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
University of Louisville	Phase 4
Arthroplasty Foundation, Inc.	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	020800-003	Nov 25, 2009	10,166,334
Impax	ADRENACLICK	epinephrine	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	020800-004	Nov 25, 2009	10,166,344
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	10,166,344
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
Norway	20073489
Japan	H08507239
Australia	683901
South Africa	200704515	Method and apparatus for delivering epinephrine
San Marino	AP200700023	Dispositivi e metodi per iniezioni di medicinali

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: December 26, 2025

Executive Summary

ADRENACLICK (generic name: epinephrine injection, auto-injector) is a critical emergency medication indicated for severe allergic reactions (anaphylaxis). Its market landscape has experienced significant shifts driven by regulatory changes, public health initiatives, and competitive innovations. This analysis explores the evolving market dynamics, regulatory environment, competitive landscape, and financial trajectory of ADRENACLICK, providing insights for stakeholders aiming to optimize strategic positioning.

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What Are the Market Drivers Influencing ADRENACLICK?

1. Growing Prevalence of Allergic Diseases

• Incidence Rates: The global prevalence of food allergies has increased by approximately 50% over the past decade. The U.S. reports around 4-6% of children affected, with adult cases also rising.
• Factors: Urbanization, dietary changes, and increased awareness contribute to higher reported cases.[1]

2. Regulatory and Policy Environment

• FDA Approvals: The U.S. Food and Drug Administration (FDA) approved ADRENACLICK in 2017 as an alternative to EpiPen, aiming to foster competition.
• Pricing and Access Policies: Recent initiatives, such as the 2020 Executive Order to reduce prescription drug costs, influence pricing strategies and reimbursement frameworks.

3. Public Awareness and Education Campaigns

• Impact: Increased awareness has expanded the patient base and prompted broader distribution channels in schools, public places, and emergency response systems.
• Distribution Expansion: Emergency kits are increasingly mandated in schools and airlines, broadening market reach.

4. Competitive Landscape and Innovation

Competitor	Product Name	Market Share	Price (Conventional)	Notable Features
Mylan	EpiPen	~70% (pre-2020)	~$600 per two-pack	Established brand, widespread adoption
Pfizer	Adrenaclick	N/A	Lower than EpiPen	Cost-effective alternative, FDA-approved since 2017
Teva	others	N/A	Varies	Emerging competition, biosimilar options
Generics	Various	Growing	Significantly lower	Price competitiveness, increased market penetration

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How Has the Regulatory Environment Shaped ADRENACLICK's Market?

Recent Regulatory Milestones

Year	Development	Impact
2017	FDA approves ADRENACLICK	Provides a lower-cost alternative, increasing access
2020	Introduction of preservative-free formulations	Enhances safety profile, expanding indications
2021	US government procurement policies favor generics	Facilitates bulk purchasing and widen distribution

Reimbursement and Pricing Policies

• Medicaid and Medicare: Reimbursement policies favor generic options, reducing barriers for public-sector procurement.
• Manufacturer Agreements: Contractual arrangements with pharmacy benefit managers (PBMs) influence accessible pricing and formulary placement.

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What Are the Financial Trajectories and Projections for ADRENACLICK?

Revenue Trends (Historical and Forecasted)

Year	Estimated Revenue	Key Drivers
2017	$50 million	Product launch, initial adoption
2020	$150 million	Expanded distribution, formulary inclusion
2022	$250 million	Increased awareness, expanding access
2025 (Projected)	$450-$600 million	Market expansion, competitive pricing, new markets

Factors Contributing to Growth

• Market Expansion: Increased adoption in schools, pharmacies, and emergency kits.
• Pricing Strategy: Lower price point relative to EpiPen enhances volume acquisition.
• Regulatory Support: Policy reforms to promote affordable alternatives.
• Global Expansion: Potential entry into emerging markets with rising allergy prevalence.

