AUTOPLEX, FEIBA NF, FEIBA VH Drug Profile

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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:

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 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

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		2038-01-17	Patent claims search
Takeda Pharmaceuticals U.s.a., Inc.	AUTOPLEX, FEIBA NF, FEIBA VH	anti-inhibitor coagulant complex	For Injection	101447		2039-03-20	Patent claims search
Takeda Pharmaceuticals U.s.a., Inc.	AUTOPLEX, FEIBA NF, FEIBA VH	anti-inhibitor coagulant complex	For Injection	101447		1997-08-08	Patent claims search

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

Last updated: September 7, 2026

AUTOPLEX, FEIBA NF and FEIBA VH are plasma-derived activated prothrombin complex concentrates used to control bleeding in patients with hemophilia A or B who develop inhibitors to replacement factor VIII or IX. FEIBA, marketed by Takeda after its acquisition of Shire, is the commercially relevant product. AUTOPLEX is a legacy Baxter product that is no longer a meaningful current competitor.

FEIBA’s financial trajectory is shaped by a shrinking inhibitor population, increasing use of emicizumab and other nonfactor therapies, limited direct competition in the activated prothrombin complex concentrate segment, and manufacturing barriers associated with plasma-derived products. Takeda does not report FEIBA revenue as a separate public line item, so product-specific sales, margins and year-over-year growth cannot be verified from company filings.

What are AUTOPLEX, FEIBA NF and FEIBA VH?

AUTOPLEX and FEIBA are bypassing agents. They are used when infused factor VIII or IX cannot adequately restore coagulation because neutralizing antibodies, known as inhibitors, block the replacement factor.

Product	Product type	Principal manufacturer or owner	Current commercial position
AUTOPLEX	Activated prothrombin complex concentrate	Baxter	Legacy product; no material current-market position
FEIBA VH	Vapor-heated activated prothrombin complex concentrate	Baxter, later Shire and Takeda	Earlier FEIBA formulation
FEIBA NF	Nanofiltered, vapor-heated activated prothrombin complex concentrate	Takeda	Principal current FEIBA formulation

FEIBA NF contains a mixture of human coagulation factors, including nonactivated factors II, IX and X and activated factor VII. Its mechanism does not depend on replacing the factor blocked by the inhibitor. The FDA label identifies FEIBA for control and prevention of bleeding episodes, perioperative management and routine prophylaxis in patients with hemophilia A or B with inhibitors.[1]

FEIBA is administered intravenously and is dosed in units of factor VIII inhibitor bypassing activity. The product is not interchangeable with recombinant factor VIIa products such as NovoSeven RT.

What is the FDA regulatory status of FEIBA?

FEIBA is an FDA-licensed plasma-derived biologic. Its regulatory status is based on a biologics license application rather than a conventional small-molecule new drug application.

The product’s main regulatory characteristics are:

Regulatory issue	FEIBA position
FDA pathway	Biologics license
Active ingredient	Human plasma-derived factor VIII inhibitor bypassing activity
Dosage form	Intravenous infusion
Primary indication	Hemophilia A or B with inhibitors
Other use	Acquired hemophilia and selected inhibitor-related bleeding settings, depending on labeling and jurisdiction
Interchangeable biosimilar	None identified
Generic substitution	Not applicable
FDA exclusivity	Historical biologic exclusivity has expired
Current competitive barrier	Manufacturing, plasma supply, quality controls and clinical familiarity

The FDA label carries a boxed warning for thromboembolic complications, including disseminated intravascular coagulation, myocardial infarction, venous thrombosis and pulmonary embolism. The risk is particularly relevant when FEIBA is used with emicizumab or at high cumulative doses.[1]

What patents protect FEIBA?

FEIBA’s principal commercial protection does not depend on an active patent monopoly. Its economic protection is based more heavily on manufacturing know-how, plasma sourcing, regulatory history and quality systems.

The key intellectual-property categories are:

1. Composition and activity specifications for the bypassing complex.
2. Plasma fractionation and purification methods.
3. Viral inactivation and nanofiltration.
4. Stabilization and formulation methods.
5. Container, vial and infusion-system technologies.
6. Manufacturing controls and release testing.

The original product and core manufacturing patents are old. A biologic marketed for decades would not retain the 12-year U.S. reference-product exclusivity period established by the Biologics Price Competition and Innovation Act. FEIBA therefore has no material remaining U.S. regulatory exclusivity based on product age alone.[2]

The remaining barrier is operational rather than purely legal. A competing manufacturer would need access to qualified plasma, validated fractionation and purification processes, viral-clearance controls, nanofiltration capability, a consistent potency assay and extensive FDA manufacturing documentation.

