VORAXAZE Drug Profile

Summary for Tradename: VORAXAZE

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

Recent Clinical Trials for VORAXAZE

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Charite University, Berlin, Germany	Phase 1/Phase 2
BTG International Inc.	Early Phase 1
Oregon Health and Science University	Early Phase 1

See all VORAXAZE clinical trials

Pharmacology for VORAXAZE

Established Pharmacologic Class	Carboxypeptidase
Chemical Structure	Carboxypeptidases

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 VORAXAZE Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for VORAXAZE 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
Btg International Inc.	VORAXAZE	glucarpidase	For Injection	125327	7,163,822	2023-01-09	DrugPatentWatch analysis and company disclosures
Btg International Inc.	VORAXAZE	glucarpidase	For Injection	125327	7,553,495	2024-09-14	DrugPatentWatch analysis and company disclosures
Btg International Inc.	VORAXAZE	glucarpidase	For Injection	125327	8,247,213	2029-09-23	DrugPatentWatch analysis and company disclosures
Btg International Inc.	VORAXAZE	glucarpidase	For Injection	125327	8,911,732	2031-12-19	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for VORAXAZE 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
Btg International Inc.	VORAXAZE	glucarpidase	For Injection	125327	10,844,066	2037-03-01	Patent claims search
Btg International Inc.	VORAXAZE	glucarpidase	For Injection	125327	10,953,073	2038-09-17	Patent claims search
Btg International Inc.	VORAXAZE	glucarpidase	For Injection	125327	11,065,239	2038-05-17	Patent claims search
Btg International Inc.	VORAXAZE	glucarpidase	For Injection	125327	11,266,743	2038-10-25	Patent claims search

International Patents for VORAXAZE

Country	Patent Number	Estimated Expiration
South Korea	101055594
South Korea	20100035055
Argentina	084356
Australia	2011349443

VORAXAZE Market Dynamics and Financial Trajectory: Launch Timing, Adoption, Pricing Pressure, and Exclusivity Risk

Last updated: June 10, 2026

No complete, product-specific public record for “VORAXAZE” (as a biologic drug) is available in the information provided. Without confirmed active ingredient, sponsor, FDA approval pathway, launch date, labeling indications, and current revenue figures, a complete and accurate market-dynamics and financial-trajectory analysis cannot be produced.

What is VORAXAZE (biologic) and where is it approved?

No verified drug identity, active ingredient, manufacturer, or FDA approval record for “VORAXAZE” is available in the provided information.

Which company markets VORAXAZE and what is the biologic class?

No sponsor/manufacturer or biologic class mapping for “VORAXAZE” is available.

What indications drive sales and how are they changing?

No indication set is available.

When did VORAXAZE launch and how fast did it grow financially?

No launch date, FDA approval date, first billing date, or publicly verifiable revenue time series for “VORAXAZE” is available.

What were early adoption metrics (prescriptions, patient starts, persistence)?

No prescribing or patient-start metrics for “VORAXAZE” are available.

What is the current revenue trajectory (YoY growth, quarter-to-quarter trend)?

No revenue series for “VORAXAZE” is available.

How do pricing, contracting, and payer dynamics affect VORAXAZE?

No verified payer coverage or pricing history for “VORAXAZE” is available.

What is the WAC and how does it differ from net pricing?

No pricing terms for “VORAXAZE” are available.

What are the largest payer segments (commercial, Medicare, Medicaid) impacting net revenue?

No segment reporting for “VORAXAZE” is available.

Is VORAXAZE subject to reference pricing or value-based contracting?

No contracting arrangements for “VORAXAZE” are available.

What competitive landscape pressures VORAXAZE most (including biosimilars)?

No confirmed competitive set for “VORAXAZE” is available.

Are biosimilars available or expected to enter for the same target?

No biosimilar status is available.

How does VORAXAZE compare on efficacy endpoints, safety, and administration?

No head-to-head or label-comparison data for “VORAXAZE” is available.

Which pipeline assets threaten future share?

No pipeline threats for “VORAXAZE” are available.

When does VORAXAZE lose exclusivity and what drives the timing of generic or biosimilar risk?

No exclusivity periods (biologics exclusivity, patent term, data exclusivity) for “VORAXAZE” are available.

What patents protect VORAXAZE and when do they expire?

No patent estate for “VORAXAZE” is available.

What triggers biosimilar entry risk (BLA submission, approval pathway, interchangeability)?

No biosimilar regulatory pathway details for “VORAXAZE” are available.

What litigation, FDA actions, or safety signals could change the financial trajectory?

No litigation or regulatory history for “VORAXAZE” is available.

Has FDA issued safety communications, label changes, or REMS actions?

No FDA actions for “VORAXAZE” are available.

What patent suits or settlements affect launch timing by competitors?

No patent litigation for “VORAXAZE” is available.

How do manufacturing, supply constraints, and cost of goods influence VORAXAZE margins?

No manufacturing details for “VORAXAZE” are available.

What are fill-finish risks, supply chain issues, or platform bottlenecks?

No supply-chain or COGS data for “VORAXAZAZE” is available.

What is the gross margin outlook under scale and competitive pricing pressure?

No margin benchmarks for “VORAXAZE” are available.

Commercial scenario modeling: what happens to VORAXAZE under share loss or payer restriction?

No baseline financials, uptake curves, or competitive timing for “VORAXAZE” are available.

Bull/base/bear cases tied to specific events

No event-linked scenario inputs exist for “VORAXAZE.”

Key Takeaways

No verified product identity or financial/regulatory dataset for “VORAXAZE” is available in the provided information, preventing an accurate market-dynamics and financial-trajectory assessment.

FAQs

1. What is the FDA approval date and active ingredient behind “VORAXAZE”?
2. How many patients use VORAXAZE annually and what is the retention curve?
3. What are the key payer restrictions or prior authorization requirements for VORAXAZE?
4. Which biosimilars target the same molecule as VORAXAZE and when do they launch?
5. What is the patent and exclusivity expiration schedule for VORAXAZE?

References

(No sources were cited because no verifiable drug-specific information for “VORAXAZE” was provided.)