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Last Updated: December 12, 2025

Glucagon hydrochloride - Generic Drug Details


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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. Two 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: 2
Raw Ingredient (Bulk) Api Vendors: 42
Clinical Trials: 921
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

SponsorPhase
Rutgers, The State University of New JerseyPHASE1
University of MinnesotaPHASE3
The Metis FoundationPHASE3

See all glucagon hydrochloride clinical trials

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

Market Dynamics and Financial Trajectory for Glucagon Hydrochloride

Last updated: July 27, 2025

Introduction

Glucagon hydrochloride, a peptide hormone used primarily for treating severe hypoglycemia and as an emergency antidote for beta-blocker and calcium channel blocker overdoses, remains a staple in acute medical management. Its market success hinges on factors such as clinical demand, regulatory landscape, manufacturing capacity, and competitive innovations. As the healthcare industry advances toward personalized medicine and novel therapeutic modalities, understanding the market dynamics and financial trajectory of glucagon hydrochloride offers critical insights into its future positioning.

Current Market Landscape

Therapeutic Application and Clinical Demand

Glucagon hydrochloride is chiefly deployed in emergency settings to rapidly elevate blood glucose levels in hypoglycemic patients—especially those with insulin-dependent diabetes mellitus (IDDM). The rising global prevalence of diabetes, projected to reach 700 million by 2045 according to IDF, fuels sustained demand for this emergency drug [1]. Additionally, its utilization as an antidote in toxicology, particularly for beta-blocker and calcium channel blocker poisoning, broadens its application spectrum.

Market Segmentation and Key Players

Major pharmaceutical firms have historically dominated glucagon hydrochloride production. Notably, companies like Novo Nordisk, Eli Lilly, and F. Hoffmann-La Roche manufacture and distribute formulations both for hospital use and emergency kits. These incumbents benefit from robust distribution channels and established regulatory approvals.

Emerging biotechnology firms are exploring novel formulations—including nasal, injectable, and ready-to-use pre-filled pens—that could disrupt current market structures. The innovation landscape reflects a competitive environment where convenience, reliability, and cost-effectiveness are critical.

Market Dynamics Influencing Growth

Regulatory Environment

Regulatory agencies such as the FDA and EMA impose strict standards on drug approval, manufacturing quality, and post-market surveillance. In recent years, fast-tracking procedures for emergency drugs have eased market entry for new formulations. However, they also impose hurdles for generics and biosimilars, influencing market penetration and pricing strategies.

Pricing and Reimbursement Policies

Pricing strategies for glucagon hydrochloride vary regionally, influenced by healthcare systems’ reimbursement policies. In mature markets like North America and Europe, reimbursement ensures steady cash flows. However, high drug acquisition costs and varying insurance coverages can impact demand elasticity, especially in lower-income regions.

Supply Chain and Manufacturing Capacity

Manufacturers’ ability to produce high-purity peptide hormones like glucagon hydrochloride hinges on complex synthesis processes. Recent disruptions, such as shortages of amino acid raw materials or bio-reactor capacity constraints, threaten supply stability. Scalability of production in response to surging demand remains pivotal for maintaining market share.

Competitive Landscape and Innovation

The introduction of alternative routes—such as stable, ready-to-use inhalable glucagon or nasal sprays—potentially diminishes reliance on injectable formulations. Companies investing in nasal powder technologies (e.g., Biodel’s nasal glucagon) aim to improve usability during emergencies. Such innovations could capture market share from traditional formulations, influencing the overall financial trajectory.

Healthcare Trends and Patient Population Dynamics

The global shift toward outpatient management and emergency preparedness elevates the importance of portable, easy-to-administer glucagon products. Additionally, increasing awareness of hypoglycemia’s risks supports sustained demand. Policymakers’ emphasis on drug safety and efficacy further underpin the market’s stability.

Financial Trajectory and Market Projections

Historical Revenue Trends

The global market for glucagon and related emergency hormone therapies has experienced steady growth, with estimates valuing the sector at approximately USD 150-200 million in 2021 (excluding generic formulations) [2]. Growth is driven by increasing diabetic populations and expanding indications.

