ADRENALIN Drug Patent Profile

When do Adrenalin patents expire, and what generic alternatives are available?

Adrenalin is a drug marketed by Ph Health and is included in three NDAs. There are eight patents protecting this drug and two Paragraph IV challenges.

This drug has nine patent family members in seven countries.

The generic ingredient in ADRENALIN is epinephrine. There are twenty-one drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the epinephrine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Adrenalin

A generic version of ADRENALIN was approved as epinephrine by BPI LABS on July 29^th, 2014.

Summary for ADRENALIN

International Patents:	9
US Patents:	8
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	10
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	48
Patent Applications:	4,176
Drug Prices:	Drug price information for ADRENALIN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ADRENALIN
What excipients (inactive ingredients) are in ADRENALIN?	ADRENALIN excipients list
DailyMed Link:	ADRENALIN at DailyMed

See drug prices for ADRENALIN

See drug sales revenues for ADRENALIN

Recent Clinical Trials for ADRENALIN

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

Sponsor	Phase
ARS Pharmaceuticals, Inc.	PHASE4
Assiut University	EARLY_PHASE1
Universidad Nacional del Nordeste, Argentina	PHASE2

See all ADRENALIN clinical trials

Pharmacology for ADRENALIN

Drug Class	Catecholamine alpha-Adrenergic Agonist beta-Adrenergic Agonist
Mechanism of Action	Adrenergic alpha-Agonists Adrenergic beta-Agonists

Paragraph IV (Patent) Challenges for ADRENALIN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ADRENALIN	Injection	epinephrine	30 mg/30 mL	204640	1	2018-08-20
ADRENALIN	Injection	epinephrine	1 mg/mL ampules	204200	1	2016-03-09

US Patents and Regulatory Information for ADRENALIN

ADRENALIN is protected by eight US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ph Health	ADRENALIN	epinephrine	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	204200-001	Dec 7, 2012		RX	Yes	Yes
Ph Health	ADRENALIN	epinephrine	SOLUTION;INTRAVENOUS	215875-003	Apr 21, 2023		RX	Yes	Yes			Y
Ph Health	ADRENALIN	epinephrine	SOLUTION;INTRAVENOUS	215875-005	Apr 21, 2023		RX	Yes	Yes
Ph Health	ADRENALIN	epinephrine	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	204640-001	Dec 18, 2013	AP	RX	Yes	Yes			Y
Ph Health	ADRENALIN	epinephrine	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	204640-001	Dec 18, 2013	AP	RX	Yes	Yes

International Patents for ADRENALIN

See the table below for patents covering ADRENALIN around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2018507915	エピネフリン製剤
Canada	2978464	FORMULATIONS D'EPINEPHRINE (EPINEPHRINE FORMULATIONS)
Australia	2016233682	Epinephrine formulations
China	107614017	肾上腺素制剂 (EPINEPHRINE FORMULATIONS)
World Intellectual Property Organization (WIPO)	2019183416

Supplementary Protection Certificates for ADRENALIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3678649	2025C/508	Belgium		PRODUCT NAME: COMBINATIE VAN EPINEPHRINE EN DODECYLMALTOSIDE, IN ALLE VORMEN BESCHERMD DOOR HET BASISOCTROOI; AUTHORISATION NUMBER AND DATE: EU/1/24/1846 20240823
3678649	LUC00378	Luxembourg		PRODUCT NAME: COMBINAISON D'EPINEPHRINE ET DE DODECYLMALTOSIDE, SOUS TOUTES SES FORMES PROTEGEES PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/24/1846 20250211

Market Dynamics and Financial Trajectory for Pharmaceutical Drug: ADRENALIN

Last updated: September 15, 2025

Introduction

Adrenaline, also known as epinephrine, remains a pivotal drug in emergency medicine and various therapeutic contexts. Its broad application spectrum, from anaphylaxis treatment to cardiac arrest management, sustains a steady demand despite evolving pharmaceutical innovations. This analysis explores the current market landscape, underlying drivers, competitive environment, and financial trends shaping adrenaline's trajectory.

Market Overview

The global adrenaline market is characterized by consistent growth, driven by rising incidences of allergic reactions, cardiovascular emergencies, and an expanding emergency response infrastructure. As per recent industry reports, the market valuation surpasses USD 2 billion as of 2022, with expectations to reach approximately USD 3 billion by 2030, at a compound annual growth rate (CAGR) of roughly 4-5% [1].

The key segments include:

• Product Forms: Auto-injectors, ampules/vials, pre-filled syringes.
• Application Areas: Anaphylaxis, cardiac emergencies, local anesthetic adjuncts, and others.
• Distribution Channels: Hospital pharmacies, retail pharmacies, emergency medical services, and online platforms.

Market Drivers

1. Rising Incidence of Allergic Disorders and Anaphylaxis

Increasing global prevalence of severe allergic reactions is a primary driver. The rising prevalence of allergies, influenced by urbanization, pollution, and lifestyle factors, consolidates adrenaline's essential role in acute management [2].

2. Expansion of Emergency Medical Services

Enhanced emergency infrastructure, especially in developing economies, facilitates broader deployment of adrenaline auto-injectors. Governments and health agencies prioritize preparedness for cardiac and allergic emergencies, fueling demand [3].

3. Patent Expirations and Generic Entry

While original branded adrenaline products retain market dominance, patent expirations on certain formulations have prompted an influx of generic options, increasing market penetration and reducing costs for healthcare providers and consumers.

4. Regulatory Approvals and Guidelines

Alignments of clinical practice guidelines, such as the American Academy of Allergy, Asthma & Immunology (AAAAI), endorsing adrenaline as first-line therapy, sustain consistent demand across healthcare settings [4].

