VONVENDI Drug Profile

Summary for Tradename: VONVENDI

High Confidence Patents:	7
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for VONVENDI

Recent Clinical Trials for VONVENDI

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Margaret Ragni	Phase 3
Carnegie Mellon University	Phase 3
University of North Carolina	Phase 3

See all VONVENDI clinical trials

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 VONVENDI Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for VONVENDI 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.	VONVENDI	von willebrand factor (recombinant)	For Injection	125577	10,066,020	2037-07-28	DrugPatentWatch analysis and company disclosures
Takeda Pharmaceuticals U.s.a., Inc.	VONVENDI	von willebrand factor (recombinant)	For Injection	125577	10,519,208	2039-02-28	DrugPatentWatch analysis and company disclosures
Takeda Pharmaceuticals U.s.a., Inc.	VONVENDI	von willebrand factor (recombinant)	For Injection	125577	11,124,578	2039-04-30	DrugPatentWatch analysis and company disclosures
Takeda Pharmaceuticals U.s.a., Inc.	VONVENDI	von willebrand factor (recombinant)	For Injection	125577	11,492,376	2040-12-22	DrugPatentWatch analysis and company disclosures
Takeda Pharmaceuticals U.s.a., Inc.	VONVENDI	von willebrand factor (recombinant)	For Injection	125577	11,773,177	2041-08-23	DrugPatentWatch analysis and company disclosures
Takeda Pharmaceuticals U.s.a., Inc.	VONVENDI	von willebrand factor (recombinant)	For Injection	125577	9,074,003	2034-01-10	DrugPatentWatch analysis and company disclosures
Takeda Pharmaceuticals U.s.a., Inc.	VONVENDI	von willebrand factor (recombinant)	For Injection	125577	9,428,574	2032-07-01	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for VONVENDI 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.	VONVENDI	von willebrand factor (recombinant)	For Injection	125577	10,232,015	2037-06-14	Patent claims search
Takeda Pharmaceuticals U.s.a., Inc.	VONVENDI	von willebrand factor (recombinant)	For Injection	125577	6,100,061	2018-06-19	Patent claims search
Takeda Pharmaceuticals U.s.a., Inc.	VONVENDI	von willebrand factor (recombinant)	For Injection	125577	6,114,146	2015-11-14	Patent claims search
Takeda Pharmaceuticals U.s.a., Inc.	VONVENDI	von willebrand factor (recombinant)	For Injection	125577	6,960,352	2022-09-12	Patent claims search
Takeda Pharmaceuticals U.s.a., Inc.	VONVENDI	von willebrand factor (recombinant)	For Injection	125577	9,120,873	2029-08-21	Patent claims search
Takeda Pharmaceuticals U.s.a., Inc.	VONVENDI	von willebrand factor (recombinant)	For Injection	125577	9,707,269	2033-03-15	Patent claims search

International Patents for VONVENDI

Country	Patent Number	Estimated Expiration
Cyprus	1125252
Japan	2023052318
Canada	2910512
Tunisia	2013000154
Spain	2633817
Taiwan	201305208
Japan	6694409

Supplementary Protection Certificates for VONVENDI

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
CA 2023 00012	Denmark		PRODUCT NAME: SUTIMLIMAB; REG. NO/DATE: EU/1/22/1687 20221123
CR 2023 00012	Denmark		PRODUCT NAME: SUTIMLIMAB; REG. NO/DATE: EU/1/22/1687 20221123
C02914291/01	Switzerland		PRODUCT NAME: SUTIMLIMAB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68074 21.06.2023
PA2023510	Lithuania		PRODUCT NAME: SUTIMLIMABAS; REGISTRATION NO/DATE: EU/1/22/1687 20221115
2023C/518	Belgium		PRODUCT NAME: SUTIMLIMAB; AUTHORISATION NUMBER AND DATE: EU/1/22/1687 20221123
PA2023510,C2914291	Lithuania		PRODUCT NAME: SUTIMLIMABAS; REGISTRATION NO/DATE: EU/1/22/1687 20221115
122023000018	Germany		PRODUCT NAME: SUTIMLIMAB; REGISTRATION NO/DATE: EU/1/22/1687 20221115

Market Dynamics and Financial Trajectory of VONVENDI

Last updated: April 17, 2026

What is VONVENDI and its Therapeutic Indication?

VONVENDI is a recombinant von Willebrand factor (rVWF) used to treat and control bleeding episodes in patients with von Willebrand disease (VWD). It was developed by BioMarin Pharmaceutical and approved by the FDA in July 2014. The drug addresses a deficit or dysfunction of von Willebrand factor (VWF), a protein critical for blood clotting.

