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-six patent family members in sixteen countries.

The generic ingredient in GVOKE PFS is glucagon. There are twelve drug master file entries for this compound. Five 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:	26
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
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/005391 Ogluo 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/003848 Baqsimi 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
Spain	2970863
Japan	6835831
Eurasian Patent Organization	201890704	СПОСОБЫ ПОЛУЧЕНИЯ СТАБИЛЬНЫХ ТЕРАПЕВТИЧЕСКИХ СОСТАВОВ В АПРОТОННЫХ ПОЛЯРНЫХ РАСТВОРИТЕЛЯХ
Australia	2016326749	Methods for producing stable therapeutic glucagon formulations in aprotic polar solvents
European Patent Office	3352780	PROCÉDÉS DE PRODUCTION DE FORMULATIONS DE GLUCAGON THÉRAPEUTIQUES STABLES DANS DES SOLVANTS POLAIRES APROTIQUES (METHODS FOR PRODUCING STABLE THERAPEUTIC GLUCAGON FORMULATIONS IN APROTIC POLAR SOLVENTS)
Canada	2999404
Canada	2999404	METHODES DE PRODUCTION DE FORMULATIONS THERAPEUTIQUES STABLES DANS DES SOLVANTS POLAIRES APROTIQUES (METHODS FOR PRODUCING STABLE THERAPEUTIC FORMULATIONS IN APROTI C POLAR SOLVENTS)

Supplementary Protection Certificates for GVOKE PFS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	CR 2024 00043	Denmark		PRODUCT NAME: DASIGLUCAGON ELLER ET FARMACEUTISK SALT ELLER SOLVAT DERAF, SASOM DASIGLUCAGONHYDROCHLORID; REG. NO/DATE: EU/1/24/1829 20240725

Market Dynamics and Financial Trajectory for GVOKE PFS

Introduction to GVOKE PFS

GVOKE PFS, developed by Xeris Pharmaceuticals, is a ready-to-use, prefilled syringe containing liquid-stable glucagon, designed to treat severe hypoglycemia in patients with diabetes. This innovative product has significantly impacted the market dynamics and financial performance of Xeris Pharmaceuticals.

Market Opportunity and Growth

The global glucagon market, which includes products like GVOKE PFS, has been growing steadily. In 2022, the global glucagon market size was valued at $278.5 million and is projected to grow to $470.8 million by 2030, with a CAGR of 6.8% from 2023 to 2030[5].

Expansion of Glucagon Prescriptions

Since the field launch of GVOKE PFS in January 2020, there has been a notable increase in glucagon prescriptions. Total glucagon prescriptions across all types and formulations were 13.1% higher in 2020 compared to 2019. Specifically, prescriptions for GVOKE PFS and Eli Lilly’s Baqsimi were approximately 38,800 and 137,900, respectively, in 2020[4].

Geographic Expansion

GVOKE PFS is not only gaining traction in the U.S. but also expanding globally. The European Commission granted marketing authorization for Ogluo (the European counterpart of GVOKE) in February 2021, with plans for commercial launch in select European countries starting in the fourth quarter of 2021. Additionally, GVOKE is expected to be available in Israel and the Palestinian Authority in 2022 through a distribution agreement[4].

Financial Performance

Initial Launch and COVID-19 Impact

During the first quarter of 2020, GVOKE PFS saw a positive response from the diabetes community, with net sales of $1.7 million. However, the COVID-19 pandemic slowed the momentum. In response, Xeris Pharmaceuticals quickly adapted to a virtual selling model and implemented several programs to minimize the pandemic's impact on the business[1].

Revenue and Sales

In 2020, total U.S. sales of glucagon products, including GVOKE PFS, were $264 million. GVOKE PFS accounted for 74,000 units sold, contributing to the overall market growth. The market access team secured broad unrestricted access to GVOKE across all payor types, further boosting sales[4].

Research and Development Expenses

Xeris Pharmaceuticals has been investing significantly in research and development. In the first quarter of 2020, R&D expenses were $15.5 million, reflecting the company's commitment to clinical programs and product development. This includes preparing for the launch of GVOKE HypoPen and reporting topline results from additional clinical programs[1].

Operating Expenses and Loss

Despite the growth in sales, Xeris Pharmaceuticals reported operating expenses of $30.4 million in the first quarter of 2020, leading to a loss from operations of $30.1 million. This is typical for a company heavily invested in R&D and launching new products[3].

