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Last Updated: December 12, 2025

GLUCAGEN Drug Patent Profile


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Which patents cover Glucagen, and when can generic versions of Glucagen launch?

Glucagen is a drug marketed by Novo Nordisk and is included in one NDA.

The generic ingredient in GLUCAGEN 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.

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Summary for GLUCAGEN
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 1
Clinical Trials: 30
Patent Applications: 332
Drug Prices: Drug price information for GLUCAGEN
What excipients (inactive ingredients) are in GLUCAGEN?GLUCAGEN excipients list
DailyMed Link:GLUCAGEN at DailyMed
Drug patent expirations by year for GLUCAGEN
Drug Prices for GLUCAGEN

See drug prices for GLUCAGEN

Recent Clinical Trials for GLUCAGEN

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

SponsorPhase
Columbia UniversityPhase 1
Albert Einstein College of MedicinePhase 1
Inreda Diabetic B.V.Phase 2

See all GLUCAGEN clinical trials

US Patents and Regulatory Information for GLUCAGEN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
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
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 (GLUCAGEN)

Last updated: July 30, 2025

Introduction

Glucagon, commercially known as GLUCAGEN, is a critical therapeutic noted for its ability to rapidly elevate blood glucose levels. Primarily used to treat severe hypoglycemia, especially among diabetics, glucagon’s unique physiological action positions it within a specialized niche. Over recent years, the landscape surrounding glucagon has experienced notable shifts driven by evolving market dynamics, technological innovation, regulatory changes, and demographic trends. This report provides an in-depth analysis of these factors and forecasts the financial trajectory of GLUCAGEN over the coming years.


Market Overview and Therapeutic Role of Glucagon

Glucagon, a peptide hormone produced by pancreatic alpha cells, plays a vital role in glucose homeostasis. Its primary pharmaceutical applications include:

  • Emergency treatment of severe hypoglycemia
  • Diagnostic procedures (e.g., gastrointestinal motility testing)
  • Off-label uses, such as managing beta-blocker overdose

The injectable form of glucagon, branded as GLUCAGEN, has historically dominated the market. Recently, novel formulations, including nasal sprays and ready-to-use auto-injectors, have entered the scene, expanding the treatment landscape and addressing unmet needs related to ease of administration.


Market Dynamics

1. Growing Diabetes Prevalence and Impact

The global burden of diabetes is a significant market driver for glucagon. The International Diabetes Federation estimates over 537 million adults worldwide suffer from diabetes, a figure projected to escalate to 643 million by 2030 [1]. As severe hypoglycemia is a common and potentially deadly complication of insulin therapy, demand for glucagon as an emergency intervention persists and expands.

2. Innovation in Drug Formulation and Delivery

Traditional glucagon formulations require reconstitution before use, which limits ease and speed of administration during hypoglycemic episodes. Innovations such as ready-to-use glucagon auto-injectors and intranasal formulations have transformed the landscape:

  • Autoinjectors: The FDA approval of Baqsimi (intranasal glucagon) in 2019 marked a pivotal moment, providing a non-injectable, user-friendly option [2].
  • Simplification: New formulations improve caregiver and patient compliance, broadening market adoption, especially in pediatric and elderly populations.

3. Competitive and Regulatory Environment

Major pharmaceutical companies such as Novo Nordisk, Eli Lilly, and Takeda dominate glucagon formulations. The market has seen increasing competition, with biosimilars under development aimed at reducing costs and expanding access.

Regulatory approvals worldwide remain crucial; the U.S. FDA has notably approved multiple glucagon products, facilitating rapid market penetration. Conversely, delays or stringent regulations in emerging markets may hinder growth.

4. Economic Factors and Reimbursement Policies

Reimbursement structures significantly influence market expansion. In countries with comprehensive healthcare coverage, the affordability and availability of glucagon treatments have improved, spurring sales. Conversely, high costs and limited reimbursement can restrict access, especially in low- and middle-income regions.

5. Market Penetration and Adoption Challenges

Despite advancements, barriers such as lack of awareness among caregivers, the stigma of emergency drug use, and the necessity of proper training hinder widespread adoption. Efforts by health authorities and pharmaceutical companies to implement education campaigns have begun to address these issues.


