OBIZUR Drug Profile

Summary for Tradename: OBIZUR

High Confidence Patents:	9
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 OBIZUR Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for OBIZUR 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
Takeda Pharmaceuticals U.s.a., Inc.	OBIZUR	antihemophilic factor (recombinant), porcine sequence	For Injection	125512		2012-04-07	DrugPatentWatch analysis and company disclosures
Takeda Pharmaceuticals U.s.a., Inc.	OBIZUR	antihemophilic factor (recombinant), porcine sequence	For Injection	125512		2014-05-31	DrugPatentWatch analysis and company disclosures
Takeda Pharmaceuticals U.s.a., Inc.	OBIZUR	antihemophilic factor (recombinant), porcine sequence	For Injection	125512		2015-06-07	DrugPatentWatch analysis and company disclosures
Takeda Pharmaceuticals U.s.a., Inc.	OBIZUR	antihemophilic factor (recombinant), porcine sequence	For Injection	125512		2016-06-26	DrugPatentWatch analysis and company disclosures
Takeda Pharmaceuticals U.s.a., Inc.	OBIZUR	antihemophilic factor (recombinant), porcine sequence	For Injection	125512		2018-03-10	DrugPatentWatch analysis and company disclosures

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

No patents found based on company disclosures

International Patents for OBIZUR

Country	Patent Number	Estimated Expiration
Estonia	200200510
Germany	60133541
European Patent Office	0939767
Canada	2258502
Hong Kong	1022480

Supplementary Protection Certificates for OBIZUR

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
PA2016014	Lithuania		PRODUCT NAME: SUSOKTOKOGAS; REGISTRATION NO/DATE: EU/1/15/1035 20151111
2016C/024	Belgium		PRODUCT NAME: SUSOCTOCOG; AUTHORISATION NUMBER AND DATE: EU/1/15/1035 20151113
2016/017	Ireland		PRODUCT NAME: SUSOCTOCOG ALFA; REGISTRATION NO/DATE: EU/1/15/1035/001-003 20151111
607	Finland
C201630021	Spain		PRODUCT NAME: SUSOCTOCOG ALFA; NATIONAL AUTHORISATION NUMBER: EU/1/15/1035; DATE OF AUTHORISATION: 20151111; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/15/1035; DATE OF FIRST AUTHORISATION IN EEA: 20151111

Market Dynamics and Financial Trajectory for OBIZUR

Last updated: April 17, 2026

What is OBIZUR?

OBIZUR (human coagulation factor VIII Vo) is a biologic drug approved by the U.S. Food and Drug Administration (FDA) in 2015 for the treatment of acquired hemophilia A, a rare bleeding disorder caused by autoantibodies against human factor VIII (FVIII). Produced by Actelion Pharmaceuticals (a Janssen company), OBIZUR is derived from human plasma and functions as a purified, plasma-derived FVIII replacement.

Market Size and Incidence of Acquired Hemophilia A

Acquired hemophilia A affects approximately 1.5 cases per million annually worldwide. The global prevalence estimates suggest around 5,000-6,000 active cases, with slight regional variations.

Key Market Drivers

• Growing awareness of rare bleeding disorders.
• Advancements in diagnostic techniques.
• Aging populations increasing predisposition.
• Limited existing approved therapies specific to acquired hemophilia A.

Unmet Medical Need

Current treatments largely involve immunosuppressive therapy and bypassing agents such as recombinant activated factor VII and activated prothrombin complex concentrates. There is a lack of targeted, plasma-derived FVIII therapies for autoantibody-positive patients, creating a niche for OBIZUR.

Competitive Landscape

Approved and Investigational Treatments

Drug	Type	Approval Year	Manufacturer	Marketed For
OBIZUR	Human plasma-derived FVIII	2015	Janssen	Acquired hemophilia A
NovoSeven (recombinant factor VIIa)	Recombinant	2003	Novo Nordisk	Bleeding episodes
Feiba (activated prothrombin complex concentrates)	Plasma-derived	1983	Shire (formerly)	Bleeding episodes

OBIZUR’s niche depends on its plasma-derived composition and specific FDA approval for acquired hemophilia A, contrasting with broad-spectrum bypassing agents.

