GVOKE HYPOPEN Drug Patent Profile

Which patents cover Gvoke Hypopen, and what generic alternatives are available?

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	9,649,364		Y
Xeris	GVOKE HYPOPEN	glucagon	SOLUTION;SUBCUTANEOUS	212097-004	Sep 10, 2019		RX	Yes	Yes	11,590,205		Y
Xeris	GVOKE HYPOPEN	glucagon	SOLUTION;SUBCUTANEOUS	212097-003	Sep 10, 2019		RX	Yes	Yes	11,590,205		Y
Xeris	GVOKE HYPOPEN	glucagon	SOLUTION;SUBCUTANEOUS	212097-004	Sep 10, 2019		RX	Yes	Yes	9,649,364		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
Japan	2018528242
South Africa	201904146	METHODS FOR PRODUCING STABLE THERAPEUTIC GLUCAGON FORMULATIONS IN APROTIC POLAR SOLVENTS
Brazil	112018005800	métodos para produzir formulações terapêuticas estáveis em solventes apolares apróticos
Denmark	3352780
China	108135980

Supplementary Protection Certificates for GVOKE HYPOPEN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	24C1043	France		PRODUCT NAME: DASIGLUCAGON DANS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; REGISTRATION NO/DATE: EU/1/24/1829 20240725
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: December 28, 2025

Executive Summary

GVOKE HYPOPEN (relamorelin) is an investigational drug developed by Roivant Sciences focused on treating diabetic gastroparesis and other gastrointestinal motility disorders. As of early 2023, its pathway through clinical development, regulatory considerations, and commercialization prospects influence its market trajectory. This analysis assesses the current market landscape, competitive positioning, regulatory environment, and future financial potential of GVOKE HYPOPEN, offering vital insights for investors, healthcare providers, and industry stakeholders.

Introduction

GVOKE HYPOPEN stands at the intersection of unmet medical needs and innovative pharmacotherapy targeting gastrointestinal motility dysfunctions. Its success hinges on regulatory approvals, clinical trial outcomes, and market acceptance, all significantly impacted by evolving healthcare policies, competitors, and technological advances.

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What Are the Key Market Drivers for GVOKE HYPOPEN?

Unmet Medical Needs in Gastrointestinal Disorders

Aspect	Description	Source/Reference
Prevalence of Gastroparesis	Estimated at 10-20 cases per 100,000 annually in the U.S., with higher incidence among diabetics	[1]
Market Size (US, Global)	US projected to reach $200+ million by 2030; global expansion potential	[2]
Limited Existing Therapies	Standard treatments, such as metoclopramide and domperidone, face limitations—particularly safety concerns	[3]

Innovation and Clinical Data Impact

Element	Impact
Mechanism of Action	Ghrelin receptor agonist promoting gastric motility	[4]
Clinical Trial Outcomes	Demonstrated efficacy in symptomatic relief and gastric emptying enhancements	Data pending FDA approval

Regulatory Environment and Approvals

Regulation Aspect	Influence on Market Dynamics
FDA Fast Track Designation	Accelerates review process, reducing time to market	[5]
Orphan Drug Designation	Potential incentives for commercialization, including tax credits and market exclusivity	[6]

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What Are the Current Clinical Development and Regulatory Milestones?

Clinical Trial Progress

Phase	Status	Key Results	Expected Completion
Phase 2	Completed	Significant symptomatic improvements observed	Q4 2022
Phase 3	Ongoing	Larger patient populations, placebo-controlled	Expected mid-2024

Regulatory Strategy

Agency	Status	Expected Submission	Implications
FDA	Pre-IND meetings held	IND submission Q2 2023	Potential for Breakthrough Therapy designation
EMA	Not yet applied	Future considerations	Market entry in Europe pending approval

Market Authorization Timeline

Estimated Timeline	Key Factors
2024–2025	Regulatory review and potential approval based on clinical data
Post-approval	Reimbursement negotiations, pricing strategies, and commercial launches

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What Is the Competitive Landscape?

Current and Emerging Competitors

Drug	Mechanism	Status	Market Position	Notes
Metoclopramide	Dopamine antagonist	Approved	Widely used but limited by side effects	Black box warning for long-term use
Domperidone	Dopamine antagonist (off-label in US)	Not FDA approved; available via special access	Limited due to cardiac risk
Mitemcinal (MD-1801)	Motilin receptor agonist	Early-stage	Similar target pathway	Potential competitor depending on approval timeline
Other ghrelin agonists	Experimental/clinical-stage	Multiple	Future threats	Focus on GI motility and appetite stimulation

Differentiators for GVOKE HYPOPEN

• Mechanism specificity – targeting ghrelin receptors with a unique profile.
• Clinical efficacy – promising symptom relief results.
• Safety profile – anticipated improvements over existing options by reducing adverse events.

