SELINEXOR - Generic Drug Details

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 eleven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Selinexor has one hundred and thirty-six patent family members in thirty-nine countries.

One supplier is listed for this compound.

Summary for SELINEXOR

International Patents:	136
US Patents:	11
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	47
Clinical Trials:	173
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SELINEXOR
What excipients (inactive ingredients) are in SELINEXOR?	SELINEXOR excipients list
DailyMed Link:	SELINEXOR at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for SELINEXOR

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
Zhengzhou University	PHASE4
Washington University School of Medicine	PHASE1
Karyopharm Therapeutics Inc	PHASE1

See all SELINEXOR clinical trials

Pharmacology for SELINEXOR

Drug Class	Nuclear Export Inhibitor
Mechanism of Action	Nuclear Export Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for SELINEXOR

L01XX	Other antineoplastic agents
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

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	212306-002	Apr 15, 2021		RX	Yes	No
Karyopharm Theraps	XPOVIO	selinexor	TABLET;ORAL	212306-003	Apr 15, 2021		RX	Yes	No			Y	Y
Karyopharm Theraps	XPOVIO	selinexor	TABLET;ORAL	212306-005	Mar 10, 2025		RX	Yes	No			Y	Y
Karyopharm Theraps	XPOVIO	selinexor	TABLET;ORAL	212306-004	Apr 15, 2021		RX	Yes	Yes
Karyopharm Theraps	XPOVIO	selinexor	TABLET;ORAL	212306-001	Jul 3, 2019		RX	Yes	No			Y
Karyopharm Theraps	XPOVIO	selinexor	TABLET;ORAL	212306-005	Mar 10, 2025		RX	Yes	No
Karyopharm Theraps	XPOVIO	selinexor	TABLET;ORAL	212306-006	Oct 20, 2025		RX	Yes	No

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/005127NEXPOVIO 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

International Patents for SELINEXOR

Country	Patent Number	Title	Estimated Expiration
South Africa	201401223	HYDRAZIDE CONTAINING NUCLEAR TRANSPORT MODULATORS AND USES THEREOF
Japan	2014521653
China	107072992
Canada	2842362
Portugal	2736887
Spain	2954991
South Korea	102022716

Supplementary Protection Certificates for SELINEXOR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2736887	2190030-3	Sweden		PRODUCT NAME: SELINEXOR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; FIRST MARKETING AUTHORIZATION NUMBER SE: EG EU/1/21/1537, 2021-03-29; PRV HAR FATTAT BESLUT OM RAETTAD SKYDDSTID FOER FOELJANDE TILLAEGGSSKYDD. 2290042-7 2290031-0 1590027-7 1590062-4 2190040-2 2290010-4 1990014-1 2190030-3 1590011-1 1490013-8 1490014-6 1490015-3 1890033-2 1990042-2 1990055-4 SKYDDSTIDEN FOER SAMTLIGA DESSA TILLAEGGSSKYDD AER FOERLAENGD MED EN DAG, I ENLIGHET MED PATENT- OCH MARKNADSDOMSTOLENS BESLUT I PMAE 7804-24. DEN BESLUTADE SKYDDSTIDEN FRAMGAR AV SVENSK PATENTDATABAS.
2736887	CR 2021 00031	Denmark		PRODUCT NAME: SELINEXOR ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/21/1537 20210329
2736887	CA 2021 00031	Denmark		PRODUCT NAME: SELINEXOR ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/21/1537 20210329
2736887	202140024	Slovenia		PRODUCT NAME: SELINEXOR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; NATIONAL AUTHORISATION NUMBER: EU/1/21/1537/001-004; DATE OF NATIONAL AUTHORISATION: 20210326; AUTHORITY FOR NATIONAL AUTHORISATION: EU
2736887	132021000000143	Italy		PRODUCT NAME: SELIXENOR O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(NEXPOVIO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/21/1537, 20210329
2736887	301119	Netherlands		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGE OF OWNER(S) NAME
2736887	122021000055	Germany		PRODUCT NAME: SELINEXOR ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1537 20210326

Market Dynamics and Financial Trajectory for Selinexor

Last updated: February 15, 2026

Overview

Selinexor is an oral Selective Inhibitor of Nuclear Export (SINE) developed by Karyopharm Therapeutics. It functions by inhibiting XPO1 (exportin 1), leading to the accumulation of tumor suppressor proteins in the nucleus and inducing apoptosis in cancer cells. Approved by the U.S. Food and Drug Administration (FDA) in December 2019 for relapsed or refractory multiple myeloma, it has expanded its indications to include certain lymphomas and solid tumors.

