AUTOPLEX, FEIBA NF, FEIBA VH Drug Profile

✉ Email this page to a colleague

Summary for Tradename: AUTOPLEX, FEIBA NF, FEIBA VH

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:

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.

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.

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 AUTOPLEX, FEIBA NF, FEIBA VH Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for AUTOPLEX, FEIBA NF, FEIBA VH Derived from DrugPatentWatch Analysis and Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for AUTOPLEX, FEIBA NF, FEIBA VH Derived from Patent Text Search

These patents were obtained by searching patent claims

Glossary

Subscribe to access the full database, or Start Trial
Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Takeda Pharmaceuticals U.s.a., Inc.	AUTOPLEX, FEIBA NF, FEIBA VH	anti-inhibitor coagulant complex	For Injection	101447	10,588,950	2038-01-17	Patent claims search
Takeda Pharmaceuticals U.s.a., Inc.	AUTOPLEX, FEIBA NF, FEIBA VH	anti-inhibitor coagulant complex	For Injection	101447	10,822,376	2039-03-20	Patent claims search
Takeda Pharmaceuticals U.s.a., Inc.	AUTOPLEX, FEIBA NF, FEIBA VH	anti-inhibitor coagulant complex	For Injection	101447	4,160,025	1997-08-08	Patent claims search
Takeda Pharmaceuticals U.s.a., Inc.	AUTOPLEX, FEIBA NF, FEIBA VH	anti-inhibitor coagulant complex	For Injection	101447	4,364,861	2000-05-27	Patent claims search
Takeda Pharmaceuticals U.s.a., Inc.	AUTOPLEX, FEIBA NF, FEIBA VH	anti-inhibitor coagulant complex	For Injection	101447	4,391,746	2002-05-05	Patent claims search
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Patent No.	>Estimated Patent Expiration	>Source

AUTOPLEX, FEIBA NF, and FEIBA VH: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

AUTOPLEX, FEIBA NF, and FEIBA VH are human plasma-derived prothrombin complex concentrates (PCCs) indicated for the treatment of bleeding in patients with hemophilia A or B, and acquired factor XIII (FXIII) deficiency. The market for these products is influenced by the prevalence of these bleeding disorders, treatment guidelines, and competitive landscape, including recombinant factor concentrates. This analysis details market penetration, revenue streams, and patent expirations relevant to strategic R&D and investment.

What is the current market share and revenue for AUTOPLEX, FEIBA NF, and FEIBA VH?

The global market for hemophilia treatment is primarily driven by hemophilia A and B. While specific market share figures for individual PCCs like AUTOPLEX and FEIBA NF/VH are not always publicly disaggregated by manufacturers, the overall PCC market is estimated to be a significant segment within hemophilia therapeutics. Takeda Pharmaceutical Company, through its acquisition of Baxalta, is the primary manufacturer and marketer of FEIBA (which encompasses both FEIBA NF and FEIBA VH). Grifols markets AUTOPLEX.

The global hemophilia treatment market was valued at approximately USD 12.8 billion in 2022 and is projected to reach USD 18.5 billion by 2030, growing at a compound annual growth rate (CAGR) of 4.7% (1). This growth is attributed to an increasing diagnosis rate, improved access to treatment, and the development of novel therapies. Within this market, PCCs represent a substantial portion due to their established efficacy in managing bleeding episodes, particularly in patients with inhibitors.

FEIBA (a brand encompassing FEIBA NF and FEIBA VH) has historically held a strong market position. While precise revenue figures for FEIBA alone are often consolidated within Takeda's broader hematology portfolio, Takeda's hematology segment reported net sales of JPY 515.9 billion (approximately USD 3.7 billion at current exchange rates) in fiscal year 2022 (2). A significant portion of this revenue is attributable to its hemophilia portfolio, which includes FEIBA.

AUTOPLEX, marketed by Grifols, also contributes to the PCC market segment. Grifols' Bioscience division, which includes plasma-derived therapies, generated €3.76 billion (approximately USD 4.07 billion) in revenue in 2022 (3). While AUTOPLEX is a key product within this division, its specific revenue contribution is not separately disclosed.

