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Last Updated: July 18, 2024

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.
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:RXDosage:TABLET;ORALStrength20MG
Approval Date:Jul 3, 2019TE: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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.