Financial Trajectory Analysis

Historical Revenue Trends

Historically, the glucagon market was modest, driven mainly by demand for injectable formulations. In 2020, the global glucagon market size was valued at approximately $430 million, with an expected compound annual growth rate (CAGR) of around 4.5% to 6% over the next five years [3].

Projected Market Growth

Factors contributing to projected growth include:

  • Expansion of Nasal and Autoinjector Products: The introduction of user-friendly delivery systems is estimated to boost global sales, potentially increasing market size to $700-$800 million by 2027.
  • Emerging Markets: Growing healthcare infrastructure and increasing diabetes prevalence are likely to promote adoption in Asia-Pacific, Latin America, and Africa.
  • Increased Awareness and Education: Efforts to educate caregivers and patients align with higher utilization.

Revenue Drivers and Potential Risks

  • Drivers: Launch of new formulations, expanded indications, and strategic collaborations.
  • Risks: Market saturation, development of cheaper biosimilars, and competition from alternative hypoglycemia management methods such as continuous glucose monitoring (CGM) devices and automated insulin delivery systems.

Impact of Novel Therapies and Adjuncts

Emerging therapies, such as glucose-responsive insulins and alternative hypoglycemia treatments, could influence demand. However, given glucagon's unique emergency role, it is expected to maintain significant relevance, especially as part of combination management strategies.


Regulatory and Technological Trends Influencing Financial Outlook

Regulatory environment adaptations, including accelerated approvals for innovative formulations, can catalyze market expansion. Additionally, increasing R&D in drug stability, delivery technologies, and formulation techniques will shape future revenue streams.

Technological advances such as microencapsulation and nanotechnology may also lead to improved formulations with better shelf-life and delivery options, further influencing sales dynamics.


Conclusion: Future Financial Outlook

The financial trajectory for GLUCAGEN appears promising, with steady growth propelled by innovation, demographic shifts, and regulatory support. The market’s evolution from injectable to nasal and autoinjector formulations enhances accessibility and adherence, positioning glucagon as a crucial component in hypoglycemia management.

However, the trajectory hinges on overcoming barriers like high costs, limited awareness, and competition from emerging therapies. Strategic investment in education, partnership formation, and technological innovation will be essential for companies aiming to capture value within this expanding niche.


Key Takeaways

  • Market Expansion Driven by Demographics: Rising diabetes prevalence globally fuels demand for glucagon, especially emergency formulations.
  • Innovation is Crucial: Non-injectable, easy-to-administer glucagon formulations are transforming market accessibility.
  • Regulatory and Reimbursement Factors Matter: Approvals and reimbursement policies significantly impact revenue growth prospects.
  • Competitive Landscape: Dominated by a few major players, with biosimilar and generic development posing challenges.
  • Future Growth Potential: Forecasts suggest a CAGR of approximately 4.5-6%, with revenues potentially surpassing $800 million by 2027.

FAQs

1. What are the key innovations influencing glucagon’s market growth?
The introduction of nasal sprays like Baqsimi and ready-to-use auto-injectors has significantly improved ease of use and adherence, broadening the market. Advances in formulation technology also enhance stability and shelf-life.

2. How does the rising prevalence of diabetes impact glucagon sales?
Higher diabetes rates increase the need for emergency hypoglycemia treatments, directly driving demand for glucagon formulations worldwide.

3. What are the primary challenges facing the glucagon market?
Cost barriers, limited awareness, regulatory hurdles, and competition from emerging hypoglycemia management options present ongoing challenges.

4. Which regions are expected to see the fastest growth in glucagon demand?
Emerging markets in Asia-Pacific and Latin America are anticipated to experience rapid growth due to expanding healthcare infrastructure and rising diabetes prevalence.

5. How might biosimilars influence the future financial performance of glucagon-based drugs?
Biosimilars may reduce prices and increase accessibility but could also impact profit margins for original manufacturers, necessitating innovation and differentiation strategies.


References

[1] International Diabetes Federation. (2021). IDF Diabetes Atlas, 9th Edition.
[2] Food and Drug Administration. (2019). FDA Approves Nasal Glucagon for Severe Hypoglycemia.
[3] MarketWatch. (2022). Global Glucagon Market Size and Forecast.

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