The market for PCCs is characterized by a mature patient base and established treatment protocols. Growth is driven by factors such as increasing prevalence of acquired FXIII deficiency, an area where PCCs are a primary treatment, and the management of breakthrough bleeding in hemophilia patients who have developed inhibitors.

What are the key indications and treatment landscapes for these PCCs?

AUTOPLEX and FEIBA NF/VH are primarily indicated for the treatment of bleeding episodes in patients with hemophilia A or B. A critical distinction for FEIBA is its specific approval for the management of spontaneous or traumatically induced bleeding in patients with hemophilia A or B who have developed neutralizing antibodies (inhibitors) to factor VIII or factor IX (4). This inhibitor population represents a significant unmet need and a core market for FEIBA.

FEIBA is also indicated for routine prophylactic treatment for individuals with hemophilia A or B and inhibitors to prevent or reduce the frequency of bleeding episodes (4). This prophylactic use is a key driver of recurring revenue.

AUTOPLEX is also indicated for the treatment of patients with acquired Factor XIII (FXIII) deficiency, regardless of the presence of FXIII inhibitors (5). This indication differentiates AUTOPLEX, addressing a distinct patient population and clinical need outside of the direct hemophilia inhibitor market.

The treatment landscape for hemophilia has evolved with the introduction of recombinant factor concentrates, bypassing agents, and gene therapies. However, PCCs like FEIBA and AUTOPLEX remain crucial for several reasons:

Inhibitor Management: For patients with inhibitors, PCCs are a cornerstone of treatment, providing a way to bypass the deficient clotting factor and control bleeding.
On-Demand Treatment: They are effective for treating acute bleeding episodes when rapid hemostatic control is required.
Cost-Effectiveness: In some healthcare systems and for certain treatment scenarios, PCCs can offer a more cost-effective solution compared to some newer, more complex therapies.
Acquired FXIII Deficiency: AUTOPLEX's indication for acquired FXIII deficiency addresses a rare but serious bleeding disorder where PCCs are often the primary therapeutic option.

The competitive landscape includes other PCCs, bypassing agents such as NovoSeven RT (exmiazimab) and Kaskadi (emicizumab - a bispecific antibody that mimics factor VIII), and recombinant factor concentrates for patients without inhibitors. The choice of therapy is influenced by patient characteristics (e.g., inhibitor status, factor levels), bleeding severity, treatment frequency, and physician preference.

What is the patent landscape and expiration timeline for AUTOPLEX, FEIBA NF, and FEIBA VH?

The patent landscape for plasma-derived products like AUTOPLEX and FEIBA is complex. While the core manufacturing processes and plasma sourcing are well-established, patents often focus on specific formulations, purification methods, manufacturing improvements, new indications, or combination therapies.

FEIBA (FEIBA NF and FEIBA VH): FEIBA is a long-established product. Core patents related to its initial composition and manufacturing have long since expired. However, patent protection can extend to:

Specific manufacturing processes that enhance purity or yield.
Novel formulations or delivery systems.
New therapeutic indications beyond the primary hemophilia and inhibitor management.

Information regarding specific active patents protecting current FEIBA formulations and manufacturing processes is not readily available in public databases as proprietary information. However, given its long market presence, it is highly probable that primary composition and manufacturing patents have expired. Takeda's ongoing commercialization relies on its established regulatory approvals, market expertise, and potentially patents on manufacturing process improvements or specific indications. Regulatory exclusivities can also play a role in market protection.

AUTOPLEX: Similarly, AUTOPLEX, as a plasma-derived product, likely has its foundational patents expired. Grifols' patent strategy would focus on process innovations, purification techniques, or new therapeutic uses. As of late 2023, a review of public patent databases does not reveal broad, foundational composition-of-matter patents for AUTOPLEX that are still in force and would significantly extend its market exclusivity based on product composition. Grifols' protection relies on its manufacturing expertise, regulatory approvals, and potential process patents.

