EPIPEN Drug Patent Profile

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

Epipen is a drug marketed by Mylan Speciality Lp and is included in one NDA. There are five patents protecting this drug.

This drug has forty-seven patent family members in eighteen countries.

The generic ingredient in EPIPEN 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 Epipen

A generic version of EPIPEN was approved as epinephrine by BPI LABS on July 29^th, 2014.

Summary for EPIPEN

International Patents:	47
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	88
Clinical Trials:	11
Patent Applications:	4,292
Drug Prices:	Drug price information for EPIPEN
Drug Sales Revenues:	Drug sales revenues for EPIPEN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EPIPEN
What excipients (inactive ingredients) are in EPIPEN?	EPIPEN excipients list
DailyMed Link:	EPIPEN at DailyMed

See drug prices for EPIPEN

Recent Clinical Trials for EPIPEN

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

Sponsor	Phase
Jeffrey Alan Klein, MD	Phase 2/Phase 3
Nasus Pharma	Phase 1
Apimeds, Inc.	Phase 3

See all EPIPEN clinical trials

Pharmacology for EPIPEN

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

US Patents and Regulatory Information for EPIPEN

EPIPEN is protected by five US patents.

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	EPIPEN	epinephrine	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	019430-001	Dec 22, 1987	AB	RX	Yes	Yes			Y
Mylan Speciality Lp	EPIPEN JR.	epinephrine	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	019430-002	Dec 22, 1987	AB	RX	Yes	Yes			Y
Mylan Speciality Lp	EPIPEN	epinephrine	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	019430-001	Dec 22, 1987	AB	RX	Yes	Yes			Y
Mylan Speciality Lp	EPIPEN JR.	epinephrine	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	019430-002	Dec 22, 1987	AB	RX	Yes	Yes			Y
Mylan Speciality Lp	EPIPEN	epinephrine	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	019430-001	Dec 22, 1987	AB	RX	Yes	Yes			Y

International Patents for EPIPEN

See the table below for patents covering EPIPEN 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

EPIPEN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Epinephrine Auto-Injectors: The Case of EpiPen

Introduction

Epinephrine auto-injectors, such as EpiPen, are crucial medical devices used to treat severe allergic reactions, anaphylaxis, and other life-threatening conditions. The market for these devices is experiencing significant growth driven by various factors. Here, we delve into the market dynamics and financial trajectory of epinephrine auto-injectors, with a focus on EpiPen.

Global Market Size and Growth

The global epinephrine market, which includes auto-injectors like EpiPen, is projected to see substantial growth. As of 2023, the global epinephrine market was valued at USD 1.92 billion and is expected to grow to USD 4.60 billion by 2032, exhibiting a Compound Annual Growth Rate (CAGR) of 10.2% during the forecast period[1][4].

Regional Market Analysis

North America dominates the global epinephrine market, with the U.S. being a significant contributor. The U.S. epinephrine market is projected to reach an estimated value of USD 2.81 billion by 2032, driven by the increasing prevalence of cardiac arrest and allergic reactions[1].

Asia Pacific is also emerging as a fast-growing region, with countries like China, India, Japan, and South Korea experiencing rapid economic development and increasing affordability of new treatments. This region is expected to drive market growth due to growing incidences of life-threatening medical conditions and improving access to healthcare[4].

Market Drivers

Several factors are driving the growth of the epinephrine auto-injector market:

Increasing Prevalence of Allergic Reactions and Medical Emergencies

The rising incidence of anaphylaxis, cardiac arrests, and other severe allergic reactions is a primary driver. These conditions require immediate treatment, making epinephrine auto-injectors essential[1][4].

Technological Advancements

The emergence of technologically advanced AI-enabled auto-injectors and needle-free auto-injectors is enhancing drug delivery and patient compliance. These innovations are creating more opportunities for market players to launch products for various medical conditions[1].

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[1].

Increasing Awareness and User-Friendly Devices

Growing awareness about the early treatment of allergic reactions and the availability of user-friendly epinephrine auto-injectors are also driving demand. The ease of use and portability of these devices make them more appealing to consumers[4].

Market Segments

The epinephrine auto-injector market can be segmented based on dosage and distribution channels.

Dosage Segments

The market includes various dosage segments such as 0.15gm, 0.30gm, and 0.5gm. The 0.15gm dosage segment is projected to record a significant CAGR, reaching USD 1.9 billion by the end of the analysis period[3].

Distribution Channels

The retail and online pharmacy segment dominated the market in 2023, driven by the increasing number of retail and online pharmacy stores globally. The hospital pharmacy segment is also expected to grow substantially due to the rising number of emergency hospital visits for severe allergic reactions and other conditions[1].

Financial Performance of Key Players

Companies like Mylan (now part of Viatris) have been significant players in the epinephrine auto-injector market.

Mylan/Viatris Financial Highlights

In 2017, Mylan reported total revenues of $3.24 billion, with the North America segment experiencing a decline partly due to the decrease in sales of the EpiPen Auto-Injector. However, the company has since seen operational revenue growth, and Viatris reported total net sales of $3.83 billion in the fourth quarter of 2023, indicating continued growth in the sector[2][5].

Impact of COVID-19

The COVID-19 pandemic had a temporary negative impact on the epinephrine market. There was a decline in market value in 2020 due to limited patient visits to hospitals and clinics, which reduced the sales of epinephrine products. However, the market has since recovered and is on a growth trajectory[1].

Future Outlook

The future of the epinephrine auto-injector market looks promising. Here are some key points to consider:

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, in particular, is expected to see significant growth due to economic development and improving healthcare access.

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 Asia Pacific is emerging as a fast-growing region.
• The retail and online pharmacy segment is a major distribution channel, with hospital pharmacies also expected to grow.
• The COVID-19 pandemic had a temporary negative impact, but the market has recovered.

FAQs

Q: What is the projected growth rate of the global epinephrine market? A: The global epinephrine market is expected to grow at a CAGR of 10.2% from 2024 to 2032[1].

Q: Which region dominates the global epinephrine market? A: North America, particularly the U.S., dominates the global epinephrine market[1].

Q: How has the COVID-19 pandemic affected the epinephrine market? A: The COVID-19 pandemic led to a temporary decline in the market value in 2020 due to reduced hospital and clinic visits, but the market has since recovered[1].

Q: What are the key drivers of the epinephrine auto-injector market? A: Key drivers include the increasing prevalence of allergic reactions, technological advancements, favorable reimbursement policies, and growing awareness about early treatment[1][4].

Q: Which dosage segment is expected to record significant growth? A: The 0.15gm dosage segment is projected to record a significant CAGR and reach USD 1.9 billion by the end of the analysis period[3].

Sources

1. Fortune Business Insights - Epinephrine Market Size, Share, Growth & Forecast [2032]
2. Viatris - Viatris Reports Fourth-Quarter and Full-Year 2023 Financial Results ...
3. PR Newswire - Global $2.7 Billion Epinephrine Auto-injector Market Trajectory ...
4. Coherent Market Insights - Epinephrine Market - Share, Size and Industry Analysis
5. Mylan - Mylan Reports Full Year and Fourth Quarter 2017 Results and ...