EPI E Z PEN JR Drug Patent Profile

When do Epi E Z Pen Jr patents expire, and what generic alternatives are available?

Epi E Z Pen Jr is a drug marketed by Mylan Speciality Lp and is included in one NDA.

The generic ingredient in EPI E Z PEN JR 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 Epi E Z Pen Jr

A generic version of EPI E Z PEN JR was approved as epinephrine by BPI LABS on July 29^th, 2014.

Summary for EPI E Z PEN JR

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	88
Patent Applications:	1,938
DailyMed Link:	EPI E Z PEN JR at DailyMed

Pharmacology for EPI E Z PEN JR

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

US Patents and Regulatory Information for EPI E Z PEN JR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan Speciality Lp	EPI E Z PEN JR	epinephrine	INJECTABLE;INTRAMUSCULAR	019430-004	Aug 3, 1995		DISCN	No	No

International Patents for EPI E Z PEN JR

See the table below for patents covering EPI E Z PEN JR around the world.

Country	Patent Number	Title	Estimated Expiration
Denmark	1786491
Cyprus	1122922
Australia	2010201665	Automatic injector with kickback attenuation
Cyprus	1117383
South Korea	20070083539	AUTOMATIC INJECTOR

EPI E Z PEN JR Market Analysis and Financial Projection Experimental

The Market Dynamics and Financial Trajectory of EpiPen Jr. and the Global Epinephrine Market

Introduction to EpiPen Jr. and the Epinephrine Market

The EpiPen Jr., a version of the epinephrine auto-injector designed for children, is a crucial component of the broader epinephrine market. This market is driven by the increasing prevalence of severe allergic reactions, such as anaphylaxis, and the need for immediate and effective treatment.

Global Epinephrine Market Overview

The global epinephrine market is projected to experience significant growth. As of 2024, the market is valued at approximately $2.91 billion and is expected to reach $6.27 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 11.6%[1].

Market Drivers

Increasing Prevalence of Allergic Reactions and Medical Emergencies

The rising incidence of anaphylaxis and other severe allergic reactions is a primary driver of the epinephrine market. Anaphylaxis, a potentially life-threatening allergic reaction, has seen its lifetime prevalence estimated between 0.05% to 3%, with an increasing incidence over the past few decades[1].

Technological Advancements

Technological innovations, such as AI-enabled auto-injectors and needle-free auto-injectors, are enhancing drug delivery and patient compliance. These advancements are creating new opportunities for market players to launch products for various medical conditions[3].

Favorable Reimbursement Policies

Positive reimbursement policies are facilitating the adoption of epinephrine auto-injectors. Easy accessibility through retail and online pharmacies further boosts market growth[3].

Teva's Generic EpiPen Jr.

Teva Pharmaceuticals has been a significant player in the epinephrine market with its generic version of the EpiPen Jr. Approved by the U.S. Food and Drug Administration in 2018, Teva's generic EpiPen Jr. is designed for children who weigh between 33 and 66 pounds and is available for $300 for a two-pack, significantly lower than the branded version[2][4].

Market Share and Financial Projections

Teva's generic EpiPen Jr. is expected to capture a substantial market share. Analysts predict that Teva could capture around 45% of the U.S. epinephrine market, translating to approximately $290 million to $300 million in annual sales[4].

Regional Market Analysis

North America

North America, particularly the U.S., dominates the global epinephrine market. The U.S. market for EpiPen is valued at roughly $750 million annually, with Teva aiming to capture a significant portion of this market[2].

Asia Pacific

The Asia Pacific region is emerging as a fast-growing market due to rapid economic development and improving access to healthcare. Countries like China, India, Japan, and South Korea are experiencing an increase in the incidence of life-threatening medical conditions, driving demand for epinephrine auto-injectors[3].

Impact of COVID-19

The COVID-19 pandemic had a temporary negative impact on the epinephrine market, with a decline in market value in 2020 due to reduced patient visits to hospitals and clinics. However, the market has since recovered and is on a growth trajectory[3].

Financial Performance of Key Players

Mylan/Viatris

Mylan, now part of Viatris, has been a major player in the epinephrine auto-injector market. Despite a decline in sales of the EpiPen Auto-Injector in 2017, Viatris reported total net sales of $3.83 billion in the fourth quarter of 2023, indicating continued growth in the sector[3].

Teva Pharmaceuticals

Teva, the largest generics maker in the world, has seen its annual revenues decline by 16% since 2017. However, the company is optimistic about the potential of its generic EpiPen to stimulate revenue growth. Teva is also shifting its focus towards the more lucrative biologics market, with expectations that half of its revenues will come from biologics in the future[2].

Market Opportunities and Challenges

Increasing Incidence of Anaphylaxis

The rising incidence of anaphylaxis and other severe allergic reactions presents a significant market opportunity for epinephrine auto-injectors. However, high treatment costs and occasional product recalls can pose challenges to market growth[1].

Future Outlook

The future of the epinephrine auto-injector market looks promising, driven by:

Growing Demand

The increasing prevalence of allergic reactions and other life-threatening conditions will continue to drive demand for epinephrine auto-injectors.

Technological Innovations

Advancements in AI and other technologies will enhance the efficacy and user-friendliness of these devices, further boosting market growth.

Expanding Market Reach

The Asia Pacific region is expected to see significant growth due to economic development and improving healthcare access[3].

Key Takeaways

• The global epinephrine market is projected to grow significantly, driven by increasing prevalence of allergic reactions and medical emergencies.
• Technological advancements and favorable reimbursement policies are key drivers.
• North America, particularly the U.S., dominates the market, but the Asia Pacific region is emerging as a fast-growing segment.
• Teva's generic EpiPen Jr. is expected to capture a substantial market share in the U.S.
• The COVID-19 pandemic had a temporary negative impact, but the market has since recovered.

FAQs

1. What is the current market size of the global epinephrine market? The global epinephrine market is valued at approximately $2.91 billion in 2024[1].

2. What is the projected growth rate of the global epinephrine market? The market is expected to grow at a CAGR of 11.6% from 2024 to 2031[1].

3. Who are the key players in the epinephrine auto-injector market? Key players include Mylan (now part of Viatris) and Teva Pharmaceuticals[2][3].

4. How much does Teva's generic EpiPen Jr. cost? Teva's generic EpiPen Jr. is available for $300 for a two-pack[4].

5. What are the main drivers of the epinephrine market? The main drivers include the increasing prevalence of allergic reactions, technological advancements, and favorable reimbursement policies[1][3].

Cited Sources:

1. Coherent Market Insights, "Epinephrine Market to Hit USD 6.27 Billion by 2031, Says Coherent Market Insights," October 28, 2024.
2. BioSpace, "Teva Eyes 25 Percent of the $750 Million EpiPen Market by Year's End," February 19, 2019.
3. Drug Patent Watch, "EPIPEN Drug Patent Profile."
4. Advisory.com, "Teva's generic EpiPen Jr. is about to hit the market for $300," August 23, 2019.