NUCALA Drug Profile

Summary for Tradename: NUCALA

High Confidence Patents:	3
Applicants:	1
BLAs:	2
Recent Clinical Trials:	See clinical trials for NUCALA

Recent Clinical Trials for NUCALA

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
GlaxoSmithKline	PHASE4
Johns Hopkins University	Early Phase 1
Centre hospitalier de l'Université de Montréal (CHUM)	Phase 4

See all NUCALA clinical trials

Pharmacology for NUCALA

Mechanism of Action	Interleukin-5 Antagonists
Established Pharmacologic Class	Interleukin-5 Antagonist

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 NUCALA Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for NUCALA 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
Glaxosmithkline Llc	NUCALA	mepolizumab	For Injection	125526	10,870,695	2036-08-22	DrugPatentWatch analysis and company disclosures
Glaxosmithkline Llc	NUCALA	mepolizumab	For Injection	125526	5,693,323	2015-06-06	DrugPatentWatch analysis and company disclosures
Glaxosmithkline Llc	NUCALA	mepolizumab	For Injection	125526	6,129,913	2015-12-22	DrugPatentWatch analysis and company disclosures
Glaxosmithkline Llc	NUCALA	mepolizumab	Injection	125526	10,870,695	2036-08-22	DrugPatentWatch analysis and company disclosures
Glaxosmithkline Llc	NUCALA	mepolizumab	Injection	125526	5,693,323	2015-06-06	DrugPatentWatch analysis and company disclosures
Glaxosmithkline Llc	NUCALA	mepolizumab	Injection	125526	6,129,913	2015-12-22	DrugPatentWatch analysis and company disclosures

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

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Glaxosmithkline Llc	NUCALA	mepolizumab	For Injection	125526	10,028,940	2037-03-16	Patent claims search
Glaxosmithkline Llc	NUCALA	mepolizumab	For Injection	125526	10,047,033	2036-05-12	Patent claims search
Glaxosmithkline Llc	NUCALA	mepolizumab	For Injection	125526	10,111,968	2036-08-10	Patent claims search
Glaxosmithkline Llc	NUCALA	mepolizumab	For Injection	125526	10,195,183	2037-08-14	Patent claims search
Glaxosmithkline Llc	NUCALA	mepolizumab	For Injection	125526	10,195,211	2037-10-27	Patent claims search
Glaxosmithkline Llc	NUCALA	mepolizumab	For Injection	125526	10,231,976	2031-02-07	Patent claims search

International Patents for NUCALA

Country	Patent Number	Estimated Expiration
Colombia	2018001840
Dominican Republic	P2018000057
Japan	2022023049
China	116327923
Japan	6821659
World Intellectual Property Organization (WIPO)	2017033121

Market Dynamics and Financial Trajectory for the Biologic Drug: NUCALA (Mepolizumab)

Last updated: September 19, 2025

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Introduction

NUCALA (mepolizumab), a monoclonal antibody developed by GlaxoSmithKline (GSK), is a leading biologic indicated primarily for severe eosinophilic asthma, eosinophilic granulomatosis with polyangiitis (EGPA), and hypereosinophilic syndrome (HES). Since its approval in 2015, NUCALA has contributed significantly to the biologic landscape, driven by growing awareness of eosinophilic disorders and pipeline expansion. This report delves into the market dynamics shaping NUCALA’s trajectory, with an emphasis on its strategic positioning, competitive environment, evolving indications, and financial outlook.

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Market Landscape and Key Drivers

1. Growing Prevalence of Eosinophilic Diseases

The global burden of eosinophilic disorders, especially severe eosinophilic asthma, fuels demand for targeted biologics like NUCALA. According to the CDC, approximately 7-10% of asthma cases are classified as severe, with a substantial subset driven by eosinophilic inflammation [1]. As diagnostic techniques improve—particularly blood eosinophil counts—more patients are identified for biologic therapies, enhancing NUCALA’s addressable market.

2. Expanding Indication Portfolio

Initially approved for severe eosinophilic asthma, subsequent approvals broadened NUCALA’s market reach. Notably:

• Eosinophilic Granulomatosis with Polyangiitis (EGPA): Approved in 2017, expanding use beyond asthma.
• Hypereosinophilic Syndrome (HES): Approved in 2019 in several regions.
• Chronic Rhinosinusitis with Nasal Polyps (CRSwNP): Regulatory review ongoing or awaited, with potential to significantly broaden utilization.

This diversification reduces dependence on a single indication and enhances revenue resilience amid market fluctuations.

3. Competitive Landscape

NUCALA faces competition from other biologics targeting eosinophilic pathways, notably:

• Fasenra (benralizumab) by AstraZeneca
• Cinqair (reslizumab) by Teva
• Dupixent (dupilumab) by Sanofi/Regeneron (indication overlap in asthma and nasal polyps)

While each has unique target profiles, NUCALA's precision targeting of IL-5 has historically provided a competitive edge. Market share shifts hinge on efficacy, safety, dosing convenience, and payer access.

