Mepolizumab - Biologic Drug Details

Summary for mepolizumab

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	2
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for mepolizumab

Recent Clinical Trials for mepolizumab

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Azienda Ospedaliero Universitaria di Cagliari	PHASE4
Eye & ENT Hospital of Fudan University	PHASE4
Rigshospitalet, Denmark	PHASE4

See all mepolizumab clinical trials

Pharmacology for mepolizumab

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 brand-side disclosures

These patents were identified from searching 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 mepolizumab Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for mepolizumab 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

3) Low Certainty: US Patents for mepolizumab 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

International Patents for mepolizumab

Country	Patent Number	Estimated Expiration
Japan	2018526369
Costa Rica	20180115
Uruguay	36868
China	116327922

Market Dynamics and Financial Trajectory for Mepolizumab

Last updated: March 22, 2026

Overview

Mepolizumab (brand name Nucala) is a monoclonal antibody developed by GlaxoSmithKline (GSK) targeting interleukin-5 (IL-5). Approved by the FDA in 2015 for eosinophilic asthma, it has since expanded into other indications, including severe eosinophilic COPD, hypereosinophilic syndrome, and eosinophilic granulomatosis with polyangiitis (EGPA). This analysis covers global market size, growth drivers, competitive landscape, revenue trends, and future projections.

Market Size and Growth

Global Market Valuation

The global biologics market for mepolizumab was approximately USD 1.2 billion in 2022. Forecasts project compound annual growth rate (CAGR) of 9.2% from 2023 to 2030, driven by expanded indications, increasing diagnosis rates, and ongoing clinical research.

Year	Market Valuation (USD billions)	CAGR (%)
2022	1.2	—
2023	1.32	10.0
2024	1.45	9.8
2025	1.59	9.6
2030	2.4	—

Regional Breakdown

North America accounts for more than 60% of the market, driven by high adoption rates and reimbursement access. Europe comprises around 25%, with Asia-Pacific representing 10%, and remaining regions including Latin America and Middle East accounting for 5%.

Market Drivers

• Expanded Indications: Beyond severe eosinophilic asthma national approvals, recent FDA clearances cover eosinophilic granulomatosis with polyangiitis (EGPA) and chronic rhinosinusitis with nasal polyps, contributing to sales growth.

• Eosinophilic Disease Prevalence: Increasing diagnosis rates of eosinophilic asthma and related disorders expand the patient pool. The Global Initiative for Asthma estimates over 250 million asthma cases worldwide, with 20-30% classified as eosinophilic.

• Biologics Adoption: Growing physician familiarity with biologics and favorable reimbursement policies support market penetration.

• Pricing and Market Access: List prices per pen vary from USD 3,600 to USD 4,200, with negotiated prices often lower. Reimbursement coverage largely positive in developed regions.

Competitive Landscape

Major Players

Company	Drug Name	Indications	Market Share (2022)	Launch Year
GlaxoSmithKline	Mepolizumab (Nucala)	Severe eosinophilic asthma, EGPA, hypereosinophilic syndrome	~70%	2015
AstraZeneca	Benralizumab (Fasenra)	Severe eosinophilic asthma, now expanding into other conditions	~20%	2017
Sanofi/Regeneron	Reslizumab (Cinqair)	Severe eosinophilic asthma	~10%	2016

Market Share Trends

Mepolizumab remains dominant due to earlier FDA approval, broader indication approvals, and established prescribing protocols. Competition from benralizumab is increasing, especially in severe asthma. Reslizumab retains niche usage but faces challenges due to mode of administration and administration costs.

Revenue Trends and Projections

Historical Sales Data (USD millions)

Year	Sales
2018	680
2019	810
2020	965
2021	1,100
2022	1,200

Growth Drivers

• Increasing patient eligibility due to expanding indications.
• Higher dosing and administration frequency in some regions.
• Biosimilar considerations are minimal due to patent protections expiring no earlier than 2030.

Future Revenue Projections

Estimated global sales will approach USD 2.4 billion by 2030, with a CAGR of approximately 9.2%. Major growth sectors include eosinophilic COPD and EGPA, where regulatory approvals are recent or pending.

Regulatory and Policy Environment

Key Approvals

• US FDA: Indications include severe eosinophilic asthma (2015), EGPA (2020), hypereosinophilic syndrome (2022).
• European EMA: Similar labels, with approval for severe eosinophilic asthma and EGPA.
• Japan and other markets: Approvals vary, but most align with US and Europe.

Reimbursement Trends

Coverage mostly positive in key markets. Costs of biologics remain a barrier in some regions, but negotiated pricing and value-based agreements are increasingly common.

Challenges and Risks

• Patent expiration around 2030 may open opportunities for biosimilars.
• Competition from newer biologics with more convenient dosing schedules.
• Market saturation in established regions may slow growth.

Key Takeaways

• Mepolizumab's market is driven by expanding indications and increasing prevalence of eosinophilic conditions.
• Global sales are projected to nearly double by 2030, with notable growth in COPD and EGPA.
• Competitive pressure from benralizumab and potential biosimilars presents long-term challenges.
• Reimbursement policies and regulatory approvals are stable in developed markets, supporting continued growth.
• Pricing strategies and regional access will influence margins and market share evolution.

FAQs

1. What are the main indications for mepolizumab?
Severe eosinophilic asthma, eosinophilic granulomatosis with polyangiitis (EGPA), hypereosinophilic syndrome, chronic rhinosinusitis with nasal polyps.

2. How does mepolizumab compare to its competitors?
Mepolizumab has earlier market entry and broader indications than some competitors. It maintains about 70% market share but faces rising competition from benralizumab.

3. What are the key factors influencing its future sales?
Indication approvals, prevalence of eosinophilic diseases, reimbursement policies, and competitive dynamics.

4. When do biosimilar versions potentially impact the market?
Patent expiry is expected around 2030; biosimilar entry could alter market share and pricing dynamics.

5. What challenges could restrict growth?
Patent expiration, high treatment costs, limited access in emerging markets, and competition from alternative biologics.

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References

[1] Globally integrated disease data, World Health Organization, 2022.

[2] GSK Annual Report, 2022.

[3] EvaluatePharma, 2023.

[4] European Medicines Agency. Nucala approval documents. 2022.

[5] US FDA, 2022. Approved indications for mepolizumab.