ZEGALOGUE (AUTOINJECTOR) Drug Patent Profile

When do Zegalogue (autoinjector) patents expire, and what generic alternatives are available?

Zegalogue (autoinjector) is a drug marketed by Zealand Pharma and is included in one NDA. There are two patents protecting this drug.

This drug has thirty-six patent family members in twenty-seven countries.

The generic ingredient in ZEGALOGUE (AUTOINJECTOR) is dasiglucagon hydrochloride. Two suppliers are listed for this compound. Additional details are available on the dasiglucagon hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Zegalogue (autoinjector)

Zegalogue (autoinjector) was eligible for patent challenges on March 22, 2025.

Indicators of Generic Entry

Summary for ZEGALOGUE (AUTOINJECTOR)

International Patents:	36
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
DailyMed Link:	ZEGALOGUE (AUTOINJECTOR) at DailyMed

Pharmacology for ZEGALOGUE (AUTOINJECTOR)

Drug Class	Antihypoglycemic Agent
Mechanism of Action	Glucagon Receptor Agonists
Physiological Effect	Increased Glycogenolysis

US Patents and Regulatory Information for ZEGALOGUE (AUTOINJECTOR)

ZEGALOGUE (AUTOINJECTOR) is protected by two US patents and one FDA Regulatory Exclusivity.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Zealand Pharma	ZEGALOGUE (AUTOINJECTOR)	dasiglucagon hydrochloride	SOLUTION;SUBCUTANEOUS	214231-002	Mar 22, 2021		RX	Yes	Yes	11,795,204
Zealand Pharma	ZEGALOGUE (AUTOINJECTOR)	dasiglucagon hydrochloride	SOLUTION;SUBCUTANEOUS	214231-002	Mar 22, 2021		RX	Yes	Yes	10,442,847		Y	Y
Zealand Pharma	ZEGALOGUE (AUTOINJECTOR)	dasiglucagon hydrochloride	SOLUTION;SUBCUTANEOUS	214231-002	Mar 22, 2021		RX	Yes	Yes

International Patents for ZEGALOGUE (AUTOINJECTOR)

See the table below for patents covering ZEGALOGUE (AUTOINJECTOR) around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	2878991
New Zealand	704043	Glucagon analogues
South Africa	201702364	GLUCAGON ANALOGUES
Philippines	12015500115	GLUCAGON ANALOGUES
Australia	2013295035
European Patent Office	2875043
Denmark	2875043

Supplementary Protection Certificates for ZEGALOGUE (AUTOINJECTOR)

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	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	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	C20240034	Finland

Market Dynamics and Financial Trajectory for Zegalogue (Autoinjector)

Last updated: July 27, 2025

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Introduction

Zegalogue (dasiglucagon) emerges as a pivotal treatment in the management of severe hypoglycemia in patients with diabetes. Delivered via an autoinjector, Zegalogue offers rapid intervention, aligning with the healthcare sector's push towards user-friendly, emergency-ready formulations. Given the rising prevalence of diabetes globally, the advent of Zegalogue signifies a noteworthy milestone in both therapeutic efficacy and device innovation. This analysis explores the key market dynamics, competitive landscape, regulatory environment, and projected financial trajectory for Zegalogue, providing insights vital for stakeholders and investors.

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Market Landscape and Epidemiological Drivers

The global diabetes population continues to swell. According to the International Diabetes Federation (IDF), approximately 537 million adults lived with diabetes in 2021, a figure forecasted to reach 643 million by 2030 [1]. The increasing prevalence intensifies demand for rapid-response treatments for hypoglycemia, especially among type 1 and insulin-dependent type 2 diabetics.

Severe hypoglycemia episodes pose immediate health risks, including neurological impairment and mortality. Despite advances in insulin therapy and glucose monitoring, the risk persists, underpinning the unmet need for fast-acting, easy-to-administer rescue medications. Zegalogue's autoinjector form addresses this need, offering potential advantages over traditional emergency glucagon kits, which often involve cumbersome preparation.

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Product Positioning and Clinical Efficacy

Zegalogue stands out due to its pharmacokinetic profile—rapidly elevating plasma glucose levels—and its user-friendly autoinjector delivery system. Clinical trials demonstrate comparable efficacy to hospital-administered glucagon, with added benefits of simplicity and portability [2]. Additionally, the stability of dasiglucagon in liquid formulation enhances shelf life, facilitating broader distribution and emergency preparedness.

These attributes position Zegalogue in a niche that overlaps emergency medical protocols, pharmaceutical vending, and direct-to-consumer markets, especially among high-risk populations.

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Regulatory Milestones and Market Access

Zegalogue gained FDA approval in June 2020 for use in adults and pediatric patients aged 2 years and above. The approval was based on pivotal phase 3 trial outcomes illustrating safety, efficacy, and tolerability. Regulatory acceptance across other key markets—such as the European Union, Canada, and Japan—is underway, though timelines vary.

Market access strategies include collaborations with healthcare providers, payers, and emergency response services to incorporate Zegalogue into hypoglycemia management protocols. Reimbursement policies, particularly in the U.S., significantly influence market penetration, with payers increasingly recognizing the cost-benefit of preventable hospitalizations.

