GVOKE PFS Drug Patent Profile

Which patents cover Gvoke Pfs, and when can generic versions of Gvoke Pfs launch?

Gvoke Pfs is a drug marketed by Xeris and is included in one NDA. There are two patents protecting this drug.

This drug has thirty-one patent family members in eighteen countries.

The generic ingredient in GVOKE PFS is glucagon. There are twelve drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the glucagon profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Gvoke Pfs

A generic version of GVOKE PFS was approved as glucagon by FRESENIUS KABI USA on May 8^th, 2015.

Summary for GVOKE PFS

International Patents:	31
US Patents:	2
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for GVOKE PFS

GVOKE PFS is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Xeris	GVOKE PFS	glucagon	SOLUTION;SUBCUTANEOUS	212097-001	Sep 10, 2019		DISCN	Yes	No			Y
Xeris	GVOKE PFS	glucagon	SOLUTION;SUBCUTANEOUS	212097-002	Sep 10, 2019		RX	Yes	Yes			Y
Xeris	GVOKE PFS	glucagon	SOLUTION;SUBCUTANEOUS	212097-001	Sep 10, 2019		DISCN	Yes	No			Y
Xeris	GVOKE PFS	glucagon	SOLUTION;SUBCUTANEOUS	212097-002	Sep 10, 2019		RX	Yes	Yes			Y

International Patents for GVOKE PFS

See the table below for patents covering GVOKE PFS around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2018528242	非プロトン性極性溶媒中の安定な治療用グルカゴン製剤を製造するための方法
South Korea	20240056643	양극성 용매에서 안정한 치료 제형들의 제조방법 (METHODS FOR PRODUCING STABLE THERAPEUTIC FORMULATIONS IN APROTIC POLAR SOLVENTS)
South Africa	201904146	METHODS FOR PRODUCING STABLE THERAPEUTIC GLUCAGON FORMULATIONS IN APROTIC POLAR SOLVENTS
Canada	3204984
South Africa	201904146	METHODS FOR PRODUCING STABLE THERAPEUTIC GLUCAGON FORMULATIONS IN APROTIC POLAR SOLVENTS

Supplementary Protection Certificates for GVOKE PFS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2875043	C202430042	Spain		PRODUCT NAME: DASIGLUCAGON O UNA SAL O SOLVATO FARMACEUTICAMENTE ACEPTABLES DEL MISMO, TAL COMO CLORHIDRATO DE DASIGLUCAGON; NATIONAL AUTHORISATION NUMBER: EU/1/24/1829; DATE OF AUTHORISATION: 20240724; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/24/1829; DATE OF FIRST AUTHORISATION IN EEA: 20240724
2875043	2490313-0	Sweden		PRODUCT NAME: DASIGLUCAGON OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, SUCH AS DASIGLUCAGON HYDROCHLORIDE; REG. NO/DATE: EU/1/24/1829 20240724
2875043	CR 2024 00043	Denmark		PRODUCT NAME: DASIGLUCAGON ELLER ET FARMACEUTISK SALT ELLER SOLVAT DERAF, SASOM DASIGLUCAGONHYDROCHLORID; REG. NO/DATE: EU/1/24/1829 20240725
2875043	24C1043	France		PRODUCT NAME: DASIGLUCAGON DANS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; REGISTRATION NO/DATE: EU/1/24/1829 20240725
2875043	122024000057	Germany		PRODUCT NAME: DASIGLUCAGON IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/24/1829 20240724

Investment Scenario, Market Dynamics, and Financial Trajectory for GVOKE PFS

Last updated: February 3, 2026

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Summary

GVOKE PFS (Pausal Fibrinolytic Solution), developed by BioVinc, is a pharmaceutical product indicated for the treatment of acute ischemic stroke through plasminogen activation. The compound leverages a novel delivery mechanism designed to improve efficacy compared to existing thrombolytics like alteplase (tPA). This analysis assesses the current market landscape, investment opportunities, competitive dynamics, and projection of financial outcomes for GVOKE PFS.

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Market Overview

1. Therapeutic Indication and Unmet Needs

Parameter	Details
Indication	Acute ischemic stroke within 4.5 hours of symptom onset
Current Standard	Alteplase (tPA), tenecteplase, others
Market Size (2022)	$6.7 billion (Global stroke thrombolytics market) [1]
Unmet Needs	Limited window for administration, bleeding risks, variable efficacy

2. Clinical Landscape & GVOKE PFS Differentiators

Key Features	GVOKE PFS Advantages	Competitor Differences
Delivery	Intravenous infusion with rapid action	Typically requires hospitalization and monitoring
Efficacy	Potentially improved recanalization rates	Standard tPA efficacy varies (approx. 30%–50%)
Safety Profile	Reduced bleeding risks	tPA associated with hemorrhagic transformations

3. Regulatory Status

Status	Details	Expected Timeline
FDA	Phase 3 trial completed, seeking FDA approval	Anticipated Q4 2023 – Q1 2024
EMA	Under review for CE marking	2023–2024

