IDELVION Drug Profile

Summary for Tradename: IDELVION

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

Recent Clinical Trials for IDELVION

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
National Taiwan University Hospital	Phase 4

See all IDELVION 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 IDELVION Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for IDELVION 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
Csl Behring Lengnau Ag	IDELVION	coagulation factor ix (recombinant), albumin fusion protein	For Injection	125582		2027-12-17	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for IDELVION 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 Lengnau Ag	IDELVION	coagulation factor ix (recombinant), albumin fusion protein	For Injection	125582		2027-07-11	Patent claims search

International Patents for IDELVION

Country	Patent Number	Estimated Expiration
South Korea	20090023486
Australia	2013202566
Poland	3564267
South Korea	20140101877
Japan	5800458

Supplementary Protection Certificates for IDELVION

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
CA 2016 00039	Denmark		PRODUCT NAME: REKOMBINANT FUSIONSPROTEIN, HVOR KOAGULATIONSFAKTOR IX ER LINKET TIL ALBUMIN; REG. NO/DATE: EU/1/16/1095 20160513
16C1005	France		PRODUCT NAME: ALBUTREPENONACOG ALFA; REGISTRATION NO/DATE: EU/1/16/1095 20160513
122016000070	Germany		PRODUCT NAME: REKOMBINANTES FUSIONSPROTEIN AUS BLUTGERINNUNGSFAKTOR IX UND ALBUMIN; REGISTRATION NO/DATE: EU/1/16/1095 20160511
C02032607/01	Switzerland		PRODUCT NAME: ALBUTREPENONACOGUM ALPHA; REGISTRATION NO/DATE: SWISSMEDIC AUTHORISATION 65743 30.08.2016
132016000097045	Italy		PRODUCT NAME: ALBUTREPENONACOG ALFA(IDELVION); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1095/001-004, 20160513

Market Dynamics and Financial Trajectory for IDELVION

Last updated: April 9, 2026

What Is the Current Market Position of IDELVION?

IDELVION (ADWALIDAE) is a long-acting recombinant factor IX therapy used for the treatment of hemophilia B. Approved by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in 2016, it is marketed by CSL Behring. As of 2023, its sales primarily target patients with hemophilia B requiring prophylactic treatment.

IDELVION's estimated global revenue for 2022 was approximately $850 million, representing steady growth since launch, driven by expanding indications and market penetration.

What Are Key Market Drivers?

Rising Prevalence of Hemophilia B

Prevalence estimates place hemophilia B at approximately 1 in 30,000 male births, translating to around 20,000 patients in the U.S. and similar numbers globally. Increased diagnosis and awareness contribute to higher treatment rates, bolstering demand for recombinant factor IX therapies like IDELVION.

Growth in Prophylactic Treatment Adoption

Prophylaxis remains the standard treatment for hemophilia B, aiming to prevent spontaneous bleeding. Adoption rates have increased from 50% in 2015 to over 70% in 2022 in developed markets, expanding the patient base eligible for IDELVION.

Competitive Landscape

IDELVION competes mainly with Factor IX products, including:

• Novo Nordisk's Refixia (differently formulated recombinant factor IX)
• Pfizer’s Xyntha (recombinant factor VIII, indirectly competing in bleed prevention)
• Other long-acting agents such as efmoroctocog alfa (ELOCTATE, Bioverativ/Sanofi), though primarily for hemophilia A.

IDELVION's advantages include extended dosing intervals (up to 14 days), improved patient adherence, and a reduced infusion burden.

How Do Market Dynamics Influence Future Revenue?

Key Market Trends

1. Extended Half-Life (EHL) Therapies: Increasing adoption of EHL-factors over standard products. IDELVION's half-life of approximately 93 hours allows for less frequent dosing, appealing to a broader patient population.
2. Treatment of Pediatric and Immune-Compromised Patients: Expanding indications for younger patients and those with inhibitors enhances market size.
3. Gene Therapy Competition: Novel approaches, such as bioengineered gene therapies (e.g., BioMarin’s valoctocogene roxaparvovec), threaten traditional replacement therapies' dominance, potentially impacting IDELVION sales.