Market Size and Growth Drivers

The global oncology drug market is projected to reach $218 billion by 2027, expanding at a compound annual growth rate (CAGR) of 7.2% from 2020 to 2027, according to Grand View Research. Selinexor's niche positions within this market have been influenced by several factors:

• Unmet Medical Need: Limited options exist for multiple myeloma patients refractory to existing therapies.
• Orphan Drug Designation: Enables market exclusivity and fee waivers, supporting commercialization.
• Expanding Indications: Ongoing trials for lymphoma, solid tumors, and other hematologic malignancies.

Sales Performance and Revenue Trajectory

Karyopharm's sales data illustrates initial growth followed by stagnation attributable to market penetration challenges and competing therapies:

Year	Revenue (USD millions)	Note
2020	57	First full-year sales post-FDA approval
2021	102	Uptick due to expanded access and clinical trial progress
2022	183	Increased prescriptions, expanded indications

• 2022 Revenue Breakdown: Approximately 65% derived from multiple myeloma sales, 25% from lymphoma indications, and 10% from other oncology uses.

Market Penetration Challenges

• Competition: Approved agents such as CAR-T cell therapies and proteasome inhibitors possess superior efficacy and safety profiles, impacting selinexor's adoption.
• Side Effect Profile: Thrombocytopenia, fatigue, and gastrointestinal toxicities limit dosage optimization.
• Pricing Pressure: Reimbursement challenges in key markets reduce margins; list prices vary but hover around USD 13,000/month in the U.S.

Regulatory and Clinical Development Outlook

The company is pursuing several clinical trials, including:

• XPORT-MM-300: Phase 3 trial for newly diagnosed multiple myeloma.
• XPORT-LM-020: Phase 2 for relapsed/refractory lymphoma.
• Combination therapies: Trials combining selinexor with other agents like bortezomib and dexamethasone aim to improve outcomes.

Regulatory ambitions include potential approvals for solid tumors pending trial results, which could diversify revenue streams.

Financial Metrics and Projections

Karyopharm's financial health reflects typical oncology biotech patterns: consistent operational expenses, reliance on licensing and strategic partnerships, and development-stage uncertainties.

• R&D Expenses: USD 239 million in 2022, representing significant investment in clinical trials.
• Cash Reserves: Approximately USD 273 million as of Q4 2022, sufficient to sustain ongoing trials into 2024 without additional financing.
• Market Valuation: As of early 2023, market cap hovers around USD 1.2 billion, reflecting growth potential but also volatility stemming from clinical trial outcomes.

Potential Impact Factors

• Efficacy Data: Positive results in upcoming trials could accelerate adoption and support price increases.
• Pricing and Reimbursement Policy: Changes in healthcare policies could pressure margins or expand access.
• Pipeline Success: New indications or formulations could significantly alter financial trajectories.

Key Takeaways

• Selinexor holds a niche in an expanding oncology market but faces competition and toxicity challenges.
• Revenues have grown with indication approvals but remain modest relative to top oncology drugs.
• The company's financial position is stable but depends heavily on clinical trial outcomes, regulatory decisions, and market access.
• Diversification through pipeline expansion and combination therapies could drive future growth.
• External factors such as reimbursement policies and market competition will significantly influence the long-term trajectory.

FAQs

1. What are the primary indications for selinexor?
   Currently FDA-approved for relapsed or refractory multiple myeloma in combination with dexamethasone. Under clinical development for lymphoma, solid tumors, and other hematologic malignancies.

2. How does selinexor compete with other therapies?
   It competes with proteasome inhibitors, immunomodulators, and CAR-T cells. Its oral administration offers convenience but is limited by toxicity and efficacy concerns.

3. What are the prospects for revenue growth?
   Expansion into new indications, positive trial outcomes, and approvals could increase revenues. However, market penetration remains challenged by existing therapies.

4. What risks could affect selinexor’s financial trajectory?
   Clinical trial failures, regulatory setbacks, adverse side effects, and reimbursement restrictions.

5. What is the outlook for Karyopharm’s pipeline?
   Promising, with ongoing trials for multiple myeloma and lymphoma. Success depends on trial results and regulatory approval timelines.

Sources

[1] Grand View Research. Oncology Drugs Market Size & Share Analysis. 2022.
[2] Karyopharm Therapeutics financial reports, 2020-2022.
[3] FDA. Selinexor (FDA Approved Label). 2019.
[4] ClinicalTrials.gov. Selinexor Trials Portfolio. 2023.