Antihemophilic factor (recombinant), porcine sequence - Biologic Drug Details

Summary for antihemophilic factor (recombinant), porcine sequence

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	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 brand-side disclosures

These patents were identified from searching 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 antihemophilic factor (recombinant), porcine sequence Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for antihemophilic factor (recombinant), porcine sequence 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	5,364,771	2012-04-07	DrugPatentWatch analysis and company disclosures
Takeda Pharmaceuticals U.s.a., Inc.	OBIZUR	antihemophilic factor (recombinant), porcine sequence	For Injection	125512	5,583,209	2014-05-31	DrugPatentWatch analysis and company disclosures
Takeda Pharmaceuticals U.s.a., Inc.	OBIZUR	antihemophilic factor (recombinant), porcine sequence	For Injection	125512	5,744,446	2015-06-07	DrugPatentWatch analysis and company disclosures
Takeda Pharmaceuticals U.s.a., Inc.	OBIZUR	antihemophilic factor (recombinant), porcine sequence	For Injection	125512	5,859,204	2016-06-26	DrugPatentWatch analysis and company disclosures
Takeda Pharmaceuticals U.s.a., Inc.	OBIZUR	antihemophilic factor (recombinant), porcine sequence	For Injection	125512	6,180,371	2018-03-10	DrugPatentWatch analysis and company disclosures
Takeda Pharmaceuticals U.s.a., Inc.	OBIZUR	antihemophilic factor (recombinant), porcine sequence	For Injection	125512	6,458,563	2020-03-10	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for antihemophilic factor (recombinant), porcine sequence 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

International Patents for antihemophilic factor (recombinant), porcine sequence

Country	Patent Number	Estimated Expiration
Austria	E391512
Hong Kong	1043543
Hungary	227804
Montenegro	00601
Czech Republic	20003282
Australia	693837

Supplementary Protection Certificates for antihemophilic factor (recombinant), porcine sequence

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
607	Finland
CA 2016 00018	Denmark		PRODUCT NAME: SUSOCTOCOG; REG. NO/DATE: EU/1/15/1035/001-003 20151113
2016/017	Ireland		PRODUCT NAME: SUSOCTOCOG ALFA; REGISTRATION NO/DATE: EU/1/15/1035/001-003 20151111
300808	Netherlands		PRODUCT NAME: SUSOCTOCOG ALFA; REGISTRATION NO/DATE: EU/1/15/1035/001-003 20151113
SPC/GB16/020	United Kingdom		PRODUCT NAME: SUSOCTOCOG; REGISTERED: UK EU/1/15/1035/001 20151113; UK EU/1/15/1035/002 20151113; UK EU/1/15/1035/003 20151113

Market Dynamics and Financial Trajectory for the Biologic Drug: Antihemophilic Factor (Recombinant), Porcine Sequence

Last updated: August 13, 2025

---

Introduction

The biologic drug, antihemophilic factor (recombinant), porcine sequence, represents an innovative therapeutic aimed at addressing hemophilia A, a hereditary bleeding disorder characterized by deficiency of coagulation factor VIII. Unlike traditional human or bovine-derived products, this recombinant porcine sequence offers unique biochemical properties, potentially improving efficacy and safety profiles. Its market trajectory hinges on complex factors including scientific advancements, regulatory pathways, competitive landscape, patient demand, and reimbursement policies. This analysis explores the evolving market dynamics, financial projections, and strategic considerations pertinent to this niche biologic.

---

Scientific and Clinical Foundations

The antihemophilic factor (recombinant), porcine sequence, is designed to emulate natural coagulation activity with potential benefits over human-based recombinant factors. Historically, porcine variants gained prominence for their efficacy in patients resistant or alloimmunized to human factors. Advances in recombinant DNA technology and protein engineering have facilitated the development of this specialized product, integrating it into the broader hemophilia management paradigm. Clinical trials demonstrate its utility in complex cases, yet its adoption is tempered by safety concerns such as immunogenicity and zoonotic transmission risks.

---

Market Landscape and Competitive Forces

Existing Therapeutic Options

The hemophilia A market is dominated by recombinant human factor VIII products, including notable players like Baxter (now Shire/Takeda), Bioverativ (Sanofi), and Novo Nordisk. These therapies benefit from established safety profiles and broad adoption. Conversely, plasma-derived products face declining demand due to safety concerns with contamination.

Emerging Biologics and Gene Therapy

The advent of gene therapy, exemplified by BioMarin’s valoctocogene roxaparvovec and others in the pipeline, introduces formidable competition by promising potentially curative outcomes. Monoclonal antibody-based treatments and non-factor therapies, such as emicizumab, are shifting market dynamics toward less invasive, longer-acting treatment modalities.

Niche for Porcine Sequence Products

The porcine recombinant factor VIII holds niche appeal for patients with inhibitors to human factors or who exhibit suboptimal responses to existing therapies. However, it faces hurdles such as:

• Limited clinical data: Authorities require extensive evidence to support widespread adoption.
• Safety considerations: Immunogenic responses may restrict usage.
• Manufacturing complexity: Ensuring consistency and safety of porcine-derived biologics is technically demanding.
• Regulatory pathways: Varying global regulatory acceptance impacts market entry.

