Epinephrine - Generic Drug Details

What are the generic sources for epinephrine and what is the scope of patent protection?

Epinephrine is the generic ingredient in thirty-five branded drugs marketed by Sterling, Armstrong Pharms, Wyeth Cons, Forest Labs, Mylan Speciality Lp, Impax, Teva Pharms Usa, Endo Operations, Am Regent, Bpi Labs, Fresenius Kabi Usa, Gland, Intl Medication Sys, Kaleo Inc, Adamis Pharms Corp, Hospira, Ars Pharms Operation, 3M, Baxter Hlthcare Corp, Astrazeneca, Dentsply Pharm, Deproco, Septodont Inc, Carlisle, B Braun Medical Inc, Belmora Llc, Eastman Kodak, West-ward Pharms Int, Abbott, Bel Mar, Dell Labs, Intl Medication, Watson Labs, Pharmaton, Septodont, Vyteris, Iomed, and Empi, and is included in sixty-six NDAs. There are thirty-five patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Epinephrine has two hundred and seventy-six patent family members in thirty-two countries.

There are twenty-one drug master file entries for epinephrine. Twenty-six suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for epinephrine

International Patents:	276
US Patents:	35
Tradenames:	35
Applicants:	38
NDAs:	66
Drug Master File Entries:	21
Finished Product Suppliers / Packagers:	26
Raw Ingredient (Bulk) Api Vendors:	88
Clinical Trials:	714
Patent Applications:	7,112
Drug Prices:	Drug price trends for epinephrine
Drug Sales Revenues:	Drug sales revenues for epinephrine
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for epinephrine
What excipients (inactive ingredients) are in epinephrine?	epinephrine excipients list
DailyMed Link:	epinephrine at DailyMed

See drug prices for epinephrine

See drug sales revenues for epinephrine

Recent Clinical Trials for epinephrine

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

Sponsor	Phase
Montefiore Medical Center	N/A
University Hospital "Sestre Milosrdnice"	N/A
Jessyka Lighthall	Phase 3

See all epinephrine clinical trials

Generic filers with tentative approvals for EPINEPHRINE

Applicant	Application No.	Strength	Dosage Form
		EQ 1MG BASE/ML (EQ 1MG BASE/ML)	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for epinephrine

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

Medical Subject Heading (MeSH) Categories for epinephrine

Adrenergic alpha-Agonists

Adrenergic beta-Agonists

Bronchodilator Agents

Mydriatics

Sympathomimetics

Vasoconstrictor Agents

Anatomical Therapeutic Chemical (ATC) Classes for epinephrine

A01AD	Other agents for local oral treatment
A01A	STOMATOLOGICAL PREPARATIONS
A01	STOMATOLOGICAL PREPARATIONS
A	Alimentary tract and metabolism

B02BC	Local hemostatics
B02B	VITAMIN K AND OTHER HEMOSTATICS
B02	ANTIHEMORRHAGICS
B	Blood and blood forming organs

C01CA	Adrenergic and dopaminergic agents
C01C	CARDIAC STIMULANTS EXCL. CARDIAC GLYCOSIDES
C01	CARDIAC THERAPY
C	Cardiovascular system

R01AA	Sympathomimetics, plain
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R03AA	Alpha- and beta-adrenoreceptor agonists
R03A	ADRENERGICS, INHALANTS
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

S01EA	Sympathomimetics in glaucoma therapy
S01E	ANTIGLAUCOMA PREPARATIONS AND MIOTICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

Paragraph IV (Patent) Challenges for EPINEPHRINE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EPINEPHRINE	Injection	epinephrine	1 mg/mL	205029	1	2020-08-13
ADRENALIN	Injection	epinephrine	30 mg/30 mL	204640	1	2018-08-20
ADRENALIN	Injection	epinephrine	1 mg/mL ampules	204200	1	2016-03-09
EPIPEN JR.	Injection (Auto- injector)	epinephrine	0.15 mg/0.3 mL and 0.3 mg/0.3 mL	019430	1	2009-07-20

