ADRENACLICK Drug Patent Profile

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

Adrenaclick is a drug marketed by Impax and is included in one NDA.

The generic ingredient in ADRENACLICK 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 Adrenaclick

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

Summary for ADRENACLICK

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	9
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	2
Patent Applications:	4,183
Drug Prices:	Drug price information for ADRENACLICK
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ADRENACLICK
DailyMed Link:	ADRENACLICK at DailyMed

See drug prices for ADRENACLICK

Recent Clinical Trials for ADRENACLICK

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

Sponsor	Phase
Arthroplasty Foundation, Inc.	Phase 4
University of Louisville	Phase 4
NYU Langone Health	N/A

See all ADRENACLICK clinical trials

US Patents and Regulatory Information for ADRENACLICK

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Impax	ADRENACLICK	epinephrine	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	020800-003	Nov 25, 2009	BX	RX	Yes	Yes
Impax	ADRENACLICK	epinephrine	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	020800-004	Nov 25, 2009	BX	RX	Yes	Yes

Expired US Patents for ADRENACLICK

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Impax	ADRENACLICK	epinephrine	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	020800-004	Nov 25, 2009	10,166,344
Impax	ADRENACLICK	epinephrine	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	020800-003	Nov 25, 2009	10,166,334
Impax	ADRENACLICK	epinephrine	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	020800-004	Nov 25, 2009	5,665,071
Impax	ADRENACLICK	epinephrine	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	020800-004	Nov 25, 2009	10,166,334
Impax	ADRENACLICK	epinephrine	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	020800-003	Nov 25, 2009	5,665,071

International Patents for ADRENACLICK

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

Country	Patent Number	Title	Estimated Expiration
Canada	2163005	SYSTEME D'INJECTION D'URGENCE, RECHARGEABLE, AUTOMATIQUE OU MANUEL (RELOADABLE AUTOMATIC OR MANUAL EMERGENCY INJECTION SYSTEM)
South Africa	200704515	Method and apparatus for delivering epinephrine
Japan	H08507239
Taiwan	200724182	Medicine injection devices and methods
Russian Federation	2431505	УСТРОЙСТВО ДЛЯ ИНЪЕКЦИИ ЛЕКАРСТВ (ВАРИАНТЫ) И СПОСОБЫ ЕГО ПРИМЕНЕНИЯ (DEVICE FOR DRUG INJECTION (VERSIONS) AND METHODS OF APPLICATION THEREOF)

Supplementary Protection Certificates for ADRENACLICK

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 ADRENACLICK

Last updated: July 27, 2025

Introduction

ADRENACLICK (generic name: epinephrine auto-injector) is a critical emergency medication designed to rapidly counteract severe allergic reactions (anaphylaxis). Since its FDA approval, ADRENACLICK has established itself within the emergency treatment space, competing with leading brands like EpiPen amid evolving market dynamics. Understanding the product’s market landscape and financial trajectory provides vital insights for stakeholders, investors, and healthcare providers navigating the complex pharmaceutical environment.

Market Overview

Growing Demand for Epinephrine Auto-Injectors

The global allergy and anaphylaxis treatment market is projected to grow substantially, driven by increasing allergy prevalence, rising awareness of emergency treatment options, and expanding healthcare access. According to a report by Grand View Research,[1] the global epinephrine auto-injector market is expected to reach USD 4.8 billion by 2026, with a compound annual growth rate (CAGR) of approximately 11.2%. Factors such as rising food allergies, insect sting allergies, and medication allergies underscore a persistent demand for auto-injectors like ADRENACLICK.

Competition and Market Penetration

EpiPen (by Mylan/EpiPen) remains the dominant market player, holding significant share through established brand recognition and broad distribution networks. However, generic auto-injectors like ADRENACLICK have gained visibility due to competitive pricing and insurance reimbursements, challenging the entrenched position of EpiPen. The entry of ADRENACLICK, with FDA approval in early 2018, marked a strategic shift toward increased affordability and accessibility.

Pricing Strategies and Insurance Dynamics

Cost sensitivity among consumers and insurers significantly influences market penetration. ADRENACLICK’s pricing strategy aims to undercut branded competitors, often priced at a fraction of EpiPen’s retail cost—vital given the high out-of-pocket expenses faced by patients. Insurance reimbursement policies and Medicaid formularies influence patient access, with favorable coverage boosting adoption rates. Notably, recent policy shifts emphasizing cost-containment foster increased preference for generic auto-injectors, improving ADRENACLICK’s market share.

