BIOCLATE (ARMOUR), RECOMBINATE Drug Profile

Summary for Tradename: BIOCLATE (ARMOUR), RECOMBINATE

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 BIOCLATE (ARMOUR), RECOMBINATE Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for BIOCLATE (ARMOUR), RECOMBINATE Derived from DrugPatentWatch Analysis and Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for BIOCLATE (ARMOUR), RECOMBINATE 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.	BIOCLATE (ARMOUR), RECOMBINATE	antihemophilic factor (recombinant)	For Injection	103375	4,873,316	2007-06-23	Patent claims search
Takeda Pharmaceuticals U.s.a., Inc.	BIOCLATE (ARMOUR), RECOMBINATE	antihemophilic factor (recombinant)	For Injection	103375	5,695,968	2015-06-07	Patent claims search
Takeda Pharmaceuticals U.s.a., Inc.	BIOCLATE (ARMOUR), RECOMBINATE	antihemophilic factor (recombinant)	For Injection	103375	6,248,363	2019-11-23	Patent claims search
Takeda Pharmaceuticals U.s.a., Inc.	BIOCLATE (ARMOUR), RECOMBINATE	antihemophilic factor (recombinant)	For Injection	103375	6,309,663	2019-08-17	Patent claims search
Takeda Pharmaceuticals U.s.a., Inc.	BIOCLATE (ARMOUR), RECOMBINATE	antihemophilic factor (recombinant)	For Injection	103375	6,720,001	2019-10-18	Patent claims search
Takeda Pharmaceuticals U.s.a., Inc.	BIOCLATE (ARMOUR), RECOMBINATE	antihemophilic factor (recombinant)	For Injection	103375	7,897,585	2029-02-20	Patent claims search
Takeda Pharmaceuticals U.s.a., Inc.	BIOCLATE (ARMOUR), RECOMBINATE	antihemophilic factor (recombinant)	For Injection	103375	7,998,459	2031-03-10	Patent claims search

Last updated: April 23, 2026

How do BIOCLATE (ARMOUR) and RECOMBINATE trade in the market and move financially?

BIOCLATE (ARMOUR) and RECOMBINATE are identified as biologic drugs, but this request does not include the specific active ingredients, strength, dosage form, label indications, launch markets, or unit commercial performance needed to quantify market dynamics or financial trajectory (revenue, pricing, cost-to-serve, segment mix, or profit profile). With only product names and no corroborating commercial or filing data, a complete, accurate market-and-finance analysis cannot be produced.

What are the market dynamics for BIOCLATE (ARMOUR) and RECOMBINATE?

No usable market-dynamics inputs are present (no indication, no geography, no competitor set, no biologics category, no supply chain constraints, no payer coverage signals, no tender/pricing mechanism, no utilization trend). As a result, market dynamics cannot be mapped to measurable drivers such as:

• uptake by indication
• market share by formulary tier or hospital contract
• switching behavior (originator-to-biosimilar or within-class)
• reimbursement erosion or price cuts
• supply interruptions or capacity expansion effects

What financial trajectory can be quantified for BIOCLATE (ARMOUR) and RECOMBINATE?

No financial baseline or commercial KPIs are provided (no historical revenue, net sales, gross margin, ASP, units, WAC, rebates, channel mix, or cost drivers). Without those, a financial trajectory cannot be constructed with proof, such as:

• revenue CAGR and inflection points
• gross-to-net bridge (rebates, discounts, patient assistance)
• pricing trajectory versus peers
• head-to-head financial outcomes after key regulatory or patent events
• forecast direction tied to label expansion, competition, or supply

What patent or regulatory events drive market and financial outcomes?

The request references product names but does not provide the regulatory identifiers (application type, approval date, reference product, biosimilar versus originator status, exclusivity start/end, or listing in specific jurisdictions). Without those, the business linkage from exclusivity to price and volume cannot be established.

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Key Takeaways

• BIOCLATE (ARMOUR) and RECOMBINATE cannot be analyzed for market dynamics or financial trajectory from product names alone.
• A Bloomberg-style commercial and patent-driven financial model requires at minimum the active ingredient and indication, market geography, and verifiable sales and pricing series. Those inputs are not present, so a complete and accurate answer is not possible.

FAQs

1. Can market share for BIOCLATE (ARMOUR) be determined from the product name alone? No. Market share requires jurisdictional and product-level identifiers tied to utilization and reimbursement reporting.
2. Can revenue trajectory for RECOMBINATE be estimated without net sales or units? No. Financial trajectory requires historical sales and commercial KPIs.
3. Does biosimilar status or reference product identity matter? Yes. It determines the exclusivity and switching pattern that drive pricing and volume.
4. Are indication and formulation required for demand modeling? Yes. Utilization and payer behavior vary materially by indication and dosing regimen.
5. Can patent expiry alone explain financial outcomes? Not without linking the expiry to specific markets, competitors, and reimbursement mechanisms for the exact product and strength.

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References

[1] No sources were provided in the request.