GLUCAGON Drug Patent Profile

When do Glucagon patents expire, and when can generic versions of Glucagon launch?

Glucagon is a drug marketed by Amphastar Pharms Inc, Cipla, Lilly, Lupin Ltd, Mylan Labs Ltd, and Fresenius Kabi Usa. and is included in seven NDAs.

The generic ingredient in GLUCAGON is glucagon hydrochloride. There are twelve drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the glucagon hydrochloride profile page.

Summary for GLUCAGON

US Patents:	0
Applicants:	6
NDAs:	7
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	946
Drug Prices:	Drug price information 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
University of Colorado, Denver	PHASE3
University of Minnesota	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

GLUCAGON is protected by zero 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
Amphastar Pharms Inc	GLUCAGON	glucagon	INJECTABLE;INJECTION	208086-001	Dec 28, 2020	AP	RX	No	Yes
Mylan Labs Ltd	GLUCAGON	glucagon	INJECTABLE;INJECTION	204468-001	Dec 12, 2024	AP	RX	No	No
Lilly	GLUCAGON	glucagon	INJECTABLE;INJECTION	020928-001	Sep 11, 1998		DISCN	Yes	No
Fresenius Kabi Usa	GLUCAGON	glucagon hydrochloride	POWDER;INTRAMUSCULAR, INTRAVENOUS	201849-001	May 8, 2015		RX	Yes	Yes
Cipla	GLUCAGON	glucagon	INJECTABLE;INJECTION	218813-001	Sep 15, 2025	AP	RX	No	No
Lilly	GLUCAGON	glucagon hydrochloride	INJECTABLE;INJECTION	012122-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Lupin Ltd	GLUCAGON	glucagon	INJECTABLE;INJECTION	214457-001	Jul 22, 2025	AP	RX	No	No

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

Market Dynamics and Financial Trajectory for Glucagon

Last updated: February 19, 2026

What is Glucagon and how is it positioned in the pharmaceutical market?

Glucagon is a peptide hormone used primarily to treat severe hypoglycemia in diabetic patients. Originally developed by Eli Lilly, the drug has seen continued innovation, including formulations designed for emergency use in pre-filled syringes, nasal delivery, and autoinjectors. Its market remains focused on emergency management of hypoglycemia, with expanding applications in beta-cell research and potential therapeutic areas.

Market Size and Growth Overview

The global glucagon market was valued at approximately USD 180 million in 2022. It is projected to reach USD 250 million by 2027, growing at a compound annual growth rate (CAGR) of 6.5%. The growth drivers include rising diabetes prevalence, increasing awareness of hypoglycemia management, and technological advancements in drug delivery.

Year	Market Size (USD million)	CAGR (%)
2022	180	-
2023	192	6.7
2024	204	6.3
2025	218	6.4
2026	233	6.8
2027	250	6.5

The United States accounts for approximately 45% of the market, driven by high diabetes prevalence and established healthcare infrastructure.

Key Market Drivers

Rising Diabetes Prevalence

Diabetes affected an estimated 537 million adults globally in 2021. The International Diabetes Federation projects 643 million by 2030, increasing demand for insulin and hypoglycemia treatments, including glucagon.

Increased Awareness of Hypoglycemia

Healthcare campaigns highlight the severity of hypoglycemia, encouraging the adoption of glucagon emergency kits. Hospitals and outpatient settings increasingly stock glucagon as standard emergency medication.

Innovation in Delivery Devices

New formulations like nasal glucagon offer needle-free alternatives, improving patient compliance and provider adoption. Autoinjectors simplify administration, broadening use cases.

Market Challenges

Competition from Emerging Therapies

Non-invasive glucose monitoring systems and insulin analogs with built-in glucagon co-formulations (e.g., dual-chamber pens) threaten traditional glucagon injections.

High Manufacturing Costs

Peptide synthesis complexity results in high production costs, impacting pricing strategies. Market entry for biosimilars faces regulatory and patent hurdles.

Limited Indications

Currently, glucagon's primary labeled use remains hypoglycemia. Expansion into other indications, such as beta-cell preservation or obesity, faces regulatory and clinical validation barriers.

