Reslizumab - Biologic Drug Details

Summary for reslizumab

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

Recent Clinical Trials for reslizumab

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
TEVA	Phase 2
National Jewish Health	Phase 2
Teva Pharmaceuticals USA	Phase 2

See all reslizumab clinical trials

Pharmacology for reslizumab

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 reslizumab Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for reslizumab 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
Teva Respiratory, Llc	CINQAIR	reslizumab	Injection	761033	6,056,957	2014-08-04	DrugPatentWatch analysis and company disclosures
Teva Respiratory, Llc	CINQAIR	reslizumab	Injection	761033	RE39548	2021-12-07	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for reslizumab 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
Teva Respiratory, Llc	CINQAIR	reslizumab	Injection	761033	10,028,940	2037-03-16	Patent claims search
Teva Respiratory, Llc	CINQAIR	reslizumab	Injection	761033	10,111,968	2036-08-10	Patent claims search
Teva Respiratory, Llc	CINQAIR	reslizumab	Injection	761033	10,195,183	2037-08-14	Patent claims search
Teva Respiratory, Llc	CINQAIR	reslizumab	Injection	761033	10,195,211	2037-10-27	Patent claims search

International Patents for reslizumab

Country	Patent Number	Estimated Expiration
Germany	69532889
Czech Republic	371296
Czech Republic	292295
European Patent Office	0765392

Market Dynamics and Financial Trajectory for the Biologic Drug: Reslizumab

Last updated: September 19, 2025

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Introduction

Reslizumab, marketed primarily under the brand name Cinqair® (or Cinquefoil in some markets), is a monoclonal antibody biologic developed by Teva Pharmaceuticals for the treatment of severe eosinophilic asthma. Approved by the U.S. Food and Drug Administration (FDA) in 2016, reslizumab has positioned itself within the burgeoning biologic landscape targeting eosinophil-driven inflammatory diseases. As an IL-5 antagonist, its market performance reflects broader trends in specialty biologics, evolving treatment paradigms, and competitive dynamics, all shaped by regulatory, scientific, and economic factors.

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1. Market Landscape and Key Drivers

Eosinophilic Asthma and Unmet Needs

Severe eosinophilic asthma accounts for a significant subset of asthma patients who exhibit persistent symptoms despite high-dose corticosteroids. Such cases demand targeted therapies with improved safety and efficacy profiles. Biologics like reslizumab serve this niche by selectively inhibiting interleukin-5 (IL-5), a cytokine central to eosinophil proliferation and survival [1].

Biologic Market Expansion

The biologic asthma market, including anti-IL-5 agents such as reslizumab, rapidly expanded with approvals of competitors like Mepolizumab (Nucala) and Benralizumab (Fasenra). The landscape's growth is fueled by increased disease recognition, advances in biologic therapies, and widening reimbursement access, with the global biologics market projected to reach over $400 billion by 2028, with respiratory indications forming a significant portion (Grand View Research, 2021).

Competitive Positioning

Reslizumab’s differentiation lies in its dosing schedule (monthly IV infusion) and purported efficacy in patients with higher eosinophil counts. However, its market share faces stiff competition from subcutaneous-administered rivals with more convenient administration, challenging reslizumab’s adoption [2].

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2. Market Dynamics: Opportunities and Challenges

Opportunities

• Rising Incidence of Severe Asthma: Global asthma prevalence exceeds 300 million, with a sizable fraction characterized as severe eosinophilic subtype. Increasing diagnosis rates expand the potential patient base [3].
• Pipeline Expansion: Clinical trials exploring reslizumab in other eosinophil-associated conditions, such as eosinophilic esophagitis and nasal polyps, promise extended indications.
• Regulatory Approvals in Emerging Markets: Entry into countries with unmet respiratory diseases, driven by rising middle-income populations and healthcare awareness, broadens revenue streams.

Challenges

• Convenience and Formulation Limitations: The intravenous route, typically administered every four weeks, hampers patient compliance relative to subcutaneous competitors. This impacts market penetration.
• Pricing and Reimbursement Pressure: International healthcare systems and insurers increasingly scrutinize biologics' high costs, pressing companies to justify premium pricing through demonstrated value.
• Market Saturation and Competition: With multiple biologics targeting eosinophil pathways, market share shifts toward drugs with superior safety profiles, patient convenience, and supportive clinical data.
• Patent and Regulatory Risks: Patent expirations and ongoing biosimilar development threaten price erosion and market exclusivity.

