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, Lilly, Mylan Labs Ltd, Xeris, Novo Nordisk, and Fresenius Kabi Usa, and is included in eight NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

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

Summary for glucagon

International Patents:	113
US Patents:	5
Tradenames:	7
Applicants:	6
NDAs:	8
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	27
Clinical Trials:	823
Patent Applications:	7,015
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
Pichamol Jirapinyo, MD, MPH	Phase 4
National Center for Advancing Translational Sciences (NCATS)	Early Phase 1
Ain Shams University	N/A

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
Novo Nordisk	GLUCAGEN	glucagon hydrochloride	POWDER;INTRAMUSCULAR, INTRAVENOUS	020918-001	Jun 22, 1998		DISCN	Yes	No
Amphastar Pharms Inc	BAQSIMI	glucagon	POWDER;NASAL	210134-001	Jul 24, 2019		RX	Yes	Yes			Y
Lilly	GLUCAGON	glucagon hydrochloride	INJECTABLE;INJECTION	012122-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Xeris	GVOKE PFS	glucagon	SOLUTION;SUBCUTANEOUS	212097-002	Sep 10, 2019		RX	Yes	Yes			Y
Xeris	GVOKE PFS	glucagon	SOLUTION;SUBCUTANEOUS	212097-002	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/005391 Ogluo 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/003848 Baqsimi 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
Hong Kong	1250644	在非質子極性溶劑中製造穩定的治療性胰高血糖素之製劑的方法 (METHODS FOR PRODUCING STABLE THERAPEUTIC GLUCAGON FORMULATIONS IN APROTIC POLAR SOLVENTS)
Japan	6835831
Philippines	12017501486
World Intellectual Property Organization (WIPO)	2016196976
South Korea	102121443
Japan	2019147817

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

Market Dynamics and Financial Trajectory of Glucagon

Market Size and Growth Projections

The glucagon market is poised for significant growth over the coming years. As of 2024, the global glucagon market is estimated to be valued at approximately USD 576.13 million and is projected to reach USD 772.75 million by 2029, growing at a Compound Annual Growth Rate (CAGR) of 6.03% during the forecast period[1][3][4].

Driving Factors

Several key factors are driving the growth of the glucagon market:

Increasing Prevalence of Diabetes

The global prevalence of diabetes is a major driver. According to the Lancet Journal, in 2021, 529 million people had diabetes worldwide, and this number is expected to reach 1.3 billion in the next 30 years. This increasing diabetic population, particularly those undergoing insulin therapy, are at a higher risk of severe hypoglycemic episodes, thereby increasing the demand for glucagon[1][4].

Healthcare Infrastructure and Regulations

North America, with its well-established healthcare infrastructure, high incidence of diabetes, and favorable regulatory frameworks, dominates the glucagon market. The American Diabetes Association's recommendations for prescribing glucagon to patients at risk of hypoglycemia further support market growth in this region[1][4].

Advancements in Delivery Methods

Innovations in delivery methods, such as nasal sprays, are enhancing patient compliance and contributing to market growth. These advancements make glucagon more accessible and easier to administer, especially in emergency situations[4].

Regional Analysis

North America

North America is the largest market for glucagon, holding over 34.5% of the global market share in 2023. The region's robust healthcare infrastructure, high diabetes prevalence, and strong research and development activities are key factors driving this dominance[4].

Asia Pacific

The Asia Pacific region is the fastest-growing market for glucagon. Increasing diabetes prevalence, better healthcare accessibility, and rising incomes are driving demand in this region. Despite slower growth compared to North America, the Asia Pacific market is expected to see significant expansion[1][4].

Europe and Latin America

Europe is experiencing a gradual uptake of glucagon therapies, supported by initiatives focused on diabetes management. Latin America also presents promising market expansion opportunities, driven by investments in healthcare infrastructure and growing healthcare spending, although economic uncertainties and regulatory challenges may hinder growth to some extent[4].

Market Concentration and Major Players

The glucagon market is characterized by high market concentration, with a few major players dominating the landscape. These companies are investing heavily in research and development to innovate glucagon formulations and delivery methods, which is a key factor in driving market growth[1].

Therapeutic Use and Product Segmentation

Injectable Glucagon

Injectable glucagon leads the market with a significant share, favored for its swift action in emergency hypoglycemia treatment. This segment holds approximately 43.9% of the market share in 2023[4].

Therapeutic Use

The therapeutic use segment, which includes the treatment of severe hypoglycemia, holds over 57.3% of the market share. This widespread use in emergency situations is a primary driver of the market[4].

Financial Trajectory

Cost Trends

The cost of glucagon has seen significant increases. Between 2011 and 2021, the total cost per dosing unit increased by 74% for commercial insurance beneficiaries and by 95% for Medicare Advantage beneficiaries. Despite these cost increases, the demand for glucagon remains strong due to its critical role in managing severe hypoglycemia[5].

Revenue Projections

The global glucagon market is expected to grow substantially, with projections indicating it will reach USD 553.3 million by 2033 at a CAGR of 6.7%[3], or alternatively, USD 1102.2 million by 2033 at a CAGR of 5.9%[4].

Challenges and Disparities

Socioeconomic Disparities

Glucagon fill rates are disproportionately low among minority patients and individuals with low income. This disparity highlights the need for more equitable access to glucagon and other diabetes management tools[5].

Regulatory and Economic Factors

Economic uncertainties and regulatory challenges, particularly in regions like Latin America, can hinder market growth. However, overall, the demand for glucagon is expected to remain robust due to its essential role in diabetes management[4].

Key Takeaways

• The global glucagon market is projected to grow significantly, driven by the increasing prevalence of diabetes and advancements in delivery methods.
• North America dominates the market due to its robust healthcare infrastructure and high diabetes prevalence.
• The Asia Pacific region is the fastest-growing market, driven by increasing diabetes rates and improving healthcare accessibility.
• Injectable glucagon and therapeutic use segments are the largest in the market.
• Despite cost increases, the demand for glucagon remains strong due to its critical role in managing severe hypoglycemia.

FAQs

1. What is the current market size of the glucagon market? The glucagon market was valued at approximately USD 576.13 million in 2024[1].

2. What is the projected growth rate of the glucagon market? The glucagon market is expected to grow at a CAGR of 6.03% from 2024 to 2029[1].

3. Which region dominates the glucagon market? North America dominates the glucagon market, holding over 34.5% of the global market share in 2023[4].

4. What are the main drivers of the glucagon market? The main drivers include the increasing prevalence of diabetes, advancements in delivery methods, and favorable healthcare infrastructure and regulations[1][4].

5. Are there any disparities in glucagon access? Yes, glucagon fill rates are disproportionately low among minority patients and individuals with low income, highlighting socioeconomic disparities in access to glucagon[5].

Citations

1. Mordor Intelligence: Glucagon Market - Growth, Trends, and Forecasts (2024-2029)
2. Morgan Stanley: GLP-1 Weight Loss Medication: Market Outlook
3. Marketresearch.biz: Glucagon Market Poised for Remarkable Growth, to Surpass USD 553.3 Million by 2033
4. Market.us: Glucagon Market Size, Share, Growth | CAGR Of 5.9%
5. Diabetes Journal: Glucagon Prescribing and Costs Among U.S. Adults With Diabetes

Last updated: 2024-12-16