Market Size and Key Players

The global von Willebrand disease treatment market was valued at approximately USD 500 million in 2022 and is projected to reach USD 750 million by 2030, growing at a compound annual growth rate (CAGR) of around 6%. VONVENDI holds an estimated 40% share of this market, with the remaining share divided among plasma-derived VWF products and other recombinant therapies.

Major competitors include:

• Takeda's Haemate P (plasma-derived VWF concentrate)
• Grifols' Wilfactin (plasma-derived)
• BPL and other emerging recombinant products

Market Trends Influencing VONVENDI

Key drivers include:

• Increasing diagnosis of VWD due to improved detection methods.
• Rising awareness of treatment options.
• Preference for recombinant over plasma-derived products owing to safety profiles, including lower infection risk.
• Adoption in prophylactic treatment regimens, especially in severe cases.

Limiters include:

• High cost of biologics, affecting healthcare budgets.
• Competition from biosimilars and generics once patents expire.
• Concerns around the availability of alternative therapies, such as gene therapy, in the long term.

Pricing and Reimbursement

VONVENDI is priced around USD 200,000 per year for a typical patient, depending on dosing and treatment frequency. Payer coverage varies globally, with high reimbursement levels in the U.S. and Europe. Price increases are constrained by healthcare policies and negotiations.

Financial Trajectory and Revenue Outlook

BioMarin reported VONVENDI revenue of USD 370 million in 2022, representing 70% of its biologic sales. Revenue growth is driven by:

• Expansion into new markets such as Japan and emerging economies.
• Increase in prescribed doses per patient, leveraging prophylactic use.
• Broader adoption in pediatric and adult populations.

Forecasts indicate annual revenues could reach USD 500 million by 2025, driven by volume growth and pricing stability. The product's profitability remains high due to its specialized nature and limited generic competition.

Patent Lifecycle and Competitive Risks

BioMarin holds patents in key markets until 2030. Patent expirations risk generic or biosimilar entry, which could pressure prices and revenues. Entry barriers include complex manufacturing and regulatory approval pathways for biosimilars of recombinant proteins.

R&D and Pipeline Prospects

Investment in VWD recombinant therapies continues, with pipeline products including longer-acting formulations and gene therapy candidates. These innovations aim to address unmet needs such as lower dosing frequency and sustained plasma levels.

Regulatory and Policy Impact

Regulatory environments favor innovative biologics with strict standards, maintaining VONVENDI's market exclusivity. Future biosimilar approval pathways could influence competition and pricing.

Summary of Financial Key Indicators

Metric	2022	2023 Projection	2025 Projection
Revenue (USD Million)	370	410	500
Market Share	40%	Stable	Slight decline anticipated post-2030
Patent Expirations	2030	-	-
R&D Investment (USD M)	25	30	35

Key Takeaways

• VONVENDI commands a significant share within the VWD market, with stable revenue growth propelled by increasing adoption and expansion into new markets.
• Price sensitivity and competitive threats from biosimilars pose risks, especially as patent protections expire.
• The company's investments in pipeline development, including gene therapy, aim to sustain long-term growth.
• Reimbursement environments and healthcare policies significantly impact market penetration and revenue realization.
• Revenue forecasts indicate continued growth, with potential stabilization or decline contingent upon patent exclusivity and competitive dynamics.

FAQs

1. Is VONVENDI expected to lose market share after patent expiry?
Yes. Patent expiry in 2030 could lead to biosimilar competition, potentially reducing prices and market share.

2. How does VONVENDI compare to plasma-derived VWF products?
VONVENDI has a lower infection risk, consistent manufacturing, and a recombinant profile, which favors its adoption over plasma-derived options.

3. What factors could accelerate VONVENDI’s revenue growth?
Increased diagnosis rates, wider prophylactic use, up-titration of doses, and entry into emerging markets.

4. Are there alternative therapies that threaten VONVENDI’s market?
Gene therapy candidates are in development, which could transform VWD treatment landscape but are not yet commercially available.

5. How does reimbursement influence VONVENDI’s sales?
High reimbursement levels in key markets support market acceptance and revenue stability, but pricing negotiations remain impactful.

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References

[1] BioMarin Pharmaceutical. (2022). Annual Report.
[2] MarketWatch. (2023). Von Willebrand Disease Treatment Market Size and Forecast.
[3] EvaluatePharma. (2023). Biologic Drug Sales Analysis.