GLUCAGON - Generic Drug Details

What are the generic sources for glucagon and what is the scope of freedom to operate?

Glucagon is the generic ingredient in seven branded drugs marketed by Amphastar Pharms Inc, Cipla, Lilly, Lupin Ltd, Mylan Labs Ltd, Xeris, Novo Nordisk, and Fresenius Kabi Usa, and is included in ten NDAs. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Glucagon has one hundred and five patent family members in forty-one countries.

There are twelve drug master file entries for glucagon. Eight suppliers are listed for this compound.

Summary for GLUCAGON

International Patents:	105
US Patents:	4
Tradenames:	7
Applicants:	8
NDAs:	10
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	926
Patent Applications:	3,966
Drug Prices:	Drug price trends for GLUCAGON
What excipients (inactive ingredients) are in GLUCAGON?	GLUCAGON excipients list
DailyMed Link:	GLUCAGON at DailyMed

See drug prices for GLUCAGON

Recent Clinical Trials for GLUCAGON

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

Sponsor	Phase
Rutgers, The State University of New Jersey	PHASE1
The Metis Foundation	PHASE3
University of Colorado, Denver	PHASE3

See all GLUCAGON clinical trials

Pharmacology for GLUCAGON

Drug Class	Antihypoglycemic Agent Gastrointestinal Motility Inhibitor
Physiological Effect	Decreased GI Motility Decreased GI Smooth Muscle Tone Decreased Glycolysis Increased Gluconeogenesis Increased Glycogenolysis

Medical Subject Heading (MeSH) Categories for GLUCAGON

Gastrointestinal Agents

Hormones

Anatomical Therapeutic Chemical (ATC) Classes for GLUCAGON

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

US Patents and Regulatory Information for GLUCAGON

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amphastar Pharms Inc	BAQSIMI	glucagon	POWDER;NASAL	210134-001	Jul 24, 2019		RX	Yes	Yes			Y
Fresenius Kabi Usa	GLUCAGON	glucagon hydrochloride	POWDER;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	201849-002	Sep 19, 2019		RX	Yes	Yes
Cipla	GLUCAGON	glucagon	INJECTABLE;INJECTION	218813-001	Sep 15, 2025	AP	RX	No	No
Xeris	GVOKE HYPOPEN	glucagon	SOLUTION;SUBCUTANEOUS	212097-003	Sep 10, 2019		RX	Yes	Yes			Y

Expired US Patents for GLUCAGON

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Amphastar Pharms Inc	BAQSIMI	glucagon	POWDER;NASAL	210134-001	Jul 24, 2019

EU/EMA Drug Approvals for GLUCAGON

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 GLUCAGON

Country	Patent Number	Title	Estimated Expiration
South Africa	201904146
Japan	7436434
Eurasian Patent Organization	201890704	СПОСОБЫ ПОЛУЧЕНИЯ СТАБИЛЬНЫХ ТЕРАПЕВТИЧЕСКИХ СОСТАВОВ В АПРОТОННЫХ ПОЛЯРНЫХ РАСТВОРИТЕЛЯХ
World Intellectual Property Organization (WIPO)	2017053922

Supplementary Protection Certificates for GLUCAGON

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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

Market Dynamics and Financial Trajectory for Glucagon: A Comprehensive Analysis

Last updated: July 27, 2025

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Introduction

Glucagon, a peptide hormone primarily produced by the pancreas, plays a pivotal role in glucose homeostasis. It stimulates hepatic glucose production, making it crucial in managing severe hypoglycemia, particularly among diabetic populations. Over the past decade, the pharmaceutical landscape has witnessed significant evolution in glucagon’s market dynamics driven by advancements in administration methods, expanding therapeutic indications, and a growing global diabetic demographic. This article offers a detailed analysis of the current market landscape, underlying forces shaping its trajectory, and future financial prospects.

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Market Overview and Current Status

Global Market Size
The global glucagon market was valued at approximately USD 150 million in 2022 and is projected to grow at a compound annual growth rate (CAGR) of around 8-10% through 2030 [1]. This growth is driven by increased diabetes prevalence, realization of glucagon’s life-saving role in hypoglycemia management, and expanding indications beyond traditional emergency use.

Key Players and Product Ecosystem
Major pharmaceutical companies such as Novo Nordisk, Eli Lilly, and Bio-Parma dominate the market with their respective formulations—namely, nasal glucagon, injectable glucagon, and emerging stable formulations. Novo Nordisk’s Gvoke and Eli Lilly’s Dasiglucagon are prominent products, with nasal glucagon gaining market share due to ease of administration. The landscape is also witnessing emerging biosimilar entries and proposed formulations aimed at improving stability and administration convenience.

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Market Dynamics

1. Increasing Diabetes Prevalence
The International Diabetes Federation estimates global diabetes cases to exceed 700 million by 2045 [2], directly fueling demand for hypoglycemia management tools, including glucagon. The rising burden is especially pronounced in developing economies, where diagnostic and treatment infrastructure is expanding.

2. Advancements in Delivery Technologies
Traditional glucagon formulations required reconstitution, limiting usability during emergencies. The advent of ready-to-use nasal and autoinjector formulations has revolutionized administration, improving patient compliance and expanding market penetration. For instance, nasal glucagon formulations launched in recent years have reported rapid adoption, driven by non-invasive administration and manufacturer marketing strategies.

