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 |
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 | ⤷ 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 | ⤷ 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 | 212306-004 | Apr 15, 2021 | RX | Yes | Yes | ⤷ 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 | ||||
| >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 |
|---|---|---|---|
| Singapore | 10201808624V | POLYMORPHS OF SELINEXOR | ⤷ Try a Trial |
| Japan | 2016199604 | 核内輸送調節因子およびその使用 (NUCLEAR TRANSPORT MODULATORS AND USE THEREOF) | ⤷ Try a Trial |
| Denmark | 3333164 | ⤷ Try a Trial | |
| South Korea | 20230042129 | 하이드라지드 함유 핵 수송 조절인자 및 이의 용도 (HYDRAZIDE CONTAINING NUCLEAR TRANSPORT MODULATORS AND USES THEREOF) | ⤷ Try a Trial |
| Luxembourg | C00219 | ⤷ 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 | C20210021 00403 | Estonia | ⤷ Try a Trial | PRODUCT NAME: SELINEKSOOR;REG NO/DATE: EU/1/21/1537 29.03.2021 |
| 2736887 | 21C1042 | France | ⤷ Try a Trial | PRODUCT NAME: SELINEXOR OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; NAT. REGISTRATION NO/DATE: EU/1/21/1537 20210329; FIRST REGISTRATION: FR - EU/1/21/1537 20210329 |
| 2736887 | PA2021007,C2736887 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: SELINEKSORAS; REGISTRATION NO/DATE: EU/1/21/1537 20210326 |
| 2736887 | PA2021007 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: SELINEKSORAS; REGISTRATION NO/DATE: EU/1/21/1537 20210326 |
| 2736887 | LUC00219 | Luxembourg | ⤷ Try a Trial | 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 |