Does FEIBA have Orange Book listings?

No conventional Orange Book patent position should be expected for FEIBA. The Orange Book is primarily used for approved drug products subject to abbreviated new drug application procedures. Biologics are generally evaluated through the Purple Book and the biologics-license framework rather than through Orange Book patent certification.

A conventional Paragraph IV generic challenge is therefore not the expected route for FEIBA. A competitor would more likely pursue a separate biologics license, a biosimilar application under section 351(k), or a full biologics pathway under section 351(a).

When does FEIBA lose exclusivity?

FEIBA’s original exclusivity has already expired in practical terms. It has been marketed for decades, and the applicable U.S. biologic exclusivity period is not the product’s current commercial constraint.

The relevant dates are best understood as a commercial timeline rather than a single patent-expiration event:

Period	Market event	Commercial effect
1970s-1980s	Early FEIBA commercialization and regulatory development	Established bypassing-agent category
1990s-2000s	Viral inactivation and manufacturing upgrades	Improved product reliability and supported continued use
2000s	FEIBA VH and later FEIBA NF evolution	Strengthened quality and process profile
2010s	Wider use of prophylaxis and introduction of emicizumab	Reduced dependence on bypassing agents in some patients
2019	Takeda acquired Shire	FEIBA became part of Takeda’s hematology portfolio
2020s	Expansion of nonfactor therapies and hemophilia gene therapy	Increased long-term pressure on bypassing-agent demand

The absence of active exclusivity does not mean immediate generic erosion. The product’s complexity and small patient population reduce the commercial incentive for a conventional biosimilar entrant.

Are there Paragraph IV challenges to FEIBA?

There is no standard Paragraph IV challenge framework for FEIBA comparable to a small-molecule product listed in the Orange Book. FEIBA is a biologic, and an abbreviated generic application would not be the normal regulatory pathway.

Potential competitive filings would more likely involve:

• A biosimilar application under section 351(k).
• A full biologics license application under section 351(a).
• A competing plasma-derived product with a different proprietary process.
• A recombinant bypassing agent or nonfactor therapy that displaces use clinically.

No established U.S. biosimilar competitor to FEIBA has materially altered the market. The practical litigation risk is therefore more likely to arise from manufacturing patents, trade secrets, process know-how or regulatory disputes than from a classic Paragraph IV patent case.

How strong is the FEIBA patent estate?

FEIBA has a mature but commercially defensible patent and manufacturing estate.

Protection category	Estimated strength	Reason
Core composition patents	Low	Product has a long commercial history
Formulation patents	Low to moderate	Older formulation claims are likely expired; newer packaging or stabilization claims may remain relevant
Method-of-use patents	Low	Clinical use is established and difficult to monopolize broadly
Manufacturing patents	Moderate	Process improvements, purification and filtration can create narrower barriers
Trade secrets	High	Process parameters, yield optimization and release testing are difficult to replicate
Regulatory history	High	Long-term quality and safety record supports physician and payer acceptance
Plasma supply	High	Qualified human plasma is a structural supply constraint
Biosimilar entry barrier	Moderate to high	Complex mixture and assay comparability increase development cost

The strongest practical protection is not a single patent claim. It is the combination of plasma access, validated manufacturing, quality-control systems and the cost of generating a commercially reliable competing product.

What formulations are protected by FEIBA?

FEIBA’s commercially relevant formulation history includes vapor-heated and nanofiltered versions.

FEIBA VH used vapor heating as a viral-reduction measure. FEIBA NF added nanofiltration and became the more advanced formulation in the FEIBA product line. These changes are important from a regulatory and manufacturing perspective because they affect viral clearance, impurity control, product consistency and process validation.

Formulation-related protection may cover:

• Protein stabilization during storage.
• Lyophilized powder characteristics.
• Reconstitution performance.
• Nanofiltration conditions.
• Viral inactivation parameters.
• Container closure and shelf-life controls.

Publicly available information does not support assigning a currently enforceable, commercially decisive formulation patent to FEIBA without a current patent-family review by jurisdiction. The product’s market position should therefore be assessed as process-protected rather than patent-monopoly protected.

What is the competitive landscape for FEIBA?

FEIBA competes in a narrow but clinically important market.

