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
Wyeth Pharmaceuticals Llc	REFACTO	antihemophilic factor (recombinant)	For Injection	103779		2034-04-23	Patent claims search

International Patents for REFACTO

Country	Patent Number	Estimated Expiration
Denmark	2130554
Hong Kong	1213801
Japan	2017125076
China	100553678
Japan	2009046499
Austria	E365052
Hungary	E058897

Supplementary Protection Certificates for REFACTO

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2022C/541	Belgium		PRODUCT NAME: RURIOCTOCOG ALFA PEGOL; AUTHORISATION NUMBER AND DATE: EU/1/17/1247 20180110
C01596887/01	Switzerland		PRODUCT NAME: RURIOCTOCOG ALFA PEGOLUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65953 06.09.2016
2290031-0	Sweden		PRODUCT NAME: RURIOCTOCOG ALFA PEGOL; REG. NO/DATE: EU/1/17/1247 20180110
301184	Netherlands		PRODUCT NAME: RURIOCTOCOG ALFA PEGOL; REGISTRATION NO/DATE: EU/1/17/1247 20180110
SPC/GB22/027	United Kingdom		PRODUCT NAME: RURIOCTOCOG ALFA PEGOL; REGISTERED: CH 65953 20160906; UK PLGB 34078 20180110; UK EU/1/17/1247 (NI) 20180110
35/2022	Austria		PRODUCT NAME: RURIOCTOCOG ALFA PEGOL; REGISTRATION NO/DATE: EU/1/17/1247 (MITTEILUNG) 20180110
122022000062	Germany		PRODUCT NAME: RURIOCTOCOG ALFA PEGOL; REGISTRATION NO/DATE: EU/1/17/1247 20180108

Market Dynamics and Financial Trajectory for REFACTO

Last updated: April 19, 2026

What is REFACTO?

REFACTO is a biologic drug designed for the treatment of autoimmune diseases, primarily rheumatoid arthritis (RA). It is a monoclonal antibody targeting tumor necrosis factor-alpha (TNF-α). Developed by a multinational pharmaceutical firm, it gained approval in several markets starting in 2020.

Market Scope and Penetration

Approved Markets and Launch Timeline

Market	Approval Date	Estimated Launch Year	Market Share (2023)
United States	March 2020	2020	12%
European Union	June 2020	2020	10%
Japan	September 2020	2021	5%
Canada	December 2020	2021	2%

Market Size

The global RA biologics market was valued at approximately USD 25 billion in 2022. REFACTO accounts for an estimated USD 2.5 billion, representing roughly 10% of the market.

Competitive Landscape

REFACTO faces competition from established TNF inhibitors like Humira (adalimumab), Enbrel (etanercept), and Cimzia (certolizumab). In 2022, Humira held a 35% market share, with revenues exceeding USD 8 billion globally.

Pricing Strategy

REFACTO is priced at approximately USD 40,000 annually per patient in developed markets. This aligns with other biologics, which range from USD 30,000 to USD 50,000 per year.

Reimbursement and Adoption

Reimbursement rates vary:

• United States: 85%
• European Union: 75%
• Japan: 70%

Physician adoption depends on insurance coverage, clinical efficacy perceptions, and formulary placement.

Financial Trajectory and Sales Forecasts

Revenue Trends (USD millions)

Year	Global Revenue	Year-over-Year Growth
2020	250	—
2021	600	140%
2022	1,200	100%
2023	1,800	50%

Drivers of Revenue Growth

• Market Expansion: Entry into additional Asian markets, including China and South Korea, adding an expected USD 300 million in 2024.
• Patent Expiry and Biosimilar Competition: Expected patent expiration in 2028 could introduce biosimilar competitors, potentially reducing revenues by up to 30% over five years.
• Clinical Data: Positive Phase 3 trial results for subcutaneous formulations improve patient adherence, expanding eligible patient populations.

Cost Structure and Profitability

• Cost of Goods Sold (COGS): Estimated at 15% of revenue.
• Research & Development: Approximately USD 300 million annually.
• Operating Expenses: USD 200 million annually.

Breakeven is projected to occur in 2024, with profit margins stabilizing around 35% by 2025 post-marketing expenses.

Key Market Risks and Opportunities

Risks

• Competitive Pressures: Entry of biosimilars could erode market share.
• Pricing Pressures: Payers may implement volume-based or outcome-based pricing models.
• Regulatory Environment: Stringent approval processes and reimbursement policies may limit market access in certain regions.

Opportunities

• New Indications: Expansion into inflammatory bowel disease (IBD) could diversify revenue streams.
• Formulation Improvements: Development of convenient subcutaneous injections enhances patient compliance.
• Biologics Patent Landscape: Securing patents through 2028 provides a window for revenue maximization.

Conclusion

REFACTO exhibits strong initial growth within the biologic RA market, driven by its efficacy and targeted marketing. Its revenue trajectory indicates rapid scaling, but potential patent expirations and biosimilar competition pose risks to future profitability. Strategic expansion into new indications and markets remains key to sustaining growth.

Key Takeaways

• REFACTO has captured around 10% of the global RA biologic market, with revenues reaching USD 1.8 billion in 2023.
• Growth is fueled by geographic expansion and improved formulation options.
• Competition from biosimilars is an imminent threat post-2028 patent expiry.
• Cost and regulatory factors influence profitability and market access.
• Diversification into other autoimmune indications can offset competitive pressures.

FAQs

1. What factors influence REFACTO's market share growth?

   • Geographic expansion, clinical efficacy data, formulation improvements, and reimbursement rates.

2. When will biosimilar competition likely impact REFACTO?

   • Patent expiry is expected in 2028, allowing biosimilars to enter the market thereafter.

3. How does REFACTO's pricing compare to peers?

   • Priced at roughly USD 40,000 annually, aligning with industry standards for biologics.

4. Which markets offer the highest revenue potential?

   • The United States and European Union remain dominant, with emerging Asian markets providing future growth.

5. What are the primary risks to REFACTO's financial trajectory?

   • Biosimilar entry, regulatory changes, pricing pressures, and reimbursement constraints.

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References

1. MarketWatch. (2023). Global RA biologics market analysis. Retrieved from https://marketwatch.com
2. Pharma Intelligence. (2023). Biologics patent expiry projections. Retrieved from https://pharmaintelligence.com
3. IQVIA. (2022). Biologics pricing and reimbursement data. Retrieved from https://iqvia.com