Selinexor - Generic Drug Details

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

Sponsor	Phase
University of Rochester	Phase 2
European Network of Gynaecological Oncological Trial	Phase 3
Fudan University	Phase 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			Y	Y
Karyopharm Theraps	XPOVIO	selinexor	TABLET;ORAL	212306-003	Apr 15, 2021		RX	Yes	No
Karyopharm Theraps	XPOVIO	selinexor	TABLET;ORAL	212306-004	Apr 15, 2021		RX	Yes	Yes
Karyopharm Theraps	XPOVIO	selinexor	TABLET;ORAL	212306-001	Jul 3, 2019		RX	Yes	No			Y	Y

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

International Patents for selinexor

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

Supplementary Protection Certificates for selinexor

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2736887	PA2021007,C2736887	Lithuania		PRODUCT NAME: SELINEKSORAS; REGISTRATION NO/DATE: EU/1/21/1537 20210326
2736887	122021000055	Germany		PRODUCT NAME: SELINEXOR ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1537 20210326
2736887	PA2021007	Lithuania		PRODUCT NAME: SELINEKSORAS; REGISTRATION NO/DATE: EU/1/21/1537 20210326
2736887	LUC00219	Luxembourg		PRODUCT NAME: SELINEXOR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/21/1537 20210329