Product Efficacy and Safety

Clinical Trials

GVOKE PFS has demonstrated efficacy and safety in several clinical trials. In two Phase 3 trials involving adults with Type 1 diabetes, 99% of patients achieved plasma glucose levels above 70 mg/dL or an increase of at least 20 mg/dL from baseline within 15 minutes of administration. The median time to initial blood glucose increase was less than 2 minutes[2].

Pediatric Use

In a Phase 3 open-label study, 100% of pediatric patients achieved a target glucose increase of at least 25 mg/dL. The most common adverse reactions in both adults and pediatric patients were mild, with nausea, vomiting, and headache being the most frequent[2].

Market Trends and Competition

Shift from Traditional Vial Form

The glucagon market is witnessing a gradual shift from traditional vial forms to more convenient and user-friendly forms such as prefilled syringes (PFS) and autoinjectors like GVOKE HypoPen. This shift is driven by the benefits of ease of use, faster administration, and higher patient compliance[5].

Competitive Landscape

Xeris Pharmaceuticals competes with other major players like Novo Nordisk A/S. However, the introduction of GVOKE PFS and GVOKE HypoPen has expanded treatment options for patients and caregivers, contributing to the segment's growth. The North America region, particularly the U.S., remains a dominant market for glucagon products[5].

Promotional and Access Strategies

Direct-to-Patient Promotion

Xeris Pharmaceuticals has implemented targeted direct-to-patient promotion and collaborated with patient advocacy groups to increase awareness and access to GVOKE PFS. The company extended a $0 copay offer for commercially insured patients until May 31, 2020, in response to the COVID-19 pandemic, to ensure continued access to the medication[1][4].

Market Access

The market access team has secured broad unrestricted access to GVOKE PFS across all payor types, which has been crucial in driving prescription growth and market penetration[4].

Future Outlook

Potential Market Opportunity

The market opportunity for GVOKE PFS and other glucagon products is significant, with estimates suggesting a potential market size of up to $3.8 billion. This is driven by the rising prevalence of diabetes and the increasing need for convenient and effective emergency hypoglycemia treatments[4].

Strategic Alliances and Expansion

Xeris Pharmaceuticals plans to pursue development and commercialization collaborations to further expand the reach of GVOKE PFS and other product candidates. The company's strategic alliances and distribution agreements will be key in maintaining its market position and driving future growth[4].

Key Takeaways

• Market Growth: The global glucagon market is growing, driven by the increasing prevalence of diabetes and the introduction of new, user-friendly products like GVOKE PFS.
• Financial Performance: Despite initial challenges due to COVID-19, GVOKE PFS has shown promising sales and revenue growth.
• Product Efficacy: Clinical trials have demonstrated the efficacy and safety of GVOKE PFS in treating severe hypoglycemia.
• Market Trends: There is a shift towards more convenient forms of glucagon, such as prefilled syringes and autoinjectors.
• Competitive Landscape: Xeris Pharmaceuticals competes with major players but has carved out a significant market share with GVOKE PFS.
• Future Outlook: The potential market opportunity is substantial, with plans for further expansion and strategic collaborations.

FAQs

What is GVOKE PFS?

GVOKE PFS is a ready-to-use, prefilled syringe containing liquid-stable glucagon, designed to treat severe hypoglycemia in patients with diabetes.

How has the COVID-19 pandemic affected GVOKE PFS sales?

The COVID-19 pandemic initially slowed the momentum of GVOKE PFS sales, but Xeris Pharmaceuticals adapted by implementing a virtual selling model and extending a $0 copay offer to minimize the impact.

What are the key benefits of GVOKE PFS over traditional glucagon forms?

GVOKE PFS offers ease of use, faster administration, and higher patient compliance compared to traditional vial forms.

What is the current market size and growth projection for the glucagon market?

The global glucagon market was valued at $278.5 million in 2022 and is projected to grow to $470.8 million by 2030, with a CAGR of 6.8% from 2023 to 2030.

Who are the major competitors in the glucagon market?

Major competitors in the glucagon market include Xeris Pharmaceuticals and Novo Nordisk A/S.

Sources

1. Business Wire: Xeris Pharmaceuticals Reports First Quarter 2020 Financial Results and Provides Corporate Updates.
2. Gvoke Glucagon: Demonstrated Efficacy | Gvoke® (glucagon injection).
3. Xeris Pharmaceuticals: Xeris Pharmaceuticals Reports Third Quarter 2019 Financial Results.
4. Annual Reports: XERIS PHARMACEUTICALS, INC. - Annual Reports.
5. Fortune Business Insights: Glucagon Market Size, Share, Growth & Trends Analysis [2030].