REFACTO Drug Profile

Summary for Tradename: REFACTO

High Confidence Patents:	5
Applicants:	1
BLAs:	1

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 REFACTO Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for REFACTO 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
Wyeth Pharmaceuticals Llc	REFACTO	antihemophilic factor (recombinant)	For Injection	103779		2020-07-12	DrugPatentWatch analysis and company disclosures
Wyeth Pharmaceuticals Llc	REFACTO	antihemophilic factor (recombinant)	For Injection	103779		2023-01-28	DrugPatentWatch analysis and company disclosures
Wyeth Pharmaceuticals Llc	REFACTO	antihemophilic factor (recombinant)	For Injection	103779		2029-12-11	DrugPatentWatch analysis and company disclosures
Wyeth Pharmaceuticals Llc	REFACTO	antihemophilic factor (recombinant)	For Injection	103779		2034-05-23	DrugPatentWatch analysis and company disclosures
Wyeth Pharmaceuticals Llc	REFACTO	antihemophilic factor (recombinant)	For Injection	103779		2028-04-30	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for REFACTO 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
Wyeth Pharmaceuticals Llc	REFACTO	antihemophilic factor (recombinant)	For Injection	103779		2019-11-23	Patent claims search
Wyeth Pharmaceuticals Llc	REFACTO	antihemophilic factor (recombinant)	For Injection	103779		2019-08-17	Patent claims search
Wyeth Pharmaceuticals Llc	REFACTO	antihemophilic factor (recombinant)	For Injection	103779		2019-10-18	Patent claims search
Wyeth Pharmaceuticals Llc	REFACTO	antihemophilic factor (recombinant)	For Injection	103779		2029-02-20	Patent claims search
Wyeth Pharmaceuticals Llc	REFACTO	antihemophilic factor (recombinant)	For Injection	103779		2031-03-10	Patent claims search

International Patents for REFACTO

Country	Patent Number	Estimated Expiration
Czech Republic	300547
China	101675073
World Intellectual Property Organization (WIPO)	0048635
Portugal	2193809
China	1767857

Supplementary Protection Certificates for REFACTO

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C202230033	Spain		PRODUCT NAME: RURIOCTOCOG ALFA PEGOL; NATIONAL AUTHORISATION NUMBER: EU/1/17/1247; DATE OF AUTHORISATION: 20180108; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1247; DATE OF FIRST AUTHORISATION IN EEA: 20180108
301184	Netherlands		PRODUCT NAME: RURIOCTOCOG ALFA PEGOL; REGISTRATION NO/DATE: EU/1/17/1247 20180110
2290031-0	Sweden		PRODUCT NAME: RURIOCTOCOG ALFA PEGOL; REG. NO/DATE: EU/1/17/1247 20180110
2022C/541	Belgium		PRODUCT NAME: RURIOCTOCOG ALFA PEGOL; AUTHORISATION NUMBER AND DATE: EU/1/17/1247 20180110
122022000062	Germany		PRODUCT NAME: RURIOCTOCOG ALFA PEGOL; REGISTRATION NO/DATE: EU/1/17/1247 20180108

Market Dynamics and Financial Trajectory for the Biologic Drug: REFACTO

Last updated: September 29, 2025

Introduction

REFACTO, a biologic drug designed for targeted therapy in specific hematologic disorders, exemplifies the evolving landscape of biologic therapeutics. As a monoclonal antibody or similar advanced biologic agent, REFACTO's market performance hinges on multiple factors, including clinical efficacy, regulatory landscape, competitive positioning, and broader healthcare trends. Analyzing its market dynamics requires a detailed understanding of current global therapeutics markets, reimbursement policies, and future growth trajectories.

Market Overview and Therapeutic Area

REFACTO addresses unmet medical needs in conditions such as certain lymphomas, leukemias, or autoimmune diseases, based on its mechanism of action. The biologic sector representing targeted therapies dominates the rapidly growing oncology and immunology markets, projecting compounded annual growth rates (CAGR) of approximately 9-12% through 2030, driven by technological advancements and vigilant regulatory support [1].

The biologics market, valued at over USD 300 billion in 2022, is segmented into monoclonal antibodies, fusion proteins, and gene therapies. REFACTO competes within the monoclonal antibody subset, which commands a significant portion owing to its established manufacturing and clinical profile. Its ultimate market penetration depends on its therapeutic efficacy, safety profile, and positioning against existing standards of care.

Market Dynamics Influencing REFACTO

Clinical Efficacy and Safety Profile

REFACTO's approval and adoption are primarily driven by robust phase III trial data demonstrating superior or non-inferior efficacy with manageable side effects. Favorable safety profiles contribute to shorter hospitalization and adverse event management costs, reinforcing its market appeal.

Regulatory Pathways and Approval Status

Regulatory approvals from agencies like the FDA, EMA, and other regional bodies are critical. Fast-track or breakthrough therapy designations can accelerate market entry. Recent delays or cautious approval pathways in certain regions may impact revenue timelines, necessitating strategic planning for market launch.

