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
Takeda Pharmaceuticals U.s.a., Inc.	OBIZUR	antihemophilic factor (recombinant), porcine sequence	For Injection	125512		2020-03-10	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
Hungary	P0300586
Cyprus	2016011
World Intellectual Property Organization (WIPO)	9320093
Spain	2161278
Japan	3495365
Poland	202936

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
16C0016	France		PRODUCT NAME: SUSOCTOCOG ALFA AINSI QUE TOUTES LES FORMES RELEVANT DE LA PROTECTION DU BREVET DE BASE; REGISTRATION NO/DATE: EU/1/15/1035 20151113
122016000031	Germany		FORMER OWNER: EMORY UNIVERSITY, ATLANTA, GA., US
2016C/024	Belgium		PRODUCT NAME: SUSOCTOCOG; AUTHORISATION NUMBER AND DATE: EU/1/15/1035 20151113
C 2016 012	Romania		PRODUCT NAME: SUSOCTOCOG; NATIONAL AUTHORISATION NUMBER: EU/1/15/1035/001, EU/1/15/1035/002, EU/1/15/1035/003; DATE OF NATIONAL AUTHORISATION: 20151111; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/15/1035/001, EU/1/15/1035/002, EU/1/15/1035/003; DATE OF FIRST AUTHORISATION IN EEA: 20151111
CR 2016 00018	Denmark		PRODUCT NAME: SUSOCTOCOG ALFA; REG. NO/DATE: EU/1/15/1035/001-003 20151113

Market Dynamics and Financial Trajectory for the Biologic Drug: OBIZUR

Last updated: September 29, 2025

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Introduction

OBIZUR (emsacta) is a recombinant human activated Factor VIII (FVIII) concentrate designed for the treatment of acquired hemophilia A, a rare autoimmune disorder characterized by autoantibodies against FVIII leading to severe bleeding episodes. Since its approval by the US Food and Drug Administration (FDA) in 2014, OBIZUR has carved a niche in the niche market of bleeding disorder therapeutics. This analysis explores the intricate market dynamics and financial implications shaping OBIZUR's trajectory within the broader biologics segment.

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Market Landscape and Unmet Needs

Acquired Hemophilia A: Rare but Critical

Acquired hemophilia A affects approximately 1 to 1.5 per million annually, predominantly impacting elderly populations and postpartum women. Its rarity constrains the market size but magnifies the importance of targeted, effective treatments. Patients often suffer from life-threatening hemorrhages requiring immediate and efficient hemostatic intervention.

Current Treatment Paradigms

Therapeutic management involves bypassing agents—such as recombinant activated factor VII (rFVIIa) or activated prothrombin complex concentrates—plus immunosuppressive therapies. OBIZUR offers a recombinant FVIII, a more pathogen-safe option, aligning with the evolving preferences for biologics that mirror physiological processes.

Unmet Needs

• Shortage of specific biologic options expressly indicated for acquired hemophilia A.
• Limitations in existing bypassing agents, including variable efficacy and safety concerns.
• The need for targeted therapy that addresses underlying autoantibodies and restores hemostasis.

This niche demand underscores key market opportunities, especially as clinicians seek precision therapies with fewer adverse effects.

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Market Dynamics Influencing OBIZUR

1. Stated Market Penetration & Adoption Factors

Obizur, being a specialty biologic, faces slow but steady adoption constrained by:

• Limited clinician familiarity owing to the rarity of the disorder.
• Preference for off-label use of more established bypassing agents.
• High treatment costs, which influence hospital formulary decisions.

2. Regulatory and Reimbursement Environment

While approved in the US, OBIZUR's reimbursement depends heavily on institutional policies and payer negotiations, given its ultra-rare indication. Reimbursement challenges could limit access, impacting revenue streams.

3. Competitive Landscape

While no direct competitors with the same mechanism exist, the market is shared among:

• Bypassing agents (rFVIIa, aPCC).
• Immunosuppressants to eradicate inhibitors.

The emergence of novel therapies influences OBIZUR's standing. For example, the approval of Emicizumab (Hemlibra), initially for hemophilia A with inhibitors—though not specific for acquired hemophilia—raises competitive questions about biologic innovation relevance.

4. Manufacturing and Supply Chain Factors

As a biologic, OBIZUR’s supply chain is sensitive to manufacturing complexities. Issues such as GMP adherence, batch consistency, and scalability influence supply stability and cost dynamics, impacting market availability.

