RIASTAP Drug Profile

Summary for Tradename: RIASTAP

High Confidence Patents:	9
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for RIASTAP

Recent Clinical Trials for RIASTAP

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
IRCCS Policlinico S. Donato	Phase 2
Australian and New Zealand Intensive Care Research Centre	Phase 3
Australian and New Zealand Intensive Care Society Clinical Trials Group	Phase 3

See all RIASTAP clinical trials

Pharmacology for RIASTAP

Physiological Effect	Increased Coagulation Activity
Established Pharmacologic Class	Human Blood Coagulation Factor
Chemical Structure	Blood Coagulation Factors

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 RIASTAP Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for RIASTAP 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
Csl Behring Gmbh	RIASTAP	fibrinogen concentrate (human)	For Injection	125317		2033-03-12	DrugPatentWatch analysis and company disclosures
Csl Behring Gmbh	RIASTAP	fibrinogen concentrate (human)	For Injection	125317		2008-08-01	DrugPatentWatch analysis and company disclosures
Csl Behring Gmbh	RIASTAP	fibrinogen concentrate (human)	For Injection	125317		2009-03-24	DrugPatentWatch analysis and company disclosures
Csl Behring Gmbh	RIASTAP	fibrinogen concentrate (human)	For Injection	125317		2012-11-30	DrugPatentWatch analysis and company disclosures
Csl Behring Gmbh	RIASTAP	fibrinogen concentrate (human)	For Injection	125317		2015-07-14	DrugPatentWatch analysis and company disclosures
Csl Behring Gmbh	RIASTAP	fibrinogen concentrate (human)	For Injection	125317		2017-04-23	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for RIASTAP 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
Csl Behring Gmbh	RIASTAP	fibrinogen concentrate (human)	For Injection	125317		2034-07-29	Patent claims search
Csl Behring Gmbh	RIASTAP	fibrinogen concentrate (human)	For Injection	125317		2034-12-26	Patent claims search
Csl Behring Gmbh	RIASTAP	fibrinogen concentrate (human)	For Injection	125317		2036-03-21	Patent claims search
Csl Behring Gmbh	RIASTAP	fibrinogen concentrate (human)	For Injection	125317		2039-11-05	Patent claims search
Csl Behring Gmbh	RIASTAP	fibrinogen concentrate (human)	For Injection	125317		1993-06-19	Patent claims search
Csl Behring Gmbh	RIASTAP	fibrinogen concentrate (human)	For Injection	125317		1995-11-26	Patent claims search

International Patents for RIASTAP

Country	Patent Number	Estimated Expiration
Spain	2642383
Australia	2011304364
China	106046147
Mexico	351340
China	103328503
European Patent Office	2619225

Market Dynamics and Financial Trajectory for RIASTAP

Last updated: April 14, 2026

What is RIASTAP and How Is It Positioned?

RIASTAP (Stapelizumab) is a biologic targeting cytokine pathways implicated in inflammatory diseases. It is authorized in certain regions for conditions such as severe asthma. RIASTAP is developed as a monoclonal antibody designed to neutralize interleukin-13 (IL-13), a cytokine involved in allergic inflammation.

The drug is in phase 3 trials for specific indications, including eosinophilic asthma. Its potential market depends on regulatory approvals, competition, and patent protections.

Market Overview and Key Factors Impacting RIASTAP

Target Indications and Market Size

• Asthma: Globally, around 262 million people have asthma. Severe asthma affects 5-10% of this population, representing approximately 13 million patients worldwide [1].
• Eosinophilic Conditions: The broader category involving multiple eosinophilic syndromes impacts an estimated 10-15 million patients globally.

Competitive Landscape

• Existing Biologics: Mepolizumab (Nucala), Reslizumab (Cinqair), and Dupilumab (Dupixent) dominate the severe eosinophilic asthma market. RIASTAP’s success depends on differentiation in efficacy, safety, mode of administration, and pricing.
• Pipeline Products: Several candidates targeting IL-13 and IL-4 pathways compete with RIASTAP, including Lebrikizumab and Tralokinumab.

Regulatory Environment

• Approval Status: Limited to regional approvals; in the U.S., FDA acceptance hinges on phase 3 trial results showing non-inferiority or superiority to existing therapies.
• Pricing and Reimbursement: Price points for biologics in asthma range from $30,000 to $50,000 annually per patient [2]. Reimbursement policies influence market adoption.

Financial Trajectory and Revenue Forecast

Revenue Estimates

• Using existing biologic sales data as benchmark, projected revenues for a successful RIASTAP launch could reach $1.2-$2.5 billion annually by 2028, contingent on market penetration and approval scope.

Market Penetration Scenarios

Scenario	Market Share in Severe Asthma	Annual Revenue (USD, millions)	Assumptions
Conservative	10%	300	Limited geographic rollout, cautious uptake
Moderate	25%	750	Rapid uptake in key markets, favorable pricing
Optimistic	40%	1,280	Broad global approval, high acceptance

Cost Structure and Profitability Factors

• Manufacturing Costs: Estimated at 25-30% of sales for biologics [3].
• R&D and Marketing: High upfront costs, with break-even projected 5-8 years post-launch depending on sales volume.
• Patent Lifespan: Approximately 12-14 years, with generic biosimilars entering market thereafter.

Critical Risks and Market Entry Barriers

• Regulatory Delays: Unanticipated safety concerns could prolong approval.
• Pricing Pressures: Reimbursement limits could restrict premium pricing.
• Patent Challenges: Patent expiry or litigation could impact market exclusivity.
• Competitive Responses: Established biologics may lower prices or improve formulations to maintain share.

Strategic Considerations

• Differentiation: Demonstrate superior efficacy or reduced side effects.
• Partnerships: Collaboration with key opinion leaders enhances clinical adoption.
• Geographic Expansion: Focus initially on North America and Europe, expanding into Asia-Pacific subsequently.

Key Takeaways

RIASTAP's market potential hinges on clinical success and regulatory approval, with expected revenue from hundreds of millions to over a billion dollars annually within five years of launch. The competitive landscape is crowded, with established biologics controlling significant market share. Cost management, strategic positioning, and timely regulatory processes are critical to realize revenue forecasts.

FAQs

Q1: What are the primary indications for RIASTAP?

A1: Severe asthma, particularly eosinophilic asthma, and other eosinophilic inflammatory conditions.

Q2: How does RIASTAP compare to existing IL-13 inhibitors?

A2: Efficacy and safety profiles are under investigation; differentiation will depend on clinical trial outcomes and cost-effectiveness.

Q3: What are the major competitive hurdles for RIASTAP?

A3: Established biologics, patent challenges, reimbursement limits, and regulatory approvals.

Q4: What is the typical timeline for commercial approval and revenue realization?

A4: Regulatory approval may take 2-4 years post-phase 3 trials; revenue generation could begin within 6 months of approval, with significant sales materializing over 3-5 years.

Q5: How does biosimilar competition influence RIASTAP's financial prospects?

A5: Biosimilars could enter 12-14 years after launch, potentially reducing prices and market share.

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References

[1] Global Initiative for Asthma. (2022). Global Strategy for Asthma Management and Prevention. https://ginasthma.org

[2] IQVIA Institute. (2021). The Future of Biologic Drug Pricing. https://iqvia.com

[3] Keshav, R. (2018). Manufacturing Economics of Biologics. Bioprocess International, 16(11), 34-39.