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
Sponsor | Phase |
---|---|
University of Rochester | Phase 2 |
European Network of Gynaecological Oncological Trial | Phase 3 |
Fudan University | Phase 1/Phase 2 |
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 |