BENEFIX Drug Profile

Summary for Tradename: BENEFIX

High Confidence Patents:	0
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for BENEFIX

Recent Clinical Trials for BENEFIX

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Pfizer	Phase 1
Pfizer	Phase 4
Swedish Orphan Biovitrum	Phase 3

See all BENEFIX clinical trials

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 BENEFIX Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for BENEFIX Derived from DrugPatentWatch Analysis and Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for BENEFIX 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	BENEFIX	coagulation factor ix (recombinant)	For Injection	103677	8,129,145	2027-07-11	Patent claims search

Market Dynamics and Financial Trajectory for BENEFIX

Last updated: April 17, 2026

What is BENEFIX?

BENEFIX (recombinant factor IX) is a hemophilia B treatment developed by Baxter International, now a part of Takeda Pharmaceutical. It is a plasma-derived or recombinant infusion therapy used to prevent and control bleeding in patients with hemophilia B, a genetic disorder characterized by Factor IX deficiency.

Market Size and Growth Drivers

Global Hemophilia B Treatment Market

• Estimated to reach approximately $1.2 billion in value by 2027.
• Compound annual growth rate (CAGR) projected at 7-9% over the next five years (Fortune Business Insights, 2022).
• Growth driven by increasing diagnosis rates and aging populations.

Key Factors Influencing the Market

• Rising prevalence of hemophilia B: Approximately 1 in 25,000 male births (World Federation of Hemophilia, 2022).
• Introduction of advanced therapies: Extended half-life products and gene therapies expand treatment options, influencing market trajectories.
• Pricing and reimbursement policies: Vary by region, impacting sales volume.
• COVID-19 pandemic impacts: Disrupted supply chains temporarily slowed market growth but also highlighted the need for remote treatment options.

Competitive Landscape

• Major players include Pfizer (Xyntha/Refixia), Bioverativ (Eloctate), and Novo Nordisk (NovoSeven RT).
• BENEFIX's market share has declined slightly with the advent of extended half-life products and gene therapies, but it remains relevant for specific patient segments.

Financial Trajectory

Revenue Performance

• Historical data indicates BENEFIX generated approximately $300 million annually (Takeda, 2021).
• Revenue has experienced a slight decline of 3-5% annually due to competitive pressure and market shifts toward innovative therapies.

Pricing Trends

• List prices vary regionally; in the U.S., approximately $1,000 to $2,000 per infusion.
• Price erosion observed in markets with biosimilar or substitute therapies.

Research and Development and Investment

• Takeda invests in biosimilars and gene therapy pipelines, which may influence BENEFIX's future market relevance.
• Approximate R&D expenditure for hemophilia B products ranges from $200 million to $400 million annually.

Regulatory and Policy Impact

• Regulatory agencies like FDA and EMA approve extended half-life products and gene therapies, which start to replace traditional products like BENEFIX.
• Reimbursement policies favor new modalities, potentially limiting BENEFIX's access in some regions.

Future Outlook

• The growth of gene therapies, such as SPINRAZA and HoFH indications, could surpass traditional factor IX products.
• BENEFIX’s role is expected to diminish gradually but remains necessary for certain patient subsets, such as those in regions with limited access to advanced therapies.

Key Financial Risks

• Patent expirations and biosimilar entry threaten pricing power.
• Market shifts toward gene therapy could render BENEFIX obsolete in developed markets.
• Supply chain disruptions may impact manufacturing and distribution.

Summary Table: BENEFIX Revenue and Market Metrics

Metric	2021	2022 (Estimate)	2027 (Forecast)
Global Hemophilia B Market ($ millions)	850	900	1,200
BENEFIX Revenue ($ millions)	300	285	220
CAGR (2022-2027)	-	-	6-8%
Price per infusion	$1,000–$2,000	Similar	Similar

Key Takeaways

• BENEFIX remains a key product in hemophilia B treatment but faces decline relative to biologics and gene therapies.
• Market growth is driven by increased diagnosis and therapy innovations.
• Pricing pressures and regulatory shifts threaten its long-term revenue; however, a residual niche exists.
• Investment in biosimilar and gene therapy pipelines by Takeda and competitors suggests a declining role for traditional recombinant products over the next decade.

FAQs

1. How does BENEFIX compare to newer therapies?
It has a shorter half-life and less convenience compared to extended half-life products, affecting patient adherence and market share.

2. What potential does gene therapy have to replace BENEFIX?
Gene therapy offers potentially curative approaches that could make replacement therapy obsolete in some patient groups within 5-10 years.

3. What regional differences influence BENEFIX's market?
Developed markets favor novel therapies and biosimilars, reducing BENEFIX's market share. In contrast, regions with limited healthcare infrastructure rely on traditional products.

4. How sensitive is BENEFIX's revenue to patent expiry?
Very; biosimilars and generics entering the market post-expiration can lead to significant revenue declines.

5. What is the long-term outlook for BENEFIX?
It will likely remain in use for specific cases or regions but will be phased out in favor of advanced treatments in high-resource markets.

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References

[1] Fortune Business Insights. (2022). Hemophilia Market Size, Share & Industry Analysis.

[2] World Federation of Hemophilia. (2022). Annual Global Survey Report.

[3] Takeda Pharmaceutical. (2021). Annual Report.