5. Increasing Awareness and Patient Advocacy

Educational initiatives and patient advocacy groups promote awareness about adrenaline availability and proper administration, contributing to market expansion.

Market Challenges

1. Price Sensitivity and Healthcare Budget Constraints

Rising healthcare costs and budget limitations, especially in resource-constrained regions, may restrict accessibility and impact market growth.

2. Competition from Alternative Therapies

Emerging biologics and novel immunotherapy approaches potentially challenge adrenaline's dominance in allergy management.

3. Manufacturing and Supply Chain Constraints

Complex manufacturing requirements, raw material shortages, and cold chain logistics can hinder supply stability, affecting market reliability.

Competitive Landscape

The adrenaline market hosts several key players:

• Mylan (now part of Viatris): A major producer of auto-injectors like EpiPen, with an extensive distribution network.
• Pfizer: Offers adrenaline formulations, focusing on both emergency medical devices and injectable solutions.
• Sanofi: Known for manufacturing adrenaline auto-injectors and syringes.
• Teva Pharmaceuticals: Providing generic adrenaline solutions.

Competitive strategies predominantly revolve around product innovation, cost competitiveness, and expanding access in emerging markets.

Financial Trajectory and Revenue Trends

Recent Financial Performance

Major companies report stable revenues from adrenaline products:

• Viatris (EpiPen): Despite pricing controversies, maintains significant sales driven by auto-injector demand.
• Pfizer: Generates considerable income from injectable adrenaline formulations utilized in hospitals.
• Sanofi: Sees steady revenues from its adrenaline auto-injector portfolio.

Growth Outlook

Financial projections suggest a CAGR of 4-5% through 2030, driven by increasing demand, product diversification, and market penetration in low- and middle-income countries (LMICs). The rapid adoption of pre-filled auto-injectors and innovations in device design further bolster revenue streams [5].

Emerging Opportunities

• Biosimilars and Generics: Entry of cost-effective biosimilars in markets with high demand.
• Novel Delivery Systems: Development of needle-free or inhalable adrenaline formulations to enhance compliance and expand usage beyond emergency scenarios.
• Digital Integration: Embedding digital features such as dose tracking in auto-injectors to add value.

Market Trends and Future Outlook

The future of adrenaline's market hinges on regulatory developments, technological innovations, and healthcare system strengthening:

• Regulatory Approvals: Broadened indications for adrenaline use, including new formulations, will expand markets.
• Global Health Initiatives: WHO and governments' emphasis on emergency preparedness will sustain demand.
• Innovative Devices: Advances in auto-injector technology, focusing on usability, safety, and cost-effectiveness, will influence market share dynamics.

Regional Insights

• North America: The largest market, driven by high allergy prevalence, advanced healthcare infrastructure, and regulatory guidance.
• Europe: Consistent demand with supportive healthcare policies; increasing adoption of auto-injector devices.
• Asia-Pacific: Rapid growth prospects due to urbanization, rising allergy incidences, and expanding healthcare access; expected to exhibit the highest CAGR [6].
• Latin America and Middle East: Emerging markets with increasing awareness and improving healthcare services.

Regulatory and Patent Landscape

Existing patents on auto-injector designs are expiring, enabling generic manufacturers to introduce competitively priced products. Regulatory agencies like the FDA (U.S.) and EMA (Europe) continue to streamline approval pathways for new formulations and device innovations, fostering market expansion.

Strategic Recommendations

• Invest in Innovation: Focus on developing user-friendly, needle-free delivery systems to meet evolving consumer preferences.
• Expand Access: Collaborate with global health organizations and governments to improve adrenaline availability in LMICs.
• Enhance Supply Chain Resilience: Invest in manufacturing agility and logistics to mitigate disruptions.
• Leverage Data Analytics: Use real-world data to optimize product portfolios and respond swiftly to market needs.

Key Takeaways

• The adrenaline market is poised for moderate growth, supported by rising allergy and emergency care needs.
• Generics and biosimilars will intensify price competition, potentially broadening access.
• Device innovations and digital health integration will serve as differentiators and revenue enhancers.
• Regulatory and geopolitical factors will influence regional market dynamics and opportunities.
• Companies investing in emerging markets and novel delivery systems are best positioned for sustained growth.

FAQs

1. What is driving demand for adrenaline auto-injectors globally?
   Increasing prevalence of allergic diseases, expanding emergency medical infrastructure, and rising awareness about adrenaline's critical role in acute care underpin global demand.

2. How do patent expirations impact adrenaline's market?
   Patent expirations facilitate entry of generic and biosimilar products, reducing prices, increasing market competition, and improving accessibility.

3. What technological innovations are emerging in adrenaline delivery systems?
   Needle-free autoinjectors, smartphone connectivity for dose tracking, and inhalable formulations are under development to enhance usability and adherence.

4. Which regions offer the most growth opportunities for adrenaline market expansion?
   Asia-Pacific and Latin America present high-growth potential due to developing healthcare systems and increasing allergy incidences.

5. How might regulatory changes influence adrenaline market dynamics?
   Streamlined approval processes for new devices and formulations can accelerate market entry, while strict safety and efficacy standards ensure quality and market stability.

References

[1] MarketsandMarkets. "Epinephrine Market by Product Type," 2022.
[2] World Allergy Organization. "Global Allergy Report," 2021.
[3] WHO. "Global Emergency Medical Response Standards," 2020.
[4] American Academy of Allergy, Asthma & Immunology. "Clinical Practice Guidelines," 2022.
[5] Global Data. "Pharmaceutical Market Forecasts," 2022.
[6] Mordor Intelligence. "Asia-Pacific Medical Devices Market," 2021.