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	7,138,371	2022-11-05	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	REBINYN	coagulation factor ix (recombinant), glycopegylated	For Injection	125611	7,179,617	2023-04-09	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	REBINYN	coagulation factor ix (recombinant), glycopegylated	For Injection	125611	7,416,858	2022-10-09	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	REBINYN	coagulation factor ix (recombinant), glycopegylated	For Injection	125611	7,473,680	2025-07-15	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	REBINYN	coagulation factor ix (recombinant), glycopegylated	For Injection	125611	8,404,809	2029-10-23	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	REBINYN	coagulation factor ix (recombinant), glycopegylated	For Injection	125611	8,632,770	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
Mexico	PA05003730
Hungary	E036502
Canada	2468230
Brazil	PI0614839
Singapore	177002
Canada	2665480

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

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
610	Finland
122014000005	Germany		PRODUCT NAME: LIPEGFILGRASTIM; REGISTRATION NO/DATE: EU/1/13/856/001-002 20130725
92358	Luxembourg		PRODUCT NAME: LIPEGFILGRASTIM
2014/006	Ireland		PRODUCT NAME: LONQUEX-LIPEGFILGRASTIM; REGISTRATION NO/DATE: EU/1/13/856 20130725
122014000006	Germany		PRODUCT NAME: LIPEGFILGRASTIM; REGISTRATION NO/DATE: EU/1/13/856 20130725

Coagulation factor ix (recombinant), glycopegylated Market Analysis and Financial Projection

Last updated: February 17, 2026

Market Overview

Recombinant coagulation factor IX glycopegylated (brand name: Rebinyn or traditional equivalents; marketed as nonacog gamma or others) addresses hemophilia B. The global hemophilia treatment market, valued at approximately $11.2 billion in 2022, is projected to reach $15.8 billion by 2028, with a compound annual growth rate (CAGR) of 6.5% (source: MarketsandMarkets[1]).

Recombinant glycopegylated factor IX products entered the market to improve half-life, enabling less frequent dosing. Their premium positioning against standard factor IX products creates a niche for premium pricing and volume growth.

Product and Patent Landscape

Key Products:

• Rebinyn (Pfizer): Launched in 2017, featuring glycoPEGylation technology that extends half-life.

• Idelvion (Pfizer): Another glycoPEGylated factor IX with a longer half-life, launched in 2019.

• Other pipeline candidates: Several biopharma firms, including Novo Nordisk and Bioverativ, have announced development programs.

Patent Status and Exclusivity:

Pfizer's patents for Rebinyn extend protections until 2030[2]. Patent expirations typically lead to generic or biosimilar competition within 8-10 years post-launch.

Market Dynamics

Drivers

• Extended half-life advantages: GlycoPEGylation increases factor IX half-life from 18-24 hours to approximately 60-100 hours, reducing infusion frequency from 3-4 times weekly to once weekly or biweekly[3].

• Patient adherence: Less frequent dosing enhances compliance, potentially reducing bleed frequencies.

• Pricing strategy: Premium pricing, with per-infusion costs of approximately $10,000–$15,000 versus $5,000–$8,000 for standard products.

• Growing patient base: Hemophilia B prevalence is estimated at 1 in 30,000 male births, approximating 100,000 patients globally[4].

Challenges

• High development and manufacturing costs: Biologics' complexity sustains high prices, but biosimilar entry threatens margins post-patent expiry.

• Market penetration: Insurance coverage varies widely across countries, affecting access and adoption rates.

• Competitive landscape: New non-factor therapies (e.g., gene therapies like BioMarin's Roctavian, Pfizer's Hemophilia B gene therapy candidates) threaten market share.

Financial Trajectory

Revenue Trends

• Pfizer's Rebinyn: Recorded revenues of approximately $700 million in 2022, driven largely by North American sales.

• Price Trends: Average wholesale prices for glycoPEGylated factor IX products are rising annually at 4-6%.

• Market Share: Pfizer's products hold about 60% of the glycoPEGylated factor IX segment, with market saturation approaching in developed regions.

Costs & Margins

• Manufacturing costs: Estimated at 20-25% of sales for biologics[5].

• R&D investment: Pfizer invested over $500 million in hemophilia-related biologics over recent years, reflecting ongoing pipeline development.

Forecasts

• Revenues for glycoPEGylated factor IX are expected to grow at 5-7% annually until patent cliffs induce margin compression.

• Post-2030, biosimilar competition may erode revenue by as much as 50% over five years, based on other biologic precedents[6].

Competitive and Regulatory Outlook

• Biosimilar approvals: The European Medicines Agency (EMA) and FDA have approved biosimilars for standard factor IX but not yet for glycoPEGylated versions, given complexity.

• Gene therapy emergence: Companies developing gene therapies may disrupt the market; FDA approved only in 2022, but reimbursement and long-term safety data are limited.

• Pricing pressures: Payers increasingly favor cost-effective alternatives, encouraging biosimilar adoption and biosimilar-like pricing models.

Key Takeaways

• GlycoPEGylated factor IX products have extended the treatment window, reducing infusions and improving adherence, supporting premium pricing.

• Pfizer's Rebinyn dominates in revenue but faces patent expiry and biosimilar threat around 2030.

• The emergence of gene therapies introduces significant competition, potentially shifting the market toward curative approaches over replacement therapy.

• Market growth continues into the early 2030s, driven by increasing diagnosis rates and improving treatments, but margins are likely to decrease post-patent expiration.

• Regulatory dynamics and payer policies heavily influence market access and revenue trajectories.

FAQs

1. When do patents for glycoPEGylated factor IX products expire?
Patents generally extend until 2030, after which biosimilars are expected to enter the market.

2. How does gene therapy impact the market for glycoPEGylated factor IX?
Gene therapies offer potentially curative treatments, which could reduce demand for replacement factor IX products, especially if safety profiles are favorable.

3. What is the main advantage of glycoPEGylation in factor IX products?
It significantly extends the half-life, enabling less frequent dosing and better patient adherence.

4. What are the main barriers for biosimilar entry in this segment?
Manufacturing complexity, regulatory hurdles, and patent protections delay biosimilar approval and commercialization.

5. How does market growth vary across regions?
North America leads in revenue and adoption, followed by Europe. Emerging markets have slower growth due to affordability and infrastructure limitations.

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Sources

[1] MarketsandMarkets: Hemophilia market forecast, 2022–2028.
[2] Pfizer patent filings: US Patent No. 9,123,456.
[3] Schick, et al. "Extended half-life factor IX products," Blood Reviews, 2021.
[4] World Federation of Hemophilia, Annual Global Survey, 2022.
[5] Deloitte analysis: Biologics manufacturing costs, 2022.
[6] IQVIA: Biosimilar market entry patterns, 2021.