GVOKE HYPOPEN Drug Patent Profile

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

Gvoke Hypopen 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 HYPOPEN 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 Hypopen

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

Summary for GVOKE HYPOPEN

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 HYPOPEN
What excipients (inactive ingredients) are in GVOKE HYPOPEN?	GVOKE HYPOPEN excipients list
DailyMed Link:	GVOKE HYPOPEN at DailyMed

See drug prices for GVOKE HYPOPEN

Pharmacology for GVOKE HYPOPEN

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 HYPOPEN

GVOKE HYPOPEN 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 HYPOPEN	glucagon	SOLUTION;SUBCUTANEOUS	212097-003	Sep 10, 2019		RX	Yes	Yes			Y
Xeris	GVOKE HYPOPEN	glucagon	SOLUTION;SUBCUTANEOUS	212097-004	Sep 10, 2019		RX	Yes	Yes			Y
Xeris	GVOKE HYPOPEN	glucagon	SOLUTION;SUBCUTANEOUS	212097-003	Sep 10, 2019		RX	Yes	Yes			Y
Xeris	GVOKE HYPOPEN	glucagon	SOLUTION;SUBCUTANEOUS	212097-004	Sep 10, 2019		RX	Yes	Yes			Y

EU/EMA Drug Approvals for GVOKE HYPOPEN

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 HYPOPEN

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

Country	Patent Number	Title	Estimated Expiration
Canada	3204984
South Africa	201801912
World Intellectual Property Organization (WIPO)	2016196976
China	115531523	在非质子极性溶剂中制备稳定的普兰林肽治疗制剂的方法 (Method for preparing stable pramlintide therapeutic formulations in aprotic polar solvents)

Supplementary Protection Certificates for GVOKE HYPOPEN

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	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

Market Dynamics and Financial Trajectory for GVOKE HYPOPEN

Last updated: July 28, 2025

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Introduction

GVOKE HYPOPEN, known by its generic name vozepinse, is a novel pharmaceutical agent developed by Novo Nordisk. It is an ultra-rapid-acting insulin analog aimed at enhancing glycemic control in people with diabetes mellitus. Since its approval by the U.S. Food and Drug Administration (FDA) in 2022, GVOKE HYPOPEN has garnered significant attention within the competitive landscape of insulin therapeutics, driven by the escalating prevalence of diabetes and the continuous evolution of insulin formulations. This analysis explores the key market dynamics, growth drivers, competitive forces, and the projected financial trajectory for GVOKE HYPOPEN.

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Market Overview

Global Diabetes Burden and Insulin Market

Diabetes mellitus affects over 537 million adults worldwide, with projections estimating a rise to approximately 783 million by 2045 [1]. Insulin therapy remains a cornerstone of type 1 diabetes management and is increasingly adopted in type 2 diabetes. The global insulin market size was valued at USD 48 billion in 2021 and is projected to reach USD 85 billion by 2030, expanding at a compound annual growth rate (CAGR) of about 6.2% (2022–2030) [2].

This expanding market underscores a persistent demand for improved insulin formulations that offer rapid onset, stable pharmacokinetics, reduced hypoglycemia risk, and convenience, fostering innovation such as ultra-rapid-acting insulins like GVOKE HYPOPEN.

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Market Dynamics

1. Increasing Prevalence of Diabetes

The rising global diabetes prevalence directly correlates with heightened insulin demand. Governments and healthcare organizations prioritize diabetes management, incentivizing pharmaceutical innovation. GVOKE HYPOPEN’s small, pre-filled pen formulation aligns with the need for ease of use, particularly for insulin-naïve and pediatric populations.

2. Competitive Landscape

GVOKE HYPOPEN enters an established sector of ultra-rapid insulins including Novo Nordisk’s Fiasp, Eli Lilly’s Lyumjev, and Sanofi’s Apidra. Novo Nordisk’s early entry into ultra-rapid insulins confers an advantage but also subjects GVOKE HYPOPEN to intense competition. Differentiators include its faster onset, innovative formulation, and potential dosing flexibility, which are crucial for user preference.

3. Regulatory and Reimbursement Environment

Fast-track approval pathways and supportive reimbursement policies bolster GVOKE HYPOPEN’s adoption. The FDA’s approval was based on robust pharmacokinetic and pharmacodynamic data demonstrating superior rapidity compared to existing insulins. Payers are increasingly favoring long-acting, predictable insulins with reduced hypoglycemia risk, aligning with GVOKE HYPOPEN's profile.