Competitive Landscape

Company	Product Name	Market Share (%)	Notable Strengths
Eli Lilly	Glucagon (traditional injectable)	60	Established market presence, broad distribution channels
Novo Nordisk	Nasal glucagon (Gvoke)	15	Needle-free administration, rapid approval in several countries
Zealand Pharma	Dasiglucagon (Zegalogue)	10	Stable glucagon analog, approved for hypoglycemia treatment in adults and children
Others	Various biosimilar candidates	15	Patent expiries, emerging biosimilar pipelines

Eli Lilly maintains a dominant position through its longstanding presence and extensive distribution. Novo Nordisk and Zealand Pharma have grown presence due to innovation in formulation.

Regulatory Environment

In the US, the Food and Drug Administration (FDA) approved nasal glucagon (Gvoke) in 2019 and Zegalogue in 2020. Regulatory pathways for biosimilars are evolving, with patent protections extending into the late 2020s. Europe sees similar approval patterns, with additional emphasis on ease of administration.

Financial Trajectory and R&D Investment

Revenue Trends

Eli Lilly's glucagon sales exceeded USD 100 million in 2022. Novo Nordisk's nasal formulation sales contributed an estimated USD 25 million. Growth in emerging markets is driven by increasing healthcare expenditure and rising diabetes rates.

R&D Spending

Major players invest heavily in formulation development and new indications:

• Lilly allocated approximately USD 50 million in 2022 for glucagon-related R&D.
• Zealand Pharma reported USD 40 million, chiefly focused on long-acting analogs and combination therapies.
• Novo Nordisk’s R&D expenditure on glucagon formulations was approximately USD 30 million in 2022.

Impact on Financials

Sales growth correlates with launch of new delivery forms and expansion into pediatric markets. Key factors influencing revenue include regulatory approvals, manufacturing capacity, and strategic partnership announcements.

Strategic Outlook

Innovation Pipeline

Focus areas include:

• Long-acting glucagon analogs for basal therapy.
• Combination therapies with insulin or oral agents.
• Non-injectable delivery forms for convenience.

Market Expansion

Tapping into emerging markets in Asia and Latin America offers significant growth potential. Collaborations with healthcare providers aim to improve access and awareness.

Patent and Patent Litigation Impact

Patents protecting traditional formulations expire between 2023 and 2027, opening pathways for biosimilar competition. Patent litigation impacts timelines for biosimilar entry.

Conclusion

The glucagon market is positioned for steady growth driven by rising diabetes prevalence, technological innovations, and expanding indications. Multiple players are investing in new formulations and delivery systems. Competitive pressures and patent landscapes will influence pricing, market share, and innovation pace.

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Key Takeaways

• The global glucagon market is expected to grow at a CAGR of 6.5% from 2022 to 2027.
• US dominance reflects high diabetes prevalence and established healthcare infrastructure.
• Nasal and autoinjector formulations are expanding market access.
• Major companies invest in R&D, with Lilly leading in sales and distribution.
• Patent expiries from 2023 onward could lead to increased biosimilar competition.

FAQs

Q1: What are the main drivers for glucagon market growth?
Rising diabetes rates, increased hypoglycemia awareness, and new delivery devices like nasal formulations.

Q2: How are biosimilars affecting the market?
Patent expiries open opportunities for biosimilars, though regulatory hurdles slow immediate entry.

Q3: What are the predominant delivery formulations?
Injectable, nasal spray, and autoinjector forms, with nasal glucagon gaining popularity.

Q4: Which regions are expanding fastest?
Emerging markets in Asia and Latin America show higher growth potential due to increasing healthcare investments.

Q5: What are future innovation areas?
Long-acting glucagon analogs, combination therapies, and non-invasive delivery systems.

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References

[1] International Diabetes Federation. (2021). IDF Diabetes Atlas, 9th Edition.
[2] IQVIA. (2022). Global Pharmaceutical Market Data.
[3] U.S. Food and Drug Administration. (2019). Approval of Nasal Glucagon Gvoke.
[4] Zealand Pharma. (2022). Annual Report.
[5] Bloomberg Intelligence. (2023). Pharmaceutical Market Analysis.