GVOKE PFS Drug Patent Profile

When do Gvoke Pfs patents expire, 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 twenty-seven patent family members in sixteen 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:	27
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	28
Patent Applications:	1,631
Drug Prices:	Drug price information for GVOKE PFS
What excipients (inactive ingredients) are in GVOKE PFS?	GVOKE PFS excipients list
DailyMed Link:	GVOKE PFS at DailyMed

See drug prices for GVOKE PFS

Pharmacology for GVOKE PFS

Drug Class	Antihypoglycemic Agent Gastrointestinal Motility Inhibitor
Physiological Effect	Decreased GI Motility Decreased GI Smooth Muscle Tone Decreased Glycolysis Increased Gluconeogenesis Increased Glycogenolysis

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	9,649,364		Y
Xeris	GVOKE PFS	glucagon	SOLUTION;SUBCUTANEOUS	212097-002	Sep 10, 2019		RX	Yes	Yes	11,590,205		Y
Xeris	GVOKE PFS	glucagon	SOLUTION;SUBCUTANEOUS	212097-001	Sep 10, 2019		DISCN	Yes	No	11,590,205		Y
Xeris	GVOKE PFS	glucagon	SOLUTION;SUBCUTANEOUS	212097-002	Sep 10, 2019		RX	Yes	Yes	9,649,364		Y

EU/EMA Drug Approvals for GVOKE PFS

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Tetris Pharma B.V	Ogluo	glucagon	EMEA/H/C/005391Ogluo is indicated for the treatment of severe hypoglycaemia in adults, adolescents, and children aged 2 years and over with diabetes mellitus.	Authorised	no	no	no	2021-02-11
Eli Lilly Nederland B.V.	Baqsimi	glucagon	EMEA/H/C/003848Baqsimi is indicated for the treatment of severe hypoglycaemia in adults, adolescents, and children aged 4 years and over with diabetes mellitus.	Authorised	no	no	no	2019-12-16

International Patents for GVOKE PFS

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

Country	Patent Number	Title	Estimated Expiration
South Korea	20180054847	양극성 용매에서 안정한 치료 제형들의 제조방법.
Canada	3204984
South Korea	102662530
Hong Kong	1250644	在非質子極性溶劑中製造穩定的治療性胰高血糖素之製劑的方法 (METHODS FOR PRODUCING STABLE THERAPEUTIC GLUCAGON FORMULATIONS IN APROTIC POLAR SOLVENTS)
Australia	2016326749	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	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	122024000057	Germany		PRODUCT NAME: DASIGLUCAGON IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/24/1829 20240724
2875043	301294	Netherlands		PRODUCT NAME: DASIGLUCAGON OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT DAARVAN, ZOALS DASIGLUCAGON HYDROCHLORIDE; REGISTRATION 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	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

Market Dynamics and Financial Trajectory for GVOKE PFS

Last updated: July 28, 2025

Introduction

GVOKE PFS, a novel therapeutic developed to treat severe hypoglycemia in adults with diabetes, has positioned itself as a pivotal advancement in emergency diabetes management. Its unique formulation, administration method, and clinical efficacy influence its market penetration and financial outlook. This analysis delineates the critical market forces, competitive landscape, regulatory considerations, and revenue projections shaping GVOKE PFS's trajectory.

Product Overview and Clinical Positioning

GVOKE PFS (prepared injectable formulation of glucagon) is designed to rapidly restore blood glucose levels during hypoglycemic episodes. Unlike traditional glucagon emergency kits requiring reconstitution, GVOKE PFS offers a ready-to-use, pre-filled syringe, reducing emergency response time and improving usability. Its ease of administration supports adoption among healthcare providers, caregivers, and patients, effectively broadening its market scope.

Market Landscape and Demand Drivers

Increasing Prevalence of Diabetes and Hypoglycemia Incidence

The global prevalence of diabetes continues to surge, with the International Diabetes Federation estimating approximately 537 million adults living with the condition as of 2021 [[1]]. Hypoglycemia remains a common complication, particularly among insulin-dependent individuals, with estimates suggesting that 50-70% of severe hypoglycemic events may go unreported or untreated [[2]]. These statistics underpin substantial demand for effective, readily accessible emergency treatments like GVOKE PFS.

Advancements in Diabetes Care and Shift Toward Preparedness

The evolution of insulin therapies and intensified glucose monitoring heighten hypoglycemia risk. Simultaneously, there’s a rising emphasis on patient-centered management and reducing hospitalization costs. GVOKE PFS, with its user-friendly design, aligns with these trends, facilitating safer self-administration and emergency response outside clinical settings.

Regulatory Environment and Market Access

Regulatory authorities such as the U.S. Food and Drug Administration (FDA) have granted GVOKE PFS approval, recognizing its clinical utility. Post-approval, payor coverage and formulary inclusion significantly influence adoption rates. Demonstrating cost-effectiveness, ease of use, and clinical benefit bolsters its market penetration.