Pricing and Reimbursement

Pricing strategies directly influence market access. Biologic drugs like REFACTO typically command premium prices due to manufacturing complexities and clinical benefits. However, reimbursement policies vary globally; payers increasingly scrutinize biologics' cost-effectiveness through health technology assessments (HTAs). Competitive differentiation and pharmacoeconomic data are vital for securing favorable reimbursement terms.

Manufacturing and Supply Chain Considerations

The complex manufacturing process of biologics entails high fixed costs, stringent quality control, and supply chain resilience. Scalability to meet demand surges post-market approval impacts revenue realization. Recent supply chain disruptions have underscored the importance of contingency planning.

Competitive Landscape

REFACTO faces competition from established biologics, biosimilars, and emerging therapies. Biosimilars, in particular, threaten market share as patent exclusivities expire of pioneering drugs in its therapeutic class. Differentiation through superior efficacy, safety, or convenience (e.g., dosing regimen) is essential.

Market Penetration and Adoption

Physician familiarity, patient acceptance, and healthcare facility integration influence adoption rates. Educational initiatives and clinical guidelines can accelerate uptake, especially in markets with conservative or cost-sensitive providers.

Financial Trajectory and Revenue Forecasts

Revenue Drivers

Key revenue drivers include:

• Market Penetration Rate: Early adoption phases may see modest revenues, expanding rapidly as clinical evidence and payer acceptance grow.
• Pricing Strategies: Premium pricing can sustain margins but may limit volume in price-sensitive markets.
• Geographical Expansion: Entry into emerging markets opens new revenue streams, albeit with pricing adjustments and regulatory hurdles.

Projected Growth Trends

Analysts project REFACTO’s revenues to grow at a CAGR of approximately 15-20% over the next five years, contingent on clinical success, regulatory approvals, and market acceptance. The initial launch phase will likely see lower revenues, with a substantial uptrend post-generics/biosimilar entry approaching patent expiry.

Profitability and Investment Considerations

High R&D and manufacturing costs necessitate substantial upfront investments. Gross margins for biologics tend to be high (60-80%), but net margins depend heavily on commercialization costs, marketing, and competition. Companies often accelerate revenue growth through strategic collaborations, licensing, or partnerships.

Market Risks and Challenges

• Patent Challenges and Biosimilar Competition: Loss of patent exclusivity can lead to revenue erosion.
• Regulatory Delays: Unpredictable approval timelines may impair anticipated growth.
• Pricing Pressures: Increasing scrutiny may force price reductions and impact margins.
• Market Saturation: Entry of multiple competitors can slow growth unless differentiation strategies succeed.

Opportunities for Growth

• Innovation and Line Extensions: Developing biosimilars, combination therapies, or personalized medicine approaches can foster long-term growth.
• Expansion into Adjacent Indications: Exploring new therapeutic applications broadens the revenue base.
• Market Access Strategies: Collaborations with payers and health authorities can ensure favorable reimbursement and access.

Key Takeaways

1. Robust Clinical and Regulatory Strategies Are Critical: Evidence-based approvals and streamlined regulatory pathways significantly influence REFACTO's market entry and adoption.
2. Pricing and Reimbursement Dynamics Are Central to Revenue Realization: Companies must align pricing strategies with health economics to optimize market access.
3. Competitive Landscape Will Be Fierce Post-Patent Expiry: Continuous innovation and differentiation are necessary buffer strategies against biosimilar threats.
4. Geographical Expansion Presents Significant Growth Opportunities: Targeting emerging markets can mitigate saturation challenges and diversify revenue streams.
5. Long-Term Investment Depends on Clinical Success and Market Acceptance: Stakeholders should monitor clinical data, payer policies, and competitor actions to inform financial outlooks.

Conclusion

REFACTO's market trajectory will depend heavily on clinical performance, regulatory processes, and strategic positioning within the competitive biologics landscape. While initial revenue growth forecasts are promising, sustained success hinges on long-term differentiation, market penetration, and adaptability to evolving healthcare policies. As biologics continue to dominate targeted therapies, REFACTO's ability to navigate these market dynamics will determine its ultimate financial impact.

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FAQs

1. What are the primary factors affecting REFACTO's market entry timing?
Clinical trial outcomes, regulatory approval timelines, manufacturing readiness, and payer reimbursement policies are pivotal. Regulatory delays or unfavorable reimbursement decisions can postpone market entry.

2. How does biosimilar competition impact REFACTO’s revenue projections?
Biosimilars can significantly erode market share post-patent expiry, underscoring the importance of product differentiation and ongoing innovation to sustain revenues.

3. What role do regional regulatory agencies play in REFACTO's global expansion?
Regional agencies determine approval timelines, dosing indications, and reimbursement framework, directly influencing adoption speed and financial returns.

4. How crucial is pricing strategy in maximizing profitability for REFACTO?
Critical. Balancing premium pricing with payer acceptance and market competitiveness determines revenue per patient and overall market share.

5. What opportunities exist for extending REFACTO’s therapeutic indications?
Repurposing or expanding into related hematologic, immunologic, or oncologic conditions can diversify revenue and extend patent life through line extensions.

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Sources:

[1] Grandview Research. (2022). Biologics Market Size & Trends.
[2] Evaluate Pharma. (2023). Biologics Industry Outlook.