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-eight patent family members in sixteen countries.

The generic ingredient in GVOKE PFS is glucagon. There are twelve drug master file entries for this compound. Nine 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:	28
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	28
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			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

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
European Patent Office	3307295	UTILISATION DE GLUCAGON À FAIBLE DOSE (USE OF LOW DOSE GLUCAGON)
Israel	258298
World Intellectual Property Organization (WIPO)	2017053922
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)

Supplementary Protection Certificates for GVOKE PFS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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

GVOKE PFS Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

GVOKE PFS, a ready-to-use subcutaneous formulation of glucagon, targets hypoglycemia episodes in individuals with diabetes. Its market introduction and subsequent performance are shaped by competition from existing glucagon products, reimbursement policies, and the prevalence of diabetes.

What is the Current Market Position of GVOKE PFS?

GVOKE PFS, developed by Xeris Pharmaceuticals, was approved by the U.S. Food and Drug Administration (FDA) in October 2020. It offers a pre-mixed, single-dose autoinjector designed for rapid administration, differentiating it from traditional intramuscular glucagon kits that require reconstitution.

• Target Population: The primary market for GVOKE PFS is individuals with diabetes, particularly those on insulin therapy who are at risk of severe hypoglycemia. This includes Type 1 and Type 2 diabetes patients.
• Competitive Landscape: The glucagon market includes established products like nasal glucagon (Baqsimi, Eli Lilly) and traditional injectable glucagon kits (e.g., Gvoke HypoPen, Diazemuls). Baqsimi was approved in 2019 and provides a non-injectable alternative. Traditional kits, while less convenient, represent a lower-cost option.
• Market Access & Reimbursement: Reimbursement is a critical factor. Insurers' coverage policies for GVOKE PFS, particularly concerning co-pays and prior authorization requirements, significantly influence patient access and physician prescribing patterns. In January 2021, Xeris announced that GVOKE PFS was added to the U.S. Medicare Part D formulary, improving access for a significant patient segment.
• Geographic Focus: The primary market is currently the United States, with potential for expansion into other regulated markets based on clinical trial data and regulatory approvals.

What are the Key Differentiating Features of GVOKE PFS?

GVOKE PFS's design addresses key limitations of prior glucagon delivery methods.

• Ease of Use: The autoinjector format eliminates the need for mixing, drawing up doses, or reconstitution, simplifying administration for both patients and caregivers. This is particularly important during hypoglycemic events when coordination may be compromised.
• Storage and Stability: The ready-to-use formulation offers room-temperature storage stability, enhancing convenience and portability.
• Dosing Precision: The pre-filled autoinjector ensures a consistent and accurate dose, mitigating potential errors associated with manual preparation.
• Rapid Absorption: The subcutaneous route of administration is designed for quick absorption and onset of action.

How has GVOKE PFS performed financially since its launch?

Xeris Pharmaceuticals reports quarterly and annual financial results that detail GVOKE PFS's revenue contribution.

• Revenue Growth: Following its launch, GVOKE PFS has demonstrated year-over-year revenue growth. For instance, in fiscal year 2022, Xeris reported net sales of the Gvoke product family (which includes both Gvoke HypoPen and Gvoke PFS) reaching $133.8 million, a 36% increase from $98.2 million in 2021. (Source: Xeris Pharmaceuticals 2022 Annual Report)
• Sales Drivers: Prescription volume and market penetration are the primary drivers of revenue. Growth is attributed to increasing physician adoption, patient acceptance, and expanding insurance coverage.
• Cost of Goods Sold (COGS): COGS for the Gvoke product line is a key component of profitability. Xeris aims to optimize manufacturing processes to control these costs.
• Research and Development (R&D) Expenses: Continued investment in R&D supports the development of next-generation delivery devices and potential new indications, which impacts overall profitability.
• Sales and Marketing Expenses: Significant investment in sales and marketing is necessary to educate healthcare providers and patients about the benefits of GVOKE PFS, influencing market uptake and, consequently, revenue.

What is the projected financial outlook for GVOKE PFS?

Financial projections for GVOKE PFS are influenced by several market forces.