Competitor	Category	Competitive relationship
NovoSeven RT	Recombinant activated factor VII	Principal direct bypassing-agent competitor
Emicizumab	Bispecific nonfactor therapy	Reduces bleed frequency and bypassing-agent use in hemophilia A
Recombinant factor VIII	Replacement therapy	Used when inhibitors are absent or overcome
Immune tolerance induction	Antibody-eradication strategy	Can reduce long-term inhibitor dependence
Concizumab and other anti-TFPI therapies	Nonfactor therapy	Potential future substitution pressure
Hemophilia gene therapy	One-time or durable factor-expression strategy	Long-term reduction in replacement and bypassing-agent demand

FEIBA has an advantage in patients requiring a plasma-derived bypassing agent, particularly where clinicians have experience with its dosing and response profile. NovoSeven RT provides an alternative mechanism and avoids some concerns associated with activated prothrombin complex concentrates, but it also carries thrombotic risk and may have a higher treatment cost in certain settings.

Emicizumab has the greatest structural impact on FEIBA demand. In patients receiving emicizumab, FEIBA use is restricted by safety concerns and prescribing guidance. NovoSeven RT is generally preferred over FEIBA for breakthrough bleeding in patients treated with emicizumab.[1]

What is the financial trajectory for FEIBA?

FEIBA likely remains a high-value specialty product, but its long-term growth profile is mature to declining rather than expansionary.

Takeda reports broad business-area and product-portfolio results, but public filings do not consistently provide a standalone FEIBA revenue series. That prevents a verified product-level calculation of revenue growth, gross margin or market share.

The financial trajectory can be characterized as follows:

Historical growth

FEIBA benefited from:

• A limited number of approved bypassing agents.
• High treatment intensity in inhibitor patients.
• Use in acute bleeding and surgery.
• Premium pricing for plasma-derived specialty biologics.
• Strong physician familiarity.

Mature-market period

The product moved into a mature-market phase as:

• Hemophilia inhibitor incidence declined in developed markets.
• Immune tolerance reduced some chronic inhibitor populations.
• Emicizumab changed routine prophylaxis.
• Competing nonfactor therapies expanded.
• Payers increased scrutiny of high-cost episodic treatment.

Downward structural pressure

FEIBA faces demand erosion from:

1. Lower use in patients controlled with emicizumab.
2. Reduced inhibitor burden through immune tolerance.
3. Hemophilia gene therapy and longer-acting treatments.
4. Hospital and payer protocols favoring alternative bypassing agents in selected patients.
5. Potential manufacturing interruptions associated with plasma-derived production.

Offsetting factors

Demand remains supported by:

• Existing patients with inhibitors.
• Breakthrough bleeding and surgical management.
• Patients unable to use or respond adequately to nonfactor therapies.
• Markets with slower adoption of gene therapy or emicizumab.
• The absence of a low-cost generic substitute.

FEIBA is therefore likely to produce durable cash flow but limited volume growth. Pricing and mix can partially offset declining unit demand, although reimbursement pressure limits the ability to raise prices indefinitely.

What revenue exposure does FEIBA create for Takeda?

FEIBA is part of Takeda’s hematology and rare-disease portfolio. Its financial importance is smaller than Takeda’s largest gastrointestinal, immunology and oncology products, but it has strategic value because it serves a specialized patient population and uses an established manufacturing platform.

The main financial exposures are:

Exposure	Effect on FEIBA
Plasma procurement	Can increase cost and constrain production
Manufacturing yield	Direct effect on gross margin
Product quality events	Can cause supply interruption and regulatory expense
Emicizumab adoption	Reduces use in hemophilia A with inhibitors
NovoSeven competition	Pressures market share in acute treatment
Gene therapy	Long-term reduction in treated population
Pricing controls	Limits net-price expansion
Geographic mix	Emerging markets may offset slower developed-market demand

Because Takeda does not separately disclose FEIBA revenue in a consistently detailed public line item, investors should use the company’s hematology revenue, plasma-derived therapies commentary and supply disclosures as the main public indicators rather than treating any third-party estimate as audited product revenue.

What generic launch risks exist for FEIBA?

The risk of an immediate conventional generic launch is low. The risk of gradual therapeutic substitution is higher.

Conventional generic risk

Low. FEIBA is a complex biologic mixture and is not a typical small-molecule product eligible for routine ANDA substitution.

Biosimilar risk

Moderate over the long term but low in the near term. Demonstrating analytical and clinical comparability for a plasma-derived activated complex is more difficult than for a structurally defined monoclonal antibody. A biosimilar applicant would need robust potency, impurity, viral-safety and consistency data.