US Patents and Regulatory Information for epinephrine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astrazeneca	DURANEST	epinephrine bitartrate; etidocaine hydrochloride	INJECTABLE;INJECTION	017751-006	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Forest Labs	SUS-PHRINE SULFITE FREE	epinephrine	INJECTABLE;INJECTION	007942-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Pharmaton	LIDOCATON	epinephrine; lidocaine hydrochloride	INJECTABLE;INJECTION	084728-001	Aug 17, 1983		DISCN	No	No

Expired US Patents for epinephrine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Impax	ADRENACLICK	epinephrine	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	020800-004	Nov 25, 2009	10,166,334
Kaleo Inc	AUVI-Q	epinephrine	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	201739-001	Aug 10, 2012	8,608,698
Kaleo Inc	AUVI-Q	epinephrine	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	201739-002	Aug 10, 2012	8,361,029

International Patents for epinephrine

Country	Patent Number	Title	Estimated Expiration
United Kingdom	2471981	Medicament delivery device having an electronic circuit system
Japan	2018507915	エピネフリン製剤
World Intellectual Property Organization (WIPO)	2019157099

Supplementary Protection Certificates for epinephrine

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3678649	122025000010	Germany		PRODUCT NAME: KOMBINATION AUS EPINEPHRIN AND DODECYLMALTOSID, IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/24/1846 20240822
3678649	CA 2025 00007	Denmark		PRODUCT NAME: KOMBINATION AF EPINEPHRIN ELLER ET SALT DERAF, OG DODECYLMATOSID; REG. NO/DATE: EU/1/24/1846 20240823
3678649	PA2025507	Lithuania		PRODUCT NAME: VISU FORMU EPINEFRINO IR DODECILMALTOZIDO DERINYS SAUGOMASPAGRINDINIO PATENTO; REGISTRATION NO/DATE: EU/1/24/1846 20240822

Market Dynamics and Financial Trajectory for Epinephrine

Introduction to Epinephrine Market

Epinephrine, a crucial medication for treating severe allergic reactions and other life-threatening conditions, has seen significant growth in its market over recent years. This article delves into the market dynamics, financial trajectory, and key factors influencing the epinephrine market.

Current Market Size and Growth

The epinephrine market has been expanding rapidly. As of 2023, the market size was valued at $2.44 billion and is projected to grow to $2.69 billion in 2024, representing a compound annual growth rate (CAGR) of 10.4%[1].

By 2028, the market is expected to reach $3.82 billion, driven by a CAGR of 9.2%. This growth is attributed to rising allergy rates, expanded access initiatives, awareness campaigns, and the emergence of new markets[1].

Key Drivers of Market Growth

Rising Allergy Rates

The increasing incidence of allergies, particularly anaphylaxis, is a significant driver of the epinephrine market. As more people are diagnosed with severe allergies, the demand for epinephrine auto-injectors and other delivery methods increases[1][4].

Regulatory Framework and Awareness

Regulatory support and awareness campaigns play a crucial role in the market's growth. Initiatives aimed at educating patients and healthcare providers about the importance of epinephrine in emergency situations have boosted demand[1].

Healthcare Expenditure

Rising healthcare expenditure is another key factor. Increased spending on healthcare ensures that hospitals, clinics, and emergency medical services are better equipped with epinephrine auto-injectors, making them more accessible to those in need[1].

Global Expansion

The Asia Pacific region has emerged as a fast-growing market for epinephrine, driven by rapid economic development and increasing affordability of new treatments. Countries like China, India, Japan, and South Korea are witnessing a surge in demand due to growing incidences of life-threatening medical conditions[4].

Market Trends

Integration of Smart Devices

The integration of smart devices into epinephrine delivery systems is a significant trend. Smart auto-injectors can provide real-time feedback and alerts, enhancing patient safety and adherence to treatment[1].

Enhanced Education and Awareness

Improved education and awareness programs are critical in increasing the use of epinephrine. These programs help in early detection and treatment of allergic reactions, thereby driving market growth[1].

Global Expansion of Epinephrine Access

Efforts to expand access to epinephrine globally are ongoing. This includes legislative initiatives, such as the EPIPEN Act in the U.S., aimed at capping the out-of-pocket costs of epinephrine auto-injectors to make them more affordable[2].

