Glucagon hydrochloride - Generic Drug Details

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

Glucagon hydrochloride is the generic ingredient in two branded drugs marketed by Lilly, Novo Nordisk, and Fresenius Kabi Usa, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for glucagon hydrochloride. Three suppliers are listed for this compound.

Summary for glucagon hydrochloride

US Patents:	0
Tradenames:	2
Applicants:	3
NDAs:	3
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	42
Clinical Trials:	823
Patent Applications:	253
What excipients (inactive ingredients) are in glucagon hydrochloride?	glucagon hydrochloride excipients list
DailyMed Link:	glucagon hydrochloride at DailyMed

Recent Clinical Trials for glucagon hydrochloride

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 hydrochloride clinical trials

Pharmacology for glucagon hydrochloride

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

Anatomical Therapeutic Chemical (ATC) Classes for glucagon hydrochloride

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 hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Fresenius Kabi Usa	GLUCAGON	glucagon hydrochloride	POWDER;INTRAMUSCULAR, INTRAVENOUS	201849-001	May 8, 2015		RX	Yes	Yes
Novo Nordisk	GLUCAGEN	glucagon hydrochloride	POWDER;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	020918-002	Jun 22, 1998		DISCN	Yes	No
Lilly	GLUCAGON	glucagon hydrochloride	INJECTABLE;INJECTION	012122-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Novo Nordisk	GLUCAGEN	glucagon hydrochloride	POWDER;INTRAMUSCULAR, INTRAVENOUS	020918-001	Jun 22, 1998		DISCN	Yes	No
Fresenius Kabi Usa	GLUCAGON	glucagon hydrochloride	POWDER;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	201849-002	Sep 19, 2019		RX	Yes	Yes
Lilly	GLUCAGON	glucagon hydrochloride	INJECTABLE;INJECTION	012122-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No

Glucagon hydrochloride Market Analysis and Financial Projection Experimental

Glucagon Hydrochloride Market Dynamics and Financial Trajectory

Market Size and Growth Projections

The glucagon hydrochloride market is poised for significant growth over the next few years, driven by several key factors. As of 2024, the market size is estimated to be around USD 576.13 million, with a projected growth to USD 772.75 million by 2029, at a Compound Annual Growth Rate (CAGR) of 6.03%[1].

Drivers of Market Growth

Increasing Prevalence of Diabetes

One of the primary drivers of the glucagon hydrochloride market is the rising global prevalence of diabetes. According to a study published in the Lancet Journal, the number of people with diabetes is expected to increase from 529 million in 2021 to 1.3 billion over the next 30 years. This increase in the diabetic population, particularly those undergoing insulin therapy, heightens the risk of severe hypoglycemic episodes, thereby boosting the demand for glucagon[1].

Regulatory Recommendations

The American Diabetes Association recommends that all patients at risk for hypoglycemia should be prescribed glucagon, further driving the market growth. For instance, in the United States, approximately 30 million people with diabetes are advised to have ready-to-use rescue glucagon for severe hypoglycemic episodes[1].

Technological Advancements and New Product Launches

Advancements in pharmaceutical technology have led to the development of more convenient and effective glucagon products. For example, Novo Nordisk A/S and Zealand Pharma A/S collaborated to commercialize ZEGALOGUE (dasiglucagon), a glucagon injection approved for treating severe hypoglycemia in pediatric and adult diabetic patients. Similarly, Xeris Biopharma Holdings Inc.'s Gvoke, a ready-to-use liquid glucagon, has seen significant adoption since its launch[1].

Market Segmentation

By Product Type

The glucagon market is segmented into injectable and inhalation forms. The injectable segment dominates the market, accounting for a significant share due to its widespread use and ease of administration. By 2032, the injectable segment is estimated to account for USD 364.7 million[3].

By Application

The primary application of glucagon is in treating severe hypoglycemia, which accounts for a substantial market share. Other applications include diagnostic aid, gastrointestinal disorders, and cardiogenic shock. The hypoglycemia segment is expected to continue its dominance due to the increasing emphasis on proactive hypoglycemia management strategies[3].

By Distribution Channel

The market is segmented into hospital pharmacies, retail pharmacies, and online pharmacies. Hospital pharmacies lead in terms of revenue, with an estimated USD 334.3 million by the end of 2032. Retail pharmacies also play a crucial role, especially with the increasing availability of glucagon products in drug stores and retail outlets[3].

Regional Analysis

North America

North America holds the largest market share, accounting for approximately 45% of the global glucagon market. This dominance is attributed to the high prevalence of diabetes, robust healthcare infrastructure, and significant investments in research and development. The U.S. glucagon market, in particular, is expected to grow at a CAGR of 5.7% during the forecast period[3][4].