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3. Financial Trajectory and Revenue Outlook

Historical Revenue Performance

Reslizumab’s initial launch introduced modest revenues, with sales reaching approximately $150 million globally in its first fully fiscal year (2017). Post-launch, revenues have fluctuated due to market penetration challenges and reimbursement dynamics, estimated to hover around $200–$250 million annually [4].

Forecasting Future Revenues

Projections suggest a compound annual growth rate (CAGR) of 5-8% over the next five years, driven by:

• Expansion into New Markets: Additional approvals in Europe, Asia, and emerging territories are expected to incrementally boost sales.
• Label Expansion: Clinical trials suggesting efficacy in other eosinophilia-related conditions could open off-label or regulatory-approved revenue streams.
• Patient Stratification: Targeted diagnostics enabling precise patient selection are likely to increase per-patient sales.

Conversely, the large-scale entry of biosimilar competitors and the growth of subcutaneous products with improved dosing convenience could exert downward pressure on reslizumab’s pricing and market share [5].

Cost Considerations

Development and commercialization costs have historically been high for biologics, with estimates ranging from $1–2 billion (including R&D, clinical trials, and regulatory processes). Continued investments into pipeline expansion and post-market data collection are necessary to sustain competitive advantages, influencing overall profitability.

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4. Strategic Implications for Stakeholders

• Manufacturers: Prioritize clinical evidence demonstrating superiority or unique niche benefits, while exploring combination therapies or new indications.
• Healthcare Providers: Emphasize personalized medicine approaches to optimize patient selection, balancing efficacy, convenience, and cost.
• Payers: Demand robust value propositions, including long-term cost savings through reduced exacerbations and improved quality of life.
• Investors: Monitor regulatory developments, pipeline advancements, and competitive movements to identify growth opportunities and mitigate risks.

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5. Regulatory and Market Entry Factors

The evolving regulatory environment impacts reslizumab’s market dynamics. The FDA and EMA favor biologics with demonstrated clinical benefit and safety profiles, with accelerated approval pathways available for novel indications. Market entry in emerging economies may benefit from orphan drug designations or special access programs.

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Key Takeaways

• Reslizumab operates in a competitive, rapidly evolving biologic landscape with growth potential, driven by increasing asthma prevalence and unmet needs in severe eosinophilic asthma.
• Differentiation challenges, particularly administration route convenience, and pricing pressures restrict growth; innovation and label expansion are vital.
• Revenue projection estimates a steady, moderate growth trajectory, assuming successful market penetration and pipeline expansion.
• Strategic focus on patient stratification, global market access, and clinical differentiation enhances resilience against biosimilar threats.
• Stakeholders should closely monitor clinical data, regulatory policies, and competitive moves to optimize investment and commercialization strategies.

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FAQs

1. How does reslizumab compare with other anti-IL-5 therapies?
Reslizumab differs primarily in administration (IV infusion monthly) and target eosinophil count thresholds. Competitors like Mepolizumab and Benralizumab offer subcutaneous administration, which improves patient compliance. Efficacy profiles are comparable, but individual patient factors influence therapy choice.

2. What are the main barriers to reslizumab’s wider adoption?
The intravenous administration route, high treatment costs, and competition from more convenient subcutaneous options limit adoption. Additionally, reimbursement challenges and clinician familiarity influence prescribing patterns.

3. Are there prospects for expanding reslizumab’s indication spectrum?
Yes. Clinical trials are evaluating its efficacy in eosinophilic conditions like eosinophilic esophagitis and nasal polyps. Successful approval could significantly broaden its market and revenue base.

4. What impact will biosimilars have on reslizumab’s market?
Biosimilars could exert price erosion and reduce market share, especially as patent protections expire. However, complex manufacturing processes and regulatory pathways may delay biosimilar entry, providing a window for continued revenue.

5. What strategies can manufacturers employ to sustain reslizumab’s market relevance?
Emphasizing evidence-based differentiation, expanding indications, improving dosing convenience, and engaging in global market development are key strategies. Collaborations with healthcare providers and payers to demonstrate value also support sustained market presence.

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References

1. National Institutes of Health. Eosinophilic Asthma. NIH.gov. (2021).
2. Grand View Research. Biologics Market Analysis. (2021).
3. World Health Organization. Asthma Fact Sheet. WHO.int. (2020).
4. Teva Pharmaceuticals. Annual Report & Financials. (2022).
5. IQVIA. Global Biologics Market Trends. (2022).