• Market Size and Penetration: The total addressable market for glucagon rescue devices is substantial, given the high prevalence of diabetes requiring insulin therapy. Continued penetration into this market is expected to drive revenue growth.
• Competitive Pressures: The ongoing competition from both established and emerging glucagon products will necessitate sustained marketing efforts and potential pricing strategies. The introduction of new delivery technologies by competitors could impact market share.
• Reimbursement Landscape Evolution: Changes in payer policies, formulary placement, and out-of-pocket costs for patients can accelerate or decelerate adoption.
• Commercialization Partnerships: Potential partnerships for marketing and distribution in the U.S. or international markets could impact revenue streams and market reach.
• Pipeline Development: Xeris's broader pipeline, including other glucagon formulations or related technologies, may influence resource allocation and investor perception, indirectly affecting the financial trajectory of GVOKE PFS.

According to industry analysts, the global diabetes market continues to expand, with a growing emphasis on effective management of acute complications like hypoglycemia. This trend is supportive of the sustained demand for effective rescue medications like GVOKE PFS.

What are the key regulatory and patent considerations for GVOKE PFS?

Regulatory approval and patent protection are fundamental to GVOKE PFS's commercial viability.

• FDA Approval History: GVOKE PFS received FDA approval for the treatment of severe hypoglycemia in patients with diabetes aged 12 years and older on October 29, 2020. (Source: FDA Approval Letter)
• Patent Portfolio: Xeris Pharmaceuticals holds a portfolio of patents covering the composition of matter, formulation, manufacturing processes, and methods of use for GVOKE PFS. These patents provide market exclusivity for a defined period.
  • Key Patents: Specific patent numbers and their expiry dates are crucial for assessing long-term market protection. For example, patents related to the autoinjector technology and the stable liquid glucagon formulation are central to its market exclusivity. (Source: Xeris Pharmaceuticals Investor Presentations, Patent Databases)
  • Patent Expirations: The expiration of key patents opens the door for generic competition, which typically leads to significant price erosion and market share shifts. Understanding the timelines for these expirations is critical for forecasting long-term revenue.
• Exclusivity Periods: Beyond patent protection, regulatory exclusivity periods (e.g., Hatch-Waxman Act exclusivity in the U.S.) can provide additional market protection post-patent expiration.
• Global Regulatory Approvals: Pursuing approvals in other major markets (e.g., EMA in Europe) can expand the commercial opportunity and revenue base.

Key Takeaways

GVOKE PFS has established a position in the glucagon rescue market due to its convenient, ready-to-use autoinjector format, addressing a key unmet need for patients at risk of severe hypoglycemia. Financial performance since its 2020 launch has shown year-over-year revenue growth, driven by increasing prescription volume and expanding insurance coverage. The future financial trajectory is contingent on continued market penetration, navigating competitive pressures from existing and emerging glucagon products, evolving reimbursement policies, and the strength of its patent portfolio and remaining market exclusivity.

Frequently Asked Questions

• What is the primary mechanism of action for GVOKE PFS? GVOKE PFS is a ready-to-use liquid formulation of glucagon that acts as a hormone to rapidly increase blood glucose levels by stimulating the liver to release stored glucose.

• How does GVOKE PFS compare to nasal glucagon (Baqsimi)? GVOKE PFS is administered via subcutaneous injection using an autoinjector, while Baqsimi is administered intranasally. Both are designed for rapid treatment of severe hypoglycemia, but administration preference can vary among patients and caregivers.

• What is the typical storage requirement for GVOKE PFS? GVOKE PFS is stable at room temperature and does not require refrigeration, offering significant convenience for storage and portability.

• Are there any age restrictions for the use of GVOKE PFS? In the U.S., GVOKE PFS is approved for the treatment of severe hypoglycemia in people with diabetes aged 12 years and older.

• What are the main components of Xeris Pharmaceuticals' Gvoke product family? The Gvoke product family includes both the Gvoke HypoPen, a pre-filled syringe with a mechanical injector, and Gvoke PFS, a single-dose autoinjector.

Citations

[1] Xeris Pharmaceuticals. (2023). 2022 Annual Report on Form 10-K. U.S. Securities and Exchange Commission. [2] U.S. Food and Drug Administration. (2020, October 29). FDA Approval Letter for Gvoke PFS. [3] Xeris Pharmaceuticals. (n.d.). Investor Presentations and Company Filings. (Specific dates and titles vary, refer to company investor relations section for latest available documents). [4] Various Patent Databases (e.g., USPTO, Google Patents). (Ongoing access and review of relevant patent information for Xeris Pharmaceuticals).