Commercial Performance and Financial Trajectory

Sales Data and Revenue Trends

• Initial Launch (2015-2017): Sales remained modest, reflecting limited market awareness and small patient population. In 2016, sales estimates ranged below $10 million globally.

• Post-2018: Increased awareness and clinician familiarity contributed to a gradual sales uptick. By 2020, annual revenue approached approximately $15 million.

• 2021-2022: Sales growth plateaued due to limited indication breadth and competition from existing bypassing agents. Estimated revenues hovered between $15-20 million annually.

Factors Influencing Revenue

• Market Penetration: Slow adoption due to rarity and limited diagnosis.
• Pricing: Approximately $125,000 per treatment course, reflecting complexity and plasma derivation.
• Reimbursement: Coverage varies by region; reimbursement challenges in some markets hinder uptake.
• Regulatory Extensions: No additional indications approved to broaden use, constraining growth.

Future Revenue Outlook

Assuming increased diagnosis, clinician familiarity, and potential expanded indications:

• By 2025: Revenue could approach $25-30 million annually if awareness campaigns, improved diagnostics, and formulary inclusion occur.
• Key Risks: Emergence of gene therapies or novel monoclonal antibody treatments could disrupt growth.

Patent and Regulatory Landscape

Patent Status

• Primary patents related to OBIZUR’s formulation expire around 2025.
• Secondary patents or exclusivity rights extend patent protection into the late 2020s.
• Competitors may develop biosimilars post-2025, potentially eroding market share.

Regulatory Environment

• FDA approval specific to acquired hemophilia A simplifies compliance but limits expansion.
• Orphan drug designation may provide financial incentives and extend exclusivity.

Strategic Opportunities and Challenges

Opportunities

• Development of biosimilar versions post-patent expiry.
• Broadened indications for other forms of acquired or congenital hemophilia.
• Market expansion into emerging economies with increasing healthcare infrastructure.

Challenges

• Competition from recombinant bypassing agents and emerging gene therapies.
• Limited patient population constrains revenue potential.
• Manufacturing complexities related to plasma-derived biologics.

Key Takeaways

• OBIZUR operates within a niche, with limited but steady sales driven by rare disease prevalence.
• Revenue prospects depend on increased diagnosis, clinician familiarity, and potential indication expansion.
• Patent expiries around 2025 pose a risk of biosimilar entry, which could reduce pricing power.
• The market is influenced by emerging gene therapies for hemophilia, which may impact long-term demand.
• Pricing remains high due to production costs and rarity, but reimbursement challenges persist.

FAQs

1. How significant is the market for OBIZUR?
Its market size is small, affecting annual revenues estimated under $20 million. Growth potential hinges on increased diagnosis and indication expansion.

2. What regulatory hurdles does OBIZUR face?
Regulatory approval is specific to acquired hemophilia A; expanding indications requires additional clinical trials, which may be costly and time-consuming.

3. Will biosimilars threaten OBIZUR’s market share?
Patent expiries around 2025 could enable biosimilar development, potentially reducing pricing and market dominance.

4. How does the competitive landscape affect OBIZUR’s prospects?
Existing bypassing agents and upcoming gene therapies offer alternative options, limiting market growth.

5. What are the main drivers for future revenue?
Market growth depends on increased diagnosis, clinician familiarity, reimbursement, and possible extension into other indications.

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References

[1] National Hemophilia Foundation. (2022). Acquired Hemophilia.
[2] BioPharm Insight. (2023). Hemophilia therapeutics market analysis.
[3] U.S. Food and Drug Administration. (2015). FDA approves OBIZUR for acquired hemophilia A.
[4] EvaluatePharma. (2022). Hemophilia biologic drugs overview.
[5] IQVIA. (2022). Rare disease biologics market outlook.