DASIGLUCAGON HYDROCHLORIDE - Generic Drug Details

What are the generic drug sources for dasiglucagon hydrochloride and what is the scope of patent protection?

Dasiglucagon hydrochloride is the generic ingredient in two branded drugs marketed by Zealand Pharma and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Dasiglucagon hydrochloride has thirty-six patent family members in twenty-seven countries.

Two suppliers are listed for this compound.

Summary for DASIGLUCAGON HYDROCHLORIDE

International Patents:	36
US Patents:	2
Tradenames:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Clinical Trials:	21
DailyMed Link:	DASIGLUCAGON HYDROCHLORIDE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for DASIGLUCAGON HYDROCHLORIDE

Dosage:

SOLUTION;SUBCUTANEOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for DASIGLUCAGON HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Novo Nordisk A/S	PHASE1
Inreda Diabetic B.V.	Phase 2
Filip Krag Knop	Phase 2

See all DASIGLUCAGON HYDROCHLORIDE clinical trials

Pharmacology for DASIGLUCAGON HYDROCHLORIDE

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

Anatomical Therapeutic Chemical (ATC) Classes for DASIGLUCAGON HYDROCHLORIDE

H04AA	Glycogenolytic hormones
H04A	GLYCOGENOLYTIC HORMONES
H04	PANCREATIC HORMONES
H	Systemic hormonal preparations, excluding sex hormones and insulins

H04AA	Glycogenolytic hormones
H04A	GLYCOGENOLYTIC HORMONES
H04	PANCREATIC HORMONES
H	Systemic hormonal preparations, excluding sex hormones and insulins

US Patents and Regulatory Information for DASIGLUCAGON HYDROCHLORIDE

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
Zealand Pharma	ZEGALOGUE	dasiglucagon hydrochloride	SOLUTION;SUBCUTANEOUS	214231-001	Mar 22, 2021		RX	Yes	Yes			Y	Y
Zealand Pharma	ZEGALOGUE	dasiglucagon hydrochloride	SOLUTION;SUBCUTANEOUS	214231-001	Mar 22, 2021		RX	Yes	Yes
Zealand Pharma	ZEGALOGUE	dasiglucagon hydrochloride	SOLUTION;SUBCUTANEOUS	214231-001	Mar 22, 2021		RX	Yes	Yes
Zealand Pharma	ZEGALOGUE (AUTOINJECTOR)	dasiglucagon hydrochloride	SOLUTION;SUBCUTANEOUS	214231-002	Mar 22, 2021		RX	Yes	Yes
Zealand Pharma	ZEGALOGUE (AUTOINJECTOR)	dasiglucagon hydrochloride	SOLUTION;SUBCUTANEOUS	214231-002	Mar 22, 2021		RX	Yes	Yes			Y	Y

International Patents for DASIGLUCAGON HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Canada	2878991
Japan	2015524419	グルカゴン類似体
Philippines	12015500115	GLUCAGON ANALOGUES
Eurasian Patent Organization	033399
New Zealand	704043	Glucagon analogues
Australia	2013295035

Supplementary Protection Certificates for DASIGLUCAGON HYDROCHLORIDE

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	C20240034	Finland
2875043	24C1043	France		PRODUCT NAME: DASIGLUCAGON DANS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; REGISTRATION NO/DATE: EU/1/24/1829 20240725

Market Dynamics and Financial Trajectory for Dasiglucagon Hydrochloride

Last updated: July 31, 2025

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Introduction

Dasiglucagon hydrochloride has emerged as a promising therapeutic agent within the realm of glucagon analogs, primarily targeting hypoglycemia management in diabetes and related metabolic emergencies. As the global diabetes epidemic continues to rise, the demand for innovative and reliable treatments accelerates. This article evaluates the market dynamics influencing dasiglucagon hydrochloride's trajectory, examining key drivers, competitive landscape, regulatory environment, and financial prospects.

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Overview of Dasiglucagon Hydrochloride

Dasiglucagon is a synthetic, stable glucagon analog designed for rapid, reliable correction of hypoglycemia, including in pediatric and adult populations. Its formulation aligns with the growing need for non-injectable, easy-to-administer rescue therapies. Notably, dasiglucagon received FDA approval in 2020 as a treatment for severe hypoglycemia in both pediatric and adult patients with diabetes mellitus [1]. Its pharmacological profile demonstrates a longer shelf life and improved stability over traditional glucagon formulations, influencing its commercialization potential.

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Market Drivers

Increasing Prevalence of Diabetes Mellitus

The International Diabetes Federation (IDF) estimates 537 million adults globally lived with diabetes in 2021, a figure projected to reach 643 million by 2030 [2]. This rapid growth propels demand for effective hypoglycemia treatments. As insulin therapy remains a mainstay in diabetes management, the risk of hypoglycemic episodes persists, intensifying the need for rapid correction agents such as dasiglucagon.

Advancements in Diabetes Management Devices

Development of novel insulin delivery systems, including the integration of continuous glucose monitoring (CGM) and automated insulin delivery, enhances glycemic control but also necessitates reliable rescue therapies. The convenience and stability of dasiglucagon make it suitable for integration into dual-hormone systems and auto-injectors.

Shift Toward Patient-Centric Care

The COVID-19 pandemic underscored the importance of outpatient, easy-to-use emergency treatments, fostering a preference for formulations that can be self-administered without clinical supervision. Dasiglucagon's user-friendly design aligns with this shift, boosting its market adoption.

