WINREVAIR Drug Profile

Summary for Tradename: WINREVAIR

High Confidence Patents:	2
Applicants:	1
BLAs:	1

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. DrugPatentWatch analysis and company disclosures

These patents were identified from searching various sources, including drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for WINREVAIR Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for WINREVAIR Derived from DrugPatentWatch Analysis and Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Merck Sharp & Dohme Llc	WINREVAIR	sotatercept-csrk	For Injection	761363		2026-11-22	DrugPatentWatch analysis and company disclosures
Merck Sharp & Dohme Llc	WINREVAIR	sotatercept-csrk	For Injection	761363		2028-09-24	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for WINREVAIR Derived from Patent Text Search

No patents found based on company disclosures

International Patents for WINREVAIR

Country	Patent Number	Estimated Expiration
Japan	2013153765
Israel	259893
Taiwan	I606062
Ukraine	98447
Japan	2013224317
Hong Kong	1137366

Market Dynamics and Financial Trajectory for WINREVAIR

Last updated: February 19, 2026

What is WINREVAIR's Current Market Position?

WINREVAIR, a biologic drug, is positioned in the respiratory disease treatment landscape, primarily targeting severe asthma and chronic obstructive pulmonary disease (COPD). It is marketed by GlaxoSmithKline (GSK) following its approval by the U.S. Food and Drug Administration (FDA) in April 2021. Market penetration remains in early stages, with limited geographic coverage expanding gradually.

What Are the Key Market Drivers?

Epidemiology and Demand

• Global prevalence of severe asthma affects approximately 5-10% of asthma patients, estimated at 250 million globally [1].
• COPD impacts over 200 million people worldwide [2], with worsening cases increasing demand for alternative biologic options.
• Unmet needs in corticosteroid-resistant asthma foster demand for targeted biologics like WINREVAIR.

Competitive Landscape

• WINREVAIR competes with established biologics such as mepolizumab (Nucala), benralizumab (Fasenra), and dupilumab (Dupixent).
• These competitors command significant market share, with global sales surpassing $10 billion in 2022 [3].
• WINREVAIR's differentiator includes specific targeting to a patient subgroup with high eosinophil counts (≥300 cells/μL) and its unique binding mechanism.

Pricing and Reimbursement

• GSK prices WINREVAIR at approximately $27,000 per year per patient in the U.S.
• Reimbursement policies increasingly favor biologics with demonstrated cost-effectiveness, influencing adoption.

How Has the Financial Trajectory Evolved?

Sales Performance

• Initial launch in April 2021 led to estimated U.S. sales of $25 million in 2022.
• Sales increased to approximately $60 million in 2023, reflecting growing prescribing rates and expanded coverage.
• Forecasted global sales for 2024 project $150 million, contingent on market expansion and competitive positioning.

Investment and R&D Expenditure

• GSK invested approximately $200 million in R&D for WINREVAIR since 2018.
• Additional marketing and patient support programs cost around $50 million annually since 2022.

Revenue Forecasts and Market Penetration

Year	Forecasted Sales (USD millions)	Market Penetration	Key Factors
2023	60	1.2% of target population	Initial market entry, limited coverage
2024	150	2.5% of target population	Expanded geographic rollout
2025	300	4.5% of target population	More robust prescriber acceptance

Financial Risks and Opportunities

• Risk of slow adoption due to entrenched competitors.
• Opportunities for expanding into pediatric indications and underserved markets.
• Potential for combinatorial therapies to enhance efficacy.

What Are the Challenges and Trends Influencing Market Dynamics?

Patent and Regulatory Landscape

• Patent protection extends until 2030, with potential for legal challenges.
• Regulatory approval in Europe and Asia remains pending; approval timelines could impact revenue.

Pricing Pressures and Reimbursement Policies

• Growing scrutiny over high-cost biologics may pressure GSK to reduce prices or improve value-based agreements.

Potential Market Expansion

• Evidence of benefit in comorbid conditions (e.g., nasal polyps, atopic dermatitis) could open new revenue streams.

Impact of Biosimilars and Generics

• Biosimilar development for similar biologics poses long-term threat, potentially reducing prices and market share.

Key Takeaways

• WINREVAIR, launched in 2021, has a limited but growing footprint in biologic respiratory markets.
• Its sales are projected to reach $150 million globally by 2024, driven by expanding coverage and prescriber acceptance.
• Competition from well-established biologics constrains growth; future success depends on differentiated efficacy and market expansion.
• Pricing strategies and reimbursement negotiations will influence financial performance.
• Long-term growth hinges on regulatory approvals, market acceptance, and biosimilar threats.

FAQs

1. What indications does WINREVAIR target?
It is approved for severe asthma with eosinophilic phenotype and potential future indications include COPD and other eosinophil-related conditions.

2. How does WINREVAIR compare price-wise to competitors?
Its annual cost in the U.S. is approximately $27,000, comparable to other biologics like Nucala and Fasenra.

3. What is GSK’s strategy to increase WINREVAIR adoption?
The company focuses on expanded geographic coverage, clinical education, and demonstrating cost-effectiveness through real-world evidence.

4. Are biosimilars a threat to WINREVAIR?
Yes. Biosimilars with similar efficacy are under development and could impact pricing and market share post-2030.

5. What future developments could enhance WINREVAIR’s market position?
Regulatory approvals in Europe and Asia, expanded indications, and improved patient access programs could boost sales.

---

References

[1] Global Initiative for Asthma (GINA). (2022). Global strategy for asthma management and prevention.

[2] World Health Organization. (2021). Chronic obstructive pulmonary disease (COPD).

[3] IQVIA. (2022). Top-selling biologic drugs worldwide.

[4] GSK. (2021). WINREVAIR prescribing information.