Regulatory Emphasis on Product Safety

Regulatory bodies are emphasizing the safety of epinephrine products. This includes stricter guidelines for manufacturing and distribution, ensuring that the products are reliable and effective in emergency situations[1].

Financial Trajectory

Market Size Projections

The global epinephrine market is estimated to be valued at $2.91 billion in 2024 and is expected to reach $6.27 billion by 2031, exhibiting a CAGR of 11.6% from 2024 to 2031[4].

By 2032, the market is projected to expand significantly to $4.489 billion, indicating a robust financial trajectory driven by increasing demand and expanding market reach[3].

Cost and Accessibility Issues

High Out-of-Pocket Costs

One of the significant challenges in the epinephrine market is the high out-of-pocket costs for auto-injectors. In the U.S., these costs can be prohibitively expensive, with prices rising from under $100 to over $600 per pack. This has led to legislative efforts, such as the EPIPEN Act, to cap these costs at $60 per pack for those with employer-based or individually purchased health insurance[2].

Comparative Costs

In contrast, epinephrine auto-injectors are more affordable in other countries. For example, in the UK, they cost on average just under $70, highlighting the need for more affordable options in other regions[2].

Cost-Effectiveness and Value

Cost-Effectiveness Studies

Studies have shown that stocking epinephrine auto-injectors can be cost-effective, especially in high-risk environments such as commercial aircraft. A study found that equipping all commercial aircraft with autoinjectors reduced fatality risk and was cost-effective at a low annual cost per passenger-at-risk of $0.08[5].

Challenges and Limitations

Alternative Treatment Options

The presence of alternative treatment options can hamper the growth of the epinephrine market. However, epinephrine remains the gold standard for treating severe allergic reactions due to its rapid and effective action[4].

Risk of Side-Effects

The risk of side-effects associated with epinephrine administration is another challenge. Despite this, the benefits of epinephrine in emergency situations far outweigh the risks, making it a critical component of emergency medical kits[4].

Regional Market Dynamics

Asia Pacific

The Asia Pacific region is the fastest-growing market for epinephrine, driven by economic development, increasing affordability of treatments, and government initiatives to reduce out-of-pocket healthcare spending. Countries like China, India, Japan, and South Korea are key drivers of this growth[4].

Key Takeaways

• The epinephrine market is growing rapidly, driven by rising allergy rates, regulatory support, and increased healthcare expenditure.
• The market is expected to reach $3.82 billion by 2028 and $6.27 billion by 2031.
• Integration of smart devices, enhanced education, and global expansion of epinephrine access are key trends.
• High out-of-pocket costs remain a challenge, but legislative efforts aim to make epinephrine more affordable.
• The Asia Pacific region is a significant growth area due to economic development and government healthcare initiatives.

FAQs

1. What is the current market size of the epinephrine market? The epinephrine market size was valued at $2.44 billion in 2023 and is projected to grow to $2.69 billion in 2024[1].

2. What are the key drivers of the epinephrine market growth? Key drivers include rising allergy rates, expanded access initiatives, awareness campaigns, and increasing healthcare expenditure[1][4].

3. How does the EPIPEN Act impact the epinephrine market? The EPIPEN Act aims to cap the out-of-pocket costs of epinephrine auto-injectors at $60 per pack, making them more affordable for individuals with severe allergies[2].

4. What are the challenges facing the epinephrine market? Challenges include high out-of-pocket costs, the presence of alternative treatment options, and the risk of side-effects associated with epinephrine administration[2][4].

5. Which region is the fastest-growing market for epinephrine? The Asia Pacific region is the fastest-growing market, driven by economic development and government healthcare initiatives[4].

Sources

1. The Business Research Company. Epinephrine Market Report 2024.
2. Frost, M. Congressman Maxwell Frost Unveils New EPIPEN Act, Legislation to Lower Costs of Life-Saving Allergy Medication.
3. Credence Research. Epinephrine Market Size, Growth, Share and Forecast 2032.
4. Coherent Market Insights. Epinephrine Market - Share, Size and Industry Analysis.
5. PubMed. Cost-Effectiveness of Stock Epinephrine Autoinjectors on Commercial Aircraft.

Last updated: 2024-12-16