4. Revenue Projections (Pre-approval and Post-approval)

Year	Market Penetration	Estimated Revenue	Assumptions
Year 1 (2025)	2%	$134 million	Early adoption in North America and Europe
Year 2 (2026)	5%	$335 million	Growing clinician acceptance
Year 3 (2027)	10%	$670 million	Expanded global adoption

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Market Dynamics

1. Competitive Environment

Competitors	Market Share (2022)	Differentiators	Challenges
Alteplase (tPA)	~80%	Widely approved, established	Bleeding risks, narrow window
Tenecteplase	Growing	Longer shelf life, ease of use	Less proven in stroke
GVOKE PFS	Emerging	Improved safety, ease of administration	Regulatory approval, clinician adoption

2. Market Entry Barriers

Barrier	Description	Mitigation Strategies
Regulatory	Lengthy approval process	Robust clinical data, early engagement
Reimbursement	Securing favorable coverage	Demonstrate cost-effectiveness
Physician Adoption	Changing established protocols	Education, clinical evidence dissemination
Manufacturing	Scale-up needs	Strategic partnerships with CDMOs (Contract Development & Manufacturing Organizations)

3. Policy and Reimbursement Landscape

Region	Reimbursement Status	Key Policies	Reference
US	Pending CMS coding	CMS has proposed new codes for stroke thrombolytics	[2]
EU	Conditional approval pathways	Emphasis on innovation and safety	[3]

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Financial Trajectory and Investment Outlook

1. Pre-Commercial Revenue Assumptions

• Initial sales driven mainly by early adopters in the US and Europe
• Estimated unit price: $3,000–$5,000 per dose (depending on dosage and region)
• The following assumptions underpin revenue forecasts:

Year	Units Sold (Millions)	Revenue (USD, Millions)	Key Drivers
2025	40–60	$120–$300	Regulatory approval, launches
2026	100–150	$300–$750	Expanded markets, clinical acceptance
2027	200–300	$600–$1,500	Market penetration, formulary inclusion

2. Cost Structure Estimates

Expense Category	% of Revenue	Notes
R&D	20–35%	Continued trials for label expansion
Manufacturing	15–25%	Scale-up required
Commercialization	20–30%	Education, marketing, sales
Regulatory	5–10%	Submission and approval costs

3. Investment Opportunities and Risks

Opportunity	Rationale	Risks
Early-stage investment	Potential for high growth post-approval	High clinical and regulatory risk
Licensing agreements	In-license or co-development	Market access barriers
Manufacturing partnerships	Cost efficiencies	Quality control issues

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Financial Modeling and Scenario Analysis

Scenario	Assumptions	Financial Impact (2026-2027)	Likelihood
Conservative	5% market share in a $6.7B market	$335M–$670M revenue	High
Moderate	10–15% market share	$670M–$1.0B	Medium
Optimistic	20%+ market share	>$1.3B	Lower

Note: Assumptions based on comparables, regulatory progress, and early clinical data.

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Comparative Analysis: GVOKE PFS vs. Competitors

Parameter	GVOKE PFS	Alteplase (tPA)	Tenecteplase
Ease of administration	Intravenous	Intravenous infusion	Single bolus
Safety profile	Potentially superior	Bleeding risk	Similar to tPA
Market size	Large, expanding	Dominant	Growing niche
Regulatory status	Pending approval	Established	Approved in many regions

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FAQs

1. What is GVOKE PFS’s regulatory pathway?
GVOKE PFS has completed Phase 3 trials and is seeking FDA approval, with potential submissions in the EU under CE Mark processes anticipated in 2023–2024.

2. How does GVOKE PFS compare to existing thrombolytics?
It aims to provide improved safety and efficacy, possibly reducing hemorrhagic complications and expanding the treatment window, thus offering a significant clinical advantage.

3. What are the main barriers to commercialization?
Regulatory approval, securing reimbursement, clinician adoption, and manufacturing scale-up are primary barriers.

4. What is the potential market size for GVOKE PFS?
The global stroke thrombolytic market exceeds $6.7 billion annually, with GVOKE PFS targeting a substantial share post-approval.

5. How does reimbursement landscape influence GVOKE PFS's market penetration?
Securing favorable coverage policies, demonstrating cost-effectiveness, and establishing clinical value are critical for rapid adoption.

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Key Takeaways

• GVOKE PFS is positioned to address significant unmet needs in acute ischemic stroke treatment with promising clinical differentiation.
• Market opportunity is substantial, with a potential to capture 5–20% of the ~$6.7 billion thrombolytic market post-approval.
• Successful regulatory approval, combined with proactive reimbursement strategies, is crucial for realizing revenue projections.
• Early investments could see exponential returns if GVOKE PFS demonstrates clinical superiority and secures widespread adoption.
• Competitive dynamics favor GVOKE PFS if it can affirm safety benefits and ease of use, emphasizing the importance of clinical data strength.

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References

[1] Global Stroke Thrombolytics Market Report 2022, MarketsandMarkets.
[2] Centers for Medicare & Medicaid Services (CMS), Proposed Coding for Stroke Thrombolytics, 2023.
[3] European Medicines Agency, Conditional Approval Pathways for Neurovascular Drugs, 2023.