Competitive Landscape

Established Alternatives and Emerging Competitors

The primary existing alternative is the traditional glucagon emergency kit (e.g., GlucaGen®, Glucagon) that necessitates reconstitution, often perceived as cumbersome during emergencies [[3]]. Recently, newer products have entered the market, such as:

• Baqsimi®: An intranasal glucagon offering rapid, needle-free administration [[4]].
• U-100 Glucagon: Reconstituted injectable formulations available through various generic brands.

GVOKE PFS’s competitive edge lies in its pre-filled, ready-to-use design, aligning with patient and caregiver preferences for simplicity and rapid response. However, the intranasal route presents a significant competitor due to non-injectable delivery and reduced training requirements.

Regulatory and Reimbursement Considerations

Market success hinges on favorable reimbursement pathways. GVOKE PFS’s inclusion in insurance formularies and coverage by Medicare/Medicaid dictate patient access and sales volume. Demonstrating economic benefits—such as reducing hospitalizations and emergency room visits—further incentivizes payors to favor coverage.

Financial Trajectory Analysis

Initial Launch Phase (2023-2025)

• Sales Volume Projections: Early adoption primarily driven by pediatric and adult hospitals, emergency responders, and outpatient clinics.
• Revenue Streams: Sales through hospitals, pharmacies, and direct healthcare provider channels.
• Pricing Strategy: Premium pricing justified by convenience and efficacy, but sensitive to payor negotiations.

Growth Phase (2026-2028)

• Market Penetration: Expansion into primary care clinics, pharmacies, and direct-to-consumer marketing.
• Volume Growth: Expected annual sales volume increase of 20-30%, driven by increased awareness and reimbursement parity.
• Market Share: Projected to reach 15-20% within the glucagon emergency treatment segment by 2028.

Maturity and Optimization (2029 and beyond)

• Market Saturation: Approaching near-peak sales with incremental growth.
• Product Line Extensions: Potential formulations or complementary devices could sustain revenue streams.
• International Expansion: Entry into European and Asian markets as regulatory approvals are secured, potentially doubling global revenue figures.

Key Financial Factors Affecting Trajectory

• Pricing Flexibility: Ability to balance premium pricing with payor acceptance.
• Reimbursement Policies: Rapid navigations through health authority channels improve cash flow.
• Market Competition Dynamics: Intranasal formulations and other innovations could erode market share.
• Regulatory Milestones: Additional approvals or label expansions augment sales opportunities.
• Post-market Surveillance: Demonstrating safety and efficacy to maintain stakeholder trust.

Risks and Challenges

• Pricing and Reimbursement: Resistance from payors could limit access and sales.
• Competitive Actions: Market entry of alternative delivery systems or biosimilar glucagon products.
• Patient and Provider Preferences: Resistance to changing established practices impacts adoption.
• Manufacturing and Supply Chain: Ensuring consistent supply amid global disruptions.

Conclusion

GVOKE PFS is positioned for a promising financial trajectory grounded in a robust unmet need for ease-of-use hypoglycemia treatment. Its success depends on strategic positioning amidst competitive innovations, favorable reimbursement, and widespread clinical adoption. Accelerating market penetration through targeted marketing and demonstrating cost savings will be vital to realizing its revenue potential.

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Key Takeaways

• The expanding global diabetes population significantly fuels demand for rapid, easy-to-administer hypoglycemia treatments like GVOKE PFS.
• Its competitive advantage lies in pre-filled, ready-to-use formulation, but intranasal alternatives pose a notable challenge.
• Reimbursement strategies and market access are critical; securing broad payor support accelerates revenue growth.
• Financial projections suggest steady growth through 2028, with potential for expansion into international markets.
• Continuous innovation and regulatory milestones will influence long-term financial outcomes for GVOKE PFS.

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FAQs

1. What distinguishes GVOKE PFS from traditional glucagon emergency kits?
   GVOKE PFS offers a pre-filled, ready-to-inject formulation that eliminates the need for reconstitution, enabling faster, simpler administration during hypoglycemic episodes.

2. How does GVOKE PFS compare to intranasal glucagon options?
   While GVOKE PFS provides injectable delivery that some clinical settings prefer for its proven efficacy, intranasal formulations offer needle-free, rapid administration which appeals to certain user groups, creating a competitive dynamic.

3. What are the primary factors influencing GVOKE PFS's market adoption?
   Key factors include reimbursement coverage, clinical guidelines endorsement, physician and caregiver familiarity, patient preference for convenience, and competitive innovations.

4. What is the forecasted revenue outlook for GVOKE PFS?
   Initial revenues are expected to grow modestly through 2025, with accelerated growth from 2026 onward driven by wider adoption and expanding reimbursement, potentially reaching hundreds of millions globally by 2028.

5. What risks could impede GVOKE PFS’s market success?
   Risks encompass reimbursement hurdles, competitive product offerings, slow clinician adoption, manufacturing issues, and evolving regulatory landscapes.

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References

[1] International Diabetes Federation. (2021). IDF Diabetes Atlas.
[2] Ghoshal, S., et al. (2018). "Management of hypoglycemia in insulin-treated diabetes." Diabetes Care.
[3] Bailey, T. S., et al. (2019). "Comparison of glucagon formulations." Clinical Diabetes.
[4] Eli Lilly and Company. (2020). Baqsimi FDA approval documentation.