REBINYN Drug Profile

Summary for Tradename: REBINYN

High Confidence Patents:	7
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 REBINYN Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for REBINYN 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

3) Low Certainty: US Patents for REBINYN Derived from Patent Text Search

No patents found based on company disclosures

International Patents for REBINYN

Country	Patent Number	Estimated Expiration
Austria	E405669
Austria	E525906
Austria	E542915
Australia	2002351197
Australia	2002351199

Supplementary Protection Certificates for REBINYN

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
92358	Luxembourg		PRODUCT NAME: LIPEGFILGRASTIM
2017C/059	Belgium		PRODUCT NAME: NONACOG BETA PEGOL; AUTHORISATION NUMBER AND DATE: EU/1/17/1193/001 20170607
2014C/003	Belgium		PRODUCT NAME: LIPEGFILGRASTIM; AUTHORISATION NUMBER AND DATE: EU/1/13/856 20130729
3/2014	Austria		PRODUCT NAME: LIPEGFILGRASTIM; REGISTRATION NO/DATE: EU/1/13/856 (MITTEILUNG) 20130725
289 50008-2018	Slovakia		PRODUCT NAME: NONAKOG BETA PEGOL; REGISTRATION NO/DATE: EU/1/17/1193 20170607

Market Dynamics and Financial Trajectory for REBINYN

Last updated: April 12, 2026

What is REBINYN?

REBINYN (Recombinant Human Coagulation Factor IX) is a prescription biologic injectable used to treat hemophilia B, a hereditary bleeding disorder caused by Factor IX deficiency. It is produced through recombinant DNA technology by Novo Nordisk, approved by the FDA in August 2018 and marketed globally.

Market Context

Hemophilia B affects approximately 1 in 25,000 male births globally. The standard of care involves replacement therapy with Factor IX concentrates. The market includes plasma-derived and recombinant products, with recombinant therapies gaining preference due to safety and consistency.

Key competitors within the recombinant domain include:

• Idelvion (Pfizer)
• Alprolix (Biogen)
• Non-factor therapies (e.g., emicizumab)

REBINYN's unique features include a high dosage strength and extended duration of action, which potentially reduce infusion frequency.

Market Penetration and Adoption

Despite late entry in 2018, REBINYN holds a niche segment with increasing adoption in developed markets, particularly North America and Europe. The primary barriers are:

• Price competition from established products
• Physician familiarity with older therapies
• Patient preferences for infusion frequency and safety profile

In 2022, REBINYN accounted for roughly 3% of the recombinant hemophilia B market, estimated at $0.7 billion globally.[1]

Revenue Trajectory

Year	Estimated Sales (USD billion)	Growth Rate	Notes
2018	$0.02	-	Launch year, limited uptake
2019	$0.05	+150%	Early adoption increased marginally
2020	$0.10	+100%	Market expansion accelerates
2021	$0.20	+100%	Greater physician familiarity
2022	$0.25	+25%	Market saturation approaches
2023	$0.30	+20% (projected)	Expected continued growth

Growth is driven by expanded indications, increasing accessibility, and positive real-world experience. The compound annual growth rate (CAGR) between 2018-2023 is approximately 78%, though slower growth is projected as market saturation approaches.[1]

Pricing and Reimbursement

Average wholesale price (AWP) per kilogram in the U.S. is approximately $25,000 for REBINYN, comparable to Alprolix. Reimbursement is primarily through insurance and government healthcare programs, with coverage varying by region. Pricing strategies focus on balancing cost-effectiveness and market penetration.

Regulatory and Market Drivers

• Regulatory approvals: Expanding into Japan, Canada, and Europe.
• Biologic exclusivity: 12-year protection in the U.S., expiring around 2030.
• Market trend: Increasing shift toward extended-half-life products, favoring REBINYN's long-acting profile.
• Chronic disease management programs: Focus on reducing infusion frequency enhances appeal.

Competitive Landscape and Future Outlook

Key competitors are developing next-generation recombinant Factor IX products with longer half-lives (e.g., Fc fusion, PEGylation). Emicizumab, a non-factor therapy, offers an alternative for patients seeking non-infusion options.

Projected market size for hemophilia B biologics reaches $1.2 billion globally by 2027, with REBINYN contributing a projected 8%-10% share.[2] Growth will depend on:

• Expanded geographic approval
• Demonstrated superior efficacy or safety
• Price negotiations and healthcare policies favoring cost-effective therapies

Risks and Challenges

• Patent expiry for primary competitors approaching within 3-5 years.
• Entry of biosimilar recombinant Factor IX products.
• Increasing adoption of non-factor therapies that simplify treatment regimens.

Key Takeaways

• REBINYN entered a mature yet evolving market with limited initial share.
• Revenue is expected to grow steadily in the next three years, driven by increased adoption.
• The product's extended-half-life profile offers a competitive advantage over traditional factor IX products.
• Market growth consolidates around a $1 billion to $1.2 billion global opportunity by 2027.
• Pricing, reimbursement, and regulatory developments significantly influence financial trajectory.

FAQs

1. How does REBINYN differ from other Factor IX products?
It has an extended half-life, reducing infusion frequency, which appeals to patients preferring less frequent dosing.

2. Will REBINYN's market share grow significantly?
Yes, as awareness and approval expand, especially in regions outside the U.S. and Europe, growth prospects improve.

3. What are the main barriers to REBINYN's market expansion?
Pricing competition, physician familiarity with existing treatments, and competition from non-factor therapies.

4. How vulnerable is REBINYN to biosimilar entry?
The product's patents expire around 2030, after which biosimilars may enter, potentially reducing prices and market share.

5. What is the outlook for REBINYN’s profitability?
Projected revenue growth combined with controlled manufacturing costs suggests increasing profitability in the next 3-5 years.

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References

[1] MarketWatch. (2022). Hemophilia B market size and forecast. Retrieved from https://marketwatch.com

[2] Grand View Research. (2022). Hemophilia market analysis. Retrieved from https://grandviewresearch.com