5. Pricing Strategies

Pricing remains critical to balance profitability with payer acceptance. Given the rarity, premium pricing supports R&D recovery but may hinder broader adoption, especially in cost-sensitive hospital settings.

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Financial Trajectory and Revenue Forecasting

Historical Performance

Since its launch, OBIZUR has experienced modest sales growth. Industry reports suggest revenues in the low tens of millions annually (estimates based on market estimates and rarity-adjusted pricing). The limited patient pool constrains potential revenue, despite high per-unit prices.

Growth Drivers

• Increasing awareness among hematologists and specialist centers.
• Expansion into international markets, particularly in Europe and Japan where orphan drug policies support biologics for rare diseases.
• Consolidation of supportive clinical evidence demonstrating safety and efficacy.

Challenges to Revenue Expansion

• High per-treatment costs.
• Limited clinical data due to infrequent use.
• Competition from emerging therapies or biosimilars.

Projected Revenue Trends

Market forecasts suggest slow but steady growth over the next five years, possibly reaching annual revenues of $50–$100 million if:

• Clinical adoption expands with continued physician education.
• Reimbursement barriers diminish.
• New indications or formulations enhance the drug’s utility.

However, given the rarity and competition landscape, OBIZUR’s financial trajectory remains inherently capped without significant breakthroughs.

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Future Outlook and Strategic Considerations

Innovation and Pipeline Development

Augmenting OBIZUR with combination therapies or new formulations could enhance its therapeutic profile.

Market Expansion Tactics

• Demonstrating efficacy and safety in broader patient subsets.
• Building awareness through professional hematology societies.
• Partnering with global health agencies to improve access.

Regulatory Pathways

Seeking orphan drug designation offers incentives such as market exclusivity, tax credits, and accelerated reviews, potentially extending OBIZUR’s market lifespan and revenue window.

Potential for Biosimilars and Competition

Biologics’ patent expiration could introduce biosimilar competitors, pressuring pricing and market share. Strategic patent management and continuous clinical innovation will be vital.

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Conclusion

OBIZUR exemplifies a specialized biologic targeting an ultra-rare but clinically significant hemophilia subtype. Its market dynamics are shaped by clinical acceptance, reimbursement, and competition within the niche of bleeding disorder therapeutics. Financial growth prospects hinge on expanding clinical use, optimizing manufacturing, and navigating the evolving orphan drug landscape. Although limited in scope, OBIZUR’s trajectory underscores the broader challenges and opportunities encountered by high-cost biologics serving small, critical patient populations.

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Key Takeaways

• Niche Opportunity: OBIZUR addresses a severe, rare bleeding disorder, positioning itself uniquely despite limited market size.
• Market Entry Barriers: Low awareness and reimbursement hurdles constrain initial adoption; ongoing clinician education is essential.
• Competitive Pressures: Emerging therapies and biosimilars threaten pricing power, necessitating strategic innovation.
• Revenue Prospects: Slow growth is expected unless market expansion or formulation improvements occur, supported by orphan drug incentives.
• Strategic Focus: Enhancing clinical evidence, expanding geographic access, and leveraging regulatory benefits are vital for long-term financial sustainability.

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FAQs

1. What is the primary indication for OBIZUR?
OBIZUR is approved for the treatment of acquired hemophilia A, a rare autoimmune bleeding disorder characterized by autoantibodies against factor VIII.

2. How does OBIZUR differentiate itself from other hemostatic agents?
OBIZUR offers a recombinant, human-derived activated factor VIII specifically designed to avoid pathogen transmission and to mimic physiological clotting mechanisms better than bypassing agents.

3. What are the main challenges facing OBIZUR’s market growth?
Challenges include limited clinician familiarity, high treatment costs, reimbursement complexities, and competition from established bypassing agents and emerging therapies.

4. Are there international markets for OBIZUR?
Yes, several countries, especially within Europe and Japan, have orphan drug frameworks that could facilitate OBIZUR’s expansion, contingent on regulatory approvals and local healthcare policies.

5. What strategies can optimize OBIZUR’s financial success?
Focusing on expanding clinical data, improving manufacturing scalability, securing orphan drug exclusivity, and raising awareness among healthcare providers are critical strategies.

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Sources

1. FDA Approval Announcement for OBIZUR [FDA, 2014].
2. Market Analysis Reports on Rare Bleeding Disorders [Industry Reports 2022].
3. Clinical Data Summaries from Hematology Journals [2021].
4. Orphan Drug Designations and Incentives Overview [FDA & EMA, 2022].
5. Biologic Pricing and Reimbursement Trends [Healthcare Economics Review, 2023].