ADRENALIN Drug Patent Profile

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

Adrenalin is a drug marketed by Endo Operations and is included in three NDAs. There are seven 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. Twenty-six 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:	7
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	60
Clinical Trials:	45
Patent Applications:	2,374
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
China-Japan Friendship Hospital	Early Phase 1
The Second Affiliated Hospital of Harbin Medical University	Early Phase 1
The First Affiliated Hospital of Nanchang University	Early Phase 1

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 seven US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Endo Operations	ADRENALIN	epinephrine	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	204200-001	Dec 7, 2012		RX	Yes	Yes
Endo Operations	ADRENALIN	epinephrine	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	204640-001	Dec 18, 2013	AP	RX	Yes	Yes			Y
Endo Operations	ADRENALIN	epinephrine	SOLUTION;INTRAVENOUS	215875-001	Apr 21, 2023		RX	Yes	Yes			Y
Endo Operations	ADRENALIN	epinephrine	SOLUTION;INTRAVENOUS	215875-002	Apr 21, 2023		RX	Yes	Yes			Y
Endo Operations	ADRENALIN	epinephrine	SOLUTION;INTRAVENOUS	215875-004	Apr 21, 2023		RX	Yes	Yes
Endo Operations	ADRENALIN	epinephrine	SOLUTION;INTRAVENOUS	215875-004	Apr 21, 2023		RX	Yes	Yes			Y
Endo Operations	ADRENALIN	epinephrine	SOLUTION;INTRAVENOUS	215875-005	Apr 21, 2023		RX	Yes	Yes			Y

International Patents for ADRENALIN

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

Country	Patent Number	Title	Estimated Expiration
Australia	2016233682	Epinephrine formulations
Canada	3093725	COMPOSITIONS ET RECIPIENTS D'EPINEPHRINE (EPINEPHRINE COMPOSITIONS AND CONTAINERS)
China	107614017	肾上腺素制剂 (EPINEPHRINE FORMULATIONS)
European Patent Office	3268045	FORMULATIONS D'ÉPINÉPHRINE (EPINEPHRINE FORMULATIONS)
Japan	2018507915	エピネフリン製剤
World Intellectual Property Organization (WIPO)	2019183416
World Intellectual Property Organization (WIPO)	2016149028

The Evolving Market Dynamics and Financial Trajectory of Epinephrine (Adrenaline)

Introduction

Epinephrine, commonly known as adrenaline, is a crucial medication used to treat severe allergic reactions (anaphylaxis), asthma attacks, and cardiac arrest. The market for epinephrine has been experiencing significant growth, driven by various factors. Here, we delve into the market dynamics and financial trajectory of this vital drug.

Market Size and Growth

The global epinephrine market has been expanding rapidly. In 2023, the market size was valued at approximately $1.92 billion and is projected to grow to $4.60 billion by 2032, exhibiting a compound annual growth rate (CAGR) of 10.2% during the forecast period[2].

Historic Growth

The historic growth of the epinephrine market can be attributed to several factors, including the increasing incidence of anaphylaxis, favorable regulatory frameworks, enhanced patient education, and improved accessibility of epinephrine products[1].

Forecasted Growth

The future growth of the market is expected to be driven by rising allergy rates, expanded access initiatives, awareness campaigns, and the integration of smart devices. The market is also expected to benefit from emerging markets and customized epinephrine delivery systems[1][2].

Regional Market Dynamics

North America

North America dominates the global epinephrine market, with the U.S. being a significant contributor. The U.S. epinephrine market size was valued at $1.07 billion in 2022 and is projected to grow at a CAGR of 10.8% during the forecast period. This growth is driven by adequate reimbursement policies for auto-injectors and the launch of technologically advanced products[2][4].

Europe

In Europe, the market growth is fueled by the increasing prevalence of anaphylaxis, cardiovascular diseases, and the demand for technologically advanced products. For instance, the prevalence of food allergies in children has been on the rise, contributing to the market's expansion[2].

Asia Pacific

The Asia Pacific region is projected to grow significantly due to changing regulatory policies and companies expanding their global presence to meet the demand for epinephrine products. Partnerships, such as ALK-Abelló A/S's collaboration with Grandpharma to launch the "Jext" auto-injector in China, are key drivers of this growth[2].

Latin America and Middle East & Africa

In Latin America, the market is growing due to increasing diagnosis and treatment rates of anaphylaxis, while in the Middle East & Africa, strategic initiatives by governments to control the prevalence of anaphylaxis are driving market expansion[2].