Asia Pacific

The Asia Pacific region is the fastest-growing market, driven by rapid urbanization, changing lifestyles, and increasing healthcare expenditure. Countries like China and India are experiencing a surge in diabetes prevalence, fueling the demand for glucagon products. This region presents considerable growth opportunities due to advancements in healthcare infrastructure and heightened awareness about diabetes management[4].

Europe

Europe is another key player in the glucagon market, with a growing diabetic population and rising demand for advanced therapeutics. The region benefits from favorable government initiatives and the presence of prominent pharmaceutical companies and research institutions, which foster the development of novel glucagon formulations and delivery methods[4].

Middle East & Africa and Latin America

These regions exhibit a growing interest in glucagon therapies, although at a slower pace due to limited healthcare infrastructure and economic constraints. However, rising diabetes awareness initiatives and improving access to healthcare services contribute to incremental growth in these regions[4].

Key Players and Strategic Initiatives

Major players in the glucagon market include Amphastar Pharmaceuticals, Inc., Xeris Biopharma Holdings, Inc., Novo Nordisk A/S, Zealand Pharma A/S, and Fresenius SE & Co. KGaA. These companies are focusing on expanding their production capacity and geographical presence to meet the growing demand. Strategic initiatives such as global license and development agreements, new product launches, and significant shipments of glucagon products are driving market growth[1].

Financial Trajectory

The financial trajectory of the glucagon hydrochloride market is promising, with steady growth projected over the next decade. Here are some key financial milestones:

• 2024: The market size is estimated to be USD 576.13 million[1].
• 2029: The market is expected to reach USD 772.75 million, growing at a CAGR of 6.03%[1].
• 2032: The market is projected to reach USD 703.2 million, with a CAGR of 5.9% from 2024 to 2032[3].
• 2033: The global glucagon market is expected to reach USD 553.3 million, with a CAGR of 6.7% from 2024 to 2033[4].

Challenges and Opportunities

Challenges

Despite the growth potential, the glucagon market faces several challenges, including:

• Side Effects: Glucagon can cause various side effects, such as nausea, vomiting, and increased heart rate, which may deter some patients[2].
• Limited Awareness: In some regions, there is limited awareness about the importance of glucagon in managing hypoglycemia, which can hinder market growth[4].

Opportunities

The market also presents several opportunities:

• Expanding Healthcare Infrastructure: The expansion of healthcare infrastructure in emerging markets offers a promising avenue for growth[4].
• Innovative Formulations: The development of more convenient and effective glucagon products, such as ready-to-use liquid glucagon, presents significant market opportunities[1].

"The increasing prevalence of diabetes globally is one of the significant factors influencing market growth. According to a study published by the Lancet Journal in June 2023, in 2021, 529 million people had diabetes worldwide, and this number is estimated to reach 1.3 billion people in the next 30 years."[1]

Key Takeaways

• The glucagon hydrochloride market is expected to grow significantly due to the increasing prevalence of diabetes and advancements in pharmaceutical technology.
• North America dominates the market, but the Asia Pacific region is the fastest-growing segment.
• Major players are focusing on expanding their production capacity and geographical presence.
• The market faces challenges such as side effects and limited awareness but presents opportunities in emerging markets and innovative formulations.

FAQs

What is the current market size of the glucagon hydrochloride market?

The glucagon hydrochloride market size is estimated to be around USD 576.13 million in 2024[1].

Who are the key players in the glucagon market?

Key players include Amphastar Pharmaceuticals, Inc., Xeris Biopharma Holdings, Inc., Novo Nordisk A/S, Zealand Pharma A/S, and Fresenius SE & Co. KGaA[1].

Which region is the fastest-growing in the glucagon market?

The Asia Pacific region is the fastest-growing segment in the glucagon market[1].

What are the primary applications of glucagon hydrochloride?

The primary applications include treating severe hypoglycemia, diagnostic aid, gastrointestinal disorders, and cardiogenic shock[3].

What are the expected market growth rates for the glucagon hydrochloride market?

The market is expected to grow at a CAGR of 6.03% from 2024 to 2029 and at a CAGR of 5.9% from 2024 to 2032[1][3].

Sources

1. Mordor Intelligence: Glucagon Market - Growth, Trends, and Forecasts (2024-2029)
2. Mayo Clinic: Glucagon (injection route) - Mayo Clinic
3. Global Market Insights: Glucagon Market Size & Share | Trends Report, 2024 – 2032
4. Market Research Biz: Glucagon Market Size, Share, Growth | CAGR of 6.7%