European Patent Office 4112615 COMPOSITIONS COMPRENANT UNE FORME CRISTALLINE DE SELINEXOR (COMPOSITIONS COMPRISING ONE CRYSTALLINE FORM OF SELINEXOR) ⤷  Sign Up
Taiwan 201311666 Hydrazide containing nuclear transport modulators and uses thereof ⤷  Sign Up
South Korea 20140066179 HYDRAZIDE CONTAINING NUCLEAR TRANSPORT MODULATORS AND USES THEREOF ⤷  Sign Up
China 107072992 赛灵克斯的多晶型物 (Polymorphs of selinexor) ⤷  Sign Up
Lithuania PA2021007 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for selinexor

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2736887 132021000000143 Italy ⤷  Sign Up PRODUCT NAME: SELIXENOR O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(NEXPOVIO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/21/1537, 20210329
2736887 LUC00219 Luxembourg ⤷  Sign Up PRODUCT NAME: SELINEXOR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/21/1537 20210329
2736887 C20210021 00403 Estonia ⤷  Sign Up PRODUCT NAME: SELINEKSOOR;REG NO/DATE: EU/1/21/1537 29.03.2021
2736887 29/2021 Austria ⤷  Sign Up PRODUCT NAME: SELINEXOR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1537 (MITTEILUNG) 20210329
2736887 301119 Netherlands ⤷  Sign Up DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGE OF OWNER(S) NAME
2736887 2021033 Norway ⤷  Sign Up PRODUCT NAME: SELINEKSOR ELLER ET FARMASOEYTISK AKSEPTABELT SALT DERAV; REG. NO/DATE: EU/1/21/1537 20210408
>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.