FASENRA Drug Profile

Summary for Tradename: FASENRA

High Confidence Patents:	7
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for FASENRA

Recent Clinical Trials for FASENRA

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Singapore General Hospital	Phase 2
University of Oxford	Phase 2
AstraZeneca	Phase 4

See all FASENRA clinical trials

Pharmacology for FASENRA

Mechanism of Action	Interleukin 5 Receptor alpha-directed Antibody Interactions
Established Pharmacologic Class	Interleukin-5 Receptor alpha-directed Cytolytic Antibody

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 FASENRA Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for FASENRA 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
Astrazeneca Ab	FASENRA	benralizumab	Injection	761070			DrugPatentWatch analysis and company disclosures
Astrazeneca Ab	FASENRA	benralizumab	Injection	761070			DrugPatentWatch analysis and company disclosures
Astrazeneca Ab	FASENRA	benralizumab	Injection	761070			DrugPatentWatch analysis and company disclosures
Astrazeneca Ab	FASENRA	benralizumab	Injection	761070			DrugPatentWatch analysis and company disclosures
Astrazeneca Ab	FASENRA	benralizumab	Injection	761070			DrugPatentWatch analysis and company disclosures
Astrazeneca Ab	FASENRA	benralizumab	Injection	761070			DrugPatentWatch analysis and company disclosures
Astrazeneca Ab	FASENRA	benralizumab	Injection	761070			DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for FASENRA 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
Astrazeneca Ab	FASENRA	benralizumab	Injection	761070		2037-03-16	Patent claims search
Astrazeneca Ab	FASENRA	benralizumab	Injection	761070		2036-08-10	Patent claims search
Astrazeneca Ab	FASENRA	benralizumab	Injection	761070		2037-08-14	Patent claims search
Astrazeneca Ab	FASENRA	benralizumab	Injection	761070		2037-05-24	Patent claims search
Astrazeneca Ab	FASENRA	benralizumab	Injection	761070		2038-06-20	Patent claims search
Astrazeneca Ab	FASENRA	benralizumab	Injection	761070		2036-02-23	Patent claims search
Astrazeneca Ab	FASENRA	benralizumab	Injection	761070		2039-07-08	Patent claims search

Market Dynamics and Financial Trajectory for FASENRA (benralizumab)

Last updated: March 20, 2026

What is the current market positioning of FASENRA in the biologic drug landscape?

FASENRA (benralizumab), developed by AstraZeneca, is a monoclonal antibody targeting the IL-5 receptor alpha. It received FDA approval in November 2017 for severe eosinophilic asthma, expanding to other eosinophil-driven diseases. Its market has grown steadily, driven by increasing prevalence of eosinophilic asthma and shift toward biologics.

Market Size and Growth Estimates

• The global severe asthma market reached $8.3 billion in 2022.
• FASENRA's share approximates 10-12%, valued around $1 billion.
• Compound annual growth rate (CAGR) from 2018 to 2022: approximately 15%.

Competitive Landscape

Primary competitors include:

• Nucala (mepolizumab): Lilly, FDA approval in 2015.
• Cinquair (reslizumab): Teva, FDA approval 2016.
• Dupixent (dupilumab): Sanofi/Regeneron, approved 2017 for asthma.

FASENRA's differentiation lies in its subcutaneous administration and approval for eosinophilic asthma, similar to Nucala, but with slightly different dosing schedules.

What factors influence FASENRA’s market penetration?

Key Drivers

• Prevalence of eosinophilic asthma: Estimated 10-30% of severe asthma cases.
• Unmet medical needs: Many patients remain uncontrolled on inhaled corticosteroids and bronchodilators.
• Physician adoption: Growing familiarity with biologics, with reports indicating over 50% of eligible patients receiving biologic therapy as of 2022.

Barriers

• Pricing and reimbursement: List price around $3,500 per injection; insurance coverage varies.
• Patient adherence: Preference for less frequent dosing influences choice.
• Reimbursement policies: Some markets restrict biologic use based on severity.

Regulatory and Market Expansion Potential

• Approval for other indications, like eosinophilic esophagitis, in Europe expands usage.
• Pending FDA approval for additional conditions, e.g., chronic rhinosinusitis with nasal polyps, could increase sales.

What does the financial trajectory look like?

Revenue Projections

• FASENRA's sales are expected to reach $1.2 billion worldwide in 2023.
• Growth is projected at a CAGR of 12-15% through 2026, driven by expanding indications and geographic reach.

R&D and Commercial Investment

• AstraZeneca invests approximately $200 million annually in marketing and R&D for FASENRA.
• Past clinical trials indicate strong phase 3 data for additional indications, which could further boost sales.

Patent and Market Exclusivity

• Patent protection extends until 2030 in major markets.
• No imminent biosimilar competition expected before 2028, providing a window for sustained revenue.

Impact of Market Dynamics on Revenue

Year	Estimated Global Sales	CAGR	Notes
2022	$1 billion	15%	Peak current sales
2023	$1.2 billion	20%	Market expansion, new indications
2024	$1.4 billion	17%	Increased adoption, expanded reimbursement
2025	$1.6 billion	14%	Continued growth

What are the key risks and opportunities?

Risks

• Entry of biosimilars as patents expire post-2030.
• Competitive pressure from emerging biologics or small-molecule alternatives.
• Regulatory delays in new indications.

Opportunities

• Expansion into indications such as eosinophilic esophagitis.
• Market penetration in emerging regions like Asia-Pacific.
• Development of biosimilars or next-generation drugs.

Final analysis

FASENRA maintains solid growth driven by unmet needs in eosinophilic asthma, with a revenue trajectory expected to remain positive until patent expiration. Market expansion hinges on new indication approvals, competitive dynamics, and reimbursement strategies.

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Key Takeaways

• FASENRA accounts for approximately 10-12% of the $8.3 billion severe asthma market.
• Sales reached an estimated $1 billion in 2022, with projections to grow 12-15% annually until 2026.
• Patent protections last until 2030, delaying biosimilar competition.
• Market growth depends on expanding indications, reimbursement policies, and geographic expansion.
• Competition from Nucala, Cinquair, and Dupixent remains intense, but FASENRA's differentiation sustains its market position.

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FAQs

1. How does FASENRA compare to its main competitors?
FASENRA competes primarily with Nucala and Cinquair. Differences include dosing schedules and approval for specific eosinophil-driven conditions. Market share favors Nucala slightly due to earlier entry.

2. What are the indications expanding FASENRA’s market?
Current approved uses include severe eosinophilic asthma. Pending approvals include eosinophilic esophagitis and potentially chronic rhinosinusitis with nasal polyps.

3. How significant is the risk of biosimilar entry?
Patent expiration in 2030 generally protects FASENRA until approximately 2028. Biosimilar development is likely post-2030, but market entry depends on regulatory and development timelines.

4. What is the affordability trend for FASENRA?
Pricing remains around $3,500 per injection. Insurance and reimbursement policies influence patient access, and expansions into emerging markets may drive pricing adjustments.

5. Which regions offer the most growth potential for FASENRA?
North America and Europe are mature markets. Asia-Pacific presents significant upside, with rising prevalence of asthma and increasing biologic adoption.

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References

[1] AstraZeneca. (2022). FASENRA prescribing information.
[2] Grand View Research. (2023). Severe Asthma Market Size & Trends.
[3] IQVIA. (2022). Global Biologic Drugs Market Data.
[4] U.S. Food and Drug Administration. (2017). FASENRA approval announcement.
[5] Evaluate Pharma. (2023). Top-selling biologics overview.