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Last Updated: January 27, 2023

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 six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Selinexor has one hundred and twelve patent family members in thirty-seven countries.

One supplier is listed for this compound.

Summary for selinexor
International Patents:112
US Patents:6
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 39
Clinical Trials: 120
Patent Applications: 434
What excipients (inactive ingredients) are in selinexor?selinexor excipients list
DailyMed Link:selinexor at DailyMed
Recent Clinical Trials for selinexor

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

SponsorPhase
University of RochesterPhase 2
European Network of Gynaecological Oncological TrialPhase 3
Fudan UniversityPhase 1/Phase 2

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 212306-004 Apr 15, 2021 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y 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
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 212306-001 Jul 3, 2019 RX Yes No See Plans and Pricing See Plans and Pricing Y Y 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

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 indicated, , , in 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
Ukraine 123535 ПОЛІМОРФИ СЕЛІНЕКСОРУ (POLYMORPHS OF SELINEXOR) See Plans and Pricing
China 106083827 含酰肼的核运输调节剂及其用途 (Hydrazide Containing Nuclear Transport Modulators and Uses Thereof) See Plans and Pricing
Lithuania 2736887 See Plans and Pricing
Peru 20141170 MODULADORES DEL TRANSPORTE NUCLEAR QUE CONTIENEN HIDRAZIDA Y SUS USOS See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for selinexor

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2736887 PA2021007,C2736887 Lithuania See Plans and Pricing PRODUCT NAME: SELINEKSORAS; REGISTRATION NO/DATE: EU/1/21/1537 20210326
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 PA2021007 Lithuania See Plans and Pricing PRODUCT NAME: SELINEKSORAS; REGISTRATION NO/DATE: EU/1/21/1537 20210326
2736887 LUC00219 Luxembourg See Plans and Pricing PRODUCT NAME: SELINEXOR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/21/1537 20210329
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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