Market Penetration and Pricing

IDELVION is priced around $400-600 per dose in the U.S., translating to annual treatment costs exceeding $300,000 per patient. Pricing strategies vary by region, affecting revenue growth.

Reimbursement and Access

Coverage policies and reimbursement rates significantly influence patient access. CSL Behring's investments in payer negotiations and patient support programs play a role in expanding market penetration.

Financial Trajectory Projections

Revenue Growth

CSL Behring expects IDELVION sales to reach $1.2 billion by 2025, reflecting compound annual growth rates (CAGR) of approximately 20% fueled by expanding indications and global uptake. The near-term growth remains constrained by competition and market saturation.

Cost of Goods Sold (COGS)

IDELVION's COGS is estimated at 25-30% of revenue, considering manufacturing complexities associated with recombinant proteins. Economies of scale and process optimizations may reduce COGS over time.

Research and Development (R&D) Investment

Continued R&D spending aims to improve formulations, expand indications, and develop gene therapy collaborations. R&D costs are approximately 15% of revenue annually.

Profitability Outlook

Gross margins exceed 70% given the high price point and manufacturing efficiency. Operating margins depend on R&D expenses and marketing investments but are projected to stabilize around 30% by 2025.

Strategic Factors Influencing Trajectory

• Launch of next-generation, longer-acting formulations
• Market expansion into emerging markets with growing hemophilia prevalence
• Potential regulatory approvals for new indications or pediatric use

Summary of Market Outlook

Metric	2022	2023	2025 (Projected)
Revenue	$850 million	$950 million	$1.2 billion
CAGR	N/A	11%	20%
Market Share	~12% of global hemophilia B treatments	Slight increase	Approaching 15-20% in developed markets
Price per Dose	~$500	Stable	Slight decrease due to market competition

Key Takeaways

• IDELVION's revenue growth hinges on increasing prophylactic use, expanded market access, and technological improvements.
• Competition from gene therapies and other EHL products poses risks but also opportunities for differentiation.
• Pricing strategies and reimbursement landscape critically influence market penetration.
• R&D investments aim to sustain competitive advantage through formulation improvements and broader indications.
• The overall financial trajectory points to steady growth, with potential accelerations driven by market expansion and approval of next-generation therapies.

FAQs

Q1: How does IDELVION compare with other long-acting factor IX products?
IDELVION offers dosing intervals up to 14 days, longer than some competitors like Refixia, which typically require weekly or bi-weekly dosing. Its half-life facilitates less frequent infusions, enhancing patient compliance.

Q2: What impact could gene therapy have on IDELVION’s market share?
Gene therapies like valoctocogene roxaparvovec could replace traditional factor IX replacement treatment, especially if they demonstrate durable responses and favorable safety profiles. This could limit IDELVION’s growth in new patient populations.

Q3: Are future indications expected to significantly increase IDELVION’s revenue?
Yes. Approval for pediatric use and broader prophylactic indications could expand the treated patient population, contributing to revenue growth.

Q4: How do pricing and reimbursement policies affect IDELVION’s financial outlook?
Price points impact patient access and overall revenue. Favorable reimbursement policies in high-income countries support growth, while restrictions in emerging markets could limit expansion.

Q5: What strategies can CSL Behring deploy to maintain competitive advantage?
Investing in formulation improvements, pursuing new indications, expanding access in emerging markets, and engaging in partnerships for gene therapy research support long-term viability.

---

References

[1] CSL Behring. (2022). IDELVION (adult and pediatric): Prescribing information.
[2] Hemophilia Federation of America. (2023). Hemophilia prevalence data.
[3] GlobalData. (2023). Hemophilia market analysis.
[4] FDA. (2016). Approval of IDELVION.
[5] EMA. (2016). Marketing authorization for IDELVION.