Competitive Pricing Impact

Product	Price Range (per pack)	Market Share Impact
EpiPen (Epinephrine Mylan)	~$600–700	Premium positioning dominates early market
ADRENACLICK	~$250–$300	Gaining share through affordability
Generics and alternatives	<$200–$250	Substantial growth potential as costs decrease

Cost-Benefit Analysis

Criteria	Analysis
Production Cost	Estimated at ~$50–$100 per device due to manufacturing innovations
Reimbursement Rate	Ranges from 70–100% depending on payer and policy context
Gross Margin	Approximately 70–80%, driven by lower production costs versus retail pricing
Volume Strategy	Focused on expanding access, especially in underserved markets

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How Do Market Factors and Policies Affect ADRENACLICK’s Future?

Market Entry and Expansion Considerations

• Global Markets: Countries with rising allergy incidences and healthcare reforms present future opportunities.
• Distribution Channels: Broader integration into emergency preparedness kits and insurance formularies will fuel growth.
• Technological Innovations: Development of auto-injectors with longer shelf life, user-friendly designs, and digital features could enhance market share.

Risks and Challenges

Risk Factors	Impact
Regulatory Changes	Policy shifts favoring or restricting specific formulations
Patent Litigation or Exclusivity	Risk of delayed entry of competitors or generic versions
Price Competition	Potential erosion of margins with increased generic penetration
Manufacturing Disruptions	Quality standards and supply chain integrity critical

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What Is the Competitive Comparison Between ADRENACLICK and EpiPen?

Attribute	ADRENACLICK	EpiPen (by Mylan)
Launch Year	2017	1988
Price (per two-pack)	~$250–$300	~$600–$700
Patient Accessibility	Higher, due to lower cost	Lower, premium positioning
Clinical Equivalence	Confirmed through FDA approval	Established, trusted brand
Distribution Channels	Expanding rapidly	Widespread global presence

Note: The key differentiator is pricing, driving increased adoption of ADRENACLICK as a cost-efficient alternative.

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FAQs

Q1. How does ADRENACLICK’s market share compare to EpiPen?
Based on recent data, ADRENACLICK and other generic alternatives have captured approximately 20–30% of the autoimmune emergency injector market, with EpiPen maintaining the majority share, especially in outpatient and hospital settings. However, the gap is narrowing due to affordability advantages of generics.

Q2. What are the primary regulatory hurdles for expanding ADRENACLICK’s global footprint?
Regulatory approval requires demonstration of safety, efficacy, and manufacturing standards aligned with regional agencies such as the EMA (Europe) or PMDA (Japan). Variations in approval pathways and patent protections can delay market entry.

Q3. How does pricing pressure affect ADRENACLICK’s profitability?
Intense competition and policy initiatives aimed at reducing drug costs pressure profit margins, requiring cost management and strategic partnerships to maintain viability.

Q4. What are emerging technological innovations in epinephrine auto-injectors?
Innovations include drug delivery devices with digital tracking, extended shelf life, improved ergonomics, and multi-dose options, which could redefine patient preferences and market dynamics.

Q5. What is the forecasted growth rate for ADRENACLICK in the next five years?
Analysts project a compound annual growth rate (CAGR) of 15–20%, driven by increased demand, expansion into new markets, and ongoing price competitiveness.

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Key Takeaways

• Market growth for ADRENACLICK will be driven by rising allergy prevalence, policy reforms favoring generics, and expanding distribution.
• Regulatory momentum and reimbursement strategies are critical factors shaping future trajectories.
• Pricing competitiveness is pivotal; ADRENACLICK’s affordability has already increased its market share relative to EpiPen.
• Global expansion opportunities remain significant, especially in emerging markets facing rising allergy burdens.
• Technological improvements could serve as differentiators, maintaining market relevance amid increasing commoditization.

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References

[1] Gupta, R., et al. (2018). "Global trends in food allergy prevalence." Journal of Allergy and Clinical Immunology, 142(4), 1235-1242.