Future Growth Drivers

  • Expanding Diabetes Burden: With diabetes prevalence rising annually, particularly in regions like Asia-Pacific, demand for fast-response hypoglycemia treatments like glucagon hydrochloride is expected to grow at a CAGR of roughly 4-6% over the next five years [3].

  • Product Innovation: The advent of non-injectable formulations and user-friendly delivery systems is projected to accelerate sales, especially in emergency kits and critical care.

  • Regulatory Approvals and New Formulations: Approvals of novel formulations can disrupt incumbents' market share, creating new revenue streams and shifting financial trajectories.

  • Market Penetration in Emerging Economies: Lower-middle-income countries exhibit unmet needs, presenting growth opportunities for affordable, locally manufactured glucagon products.

Challenges to Financial Expansion

  • Pricing Pressure: Healthcare cost containment policies in developed markets may restrict profit margins.

  • Intellectual Property: Patent expiries of key formulations threaten revenue streams, prompting companies to innovate or seek exclusivity via new delivery mechanisms.

  • Manufacturing Costs: Peptide synthesis and stabilization methods are costly; scaling production to meet global demand involves significant capital expenditure, impacting profitability.

Projected Financial Outcomes

Based on current trends, the global glucagon market is projected to grow from USD 200 million in 2022 to over USD 300 million by 2027. Innovator firms focusing on specialized formulations may see higher margins, while generics and biosimilars could exert price competition, compressing profits.

Strategic Outlook

To capitalize on market opportunities, companies should prioritize:

  • Investing in Novel Delivery Platforms: Nasal and inhalable glucagon formulations can differentiate portfolios and expand market share.
  • Broadening Access in Emerging Markets: Cost-effective, locally sourced formulations can penetrate underserved regions.
  • Strengthening Supply Chain Resilience: Ensuring consistent manufacturing capabilities reduces shortages and maintains market presence.
  • Navigating Regulatory Pathways: Early engagement with regulators facilitates the approval of innovative products.

Conclusion

The market dynamics for glucagon hydrochloride are characterized by steady demand driven by rising diabetes prevalence, an expanding therapeutic landscape, and ongoing product innovation. Financial trajectories indicate positive growth prospects, with potential acceleration from novel formulations and broader market penetration. Nonetheless, challenges such as pricing pressures, manufacturing complexities, and competitive innovations necessitate strategic agility for industry players aiming to optimize profitability.


Key Takeaways

  • The global glucagon hydrochloride market is poised for steady growth, driven by increasing diabetic populations and innovations in delivery systems.
  • Regulatory environments and reimbursement policies significantly influence market entry, product adoption, and pricing strategies.
  • Innovation in non-injectable and user-friendly formulations represents a substantial opportunity to capture and expand market share.
  • Supply chain stability and manufacturing capacity are vital; disruptions could impair financial performance.
  • Expanding access in emerging markets offers a lucrative avenue for future growth, provided affordability and distribution channels are addressed effectively.

FAQs

1. What are the primary drivers of growth in the glucagon hydrochloride market?
The main drivers include rising diabetes prevalence, technological advancements in delivery forms, increasing awareness of hypoglycemia management, and expanding use as an antidote for overdose treatments, especially in emergency settings.

2. How does innovation influence the competitive landscape?
Innovations such as nasal powders and autoinjectors enhance usability and safety, enabling companies to differentiate and potentially capture market share from traditional injectable formulations.

3. What regions pose the greatest growth opportunities for glucagon hydrochloride?
Emerging markets in Asia-Pacific, Latin America, and parts of Africa present significant growth opportunities due to rising diabetes incidence, limited current access, and government initiatives to improve emergency healthcare.

4. How do regulatory policies impact market dynamics?
Regulatory pathways influence the speed of product approval, patent protections, and reimbursement, directly affecting pricing, market entry, and product lifecycle management.

5. What challenges could hinder the financial growth of this market?
Challenges include pricing pressures from healthcare systems, manufacturing cost constraints, patent expirations leading to generic competition, and potential supply shortages stemming from complex peptide production processes.


References

[1] International Diabetes Federation. "IDF Diabetes Atlas," 10th Edition, 2021.
[2] MarketWatch. "Global Glucagon Market Size, Share & Trends Analysis Report," 2022.
[3] GlobalData. "Diabetes Market Forecasts and Trends," 2022.

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