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:	170
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

Constraining patent/regulatory exclusivity:

10,519,139

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	PHASE1
Karyopharm Therapeutics Inc	PHASE1
Tianjin Medical University Cancer Institute and Hospital	PHASE2

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	11,753,401		Y
Karyopharm Theraps	XPOVIO	selinexor	TABLET;ORAL	212306-002	Apr 15, 2021		RX	Yes	No	12,291,508
Karyopharm Theraps	XPOVIO	selinexor	TABLET;ORAL	212306-004	Apr 15, 2021		RX	Yes	Yes	11,746,102
Karyopharm Theraps	XPOVIO	selinexor	TABLET;ORAL	212306-004	Apr 15, 2021		RX	Yes	Yes	12,291,508

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
Mexico	350442	MODULADORES DEL TRANSPORTE NUCLEAR Y USOS DE LOS MISMOS. (NUCLEAR TRANSPORT MODULATORS AND USES THEREOF.)
Brazil	112014001934
Taiwan	201311666	Hydrazide containing nuclear transport modulators and uses thereof
South Korea	20140062480

Supplementary Protection Certificates for selinexor

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2736887	2021033	Norway		PRODUCT NAME: SELINEKSOR ELLER ET FARMASOEYTISK AKSEPTABELT SALT DERAV; REG. NO/DATE: EU/1/21/1537 20210408
2736887	C20210021 00403	Estonia		PRODUCT NAME: SELINEKSOOR;REG NO/DATE: EU/1/21/1537 29.03.2021
2736887	21C1042	France		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	132021000000143	Italy		PRODUCT NAME: SELIXENOR O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(NEXPOVIO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/21/1537, 20210329

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: SELINEXOR

Last updated: July 30, 2025

Introduction

Selinexor, marketed as Xpovio® (or Oncoprev in some regions), is a first-in-class selective inhibitor of nuclear export (SINE) compound developed by Karyopharm Therapeutics. Approved by the U.S. Food and Drug Administration (FDA) in July 2020 for multiple myeloma (MM), this innovative agent operates by targeting exportin 1 (XPO1), a nuclear export protein overexpressed in various malignancies. Given its novel mechanism and expanding clinical applications, understanding the market dynamics and financial trajectory of Selinexor offers critical insights into its potential growth, competitive positioning, and investment viability.

Market Overview

Therapeutic Area and Unmet Needs

Multiple myeloma remains a significant hematologic malignancy, with over 34,000 new cases diagnosed annually in the U.S. alone. Despite advances with proteasome inhibitors, immunomodulatory drugs, and monoclonal antibodies, MM remains incurable, with relapse and refractory disease common. Selinexor addresses this unmet medical need by offering a distinct mechanism in the treatment arsenal, particularly for patients who are refractory to other therapies.

Additionally, ongoing clinical trials are exploring Selinexor's efficacy in various hematologic and solid tumors, broadening its potential therapeutic scope. This expansion enhances its market relevance amidst increasing oncology drug development activity.

Competitive Landscape

Selinexor faces competition from established drugs such as lenalidomide, bortezomib, and daratumumab, which dominate multiple myeloma treatment. However, its unique mechanism offers differentiation, particularly in refractory settings. Importantly, several competitors are developing alternative nuclear export inhibitors or drugs with similar efficacy profiles, imposing competitive pressures.

In the broader oncology segment, Selinexor's position depends on clinical trial outcomes and regulatory approvals for additional indications. Its distinct mechanism could serve as a pivotal advantage if clinical benefits are confirmed across tumor types.

Market Penetration and Adoption

Regulatory Approvals and Clinical Guidelines

The FDA's approval in 2020 facilitated initial market access, primarily in relapsed/refractory multiple myeloma after at least four prior therapies. Post-approval, inclusion in clinical guidelines, such as those from the National Comprehensive Cancer Network (NCCN), has bolstered its clinical acceptance.

Pricing and Reimbursement Landscape

Pricing per treatment cycle is approximately $15,000 to $18,000, reflecting its targeted, novel status. Reimbursement strategies hinge on insurance coverage, with payers increasingly incorporating Selinexor into formularies due to its proven efficacy in refractory MM. The high treatment costs pose challenges but are mitigated by its clinical benefits and positioning as an option for heavily resistant cases.

Market Penetration Metrics

Karyopharm reports that Selinexor has achieved differentiated penetration within the growing MM segment. In the company's Q4 2022 filings, Selinexor accounted for a substantial portion of its oncology sales, with estimates indicating global sales approaching $200 million in 2022. Continued adoption hinges on further clinical data, combination therapy approvals, and expanded indication filings.