Therapeutic substitution risk

High. Emicizumab, recombinant factor VIIa, immune tolerance and emerging nonfactor treatments can displace FEIBA without directly copying the product.

Manufacturing competition

Moderate. A well-capitalized plasma-products manufacturer could develop a competing bypassing complex, but the small addressable market and high validation cost limit the incentive.

What patent litigation and settlement agreements affect FEIBA?

No major current U.S. patent litigation or Paragraph IV settlement appears to define FEIBA’s commercial position. The product’s principal risks are regulatory, manufacturing and therapeutic rather than litigation-driven.

Potential disputes could involve:

• Plasma-derived factor-complex manufacturing.
• Nanofiltration and viral-clearance technology.
• Product quality or contamination allegations.
• Trade-secret misappropriation.
• Distribution and supply agreements.
• Hospital purchasing and reimbursement contracts.

The absence of a prominent current patent case is consistent with FEIBA’s age and its complex biologic status.

How does FEIBA compare with NovoSeven RT?

Issue	FEIBA NF	NovoSeven RT
Molecular category	Plasma-derived activated prothrombin complex	Recombinant activated factor VII
Manufacturer	Takeda	Novo Nordisk
Main use	Hemophilia A or B with inhibitors	Hemophilia A or B with inhibitors and other bleeding disorders
Plasma exposure	Yes	No human plasma-derived active ingredient
Use with emicizumab	Generally restricted because of thrombotic risk	Commonly preferred bypassing option
Manufacturing barrier	Plasma supply and fractionation	Recombinant production and cell-culture process
Patent position	Mature legacy estate	Product and process estate also mature, with possible formulation and manufacturing protections
Main market risk	Nonfactor substitution and plasma constraints	Pricing pressure and nonfactor substitution

FEIBA remains relevant where its mechanism, physician experience and availability fit the clinical situation. NovoSeven RT has a stronger position in patients receiving emicizumab.

Key Takeaways

• FEIBA NF is the commercially relevant successor to FEIBA VH; AUTOPLEX is a legacy product.
• FEIBA has no meaningful remaining original regulatory exclusivity and is not a conventional Orange Book product.
• A Paragraph IV generic challenge is not the expected competitive route.
• The strongest protection is manufacturing know-how, plasma access, quality systems and regulatory history.
• FEIBA revenue is not separately disclosed by Takeda in a consistently auditable public series.
• The product likely generates durable specialty-biologic cash flow, but its long-term volume trajectory is pressured.
• Emicizumab is the most important near-term demand risk in hemophilia A with inhibitors.
• Biosimilar risk is lower than therapeutic substitution risk.
• NovoSeven RT remains the principal direct bypassing-agent competitor.
• No major current patent litigation or settlement appears to control FEIBA’s market position.

FAQs

Is AUTOPLEX still available in the United States?

AUTOPLEX is a legacy activated prothrombin complex concentrate and does not have the commercial relevance of current FEIBA products. Availability should not be assumed from historical FDA references.

Is FEIBA a biosimilar?

No. FEIBA is an established plasma-derived biologic. No interchangeable or FDA-approved biosimilar has materially entered the U.S. market.

Can FEIBA be used with Hemlibra?

FEIBA use with emicizumab is restricted because combined exposure can increase thrombotic microangiopathy and thrombotic events. Treatment decisions must follow the current FDA label and specialist protocols.[1]

Does FEIBA have a patent expiration date?

There is no single current patent expiration date that defines FEIBA’s market exclusivity. The original product and core technology are mature, while process and formulation rights may have had different jurisdiction-specific terms.

Is FEIBA more expensive than NovoSeven RT?

Cost depends on dose, bleed severity, treatment duration, payer contracting and patient weight. Both are high-cost bypassing agents, and direct comparisons require a defined clinical episode and dosing protocol.

References

1. U.S. Food and Drug Administration. (2023). FEIBA NF: Anti-Inhibitor Coagulant Complex prescribing information. FDA.

2. U.S. Food and Drug Administration. (2020). Purple Book: Database of licensed biological products. FDA.

3. Takeda Pharmaceutical Company Limited. (2024). Annual report 2024. Takeda.

4. World Federation of Hemophilia. (2020). Guidelines for the management of hemophilia (3rd ed.). WFH.

5. U.S. Food and Drug Administration. (2024). Biologics Price Competition and Innovation Act. FDA.