3. Regulatory Approvals and Reimbursement Policies
Regulatory authorities like the FDA and EMA have approved new formulations, emphasizing safety, efficacy, and ease of use. Additionally, reimbursement policies in key markets such as the US, Europe, and Japan favor outpatient and emergency use drugs, supporting market growth. Government and insurance-led initiatives to improve hypoglycemia management further bolster demand.

4. Expanding Therapeutic Applications
While primarily indicated for hypoglycemia episodes in diabetics, research is exploring glucagon’s potential in broader contexts, such as obesity, critical care, and emerging metabolic disorders. This diversification could augment market scope but remains in nascent stages.

5. Competitive Landscape and Patent Expirations
Patent expirations for pioneer glucagon products over the coming 3-5 years may facilitate biosimilar entry, potentially reducing prices and altering market share distribution. However, companies are actively innovating, focusing on formulation stability, non-injectable delivery systems, and combination products.

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Financial Trajectory and Growth Drivers

Revenue Forecasts
Analysts project that the glucagon market could reach USD 300 million by 2030, assuming sustained CAGR of approximately 8-10%. Key growth drivers include:

• Increasing adoption of nasal glucagon: projected to comprise 60-70% of the market by 2030 due to superior ease of use.
• Broadened clinical indications: research on glucagon's role in weight management and critical care could open new revenue lines.
• Market penetration in emerging economies: rising diabetes prevalence with increasing insurance coverage will uplift sales.

Pricing Trends
Innovative formulations bolster pricing power; however, biosimilar entries and increased competition are expected to moderate prices over time. Initiatives aimed at affordability, especially in low-income regions, could influence overall revenue.

Research & Development and Pipeline Activities
Investments in R&D, including stable, thermally resilient formulations and needle-free delivery systems, aim to extend market exclusivity and meet unmet clinical needs. Successful pipeline progression will directly impact future financial performance.

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Regulatory and Market Challenges

• Regulatory Hurdles: Approval delays or stringent regulations in emerging markets could hinder rapid expansion.

• Pricing Pressures: Payer controls and competitive biosimilar pricing may constrain profit margins.

• Reimbursement and Access: Limited reimbursement coverage in certain regions could restrict uptake, impacting revenues.

• Market Saturation Risks: Once widespread adoption is achieved, growth rates may plateau absent new indications or delivery innovations.

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Future Outlook

The trajectory for glucagon’s market is cautiously optimistic. Continuous innovation, especially the development of stable, user-friendly formulations, offers significant upside. Emerging indications like obesity and critical care represent potential growth vectors, albeit currently under clinical investigation. Furthermore, strategic partnerships, aggressive R&D, and targeted marketing in emerging markets will be essential to capitalize on the expanding diabetic population.

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Key Market Segments and Opportunities

Segment	Opportunity Focus	Challenges
Nasal Glucagon	Rapid adoption, market dominance, label expansion	Competition from injectables, price sensitivity
Injectable Glucagon	Emergency kits, hospital use, biosimilar entry	Reconstitution requirement, convenience issues
Stable Formulations	Cold chain independence, global accessibility	Development costs, regulatory approval pathways
Emerging Indications	Obesity, critical care, metabolic disorders	Validation through clinical trials

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Conclusion

The glucagon market is set for steady growth driven by demographic shifts, technological advancements, and evolving clinical strategies. While challenges such as pricing pressures and regulatory landscapes persist, innovation and expanding indications are poised to reshape the market’s financial outlook substantially. Strategic investments in formulation science, market expansion, and clinical validation will be vital for participants seeking sustainable growth.

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Key Takeaways

• The global glucagon market is projected to reach nearly USD 300 million by 2030, fueled by rising diabetes prevalence and innovative delivery systems.
• Nasal glucagon is rapidly gaining market share due to ease of use, representing a primary growth driver.
• Patent expirations and biosimilar development pose both risks and opportunities, potentially driving down prices but expanding access.
• Emerging indications beyond hypoglycemia management, such as obesity and critical care, hold promising future revenue streams.
• Strategic focus on Asia-Pacific and Latin America markets will be critical to capitalize on demographic and healthcare infrastructure growth.

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FAQs

1. What are the main factors driving glucagon market growth?
Rising diabetes prevalence, technological innovations in drug delivery, better awareness of hypoglycemia management, and expanding clinical indications are primary drivers.

2. How are newer formulations impacting market dynamics?
Non-invasive, ready-to-use formulations like nasal glucagon enhance user convenience, foster broader adoption, and enable rapid market growth.

3. What challenges does the glucagon market face?
Regulatory hurdles, pricing pressures from biosimilars, reimbursement limitations, and market saturation are key challenges.

4. Which regions offer the most growth opportunity for glucagon?
Emerging markets in Asia-Pacific, Latin America, and parts of Africa, due to increasing diabetes prevalence and improving healthcare infrastructure.

5. What future innovations could impact glucagon’s market trajectory?
Development of thermostable formulations, needle-free delivery systems, and expansion into new therapeutic areas such as obesity treatment.

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References

[1] Market Research Future. "Glucagon Market Analysis and Forecast," 2022.

[2] International Diabetes Federation. "IDF Diabetes Atlas," 10th Edition, 2021.