Clinical Expansion and Pipeline Progress

Additional Indications

Clinical trials are evaluating Selinexor in non-Hodgkin's lymphoma, solid tumors such as pancreatic and ovarian cancers, and rare diseases. Successful trials could substantially diversify its revenue base, aligning with strategic interests to extend market opportunity horizons.

Combination Therapies

Combining Selinexor with other agents, including proteasome inhibitors, monoclonal antibodies, and chemotherapy, aims to enhance efficacy and overcome resistance. Early data indicates promising synergy, which can catalyze broader adoption and higher dosing regimens.

Financial Trajectory

Revenue Growth Forecasts

Based on recent financial disclosures, Karyopharm's annual revenue from Selinexor is projected to grow at a compounded annual growth rate (CAGR) of approximately 20-25% over the next five years. Factors driving this include increased market penetration, new indications, and strategic collaborations.

Profitability and Investment Outlook

While current revenues predominantly sustain R&D and operational costs, anticipated revenue growth and the potential for expanded indications suggest improved profit margins by 2025. Strategic investments into manufacturing capacity and global commercialization agreements are expected to support this trajectory.

Market Risks

Key risks include patent expiration timelines, competitive drug launches, potential safety concerns, and regulatory hurdles for new indications. These factors could temper growth projections if adverse or delayed outcomes materialize.

Strategic Initiatives and Market Opportunities

Karyopharm’s strategy involves collaborations with global pharmaceutical partners to accelerate commercialization, especially in Europe and Asia-Pacific. Moreover, ongoing trials aim to secure approval for earlier lines of treatment, which could significantly expand the market size.

Regulatory and Competitive Challenges

Regulatory agencies have expressed interest in ongoing safety data, especially considering Selinexor's side effect profile. Managing adverse events such as thrombocytopenia and fatigue remains critical for regulatory approval of new indications.

The competitive landscape will intensify as biosimilar and small-molecule competitors evolve, necessitating continuous innovation and strategic partnerships to sustain market share.

Conclusion

Selinexor's market dynamics are characterized by promising growth potential driven by its specific mechanism, clinical indications expansion, and strategic collaborations. While challenges such as competition and safety profiles exist, its current trajectory indicates a robust financial outlook contingent on successful clinical development and regulatory navigation.

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Key Takeaways

• Innovative Mechanism: Selinexor’s targeted inhibition of nuclear export differentiates it within multiple myeloma and potential future indications.
• Growth Potential: Factory expansion, pipeline developments, and ongoing clinical trials position Selinexor for sustained revenue growth, with forecasts indicating a 20-25% CAGR over the next five years.
• Market Challenges: Competitor developments, safety considerations, and reimbursement policies may influence market penetration.
• Strategic Collaborations: Partnerships with global pharmaceutical companies will be pivotal for market expansion, particularly outside North America.
• Financial Viability: While current revenues cover operational costs, increasing adoption and new indications are expected to improve profitability margins moving forward.

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Frequently Asked Questions (FAQs)

1. What distinguishes Selinexor from other multiple myeloma treatments?
Selinexor's mechanism involves selectively inhibiting XPO1, leading to the accumulation of tumor suppressor proteins within the nucleus. This novel approach provides an alternative pathway for refractory cases, setting it apart from proteasome inhibitors and immunomodulatory agents.

2. What are the primary safety concerns associated with Selinexor?
Adverse events such as thrombocytopenia, fatigue, nausea, and hyponatremia are common. Management of these side effects is crucial for maintaining adherence and optimizing clinical outcomes.

3. How does Selinexor’s market size compare to existing therapies?
While the total multiple myeloma treatment market exceeds $15 billion globally, Selinexor’s current share is modest (~$200 million in 2022). Its growth depends on expanding approvals and shifting its role from salvage therapy to earlier lines.

4. What are upcoming development milestones for Selinexor?
Key milestones include trial results for additional indications, regulatory filings in Europe and Asia, and potential approvals for first-line treatment in specific malignancies.

5. How might competitive pressures impact Selinexor's financial trajectory?
Emerging agents with similar efficacy, safety, or combination potential could erode market share. Continuous innovation and clinical validation remain essential to sustain its competitive edge.

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References

1. Karyopharm Therapeutics. (2022). Annual Report.
2. U.S. Food and Drug Administration. (2020). FDA approval statement for Xpovio.
3. National Comprehensive Cancer Network. (2023). Multiple Myeloma Guidelines.
4. Market data reports—evaluate, April 2023.