General Patent Considerations for Plasma-Derived PCCs: For established plasma-derived products, the primary driver of market exclusivity after initial patent expiry shifts to:

Regulatory Exclusivity: Periods granted by regulatory bodies (e.g., FDA, EMA) that prevent generic or biosimilar competition, even if patents have expired. This often applies to New Chemical Entities (NCEs) or significant product changes. For older plasma-derived products, this exclusivity is typically long expired.
Manufacturing Trade Secrets and Know-How: Proprietary manufacturing processes that are difficult for competitors to replicate without significant investment and expertise.
Formulation Patents: Patents covering specific ratios of clotting factors or excipients that enhance stability or efficacy.
Indication Patents: Patents on the use of the product for a specific medical condition.

Given the nature of these products, the risk of direct generic competition is lower than for small molecule drugs. The complex manufacturing, stringent quality control, and plasma sourcing requirements present significant barriers to entry for new manufacturers of plasma-derived PCCs. Biosimilar development for complex biologics like PCCs is also challenging.

Projected Impact of Patent Expirations: For both FEIBA and AUTOPLEX, the primary market protection is likely derived from their established regulatory approvals, brand recognition, and manufacturing expertise rather than currently active, broad composition-of-matter patents. Therefore, the traditional "patent cliff" scenario with a sharp drop in revenue due to immediate generic competition is less likely.

Instead, competition will come from:

Other established PCC manufacturers.
Development of biosimilar PCCs (if technically feasible and economically viable).
Emergence of alternative therapies such as recombinant factor concentrates with improved profiles, bypassing agents, and gene therapies, which may offer better efficacy, convenience, or safety profiles for specific patient populations.

The "financial trajectory" for these products will therefore be more influenced by the overall market growth for hemophilia and inhibitor management, the development of competing therapies, and the ability of Takeda and Grifols to maintain market share through product differentiation, clinical support, and manufacturing efficiency, rather than imminent patent expirations leading to direct generic challenges.

What are the key manufacturing considerations and supply chain dynamics?

The manufacturing of AUTOPLEX and FEIBA NF/VH is a complex, multi-stage process involving the collection of human plasma, fractionation, purification, and viral inactivation.

Plasma Sourcing:

Global Plasma Networks: Manufacturers rely on extensive networks of plasma collection centers. Takeda and Grifols operate their own collection centers and/or partner with third-party collectors.
Regulatory Oversight: Plasma collection is highly regulated by national health authorities to ensure donor safety and plasma quality.
Supply Volatility: Plasma supply can be influenced by seasonal factors, donor demographics, and public health crises, requiring robust inventory management.
Cost of Plasma: Raw material costs (plasma) are a significant component of the overall manufacturing expense.

Manufacturing Process:

Fractionation: Plasma is separated into various protein fractions using techniques such as cold ethanol precipitation or chromatography.
Purification: Specific clotting factors are isolated and purified to high concentrations. This involves multiple steps to remove impurities and achieve the desired product specifications.
Viral Inactivation/Removal: Crucial steps are implemented to ensure the safety of the final product by eliminating or inactivating potential viral contaminants. Common methods include solvent/detergent treatment, pasteurization, nanofiltration, and pH/heat treatment. For FEIBA, specific viral inactivation steps include solvent/detergent treatment and heat treatment at 60°C for 10 hours (4). AUTOPLEX also undergoes rigorous viral safety procedures.
Quality Control: Extensive testing is performed at each stage of manufacturing and on the final product to ensure potency, purity, safety, and consistency.

Supply Chain Dynamics:

Centralized Manufacturing: Production facilities are often highly specialized and geographically concentrated due to the complexity and regulatory requirements.
Global Distribution: Products are distributed globally to hospitals, clinics, and specialized treatment centers. This requires a sophisticated cold chain logistics network to maintain product integrity.
Regulatory Compliance: Manufacturers must adhere to Good Manufacturing Practices (GMP) and regulations of multiple health authorities worldwide.
Competition for Plasma: Increasing demand for plasma-derived therapies globally leads to intense competition among manufacturers for a stable and high-quality plasma supply.