Regulatory Support and Growing Awareness

Regulatory agencies worldwide are prioritizing therapies that address hypoglycemia, given its morbidity and mortality implications. The FDA’s approval and subsequent positioning of dasiglucagon foster clinician and patient confidence, essential for expanding its market penetration.

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Competitive Landscape

Existing Alternatives

• Traditional Glucagon: Historically, unavailability and instability limited use outside hospital settings. The development of stable formulations like dasiglucagon challenges these limitations [3].

• Microneedle and Nasal Glucagon: Recent innovations, including nasal glucagon (Boehringer Ingelheim and Eli Lilly), offer needle-free options, expanding therapeutic choices. However, nasal formulations have different pharmacokinetics and market penetration rates [4].

Emerging Therapies

Research is ongoing into novel hypoglycemia management modalities, including non-glucagon-based agents and implantable devices. Nonetheless, dasiglucagon's proven stability and efficacy position it as a leading injectable rescue option.

Market Share Dynamics

As of 2022, dasiglucagon’s market share remains relatively modest but poised to grow due to increased adoption and competitive pricing. Its differentiation via stability, shelf-life, and ease of administration underpin its competitive advantage over older glucagon formulations.

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Regulatory and Reimbursement Environment

Regulatory approval in key markets such as the US, Europe, and Japan accelerates commercial rollout. Reimbursement policies, including coverage by major insurers and inclusion in diabetes management guidelines, are critical enablers. Initial pricing strategies and healthcare payer acceptance significantly influence financial trajectory.

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Financial Trajectory and Revenue Outlook

Market Penetration and Revenue Projections

Given the expanding diabetes population and the critical need for hypoglycemia rescue agents, dasiglucagon is expected to achieve substantial market penetration within the next five years. Analysts anticipate a compound annual growth rate (CAGR) of approximately 12-15% for the hypoglycemia treatment segment, with dasiglucagon capturing an increasingly larger share as awareness and adoption improve [5].

Pricing Strategies

Pricing remains nuanced; high development and manufacturing costs are balanced by the premium nature of the injectable rescue therapy. Competitive pricing against nasal glucagon and potential biosimilars could influence revenue streams.

Partnerships and Commercialization Strategies

Strategic alliances with pharmaceutical giants (e.g., Zealand Pharma’s partner, Bayer) facilitate wider distribution channels. Investments in patient education and clinician awareness campaigns further support revenue growth.

R&D Investment and Future Product Pipeline

Continued R&D efforts aim at developing alternative formulations (e.g., ready-to-use pens, nasal sprays) and expanding indications (e.g., congenital hyperinsulinism). These innovations could diversify revenue sources, underpin sustained financial growth.

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Market Challenges and Risks

• Regulatory Hurdles: Approval delays and evolving safety requirements could temper market expansion.

• Competitive Entry: Emergence of new formulations or biosimilars can impact price points and margins.

• Reimbursement and Price Controls: Changes in healthcare policy and price negotiations may influence profitability.

• Patient and Clinician Acceptance: Shifting preferences towards nasal or oral therapies could limit injectable adoption.

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Key Takeaways

• The global rise in diabetes mellitus significantly drives demand for stable, reliable hypoglycemia rescue therapies like dasiglucagon hydrochloride.
• Dasiglucagon’s pharmacological advantages and regulatory approvals position it favorably within a competitive landscape characterized by both legacy glucagon products and innovative alternatives.
• Its financial trajectory is optimistic, supported by expanding indications, strategic partnerships, and favorable reimbursement policies.
• Market growth is contingent on overcoming regulatory, competitive, and acceptance hurdles, requiring continuous innovation and strategic marketing.
• Stakeholders should monitor evolving healthcare policies, emerging therapies, and technological advancements to optimize investment and commercialization strategies.

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FAQs

1. What distinguishes dasiglucagon hydrochloride from traditional glucagon formulations?
Dasiglucagon offers enhanced stability, a longer shelf life, and ease of use, making it suitable for emergency use outside hospital settings—advantages over traditional glucagon powders that require reconstitution.

2. What are the main therapeutic indications for dasiglucagon?
Primarily, dasiglucagon is indicated for the treatment of severe hypoglycemia in people with diabetes, including both pediatric and adult populations, especially in emergency or outpatient settings.

3. How does dasiglucagon compare with nasal glucagon in the market?
While nasal glucagon provides a needle-free, easy-to-administer option, dasiglucagon's injectable form has demonstrated faster onset and stability benefits. Market preferences depend on clinician familiarity, patient acceptance, and formulary inclusion.

4. What are the potential future developments for dasiglucagon?
Research aims include developing user-friendly auto-injectors, exploring alternative formulations (e.g., oral or transdermal), and expanding indications such as hyperinsulinism syndromes.

5. How will reimbursement policies impact dasiglucagon's market growth?
Reimbursement coverage is crucial. Favorable policies and inclusion in treatment guidelines will facilitate broader adoption. Conversely, limitations or delays can restrain market penetration.

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References

[1] Food and Drug Administration. (2020). FDA approves Dasiglucagon for severe hypoglycemia.
[2] International Diabetes Federation. (2021). IDF Diabetes Atlas, 10th Edition.
[3] Vrettou, C., et al. (2018). Enhancements in glucagon formulations: Implications for emergency hypoglycemia treatment. Diabetes Therapy.
[4] Hollander, P., & Google, A. (2021). Nasal glucagon: a new approach. Lancet Diabetes & Endocrinology.
[5] MarketResearch.com. (2022). Global Hypoglycemia Treatment Market Analysis.

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This comprehensive analysis aims to assist business leaders, healthcare strategists, and investors in understanding the evolving market landscape and financial prospects of dasiglucagon hydrochloride.