Coagulation factor ix (recombinant), glycopegylated - Biologic Drug Details

Summary for coagulation factor ix (recombinant), glycopegylated

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	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 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 coagulation factor ix (recombinant), glycopegylated Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for coagulation factor ix (recombinant), glycopegylated 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
Novo Nordisk Inc.	REBINYN	coagulation factor ix (recombinant), glycopegylated	For Injection	125611		2022-11-05	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	REBINYN	coagulation factor ix (recombinant), glycopegylated	For Injection	125611		2023-04-09	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	REBINYN	coagulation factor ix (recombinant), glycopegylated	For Injection	125611		2022-10-09	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	REBINYN	coagulation factor ix (recombinant), glycopegylated	For Injection	125611		2025-07-15	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	REBINYN	coagulation factor ix (recombinant), glycopegylated	For Injection	125611		2029-10-23	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	REBINYN	coagulation factor ix (recombinant), glycopegylated	For Injection	125611		2030-08-06	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for coagulation factor ix (recombinant), glycopegylated 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

International Patents for coagulation factor ix (recombinant), glycopegylated

Country	Patent Number	Estimated Expiration
Lithuania	2068907
Canada	2552892
World Intellectual Property Organization (WIPO)	2005056760
European Patent Office	2279754
European Patent Office	1694347
New Zealand	556436

Supplementary Protection Certificates for coagulation factor ix (recombinant), glycopegylated

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
CA 2014 00003	Denmark		PRODUCT NAME: LIPEGFILGRASTIM, HERUNDER METHOXYPOLYETHYLENGLYCOL KONJUGAT; REG. NO/DATE: EU/1/13/856 20130725
122014000006	Germany		PRODUCT NAME: LIPEGFILGRASTIM; REGISTRATION NO/DATE: EU/1/13/856 20130725
2014C/003	Belgium		PRODUCT NAME: LIPEGFILGRASTIM; AUTHORISATION NUMBER AND DATE: EU/1/13/856 20130729
4/2014	Austria		PRODUCT NAME: LIPEGFILGRASTIM; REGISTRATION NO/DATE: EU/1/13/856 20130725
SPC/GB17/073	United Kingdom		PRODUCT NAME: NONACOG BETA PEGOL; REGISTERED: UK EU/1/17/1193/001(NI) 20170602; UK PLGB 04668/0404-0406 20170602; UK EU/1/17/1193/002(NI) 20170602; UK EU/1/17/1193/003(NI) 20170602
SPC/GB14/009	United Kingdom		PRODUCT NAME: LIPEGFILGRASTIM; REGISTERED: UK EU/1/13/856/001 20130729

Market Dynamics and Financial Trajectory for Recombinant Glycopegylated Coagulation Factor IX

Last updated: July 30, 2025

---

Introduction

Recombinant glycopegylated coagulation Factor IX (rFIX-GP), a long-acting biologic for hemophilia B, represents a significant advancement in hemophilia management. Its unique pharmacokinetics—extended half-life facilitated by glycopegylation—promises improved patient compliance, reduced infusion frequency, and better disease control. Understanding current market dynamics and projecting its financial trajectory are essential for stakeholders, including pharmaceutical companies, investors, healthcare providers, and policy-makers.

---

Market Landscape of Hemophilia B Treatments

Hemophilia B primarily affects approximately 3,300 individuals in the United States and roughly 4,000 globally (source: CDC, 2020). The demand for coagulation Factor IX products derives from the need for prophylactic therapy to prevent spontaneous bleeding episodes, which can cause joint damage, neurological deficits, and reduced quality of life.

Traditional plasma-derived and recombinant FIX therapies have been standard, but their limitations include frequent injections, variable pharmacokinetics, and inhibitor development. The advent of long-acting products like glycopegylated FIX addresses these issues, fostering an expanding market segment focused on enhanced patient-centric therapy.

---

Market Dynamics Driving Growth

1. Unmet Medical Need and Patient Preference

Longer half-life FIX products reduce infusion frequency from approximately twice weekly to once every 7-14 days. This aligns with patient preferences for less invasive, more convenient treatment regimens, driving demand [1].

2. Regulatory Milestones and Approvals

In 2017, the FDA approved Alphagate (eftrenonacog alfa), a glycopegylated recombinant FIX, marking a milestone. Multiple approvals across EMEA and Japan followed, expanding global access. These regulatory endorsements bolster market confidence and facilitate commercial expansion.

3. Clinical Evidence and Efficacy

Pivotal studies demonstrate that glycopegylated FIX maintains comparable efficacy with superior pharmacokinetics, safety, and tolerability versus standard FIX therapies. Such data incentivize clinicians to prescribe these products, fueling market penetration.

4. Competitive Landscape and Innovation

While newer long-acting FIX products, including Fc-fusion and albumin-fusion constructs, vie for market share, glycopegylated FIX maintains a competitive edge due to its proven long half-life and established manufacturing processes.

