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-four patent family members in thirty-eight countries.
One supplier is listed for this compound.
Summary for selinexor
International Patents: | 124 |
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
Sponsor | Phase |
---|---|
Washington University School of Medicine | Phase 2 |
Chinese PLA General Hospital | Phase 2 |
The First Affiliated Hospital of Soochow University | N/A |
Anatomical Therapeutic Chemical (ATC) Classes for selinexor
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 | 212306-003 | Apr 15, 2021 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Karyopharm Theraps | XPOVIO | selinexor | TABLET;ORAL | 212306-001 | Jul 3, 2019 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Karyopharm Theraps | XPOVIO | selinexor | TABLET;ORAL | 212306-001 | Jul 3, 2019 | 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 | Y | Y | ⤷ 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 | 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 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 |
---|---|---|---|
China | 111484483 | 赛灵克斯的多晶型物 (Polymorphs of selinexor) | ⤷ Try a Trial |
Singapore | 10201808624V | POLYMORPHS OF SELINEXOR | ⤷ Try a Trial |
Ukraine | 115532 | МОДУЛЯТОРИ НУКЛЕАРНОГО ТРАНСПОРТУ, ЩО МІСТЯТЬ ГІДРАЗИД, І ЇХНЄ ЗАСТОСУВАННЯ (HYDRAZIDE CONTAINING NUCLEAR TRANSPORT MODULATORS AND USES THEREOF) | ⤷ Try a Trial |
Australia | 2012290467 | Nuclear transport modulators and uses thereof | ⤷ Try a Trial |
Chile | 2015001257 | Compuestos derivados de 3-(3-(3,5-bis(trifluorometil)fenil)-1h-1,2,4-triazol-1-il)-hidrazida; composicion farmaceutica; procedimiento para preprar precursores; procedimiento para tratar; uso para tratar trastornos asociados a crm1 tal como trastorno proliferativo, inflamatorio, entre otros (divisional de solicitud n° 225-2014). | ⤷ Try a Trial |
Poland | 2736887 | ⤷ Try a Trial | |
>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 | ⤷ Try a Trial | PRODUCT NAME: SELINEKSORAS; REGISTRATION NO/DATE: EU/1/21/1537 20210326 |
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 | 2190030-3 | Sweden | ⤷ Try a Trial | PRODUCT NAME: SELINEXOR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/21/1537 20210329 |
2736887 | C202130053 | Spain | ⤷ Try a Trial | PRODUCT NAME: SELINEXOR O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/21/1537; DATE OF AUTHORISATION: 20210326; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/21/1537; DATE OF FIRST AUTHORISATION IN EEA: 20210326 |
2736887 | CR 2021 00031 | Denmark | ⤷ Try a Trial | PRODUCT NAME: SELINEXOR ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/21/1537 20210329 |
2736887 | 301119 | Netherlands | ⤷ Try a Trial | DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGE OF OWNER(S) NAME |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |