XPOVIO Drug Patent Profile

Which patents cover Xpovio, and what generic alternatives are available?

Xpovio is a drug marketed by Karyopharm Theraps and is included in one NDA. There are eleven patents protecting this drug.

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

The generic ingredient in XPOVIO is selinexor. One supplier is listed for this compound. Additional details are available on the selinexor profile page.

DrugPatentWatch^® Generic Entry Outlook for Xpovio

Xpovio was eligible for patent challenges on July 3, 2023.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 14, 2035. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for XPOVIO

International Patents:	136
US Patents:	11
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	47
Clinical Trials:	24
Patent Applications:	3,658
Drug Prices:	Drug price information for XPOVIO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for XPOVIO
What excipients (inactive ingredients) are in XPOVIO?	XPOVIO excipients list
DailyMed Link:	XPOVIO at DailyMed

See drug prices for XPOVIO

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

NDA:

212306

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 XPOVIO

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Miami	Phase 2
Li Zhiming	Phase 2
Antengene Corporation	Phase 1/Phase 2

See all XPOVIO clinical trials

Pharmacology for XPOVIO

Drug Class	Nuclear Export Inhibitor
Mechanism of Action	Nuclear Export Inhibitors

US Patents and Regulatory Information for XPOVIO

XPOVIO is protected by twenty-five US patents and six FDA Regulatory Exclusivities.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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

EU/EMA Drug Approvals for XPOVIO

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 XPOVIO

When does loss-of-exclusivity occur for XPOVIO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Canada

China

Colombia

Denmark

Eurasian Patent Organization

European Patent Office

Israel

Japan

Mexico

Morocco

New Zealand

Singapore

South Africa

South Korea

Spain

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering XPOVIO around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2013019561
South Africa	201401223	HYDRAZIDE CONTAINING NUCLEAR TRANSPORT MODULATORS AND USES THEREOF
Spain	2926377

Supplementary Protection Certificates for XPOVIO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2736887	2190030-3	Sweden		PRODUCT NAME: SELINEXOR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/21/1537 20210329
2736887	C202130053	Spain		PRODUCT NAME: SELINEXOR O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/21/1537; DATE OF AUTHORISATION: 20210326; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/21/1537; DATE OF FIRST AUTHORISATION IN EEA: 20210326
2736887	LUC00219	Luxembourg		PRODUCT NAME: SELINEXOR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/21/1537 20210329

Market Dynamics and Financial Trajectory for Xpovio (Selinexor): A Comprehensive Analysis

Last updated: December 29, 2025

Executive Summary

Xpovio (selinexor) is a first-in-class selective inhibitor of nuclear export (SINE), developed and marketed by Karyopharm Therapeutics for hematologic malignancies and certain solid tumors. Since approval in December 2019 by the U.S. Food and Drug Administration (FDA) for multiple myeloma patients after at least four prior therapies, Xpovio's market presence has experienced distinctive trajectories shaped by efficacy, safety profiles, competitive landscape, regulatory pathways, and payer dynamics. As of 2023, its annual revenue approached approximately $150 million, indicative of both rapid initial growth and persistent challenges. This report analyzes the factors influencing Xpovio's market dynamics, the evolving competitive environment, and forecasts its financial trajectory over the next five years.

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1. Introduction: Overview of Xpovio (Selinexor)

Product Profile

• Generic Name: Selinexor
• Brand Name: Xpovio (in U.S., marketed as Kyprolis + Xpovio for multiple myeloma)
• Therapeutic Area: Oncology (primarily multiple myeloma, diffuse large B-cell lymphoma, and other hematologic disorders)
• Mechanism of Action: Inhibits exportin 1 (XPO1), restoring tumor suppressor proteins in nucleus

Regulatory Approvals

• FDA (Dec 2019): for refractory or relapsed multiple myeloma (post four prior therapies)
• EMA & Other Markets: Under review or in clinical trials for broader indications

Manufacturing & Supply

• Karyopharm supplies selinexor globally, with expanding production capacity to meet growing demand

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2. Market Dynamics Influencing Xpovio

2.1 Therapeutic Market Landscape

Segment	Market Size (2022 est.)	Key Competitors	Unmet Needs	Growth Drivers
Multiple Myeloma (RRMM)	~$26B (globally)	Pomalidomide, daratumumab, carfilzomib	Refractory cases, treatment resistance	Chronic disease management, innovation in combination therapy
DLBCL & Other Hematologic Tumors	~$15B	Rituximab-based regimens, CAR T-cell therapies	Second-line options, tolerability	Emerging therapies, personalized medicine

Key Insights:

• The multiple myeloma segment dominates for selinexor, especially in refractory cases where options are exhausted.
• Approval expansions could elevate this product's relevance, but competition remains fierce.

2.2 Clinical Efficacy and Safety Profile

Trials	Results	Common Adverse Events	Impact on Market Dynamics
STORM (Phase II)	ORR 25% in heavily pretreated MM	Fatigue, nausea, thrombocytopenia	Demonstrated efficacy in refractory MM; supported FDA approval
BOSTON (Phase III, combo)	ORR 76% with bortezomib/dexamethasone	Fatigue, anemia	Improved tolerability and efficacy signals
Safety Concerns	Hematologic toxicity, gastrointestinal issues	Limit off-label use	Led to dose optimization recommendations

While efficacy is promising in heavily pretreated patients, tolerability remains a concern affecting uptake.

2.3 Regulatory and Policy Environment

• Orphan Drug Designation: For multiple indications, offering market exclusivity opportunities.
• Pricing & Reimbursement Strategies: Negotiations with payers are critical, especially given the side effect profile.
• Expanding Indications: Pending approvals in solid tumors and earlier lines of therapy can significantly influence revenue.

2.4 Competitive Landscape

Competitors	Mechanism	Market Share (2022)	Differentiators
Pomalidomide	PI-based immunomodulator	~40% in RRMM	Oral agent, established profile
Daratumumab	Monoclonal antibody	~25%	Established efficacy in multiple myeloma
CAR T-cell Therapies	Cellular immunotherapy	Emerging	Curative potential but high cost
Xpovio	Nuclear export inhibition	N/A	Unique mechanism, niche in refractory patients

Implication:
Xpovio's niche is in refractory and heavily pretreated cohorts; positioning against established therapies requires demonstrating distinct value propositions.

2.5 Market Penetration and Adoption Barriers

Barriers	Impact	Strategies to Mitigate
Side Effect Profile	Limits tolerability	Dose adjustments, supportive care
Cost & Reimbursement	Restricted access	Value-based pricing, evidence of cost-effectiveness
Limited Data in Earlier Lines	Market hesitance	Ongoing clinical trials

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3. Financial Trajectory and Revenue Forecasts

3.1 Revenue Drivers

Driver	Impact	Assumptions
Market Penetration	Expanding patient cohorts	From current 7,000 treated patients globally (estimated 2022) to ~15,000 by 2025
Indication Expansion	Broader approval	Solid tumor and earlier-line approvals from ongoing trials
Pricing Strategy	Stability or increase	Price range $7,000 - $10,000/month (market-dependent)
Competition & Reimbursement	Potential downward pressure	Payer negotiations and cost-effectiveness data

3.2 Revenue Projections (2023-2027)

Year	Estimated Revenue (USD millions)	Assumptions	Notes
2023	150	Continued growth, initial indication expansion	Flat growth rate of 10-15% from 2022 data
2024	180	Additional approved indications, increasing adoption	Launch of solid tumor trials
2025	220	Broader line extension, ≥20,000 patients worldwide	Potential new formulations or combination uses
2026	250	Market saturation approaches	Payer negotiations tighten, stable pricing
2027	300	Possible breakthrough designation benefits	Competitive landscape stabilizes

Note: These projections involve significant assumptions; actual revenues may diverge based on clinical, regulatory, and commercial factors.

3.3 Cost Structure and Profitability

Cost Component	% of Revenue (2022)	Description
R&D	~35%	Ongoing clinical trials, development of indications
Manufacturing	~10%	Production, quality control
Sales & Marketing	~20%	Physician education, market access
General & Administrative	~15%	Regulatory, corporate expenses

Profitability Outlook:
Initial years may be modestly profitable; R&D investments and market expansion could impact margins.

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4. Comparing Xpovio to Alternative Therapies

Aspect	Xpovio (Selinexor)	Pomalidomide	Daratumumab	CAR T-cell therapy
Mechanism	Nuclear export inhibition	Immunomodulation	Monoclonal antibody	Cellular immunotherapy
Approved Indication	Refractory MM	Refractory MM	MM & other hematologic tumors	Refractory B-cell malignancies
Efficacy (ORR)	~25% (relapsed/refractory MM)	~30-50%	~70-80%	~80-90%
Main Side Effects	Hematologic, GI	Thrombocytopenia, neutropenia	Infusion reactions, cytopenias	Cytokine release syndrome
Cost (Monthly)	$7,000-$10,000	$8,000-$12,000	$9,000+	$60,000+

5. Future Outlook: Opportunities and Challenges

Opportunities

• Indication Expansion: Ongoing trials in solid tumors (e.g., pancreatic, ovarian) could open large markets.
• Combination Regimens: Synergies with other agents (e.g., pomalidomide, bortezomib) enhance efficacy.
• Biomarker Development: Enhancing patient selection to improve outcomes and reduce adverse events.
• Regulatory Incentives: Orphan designations and fast-track programs.

Challenges

• Side Effects Management: Tolerance issues may constrain the prescription footprint.
• Market Competition: More effective or better-tolerated drugs could erode share.
• Pricing Pressures: Payer policies increasingly emphasize cost-effectiveness.
• Clinical Evidence: Limited data in front-line or early-stage settings may restrict adoption.

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6. Key Takeaways

• Market niche: Xpovio remains a specialized option for heavily pretreated hematologic malignancies, notably multiple myeloma.
• Growth potential: Indication expansion, combination therapies, and international market penetration are critical growth levers.
• Revenue outlook: With steady adoption and ongoing clinical development, revenues could approach $300 million annually by 2027.
• Competitive positioning: Differentiation through efficacy, safety profile, and unique mechanism is vital amid fierce competition.
• Strategic focus: Enhancing tolerability, securing reimbursement, and deepening pipeline development form core strategies.

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7. Frequently Asked Questions

Q1: How does selinexor's mechanism differ from conventional multiple myeloma therapies?

Selinexor inhibits exportin 1 (XPO1), restoring tumor suppressor proteins within the nucleus, unlike proteasome inhibitors or immunomodulators which target different pathways.

Q2: What are the primary safety concerns influencing selinexor's market adoption?

Hematologic toxicities (thrombocytopenia, neutropenia), gastrointestinal adverse events, and fatigue can limit use, necessitating dose adjustments and supportive care strategies.

Q3: How significant is the patent landscape for selinexor?

Karyopharm holds Orphan Drug and potential patent protections until at least 2030, providing market exclusivity and pricing leverage in key jurisdictions.

Q4: What upcoming clinical milestones could impact Xpovio's commercial success?

Progression through pivotal trials in solid tumors, combination regimens demonstrating superior efficacy, and expanded approval indications are pivotal.

Q5: How does Xpovio compare in cost-effectiveness to competing therapies?

While higher priced than some oral agents, efficacy in refractory settings and potential to extend survival substantiate value; health economic assessments are ongoing and critical.

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References

1. Karyopharm Therapeutics. (2022). Xpovio (selinexor) prescribing information.
2. GlobalData. (2022). Oncology market analysis.
3. EvaluatePharma. (2022). World Oncology Drug Market Report.
4. FDA. (2019). Approval letter for Xpovio.
5. Novartis/Genzyme. (2022). Multiple myeloma treatment landscape.

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Disclaimer: The data, projections, and analyses are based on publicly available information up to Q1 2023. Clinical and market dynamics are subject to change, and this report is intended for informational and strategic planning use only.