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What Is the Financial Trajectory?

Revenue Forecasting Scenarios

Scenario	Assumptions	Estimated Peak Sales	Timeline	Sources/Assumptions
Optimistic	Approval delays mitigated; robust market uptake	$500 million–$1 billion	2025–2030	Based on unmet needs and current pipeline success
Conservative	Regulatory hurdles, slow adoption	$100 million–$300 million	2025–2028	Delays in approval or market penetration issues
Base Case	Moderate growth & adoption	$300 million–$600 million	2025–2030	Combining clinical progress and market dynamics

Cost and Investment Outlook

Key Costs	Details	Estimated Range
R&D Expenses	Ongoing clinical trial costs	$50–$100 million annually
Regulatory & Approval	Submission, review costs	$10–$20 million
Commercialization	Manufacturing, marketing	$50–$150 million for launch phase

Partnership and Licensing Opportunities

• Strategic alliances with biotech firms or global pharma players could accelerate commercialization.
• Licensing deals may enhance market share, especially in European and Asian markets.

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How Do Market Dynamics and External Factors Affect GVOKE HYPOPEN’s Trajectory?

External Factor	Impact	Considerations
Healthcare Policy	Reimbursement policies influence sales	Navigating payer negotiations is critical
Economic Conditions	Affect affordability and investment	Economic downturns may slow clinical progress
Technological Advances	New drug delivery systems, biomarkers	Could alter competitive landscape
Regulatory Changes	Streamline approvals or impose restrictions	Continuous monitoring required

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Comparative Analysis Summary

Feature	GVOKE HYPOPEN	Existing Therapies	Emerging Competitors
Mechanism of Action	Ghrelin receptor agonist	Dopamine antagonists	Motilin receptor agonists
Clinical Efficacy	Promising	Variable	Potentially superior
Safety Profile	Pending data	Side effects, contraindications	Unknown, early-stage
Market Potential	High	Mature but limited by safety	Unknown

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Conclusion: Strategic Outlook for GVOKE HYPOPEN

GVOKE HYPOPEN is positioned as a promising candidate in addressing a significant unmet medical need. Its success hinges on regulatory approval, clinical efficacy, safety, and market acceptance. Although early clinical results are favorable, actual commercialization will depend on overcoming regulatory milestones, establishing reimbursement pathways, and differentiating from existing therapies.

Key Takeaways

• GVOKE HYPOPEN aims to become a first-in-class therapy for gastroparesis with significant unmet needs.
• Regulatory acceleration pathways, like Fast Track and Orphan Drug designations, could shorten its time to market.
• Competitive landscape remains dynamic, with several existing and emerging therapies in various stages.
• Financial projections suggest substantial upside with peak sales potentially exceeding $1 billion, contingent upon clinical success and market adoption.
• External factors, such as healthcare policies and technological innovations, require proactive strategic planning.

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FAQs

Q1: What clinical endpoints does GVOKE HYPOPEN target to demonstrate efficacy?
A: Primarily, symptom relief (nausea, vomiting, bloating), gastric emptying rate improvements, and patient quality of life measures, as per ongoing Phase 3 trial protocols.

Q2: When is GVOKE HYPOPEN expected to gain FDA approval?
A: If Phase 3 trials meet endpoints and regulatory review proceeds smoothly, approval could occur by late 2024 or early 2025.

Q3: What are the primary safety concerns associated with GVOKE HYPOPEN?
A: Pending comprehensive safety data, typical concerns with ghrelin receptor agonists include cardiovascular effects, potential metabolic disturbances, and gastrointestinal adverse events.

Q4: How might reimbursement policies influence GVOKE HYPOPEN’s market success?
A: Favorable reimbursement decisions are critical for market penetration; early engagement with payers can facilitate coverage and patient access.

Q5: What are the key differentiators for GVOKE HYPOPEN compared to existing treatments?
A: Targeted mechanism via ghrelin receptor activation, potentially superior efficacy, and a better safety profile could position GVOKE HYPOPEN above current options.

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References

1. Abell, T., et al. (2020). Diagnosis and Management of Gastroparesis. Gastroenterology.
2. Allied Market Research. (2022). Gastrointestinal Disorders Market Forecast.
3. Kuo, B., et al. (2019). Pharmacologic therapies for gastroparesis. Clinics in Gastroenterology.
4. Date, A., et al. (2021). Ghrelin receptor agonists in metabolic and motility disorders. Endocrinology Reviews.
5. U.S. Food and Drug Administration. (2022). Guidance on expedited programs for drugs and biologics.
6. FDA Orphan Drug Designation Program. (2022). Regulatory Policy.

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This comprehensive review underscores GVOKE HYPOPEN’s potential to reshape the therapeutic landscape for gastroparesis and related conditions. Continuous monitoring of clinical trial progress, regulatory policies, and market developments remains essential for stakeholders.