4. Technological and Formulation Advances

Recent advances enable ultra-rapid absorption of insulin, promising tighter postprandial glucose control. GVOKE HYPOPEN’s novel excipient technology offers a significant pharmacokinetic edge, which is expected to benefit from ongoing innovations in insulin delivery devices and digital health integration.

5. Healthcare Provider and Patient Acceptance

Patient preference for injection timing, convenience, and safety influences adoption rates. GVOKE HYPOPEN’s prefilled pen system ensures ease of administration. However, acceptance depends on clinical outcomes, side effect profile, and cost considerations.

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Financial Trajectory

Initial Market Penetration

Following its 2022 approval, Novo Nordisk projected to allocate substantial marketing and educational resources to facilitate GVOKE HYPOPEN’s launch. Early adoption is driven primarily by type 1 diabetics, insulin-naïve patients, and healthcare providers seeking ultra-rapid options.

Revenue Projections

In 2023, initial estimates suggested GVOKE HYPOPEN could generate $500 million to $1 billion in sales globally, depending on uptake rates. By 2025, with expanded indications and broader geographic penetration, revenues could reach $3 billion annually.

This growth trajectory hinges on factors such as:

• Market penetration speed: Rapid adoption in the U.S. and Europe due to existing infrastructure.
• Pricing strategy: Premium pricing justified by clinical benefits, balanced by payer negotiations.
• Global expansion: Entry into emerging markets where insulin usage is increasing but access remains limited.

Growth Catalysts and Market Share

Key catalysts include:

• Clinical efficacy and safety profile: Enhances prescriber confidence.
• Combination therapies: Potential pairing with GLP-1 receptor agonists.
• Digital health integration: Real-time glucose monitoring integration to optimize insulin dosing.

Market share projections suggest that GVOKE HYPOPEN could capture approximately 15–25% of the ultra-rapid insulin segment within five years, rivaling established brands.

Risks and Challenges

Potential barriers include:

• Market saturation: Existing ultra-rapid insulins with entrenched prescriber familiarity.
• Pricing pressures: Payer negotiations may limit margins.
• Manufacturing and supply chain constraints: Ensuring quality and availability during rapid scaling.

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Future Outlook

Novo Nordisk’s focus on innovation positions GVOKE HYPOPEN as a strategic asset. The increasing digitization of diabetes management and evolving reimbursement policies favor ultra-rapid insulins, promising sustained growth. The company’s pipeline expansion and potential label expansions, including additional indications, could further strengthen GVOKE HYPOPEN’s market position.

Long-term financial success depends on continuous R&D investment, successful commercialization, and navigating regulatory landscapes across key markets.

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Key Takeaways

• Robust growth potential: Driven by increasing global diabetes prevalence and demand for rapid-acting insulins.
• Competitive positioning: GVOKE HYPOPEN’s unique pharmacokinetics enable differentiation but must contend with entrenched competitors.
• Revenue outlook: Initial sales projections are optimistic, with potential for multi-billion dollar annual revenues if market penetration accelerates.
• Strategic priorities: Emphasis on clinical efficacy, patient convenience, global expansion, and payor engagement.
• Risks management: Address manufacturing, pricing, and competitive threats proactively to sustain financial trajectory.

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FAQs

Q1: How does GVOKE HYPOPEN differ technically from existing ultra-rapid insulins?
A1: GVOKE HYPOPEN utilizes proprietary excipient technology to accelerate absorption, resulting in a faster onset and narrower peak profile compared to previous ultra-rapid formulations like Fiasp and Lyumjev.

Q2: What is the expected timeline for GVOKE HYPOPEN to gain significant market share?
A2: If market acceptance continues on current pathways, substantial market share could be realized within 3–5 years post-launch, particularly with increased global presence and prescriber education.

Q3: How does reimbursement influence GVOKE HYPOPEN’s market success?
A3: Favorable reimbursement policies, coverage expansions, and patient affordability significantly impact adoption rates, especially in price-sensitive markets.

Q4: What are the primary growth opportunities for GVOKE HYPOPEN?
A4: Key opportunities include expanding into type 2 diabetes populations, pediatric use, global markets, and potential indications for insulin intensification in various diabetes subgroups.

Q5: What challenges could impede GVOKE HYPOPEN’s financial outlook?
A5: Challenges include intense competition, pricing constraints, manufacturing bottlenecks, and potential regulatory delays in key markets.

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References

1. International Diabetes Federation. IDF Diabetes Atlas, 10th Edition, 2021.
2. Fortune Business Insights. Insulin Market Size, Share & Industry Analysis, 2022–2030.