Financial Trajectory

Revenue Growth and Market Penetration

Since its launch, ADRENACLICK’s revenues have exhibited a gradual upward trajectory. While precise revenue figures are proprietary, market estimates suggest that the product captured approximately 5-7% of the epinephrine auto-injector market by 2022, translating into tens of millions of dollars in annual revenue.[2] The growth trajectory is influenced by factors such as expanding distribution channels, insurance reimbursement strategies, and direct-to-consumer marketing.

Cost Structure and Profitability

As a generic auto-injector, ADRENACLICK benefits from lower manufacturing costs relative to branded counterparts, enabling competitive pricing and margin maintenance. Economies of scale, achieved through manufacturing efficiencies and increased volume, are expected to enhance profitability over time. However, R&D expenses for related product development, regulatory compliance, and marketing contribute to initial investments delaying profitability.

Impact of Regulatory and Legal Factors

Regulatory compliance, including ongoing FDA post-marketing requirements and risk management plans, impacts financial planning. Additionally, patent disputes and legal challenges—common in the auto-injector segment—pose potential risks. For instance, lawsuits alleging patent infringements or safety concerns could entail legal costs and reputational repercussions, affecting revenue flow.

Market Expansion and International Opportunities

While the US remains the primary market, international expansion presents lucrative opportunities. Countries with rising allergy prevalence and limited access to branded auto-injectors are prime targets. However, regulatory approval processes, local reimbursement policies, and distribution logistics influence growth potential.

Key Market Drivers

• Rising Allergy Incidents: An increase in food allergies and environmental allergens globally drives demand for emergency auto-injectors.

• Cost-Effective Alternatives: Competitive pricing offers a significant advantage, influencing prescribing behaviors among healthcare professionals.

• Insurance Policy Shift: Favoring generics enhances reimbursement rates and patient access.

• Awareness Campaigns: Public health initiatives and advocacy improve recognition and timely administration.

Challenges and Risks

• Market Dominance of EpiPen: High brand loyalty and entrenched supplier relationships inhibit rapid market share gains.

• Regulatory Hurdles: Ongoing approval processes and compliance costs can delay market expansion.

• Legal Litigations: Patent disputes and safety concerns can impact reputation and sales.

• Pricing Pressures: Payers’ increasing emphasis on cost savings threaten price erosion.

Future Outlook and Strategic Recommendations

The outlook for ADRENACLICK remains cautiously optimistic, contingent upon continued market penetration, strategic partnerships, and regulatory navigation. To maximize financial growth, stakeholders should focus on:

• Expanding Insurance Coverage: Partner with insurers for formulary placements and reimbursement agreements.

• Enhancing Distribution Channels: Broaden access through pharmacies, hospitals, and direct-to-consumer platforms.

• Innovating Product Features: Invest in user-friendly and compact designs to differentiate from competitors.

• International Market Entry: Pursue regulatory approvals and local partnerships to access emerging markets.

Key Takeaways

• The global epinephrine auto-injector market is expanding at a CAGR of approximately 11.2%, driven by rising allergy prevalence.

• ADRENACLICK has gained market share through competitive pricing, enhancing access and affordability.

• Revenue growth is expected to rise steadily as insurance reimbursements improve and distribution expands.

• The product’s financial performance hinges on regulatory compliance, legal stability, and strategic marketing.

• International expansion presents a significant opportunity, although regulatory and logistical challenges exist.

FAQs

1. How does ADRENACLICK’s market share compare to EpiPen?
ADRENACLICK holds approximately 5-7% of the market as of 2022, bolstered by cost advantages. EpiPen remains the market leader, retaining over 70% share domestically.

2. What are the primary factors influencing ADRENACLICK’s revenue growth?
Key factors include insurance reimbursement policies, distribution expansion, competitive pricing, and increasing awareness of allergy-related emergencies.

3. What legal risks could impact ADRENACLICK’s financial performance?
Patent disputes, safety lawsuits, and regulatory compliance issues could result in legal costs, restrictions, and reputational damage, affecting sales.

4. How does the international market outlook affect ADRENACLICK’s prospects?
Emerging markets with rising allergy incidences and limited access to affordable auto-injectors offer substantial growth opportunities, although regulatory and logistical hurdles must be addressed.

5. What strategic actions can enhance ADRENACLICK’s market trajectory?
Forming partnerships with payers, expanding distribution channels, innovating product features, and pursuing international regulatory approvals are essential strategies.

References

[1] Grand View Research. “Epinephrine Auto-Injectors Market Size, Share & Trends Analysis Report.” 2022.
[2] Market estimates based on industry reports and company disclosures, 2022.