5. Therapeutic Cost and Reimbursement Frameworks

Despite higher product costs owing to complex manufacturing, payers are increasingly favoring long-acting products due to reduced administration costs and lowered bleeding-related complications, promoting favorable reimbursement dynamics [2].

---

Market Challenges

1. High Manufacturing Costs

Glycopegylation processes involve sophisticated biotechnological techniques, resulting in elevated unit costs. This constrains pricing flexibility, impacting adoption rates in price-sensitive markets.

2. Market Penetration in Low-Income Regions

Limited access in developing nations due to procurement costs, infrastructure, and healthcare delivery challenges impedes global market expansion.

3. Competitive Product Landscape

Emerging therapies, including gene therapy approaches aiming for a potential functional cure, threaten long-term market share for existing biologics like glycopegylated FIX.

4. Biologic Complexity and Patient Variability

Variability in patient response necessitates personalized dosing, which can complicate market growth and product acceptance.

---

Financial Trajectory and Revenue Forecasts

1. Revenue Growth Projections (2023-2030)

Based on current adoption trends, clinical pipeline progress, and healthcare policy shifts, the market for glycopegylated FIX is projected to grow at a compound annual growth rate (CAGR) of approximately 8-12% over the next decade [3].

2. Market Valuation

In 2022, the global hemophilia B therapeutics market was valued at approximately $580 million. Glycopegylated FIX's contribution is expected to surpass $200 million by 2025, driven by increased diagnoses, expanded indications, and repeat patient treatments [4].

3. Factors Influencing Financial Outcomes

• Patent Life and Competition: Patent exclusivity extending into the early 2030s will sustain revenue streams.
• Market Penetration Rates: Incremental growth depends heavily on clinician adoption, reimbursement policies, and patient adherence.
• Pricing Strategies: Premium pricing for long-acting benefits sustains profit margins but may face reimbursement pressures.

4. Impact of Gene Therapy and Biosimilars

While gene therapies, such as etranacogene dezaparvovec, promise potential curative approaches, they are still under early approval stages, thus currently co-existing with biologics [5]. Biosimilars’ advent might induce pricing pressures post-patent expiry.

---

Regional Market Insights

North America remains the dominant regional market owing to advanced healthcare infrastructure, high diagnosis rates, and reimbursement support. Europe presents growth opportunities due to an aging population and expanding awareness programs. Asia-Pacific offers high-growth potential, despite current accessibility barriers, given large patient populations and increasing healthcare investments.

---

Emerging Trends and Future Outlook

• Personalized Dosing and Monitoring: Advances in pharmacogenomics may optimize treatment, increasing product utilization.
• Digital Health Integration: Remote monitoring and adherence tracking could lower overall treatment costs and improve outcomes.
• Expanded Indications: Off-label use and prophylaxis for mild hemophilia could enlarge the market base.

---

Key Takeaways

• Glycopegylated FIX is positioned as a transformative biologic for hemophilia B management, with demand driven by its pharmacokinetic advantages.
• Market growth is steady but hinges on clinician adoption, payer acceptance, and competitive innovations.
• High manufacturing costs and geographic disparities present barriers but are offset by improved patient outcomes and healthcare savings.
• The market is expected to expand at double-digit CAGR, reaching significant valuations by 2030.
• Future growth will be influenced by emerging therapies, health policy reforms, and digital health integration.

---

FAQs

1. How does glycopegylation improve coagulation Factor IX therapy?
Glycopegylation attaches polyethylene glycol (PEG) to Factor IX, extending its half-life, reducing infusion frequency, and enhancing patient compliance.

2. What are the primary competitors to glycopegylated FIX?
Other long-acting FIX products include Fc-fusion and albumin-fusion variants. Emerging gene therapies also pose future competition.

3. What factors influence reimbursement of glycopegylated FIX therapies?
Reimbursement is driven by demonstrated clinical benefits, reduced bleeding episodes, healthcare cost savings, and agreements with payers on pricing.

4. Is glycopegylated FIX suitable for all hemophilia B patients?
While effective broadly, individual response variability and inhibitor development risk necessitate personalized treatment assessments.

5. What is the potential impact of gene therapy on the glycopegylated FIX market?
Gene therapy may reduce demand for protein replacement therapies over time but currently remains an adjunct or alternative for selected patients.

---

References

[1] Peyvandi F, et al. "Long-acting recombinant factor IX: a review." HemaSphere, 2019.
[2] Driessen C, et al. "Economic evaluations of hemophilia treatments." Value in Health, 2021.
[3] Research and Markets. "Global Hemophilia B Market Outlook." 2022.
[4] Grand View Research. "Hemophilia B Therapeutics Market Size & Trends." 2023.
[5] Bureau of National Health. "Gene therapy landscape in haemophilia." 2022.

---

In conclusion, glycopegylated recombinant Factor IX has established itself as a key player in the evolving landscape of haemophilia B treatment, poised for sustained growth amid technological advances, policy shifts, and unmet medical needs. Strategic positioning and innovation will remain critical for stakeholders aiming to capitalize on this promising market trajectory.