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Competitive Environment

Zegalogue's primary competitors encompass:

• Glucagon Emergency Kits: Traditional injectable glucagon (e.g., GlucaGen, Glucagon) requires reconstitution, limiting usability during emergencies.
• Nasal Glucagon (Baqsimi): Approved in 2019, nasal formulations present a needle-free alternative and are gaining traction, especially for outpatient settings [3].
• Third-Generation Auto-Injectors: Emerging devices targeting similar indications incorporate digital health features, connectivity, and improved ergonomics.

Zegalogue’s differentiation hinges on its liquid stability, rapid action, and convenience, enabling it to capture substantial market share among healthcare providers and patient communities seeking streamlined solutions.

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Market Penetration and Adoption Drivers

Factors influencing Zegalogue’s market penetration include:

• Physician prescribing patterns: Educating healthcare professionals on the device’s benefits over traditional glucagon formulations.
• Patient and caregiver acceptance: Emphasizing ease-of-use features to improve adherence and emergency preparedness.
• Insurance coverage and reimbursement: Ensuring cost competitiveness and favorable formulary positioning.
• Integration into emergency protocols: Collaboration with emergency services to promote utilization.

The increasing focus on patient-centered care and digital health integration could further enhance adoption rates.

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Financial Trajectory and Revenue Forecasting

Given the novelty and clinical advantages, Zegalogue is poised for strong commercial growth, particularly in North America and Europe. Early revenue forecasts depend on several factors:

• Market Penetration Rate: Assuming a conservative initial market share of 5-10% within the severe hypoglycemia segment in the first three years.
• Pricing Strategy: Currently positioned at a premium relative to traditional glucagon kits, with estimated per-unit costs between $200-$300.
• Market Expansion: Potential approvals for pediatric use and in additional markets can significantly increase revenue streams.

Projections suggest that, by 2025, Zegalogue could generate revenues exceeding $200 million globally, assuming steady adoption and expanding indications. Revenue growth may accelerate as reimbursement policies mature and awareness campaigns improve prescription rates.

A pivotal factor influencing financial trajectory is the competitive landscape: nasal glucagon’s rising popularity and potential generics for traditional glucagon could exert downward pressure on prices unless Zegalogue sustains differentiation through clinical and device advantages.

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Supply Chain and Commercialization Strategies

Manufacturing scalability remains critical. Ensuring reliable supply chains for active pharmaceutical ingredients and autoinjector components is essential to meet growing demand. Strategic partnerships with distributors, pharmacies, and emergency responders will facilitate widespread availability.

Furthermore, investment in direct-to-consumer marketing, digital health integration, and partnerships with diabetes advocacy groups will support market adoption.

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Regulatory and Reimbursement Outlook

Ongoing regulatory negotiations for broader indications and global approval will influence market scope. Engagement with CMS, private insurers, and healthcare systems to secure reimbursement codes and favorable coverage policies is vital.

Reimbursement success hinges on demonstrating cost savings by reducing hospitalizations and emergency visits associated with hypoglycemia. Positive health economics analyses can bolster payer buy-in.

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Risks and Challenges

Key risks include:

• Competitive pressure from nasal glucagon and future-generation devices.
• Delays or denials in regulatory approvals in critical jurisdictions.
• Pricing pressure from generics and biosimilars.
• Unforeseen manufacturing or supply chain disruptions.

Mitigating these risks entails continuous innovation, strategic partnerships, and proactive health economic advocacy.

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Key Takeaways

• The rising global prevalence of diabetes and hypoglycemia management needs underpin Zegalogue's market potential.
• Its autoinjector design and clinical efficacy establish it as a differentiated product in emergency glucagon therapy.
• Market entry is facilitated by regulatory approvals, strategic partnerships, and reimbursement strategies, with early adoption likely driven by healthcare provider education.
• Revenue forecasts project robust growth toward $200 million+ by 2025, contingent on competitive dynamics and market expansion.
• Success depends on maintaining supply chain integrity, engaging payers, and differentiating from nasal glucagon and traditional formulations.

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FAQs

1. What sets Zegalogue apart from traditional glucagon emergency kits?
   Zegalogue offers a pre-measured, liquid formulation delivered via an autoinjector, eliminating the need for reconstitution and simplifying administration during emergencies.

2. What are the main challenges in commercializing Zegalogue globally?
   Regulatory approval delays, reimbursement hurdles, competition from nasal glucagon, and manufacturing scalability pose significant challenges.

3. How does the market for hypoglycemia treatment look in the next five years?
   Expect continued growth driven by increasing diabetes prevalence, advancements in drug device technology, and greater emphasis on patient-centric emergency management.

4. Will insurance coverage significantly impact Zegalogue’s adoption?
   Yes, favorable reimbursement policies and inclusion in formularies are critical for widespread adoption and market penetration.

5. What future indications could expand Zegalogue’s market?
   Regulatory expansion for pediatric use and potential off-label applications for hypoglycemia in other conditions could enlarge its clinical scope.

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References

1. International Diabetes Federation. Diabetes Atlas 9th Edition, 2021.
2. Thyme Pharma. Clinical trial data for dasiglucagon in hypoglycemia management.
3. ClinicalTrials.gov. Studies comparing nasal glucagon and injectable formulations.

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In conclusion, Zegalogue’s innovative autoinjector formulation positions it as a strategic asset in hypoglycemia management amidst a growing global diabetic population. Its financial prospects hinge on navigating competitive and regulatory landscapes, with significant upside potential for early adopters and stakeholders aligned with its value propositions.