---

Regulatory and Reimbursement Environment

Regulatory Landscape

Regulatory agencies like the FDA and EMA scrutinize biologics for safety, efficacy, and manufacturing standards. Porcine-derived products may encounter additional review layers due to zoonotic risk considerations. Accelerated pathways, such as breakthrough therapy designation or orphan drug status, can expedite development for unmet needs.

Reimbursement Dynamics

Coverage hinges on demonstrating clinical value and cost-effectiveness. Payers favor therapies that reduce bleeding episodes, hospitalization, and long-term complications. The high manufacturing costs of biologics necessitate premium pricing models, which, combined with reimbursement constraints, influence financial viability.

---

Market Penetration and Adoption Trends

Pricing and Market Access

Pricing strategies for niche biologics often balance recoupment of R&D investments with market penetration goals. Early adopters include specialized treatment centers and compassionate use programs. As clinical evidence accumulates, broader payer acceptance can enhance access, fostering incremental growth.

Patient Population Dynamics

The global hemophilia A patient population is estimated at approximately 300,000, with growth driven by improved diagnosis and treatment access in emerging markets. The subset with inhibitors or refractory responses to existing therapies constitutes a key target demographic for porcine sequence products.

Distribution and Storage Challenges

Biologics demand cold chain logistics, impacting distribution costs and accessibility, especially in low-income regions. Strategic partnerships with logistics providers and regional distributors are critical for market expansion.

---

Financial Projections and Revenue Trajectory

Market Entry Phase

Initial revenues are anticipated to be modest, primarily from specialized centers and clinical trial participants. Licensing agreements or partnerships with established pharmaceutical firms can mitigate initial market entry barriers.

Growth Phase

With accumulated clinical data and regulatory approval, revenues are expected to grow in line with expanding indications and geographic approvals. Conservative estimates project a compounded annual growth rate (CAGR) of approximately 10-15% over the medium term, contingent upon clinical success and market acceptance.

Long-term Outlook

The potential integration of gene therapy as a one-time curative approach might cap long-term revenues for biologics. Nonetheless, niche indications and resistant patient populations will sustain demand. Market share for porcine recombinant products could stabilize at around 2-5% of the overall hemophilia A therapeutics market, driven by specialized use cases.

---

Strategic Considerations for Stakeholders

Manufacturing Innovation

Streamlining production processes and enhancing yield can reduce costs, enabling competitive pricing. Addressing immunogenicity through protein engineering enhances safety, fostering wider acceptance.

Regulatory Engagement

Proactive regulatory dialogues facilitate smoother approval pathways. Emphasizing safety data and real-world evidence expedites market entry.

Market Expansion

Targeted marketing to hematologists, patient advocacy organizations, and healthcare policymakers accelerates awareness and adoption. Education on unique benefits in specific patient cohorts enhances market penetration.

Collaborative Approaches

Considerations for licensing, co-development, or mergers with firms possessing robust distribution networks or advanced biologic manufacturing capabilities can accelerate growth.

---

Key Takeaways

• The antihemophilic factor (recombinant), porcine sequence, occupies a niche within a highly competitive and rapidly evolving hemophilia therapeutics market.
• Clinical utility is primarily limited to patients with inhibitors or refractory responses, constraining overall market size but offering high-value positioning.
• Market growth hinges on regulatory acceptance, demonstration of safety and efficacy, and strategic collaborations.
• The advent of gene therapy and non-factor therapies poses long-term challenges, but niche indications sustain demand.
• Financial success depends on optimizing manufacturing efficiencies, securing regulatory approvals, and establishing reimbursement pathways that reflect clinical value.

---

FAQs

1. What differentiates antihemophilic factor (recombinant), porcine sequence from traditional treatments?
It can be effective in patients with inhibitors to human factors, offering an alternative when standard therapies fail or are contraindicated. Its unique biochemical profile may reduce immunogenicity in specific patient subsets.

2. What are the main risks associated with porcine-derived biologics?
Risks include zoonotic transmission and immunogenic responses, which can diminish efficacy or induce allergic reactions. Rigorous manufacturing controls mitigate these concerns.

3. How does the emergence of gene therapy affect the market for recombinant porcine factors?
Gene therapies aim for a curative single administration, potentially reducing demand for replacement biologics. However, gene therapy's accessibility, durability, and safety profile remain under evaluation, leaving room for niche biologics.

4. Which regulatory pathways facilitate the approval of porcine recombinant products?
Accelerated programs like fast track or orphan drug designations can expedite approval, especially if the product addresses unmet needs in rare hemophilia presentations.

5. What factors influence reimbursement decisions for niche hemophilia biologics?
Clinical efficacy, safety, quality of life improvements, and cost-effectiveness determine reimbursement. Payers favor therapies that reduce bleeding episodes and overall long-term healthcare costs.

---

References

[1] National Hemophilia Foundation. (2021). Hemophilia Facts and Figures.
[2] European Medicines Agency. (2022). Guidance on Biologics and Biosimilars.
[3] BioMarin. (2022). Valoctocogene Roxaparvovec Clinical Data.
[4] MarketWatch. (2023). Hemophilia Market Analysis and Forecasts.
[5] U.S. Food and Drug Administration (FDA). (2022). Guidance for Industry: Biologics Licensing.