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.

One supplier is listed for this compound.

Summary for DASIGLUCAGON HYDROCHLORIDE

International Patents:	36
US Patents:	2
Tradenames:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
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	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
Zealand Pharma	ZEGALOGUE (AUTOINJECTOR)	dasiglucagon hydrochloride	SOLUTION;SUBCUTANEOUS	214231-002	Mar 22, 2021		RX	Yes	Yes			Y	Y
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

International Patents for DASIGLUCAGON HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Israel	236554
Finland	C20240034
Taiwan	I642682
Netherlands	301294
China	104662038
Japan	2015524419	グルカゴン類似体

Supplementary Protection Certificates for DASIGLUCAGON HYDROCHLORIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	24C1043	France		PRODUCT NAME: DASIGLUCAGON DANS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; 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
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

Market Overview and Financial Trajectory of Dasiglucagon Hydrochloride

Last updated: February 16, 2026

Dasiglucagon hydrochloride is a synthetic glucagon analog, primarily developed for adjunctive therapy in severe hypoglycemia among patients with diabetes. Its approval by the FDA in March 2021 marked a significant milestone, positioning it as a potential competitor to existing emergency hypoglycemia treatments such as glucagon emergency kits and nasal glucagon products.

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Market Size and Growth Potential

The global hypoglycemia treatment market was valued at approximately $1.7 billion in 2022. The market for injectable glucagon therapies, including dasiglucagon, is projected to reach $3.2 billion by 2030, growing at a compounded annual growth rate (CAGR) of around 7.5% (2023–2030). The expansion hinges on the increasing prevalence of diabetes, improved treatment protocols, and the demand for user-friendly emergency management options.

Key Market Drivers:

• Rising diabetes prevalence: Estimated to reach 600 million globally by 2040 (WHO).
• Preference for non-injectable treatments: Nasal and autoinjector formulations increase adherence.
• Regulatory endorsements: FDA approval in 2021 and subsequent approvals in Europe and Asia expand market access.

Major Regional Markets:	Region	Market Size (2022)	Projected CAGR (2023–2030)	Notes
North America	$850 million	7.2%	Dominance due to high diabetes prevalence, healthcare infrastructure
Europe	$420 million	7.8%	Market expansion driven by approvals and awareness
Asia-Pacific	$200 million	10.0%	Rapidly growing, emerging regulatory pathways
Rest of World	$230 million	8.0%	Growing access and aging populations

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Competitive Landscape

Dasiglucagon faces competition from established glucagon formulations:

• Glucagon emergency kits (e.g., Lilly's Glucagon)
• Nasal glucagon (e.g., Avonex)
• Other glucagon analogs in development

Market share estimations (2022):	Company	Product	Estimated Market Share	Notes
Eli Lilly	Glucagon emergency kits	65%	Market leader, lengthy patent protection until 2028
Zealand Pharma	Nasal glucagon	25%	Growing segment, easier administration
Others	Various glucagon products	10%	Niche products, emerging entries

Dasiglucagon’s differentiator lies in its stability at room temperature and its suitability for continuous infusion or prefilled autoinjectors, improving ease of use over traditional kits.

Regulatory and Commercialization Trajectory

After FDA approval in March 2021, dasiglucagon received approval in the European Union in early 2022. Market penetration strategies include:

• Partnering with large distributors such as McKesson and Cardinal Health
• Collaborations with diabetes drug manufacturers for inclusion in treatment protocols
• Adoption in hospital and emergency settings

Projected revenues for dasiglucagon are conservative initially, estimated at $120–150 million in 2023, with potential to exceed $500 million by 2027 contingent on formulary inclusion and physician adoption rates.

Pricing assumptions:

• Wholesale acquisition cost (WAC): approximately $70–$110 per autoinjector
• Patient access programs and insurance coverage influence net revenue

Risks and Challenges

• Competition from more established glucagon formulations
• Physician and patient familiarity with existing treatments
• Regulatory delays or restrictions in emerging markets
• Manufacturing scalability and drug stability concerns

Intellectual Property and Patent Landscape

Key patents protecting dasiglucagon expire between 2030 and 2035. Patent extensions or formulations improvements could prolong exclusivity periods, influencing long-term market share.

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Summary

Dasiglucagon hydrochloride is positioned as a next-generation emergency hypoglycemia treatment, supported by regulatory approvals, improving stability, and administration features. While initial market penetration remains moderate, growth hinges on formulary placements and marketing strategies. The overall market for glucagon-based therapies demonstrates steady growth, driven by diabetes prevalence and unmet needs for easy-to-use emergency solutions.

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Key Takeaways

• The hypoglycemia treatment market is projected to nearly double by 2030, with dasiglucagon contributing significantly.
• Competitive positioning depends on efficacy, ease of use, and manufacturing capacity.
• Pricing and reimbursement strategies are crucial for commercial success.
• Regulatory approvals extend through 2030–2035, shaping patent and market exclusivity.
• Market growth is driven by rising diabetes prevalence, especially in Asia-Pacific.

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FAQs

1. What advantages does dasiglucagon offer over traditional glucagon kits?
It is thermally stable at room temperature, can be administered via autoinjectors, and facilitates easier emergency use.

2. How does the regulatory environment impact dasiglucagon’s market?
FDA approval in 2021 and subsequent European approval in 2022 support early market expansion, but heterogenous approvals in emerging markets may delay reach.

3. What are the main competitive threats for dasiglucagon?
Competition from nasal glucagon products, existing injectable forms, and emerging competitors with similar stability profiles.

4. How does patent expiration influence dasiglucagon’s market longevity?
Patents extend through 2030–2035; beyond that, generic manufacturing could reduce prices and market share unless new formulations are developed.

5. What factors influence the pricing and reimbursement of dasiglucagon?
Efficacy, ease of administration, manufacturing costs, payer policies, and formulary negotiations.

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Sources:

1. MarketsandMarkets, "Hypoglycemia Treatment Market," 2023.
2. WHO, "Diabetes Facts and Figures," 2022.
3. FDA, "New Drug Approvals," March 2021.
4. Evaluate Pharma, "Market Data for Glucagon Therapies," 2023.
5. Company filings and press releases.