4. Evolving Pricing and Reimbursement Strategies

Pricing strategies influence NUCALA’s financial performance. High-value biologics often face reimbursement hurdles; however, the demonstrated efficacy in severe eosinophilic conditions ensures payer support. GSK's engagement in risk-sharing agreements and patient assistance programs aim to optimize access.

5. Impact of COVID-19 Pandemic

The pandemic disrupted routine healthcare delivery, affecting prescription refills and new patient initiation. Nonetheless, telehealth adoption and an increased focus on managing respiratory comorbidities stabilizes long-term demand. GSK reports steady sales growth despite temporary declines during peak pandemic periods.

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Financial Trajectory and Revenue Outlook

1. Historical Performance

Since its launch, NUCALA has experienced robust growth. GSK's annual reports indicate:

• 2019: ~$1.2 billion in global sales
• 2020: ~15% year-over-year increase, reaching ~$1.4 billion
• 2021: Continued momentum, approximately $1.6 billion in sales

This growth reflects expanded indications, increased diagnosis, and improved reimbursement.

2. Projected Revenue Growth

Analysts predict a compound annual growth rate (CAGR) of approximately 10-12% over the next five years, driven by:

• Increased uptake in new indications such as nasal polyps
• Emergence in emerging markets, where prevalence rates and access expand
• Pipeline approvals: Pending approvals for additional indications could act as catalysts

GSK’s commitment to clinical development and strategic marketing positions NUCALA for sustained growth.

3. Factors Influencing Financial Outcomes

• Pipeline and Lifecycle Management: GSK’s focus on next-generation IL-5 inhibitors and combination therapies could influence market share.
• Patent Expiry and Biosimilar Entry: As patents expire in the late 2020s, biosimilar competition may exert downward pressure.
• Pricing and Reimbursement Trends: Payer negotiations and healthcare policies aimed at controlling biologic costs will shape revenue trajectories.
• Emerging Competition: The entrance of more effective or convenient biologics could challenge NUCALA’s market dominance.

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Strategic Considerations

1. Market Penetration and Geographic Expansion

GSK actively promotes NUCALA in North America and Europe, with strategic investments in emerging markets. Local regulatory approvals and infrastructure development are pivotal for growth in Asia-Pacific, Latin America, and Africa.

2. Innovation and Pipeline Development

GSK’s R&D pipeline for eosinophilic and related inflammatory diseases is robust. Collaboration agreements and licensing deals aim to expand therapeutic options and complement NUCALA’s portfolio.

3. Patient-Centric Approaches

Enhanced patient support programs and digital health integration improve adherence and retention, driving sales.

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Regulatory and Market Risks

• Regulatory Delays or Rejections: Pending approvals, notably for additional indications, remain susceptible to clinical trial outcomes.
• Market Saturation: As the eosinophilic asthma market becomes more competitive, NUCALA's growth may plateau without new indications.
• Pricing Pressure: Government and insurer efforts to control biologic drug costs threaten profit margins.

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Key Takeaways

• Strong Market Position: NUCALA benefits from its early entry, broadening indications, and established efficacy, securing a dominant position in eosinophilic inflammatory disorders.
• Growth Potential: The expanding indication portfolio and geographic outreach suggest a double-digit revenue growth trajectory over the coming years.
• Competitive Landscape: While competition intensifies, NUCALA’s targeted approach and ongoing pipeline investments aim to sustain its market leadership.
• Financial Outlook: Revenue is forecasted to grow steadily, with potential accelerators from new indications and emerging markets, tempered by patent expiries and reimbursement challenges.
• Strategic Focus: Continued innovation, regulatory navigation, and patient engagement are crucial for maintaining trajectory.

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FAQs

1. What are the primary indications driving NUCALA sales?
Severe eosinophilic asthma remains the cornerstone, with additional growth driven by approvals for eosinophilic granulomatosis with polyangiitis (EGPA) and hypereosinophilic syndrome (HES). Pending approvals for nasal polyps could significantly elevate demand.

2. How does NUCALA compare with its competitors?
NUCALA’s targeted IL-5 inhibition confers a competitive edge regarding efficacy and safety profiles. However, drugs like Fasenra and Cinqair introduce alternative dosing and administration advantages that influence market share.

3. What factors could threaten NUCALA’s future revenue?
Patent expiration, biosimilar competition, pricing pressures, and shifts in healthcare reimbursement policies pose potential risks. Additionally, emerging therapeutics with superior efficacy or convenience could alter the competitive landscape.

4. How significant is the impact of COVID-19 on NUCALA’s market growth?
The pandemic temporarily disrupted prescriptions and diagnosis rates but stabilization has occurred due to telehealth and prioritization of respiratory disease management, enabling a resilient outlook.

5. What opportunities exist for GSK to expand NUCALA’s market?
Key prospects include approval for additional indications such as nasal polyps, expansion into emerging markets, and integration with digital health initiatives to enhance adherence and access.

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References

[1] Centers for Disease Control and Prevention (CDC). Asthma Data and Statistics.
[2] GSK Annual Reports (2019-2021).
[3] Market Research Future. Global Biologics Market Analysis.
[4] Clinical Trial Registries and Regulatory Agencies.
[5] Industry Analyst Reports.