Details for New Drug Application (NDA): 212306
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NDA 212306 describes XPOVIO, which is a drug marketed by Karyopharm Theraps and is included in one NDA. It is available from one supplier. There are ten patents protecting this drug. Additional details are available on the XPOVIO profile page.
The generic ingredient in XPOVIO is selinexor. One supplier is listed for this compound. Additional details are available on the selinexor profile page.
The generic ingredient in XPOVIO is selinexor. One supplier is listed for this compound. Additional details are available on the selinexor profile page.
Summary for 212306
| Tradename: | XPOVIO |
| Applicant: | Karyopharm Theraps |
| Ingredient: | selinexor |
| Patents: | 10 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 212306
Generic Entry Date for 212306*:
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.
Suppliers and Packaging for NDA: 212306
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| XPOVIO | selinexor | TABLET;ORAL | 212306 | NDA | Karyopharm Therapeutics Inc. | 72237-101 | 72237-101-01 | 4 BLISTER PACK in 1 CARTON (72237-101-01) / 3 TABLET, FILM COATED in 1 BLISTER PACK (72237-101-11) |
| XPOVIO | selinexor | TABLET;ORAL | 212306 | NDA | Karyopharm Therapeutics Inc. | 72237-101 | 72237-101-02 | 4 BLISTER PACK in 1 CARTON (72237-101-02) / 4 TABLET, FILM COATED in 1 BLISTER PACK (72237-101-12) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
| Approval Date: | Jul 3, 2019 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Dec 18, 2027 | ||||||||
| Regulatory Exclusivity Use: | FOR THE TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY, EXCLUDING ADULT PATIENTS COVERED BY XPOVIO'S PREVIOUS INDICATION FOR MULTIPLE MYELOMA APPROVED ON JULY 3, 2019 | ||||||||
| Regulatory Exclusivity Expiration: | Jul 3, 2026 | ||||||||
| Regulatory Exclusivity Use: | IN COMBO W/ DEXAMETHASONE FOR ADULTS W/ RELAPSED OR REFRACTORY MULTIPLE MYELOMA WHO RECEIVED AT LEAST 4 PRIOR THERAPIES AND REFRACTORY TO AT LEAST 2 PROTEASOME INHIBITORS, AT LEAST 2 IMMUNOMODULATORY AGENTS, AND AN ANTI-CD38 MONOCLONAL ANTIBODY | ||||||||
| Regulatory Exclusivity Expiration: | Jun 22, 2027 | ||||||||
| Regulatory Exclusivity Use: | INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL), NOT OTHERWISE SPECIFIED, INCLUDING DLBCL ARISING FROM FOLLICULAR LYMPHOMA, AFTER AT LEAST 2 LINES OF SYSTEMIC THERAPY | ||||||||
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