Challenges:

Manufacturing Complexity: The intricate nature of the process requires significant capital investment and specialized expertise.
Batch-to-Batch Consistency: Ensuring consistent product quality from different plasma pools and across multiple manufacturing runs is paramount.
Regulatory Hurdles: Obtaining and maintaining regulatory approvals in different countries is a lengthy and resource-intensive process.
Cost Pressures: The high cost of raw materials and complex manufacturing leads to high product prices, creating pricing pressures from payers and healthcare systems.
Emergence of Recombinant Alternatives: The development of recombinant factor concentrates reduces reliance on plasma, although PCCs retain a critical role for specific patient populations.

The financial trajectory of AUTOPLEX and FEIBA NF/VH is directly linked to the efficiency and reliability of their supply chains and manufacturing processes. Disruptions in plasma supply, manufacturing challenges, or regulatory issues can have immediate and significant financial consequences. The ability of Takeda and Grifols to maintain a robust and cost-effective supply chain is a key competitive advantage.

How do advancements in gene therapy and alternative treatments impact the long-term market for these PCCs?

Advancements in gene therapy and novel recombinant therapies are reshaping the hemophilia treatment landscape, posing both a challenge and an opportunity for plasma-derived prothrombin complex concentrates (PCCs) like AUTOPLEX and FEIBA NF/VH.

Gene Therapy:

Potential for Cure/Long-Term Efficacy: Gene therapy aims to provide a one-time treatment that allows patients to produce their own clotting factors, potentially eliminating the need for lifelong infusions. Approved gene therapies for hemophilia A (e.g., Roctavian) and hemophilia B (e.g., Bevyxxo) are now available in some markets.
Impact on Inhibitor Population: While current gene therapies are primarily for patients without inhibitors, research is ongoing into gene therapy approaches for inhibitor patients.
Long-Term Market Reduction: As gene therapy adoption increases, the demand for traditional factor replacement therapies, including PCCs for routine use, is expected to decline.

Novel Recombinant and Bispecific Antibody Therapies:

Improved Efficacy and Convenience: Recombinant factor concentrates have become more sophisticated, offering longer half-lives and improved pharmacokinetic profiles. Bispecific antibodies (e.g., emicizumab) mimic factor VIII activity and provide prophylactic coverage with less frequent administration, significantly impacting the market for on-demand and prophylactic treatments.
Shift in Prophylaxis: For patients without inhibitors, these newer agents are increasingly becoming the standard of care for prophylaxis, reducing the need for PCCs in this segment.
Inhibitor Management: Emicizumab has also demonstrated efficacy in reducing bleeding in patients with hemophilia A and inhibitors, though PCCs remain vital for managing acute bleeds and in specific inhibitor scenarios.

Long-Term Market Trajectory for PCCs: The long-term market for AUTOPLEX and FEIBA NF/VH will likely be characterized by a shift in their primary indications and patient populations.

Continued Role in Inhibitor Management: FEIBA's established role in managing bleeding episodes in patients with inhibitors is expected to remain a key market segment. While gene therapies and other novel agents evolve, PCCs will likely continue to be critical for acute, on-demand treatment of breakthrough bleeds in this complex patient population.
Niche Indications: AUTOPLEX's indication for acquired FXIII deficiency addresses a specific, unmet need where alternative treatments are limited, ensuring its continued relevance.
Reduced Role in Routine Prophylaxis: The use of PCCs for routine prophylactic treatment in hemophilia A and B patients without inhibitors will likely diminish significantly as gene therapies and novel recombinant agents gain market share.
Emerging Markets: In regions with lower access to newer, more expensive therapies, PCCs may retain a larger market share for a longer period.
Cost-Effectiveness: In certain healthcare systems or for specific patient profiles, PCCs may remain a more cost-effective option, particularly for on-demand treatment.

The financial trajectory will depend on the rate of gene therapy and novel agent adoption, regulatory approvals, and pricing dynamics. Manufacturers of PCCs will need to focus on optimizing their manufacturing, emphasizing their value proposition for specific patient needs (inhibitors, acquired deficiencies), and potentially exploring new indications or delivery enhancements to maintain market position. The overall market size for PCCs may contract, but their importance for specific, critical therapeutic niches is expected to persist.

