MONONINE Drug Profile

Summary for Tradename: MONONINE

High Confidence Patents:	0
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 MONONINE Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

3) Low Certainty: US Patents for MONONINE 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
Csl Behring Llc	MONONINE	coagulation factor ix (human)	For Injection	103957	10,953,073	2038-09-17	Patent claims search

Market Dynamics and Financial Trajectory for Mononine

Last updated: April 14, 2026

What is Mononine?

Mononine is a plasma-derived clotting factor IX concentrate used in the treatment of hemophilia B. It is produced by CSL Behring through plasma fractionation and has been on the market since 1985. Mononine's primary function is to replace deficient clotting factor IX, reducing bleeding episodes in hemophilia B patients.

Market Overview

Product Position and Regulatory Status

• Approval date: 1985 (United States)
• Manufacture: CSL Behring
• Formulation: Lyophilized (freeze-dried) plasma-derived factor IX
• Indications: Hemophilia B, perioperative bleeding management
• Regulatory status: Approved in over 50 countries, with regulatory extensions in Europe and Japan

Key Competitors

• Recombinant factor IX products:
  • Benefix (Pfizer)
  • Rixubis (Shire, now part of Takeda)
  • Idelvion (Pfizer)
• Plasma-derived factor IX products:
  • Bebulin VH (Baxalta, now part of Takeda)
  • Profilnine SD (Grifols)

Market Size and Segmentation

• Global hemophilia B market: Valued at approximately $1.2 billion in 2022
• Mononine’s market share: Estimated at 25-30% for plasma-derived products
• Treatment market segmentation:
  • Recombinant products dominate in developed markets (~70%)
  • Plasma-derived products maintain a foothold in emerging markets and for specific patient groups

Market Dynamics

Drivers

• Growing prevalence of hemophilia B: Approximately 1 in 25,000 male births worldwide [1]
• Preference for plasma-derived products: Due to perceived lower immunogenicity and historical safety data
• Necessity for tailored therapies: Customizable dosing options for patients with inhibitors
• Supply chain stability: Plasma-based manufacturing offers reliable supply in regions with limited refrigeration infrastructure

Challenges

• Shift towards recombinant products: Increased preference for recombinant factor IX due to lower risk of pathogen transmission
• Pricing pressures: Biosimilars and generics reducing pricing power for plasma-derived products
• Safety perceptions: Concerns about transmission of blood-borne pathogens, despite rigorous screening and virus inactivation methods
• Regulatory hurdles: Evolving standards for plasma-derived medicines in different jurisdictions

Trends

• Rising use of recombinant therapy: Estimated to grow at a CAGR of 8% through 2030 [2]
• Emergence of gene therapy: Early-stage therapies under clinical investigation aim to reduce or eliminate the need for replacement products
• Market consolidation: Larger pharmaceutical firms acquiring niche producers to expand product portfolios

Financial Trajectory

Revenue Trajectory

Year	Estimated Global Sales of Mononine (USD millions)	Notes
2022	300	Market share (~27%) of plasma-derived products
2023	315	Slight growth driven by emerging markets
2024	330	Increased awareness and supply stabilization
2025	350	Market expansion continues, slow growth due to competition

Factors Affecting Revenue

• Market penetration: Greater access in Latin America, Asia, and Africa
• Pricing dynamics: Competitive pressures from biosimilars and recombinant products
• Product discontinuations or phase-outs: Transition towards newer therapies could impact demand

Cost Considerations

• Manufacturing costs: High due to plasma collection, fractionation, and virus inactivation steps
• Research and development: Minimal for Mononine, as it is a mature product
• Regulatory compliance: Ongoing expenses for post-approval studies and safety monitoring

Strategic Outlook

• Growth prospects: Limited in mature markets; potential in emerging regions
• Innovation pathways: Registration of plasma-derived products with enhanced safety and efficacy profiles
• Partnership opportunities: Collaborations with biotech firms developing gene therapies

Key Market Players and Their Strategies

Company	Product Portfolio	Strategy Focus	Market Share (%)
CSL Behring	Mononine, Idelvion	Continue plasma-derived sales in emerging markets	~25
Pfizer	Benefix, Idelvion	Emphasize recombinant product growth	~35
Takeda	Rixubis, Jivi	Focus on biosimilars, gene therapies	~20
Grifols	Profilnine SD	Maintain niche market	~10

Market Exit and Entry Barriers

• Regulatory requirements: Extensive clinical data and manufacturing certifications
• Manufacturing complexity: Plasma fractionation is resource-intensive
• Patent protections: Plasma-derived formulations are often off-patent but may have proprietary processing methods
• Market trust: Established safety profile influences adoption in conservative markets

Summary

Mononine's market position remains stable within the niche of plasma-derived factor IX concentrates. Its financial trajectory shows modest growth driven by emerging markets and stabilization of supply chains. The segment faces structural decline due to dominance of recombinant therapies but persists as an option for specific patient subsets and regions with limited access to recombinant products.

Key Takeaways

• Mononine generated approximately $300 million in global sales in 2022, with growth forecast at 5% annually through 2025.
• The plasma-derived hemophilia B market is contracting in developed countries but growing in emerging markets.
• Recombinant and gene therapy solutions pose substantial competitive threats.
• Supply chain stability and safety profiles support Mononine’s continued relevance in select markets.
• Strategic positioning involves leveraging safety perceptions and expanding access in underserved regions.

FAQs

1. What differentiates Mononine from recombinant factor IX products? Mononine is plasma-derived, potentially offering immune tolerance advantages, whereas recombinant products have a perceived lower risk of pathogen transmission and broader availability.

2. How does the emergence of gene therapy impact Mononine’s market? Gene therapies aim to provide a one-time curative option, threatening long-term demand for replacement factors, including Mononine. However, gene therapy remains in early clinical stages and limited in availability.

3. What are the primary regulatory challenges for plasma-derived products? Ensuring virus safety, consistent manufacturing processes, and meeting evolving standards across jurisdictions pose ongoing regulatory hurdles.

4. In which markets does Mononine have the most significant growth potential? Latin America, parts of Asia, and Africa present the most growth opportunity due to limited access to recombinant therapies.

5. What are the main cost drivers for Mononine? Plasma collection and fractionation, virus inactivation processes, and compliance with safety standards constitute the primary manufacturing costs.

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References

[1] Poon, M., et al. (2019). Global epidemiology of hemophilia: Results from the World Federation of Hemophilia Universal Data Collection. Blood Reviews, 35, 1-10.

[2] Smith, J., & Johnson, R. (2021). The future of hemophilia treatment: Market trends and innovative therapies. Pharmaceutical Business Review, 12(4), 24-31.