Key Drivers of Market Growth

Increasing Prevalence of Allergies and Cardiovascular Diseases

The rising prevalence of severe allergic reactions and cardiovascular diseases is a major driver of the epinephrine market. As these conditions become more common, the demand for rapid and reliable treatments like epinephrine auto-injectors increases[2][3].

Technological Advancements

Technological advancements in drug delivery systems, such as the development of smart auto-injectors, are enhancing patient convenience and efficacy, thereby driving market growth[3].

Regulatory and Reimbursement Policies

Favorable reimbursement policies, especially in regions like North America, and regulatory emphasis on product safety are crucial for the market's expansion. These policies ensure that epinephrine products are more accessible and affordable for patients[2].

Awareness and Education

Enhanced education and awareness programs about anaphylaxis management are also boosting the market. These initiatives increase the demand for epinephrine products as more people become aware of the need for emergency treatments[1].

Challenges and Limitations

High Cost of Epinephrine Auto-Injectors

One of the significant challenges facing the market is the high cost of epinephrine auto-injectors, which restricts access, particularly in developing regions. Despite the introduction of generic versions, prices remain high, limiting affordability[3][5].

Regulatory Requirements

Stringent regulatory requirements complicate product approvals and can slow down market growth. Additionally, potential shortages and competition from generic brands add layers of complexity to the market[3].

Supply Chain Disruptions

The market is also vulnerable to supply chain disruptions, which can impact the availability of epinephrine products. This vulnerability is a significant challenge, especially in regions with fragile healthcare systems[3].

Impact of COVID-19

The COVID-19 pandemic had a negative impact on the epinephrine market in 2020. The pandemic led to reduced patient visits, limited diagnosis of anaphylaxis, and disruptions in drug manufacturing, resulting in a temporary decline in market growth[4].

Financial Trajectory

Revenue Projections

The epinephrine market is expected to continue its strong financial trajectory, with projected revenues reaching $4.60 billion by 2032. This growth is supported by increasing healthcare expenditure, which enables wider availability of epinephrine products in healthcare settings[1][2].

Key Players

Companies like Teva Pharmaceutical Industries Ltd. are leading the market with strong portfolios of auto-injectors. The launch of new products and partnerships, such as the availability of ALLERJECT auto-injector in Canada, are contributing to the financial growth of these companies[2].

Telehealth and Future Opportunities

The expansion of telehealth services presents potential opportunities for the epinephrine market. Telehealth can enhance patient education and improve the accessibility of epinephrine products, especially in remote or underserved areas[3].

Conclusion

The epinephrine market is poised for significant growth driven by increasing allergy rates, technological advancements, and favorable regulatory policies. However, the market faces challenges such as high costs, stringent regulatory requirements, and supply chain vulnerabilities.

Key Takeaways

• The global epinephrine market is projected to grow from $1.92 billion in 2023 to $4.60 billion by 2032.
• North America, particularly the U.S., dominates the market due to favorable reimbursement policies and advanced product launches.
• Technological advancements and increasing awareness of anaphylaxis management are key drivers of market growth.
• High costs and regulatory complexities are significant challenges.
• Telehealth services offer future opportunities for market expansion.

FAQs

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

A: The primary drivers include the increasing prevalence of severe allergic reactions and cardiovascular diseases, technological advancements in drug delivery systems, and favorable regulatory and reimbursement policies.

Q: How has the COVID-19 pandemic impacted the epinephrine market?

A: The pandemic had a negative impact in 2020 due to reduced patient visits, limited diagnosis of anaphylaxis, and disruptions in drug manufacturing.

Q: Which region dominates the global epinephrine market?

A: North America, particularly the U.S., dominates the global epinephrine market due to favorable reimbursement policies and the launch of technologically advanced products.

Q: What are the challenges facing the epinephrine market?

A: The challenges include the high cost of epinephrine auto-injectors, stringent regulatory requirements, potential shortages, and competition from generic brands.

Q: How is telehealth impacting the epinephrine market?

A: Telehealth is enhancing patient education and improving the accessibility of epinephrine products, especially in remote or underserved areas.

Sources

1. The Business Research Company - Epinephrine Market Report 2024
2. Fortune Business Insights - Epinephrine Market Size, Share, Growth & Forecast [2032]
3. Research and Markets - Epinephrine Market Size, Competitors & Forecast to 2030
4. Fortune Business Insights - U.S. Epinephrine Market Size, Share, Growth | Report [2030]
5. Pew Trusts - Beyond EpiPen: Prices of Lifesaving Epinephrine Products Soar