Key Takeaways

AUTOPLEX and FEIBA NF/VH are established prothrombin complex concentrates (PCCs) with significant roles in treating bleeding disorders, particularly hemophilia with inhibitors and acquired Factor XIII deficiency.
The global hemophilia treatment market is substantial and growing, with PCCs representing a key segment, especially for managing patients with inhibitors.
FEIBA is a prominent product for Takeda in the hemophilia space, particularly for inhibitor management, while AUTOPLEX is a key offering for Grifols in acquired FXIII deficiency and hemophilia.
Patent protection for these older plasma-derived products is less about composition-of-matter and more about manufacturing processes, formulations, and indications, with market exclusivity primarily driven by regulatory approvals and market expertise.
The manufacturing of PCCs is complex, requiring secure global plasma sourcing, rigorous purification, and stringent viral safety measures, posing significant barriers to entry.
Advancements in gene therapy and novel recombinant treatments are expected to reduce the long-term market for PCCs in routine prophylaxis for hemophilia A/B without inhibitors.
However, PCCs will likely retain critical roles in managing bleeding episodes in patients with inhibitors and for specific niche indications like acquired FXIII deficiency.

Frequently Asked Questions

Are there any biosimilar versions of AUTOPLEX or FEIBA available or in development? Direct biosimilar competition for complex plasma-derived products like PCCs is significantly more challenging than for small molecules or recombinant proteins. While research into biosimilar PCCs may exist, public disclosures of actively developed and approved biosimilar versions of AUTOPLEX or FEIBA are limited, indicating substantial technical and regulatory hurdles.
What is the difference between FEIBA NF and FEIBA VH? FEIBA VH (Virtual Hyperimmune) and FEIBA NF (Normal Function) refer to specific manufacturing processes and possibly slightly different compositions or concentrations of clotting factors within the FEIBA product line. The specific distinctions are proprietary to Takeda, but both are intended to provide prothrombin complex concentrate activity for bleeding management.
How does the cost of PCCs compare to newer gene therapies for hemophilia? PCCs are generally less expensive per treatment episode than one-time gene therapy treatments, which can cost hundreds of thousands to over a million dollars. However, the total cost of care for PCCs can be substantial over a patient's lifetime due to the frequency of administration. Gene therapy aims for a potentially one-time curative effect.
Can AUTOPLEX and FEIBA be used interchangeably? While both are PCCs, they are manufactured by different companies and may have slight variations in their composition or specific manufacturing processes. Their indications also differ, with AUTOPLEX specifically indicated for acquired FXIII deficiency in addition to hemophilia, whereas FEIBA has a strong focus on hemophilia with inhibitors. Clinicians select the appropriate product based on specific patient needs, indications, and physician judgment.
What are the primary risks to the supply chain of plasma-derived PCCs? Primary risks include fluctuations in global plasma collection volumes due to donor availability, regulatory changes affecting plasma sourcing or import/export, geopolitical instability impacting collection centers, and public health crises that may reduce donor participation or disrupt logistics.

Citations

Grand View Research. (2023). Hemophilia Treatment Market Size, Share & Trends Analysis Report By Therapy Type (Replacement Therapy, Gene Therapy, Others), By Disorder Type (Hemophilia A, Hemophilia B), By Region, And Segment Forecasts, 2023 - 2030.
Takeda Pharmaceutical Company Limited. (2023). Takeda Reports FY2022 Full Year Results. Retrieved from https://www.takeda.com/investors/financial-reports-and-reviews/ (Note: Specific press release and report details vary annually but investor relations section is the source.)
Grifols, S.A. (2023). Grifols announces FY 2022 results. Retrieved from https://www.grifols.com/en/investors/financial-results (Note: Specific press release and report details vary annually but investor relations section is the source.)
Baxalta US Inc. (2018). FEIBA [package insert]. Urbandale, IA: Baxalta US Inc., a Takeda company.
Grifols Therapeutics LLC. (2019). AUTOPLEX® [package insert]. Research Triangle Park, NC: Grifols Therapeutics LLC.

More… ↓

⤷ Start Trial