ADRENACLICK Drug Patent Profile

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

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. Twenty-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:	7
Raw Ingredient (Bulk) Api Vendors:	60
Clinical Trials:	2
Patent Applications:	4,300
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	5,665,071
Impax	ADRENACLICK	epinephrine	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	020800-004	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
World Intellectual Property Organization (WIPO)	2009150078
European Patent Office	1824560	PROCEDE ET DISPOSITIF DE DELIVRANCE D'EPINEPHRINE (METHOD AND APPARATUS FOR DELIVERING EPINEPHRINE)
Brazil	PI0518415	aparelho formando um dispositivo de injeÇço de medicamento, e, mÉtodos para acionar uma agulha de seringa atÉ uma profundidade de penetraÇço selecionada, e para injetar medicamento de uma seringa e armazenar a seringa apàs injeÇço do medicamento
Japan	2008522659
China	101850143	Medicine injection devices and methods

ADRENACLICK Market Analysis and Financial Projection Experimental

The Epinephrine Market: Dynamics and Financial Trajectory for Adrenaclick

Introduction

The epinephrine market, which includes products like Adrenaclick, is experiencing significant growth driven by increasing cases of severe allergic reactions and other medical emergencies. This article delves into the market dynamics, financial trajectory, and key factors influencing the growth of the epinephrine market, particularly focusing on Adrenaclick.

Market Size and Growth

The global epinephrine market is projected to grow substantially over the next decade. According to recent forecasts, the market is expected to reach USD 6.27 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 11.6% from 2024 to 2031[1][4][5].

Key Drivers of Market Growth

Several factors are driving the growth of the epinephrine market:

Increasing Incidence of Anaphylaxis

Anaphylaxis, a severe and potentially life-threatening allergic reaction, is becoming more prevalent. Nearly 5% of the U.S. population has experienced anaphylaxis, highlighting the growing need for effective treatment options like epinephrine auto-injectors[4].

Growing Adoption of Epinephrine Autoinjectors

Auto-injectors, such as Adrenaclick, are gaining popularity due to their ease of use and immediate relief in emergency situations. In 2023, auto-injectors held a market share of 52.3% in the epinephrine market[4].

Increasing Occurrence of Cardiac Arrests

Cardiac arrests are another significant driver, with epinephrine playing a crucial role in emergency resuscitation efforts. The high incidence of out-of-hospital cardiac arrests (OHCA) in the U.S., with over 356,000 cases annually, underscores the need for epinephrine in emergency medical settings[4].

Regional Analysis

North America

North America dominates the epinephrine market, with a significant market share of 40.2% in 2023. This is attributed to the increasing prevalence of allergic reactions, favorable reimbursement policies, and the launch of technologically advanced products like the ALLERJECT auto-injector in Canada[4][5].

Asia Pacific

The Asia Pacific region is expected to experience the highest CAGR during the forecast period. Changing regulatory policies and the expansion of global pharmaceutical companies into this region are key factors driving growth. For instance, ALK-Abelló A/S partnered with Grandpharma to launch the adrenaline auto-injector “Jext” in China[5].

Europe and Other Regions

Europe and other regions, such as Latin America and the Middle East & Africa, are also experiencing growth due to increasing diagnosis and treatment rates of anaphylaxis and strategic government initiatives to control the prevalence of allergic reactions[5].

Product Segmentation

The epinephrine market is segmented by product type, with auto-injectors being the leading segment. Other product types include prefilled syringes, ampoules, and vials. Auto-injectors like Adrenaclick are preferred due to their ease of use and rapid administration in emergency situations[4].

Distribution Channels

Hospital pharmacies dominate the distribution channel segment, holding the largest revenue share of 48.7% in the epinephrine market. Retail pharmacies and online pharmacies also play significant roles, especially with the increasing trend of online healthcare services[4].

Financial Trajectory

Revenue Forecast

The global epinephrine market was valued at USD 2.8 billion in 2023 and is expected to reach USD 6.3 billion by 2033, growing at a CAGR of 8.4% during the forecast period[4].

Competitive Landscape

Companies like Pfizer, Nasus Pharma Ltd, Lincoln Medical, Ltd., and Harvest are key players in the epinephrine market. Teva Pharmaceutical Industries Ltd. leads the market with a strong portfolio of auto-injectors. These companies are focusing on new product launches, expanding distribution networks, and capitalizing on favorable reimbursement policies to drive market growth[4][5].

Challenges and Opportunities

High Treatment Costs

Despite the growing demand, high treatment costs and the recall of product batches pose significant challenges to the market. For instance, Amneal Pharmaceuticals faced challenges due to the uncertainty of supply of epinephrine auto-injectors from its third-party supplier[3].

Increasing Government Scrutiny

Pharmaceutical companies are also under increased government scrutiny related to agreements to settle patent litigation and other regulatory issues. This can impact the financial performance and operational efficiency of companies involved in the epinephrine market[2].

Opportunities for Growth

The increasing incidence of cardiac arrests and the growing need for advanced epinephrine delivery systems present substantial opportunities for market growth. Companies are expanding their product portfolios and global presence to meet the rising demand for epinephrine products[4][5].

Key Takeaways

• The global epinephrine market is projected to grow significantly, reaching USD 6.27 billion by 2031.
• Auto-injectors, such as Adrenaclick, dominate the market due to their ease of use and rapid administration.
• North America leads the market, driven by favorable reimbursement policies and the launch of advanced products.
• The Asia Pacific region is expected to experience the highest CAGR during the forecast period.
• High treatment costs and regulatory challenges are key hurdles, but the increasing incidence of anaphylaxis and cardiac arrests offer significant growth opportunities.

FAQs

Q: What is the projected market size of the epinephrine market by 2031?

A: The global epinephrine market is expected to reach USD 6.27 billion by 2031[1].

Q: Which region dominates the epinephrine market?

A: North America dominates the epinephrine market, with a significant market share driven by increasing allergic reactions and favorable reimbursement policies[4][5].

Q: What are the main product types in the epinephrine market?

A: The main product types include auto-injectors, prefilled syringes, ampoules, and vials, with auto-injectors being the leading segment[4].

Q: What are the key drivers of the epinephrine market growth?

A: The increasing incidence of anaphylaxis, growing adoption of epinephrine auto-injectors, and increasing occurrence of cardiac arrests are key drivers of market growth[4].

Q: Which companies are leading the epinephrine market?

A: Companies like Teva Pharmaceutical Industries Ltd., Pfizer, Nasus Pharma Ltd, and Lincoln Medical, Ltd. are key players in the epinephrine market[4][5].

Sources

1. Coherent Market Insights: Epinephrine Market to Hit USD 6.27 Billion by 2031, Says Coherent Market Insights.
2. Amneal Pharmaceuticals: Expiration Dates for Certain Lots of Generic Adrenaclick Epinephrine Injection USP Auto-Injector Extended to 20 Months.
3. Amneal Pharmaceuticals: Amneal Pharmaceuticals Announces Restructuring and Costs Savings Plan to Improve Operations and Position the Company for Future Growth.
4. Market.US: Epinephrine Market Size, Share | Growth CAGR Of 8.4%.
5. Fortune Business Insights: Epinephrine Market Size, Share, Growth & Forecast [2032].