EPIPEN JR. Drug Patent Profile

When do Epipen Jr. patents expire, and when can generic versions of Epipen Jr. launch?

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

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

The generic ingredient in EPIPEN 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 Epipen Jr.

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

Summary for EPIPEN JR.

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:	2,084
DailyMed Link:	EPIPEN JR. at DailyMed

Recent Clinical Trials for EPIPEN JR.

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 JR. clinical trials

Pharmacology for EPIPEN JR.

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

Paragraph IV (Patent) Challenges for EPIPEN JR.

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
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 EPIPEN JR.

EPIPEN JR. 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 JR.	epinephrine	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	019430-002	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 JR.	epinephrine	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	019430-002	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

International Patents for EPIPEN JR.

See the table below for patents covering EPIPEN JR. around the world.

Country	Patent Number	Title	Estimated Expiration
Cyprus	1115201
World Intellectual Property Organization (WIPO)	2006017732
Taiwan	200613027	Automatic injector
Australia	2010201665	Automatic injector with kickback attenuation

EPIPEN JR. Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Epinephrine Autoinjectors: A Focus on EpiPen Jr.

Introduction to Epinephrine Autoinjectors

Epinephrine autoinjectors, such as EpiPen Jr., are critical devices designed to administer epinephrine in emergency situations to treat severe allergic reactions, including anaphylaxis. These devices have become increasingly important due to the rising prevalence of allergies globally.

Market Size and Growth Projections

The global epinephrine autoinjector market is anticipated to experience significant growth. By 2030, the market is expected to reach approximately $3.91 billion, up from $2.20 billion in 2023, with a Compound Annual Growth Rate (CAGR) of 8.6% during the forecast period[1].

Key Drivers of Market Growth

Rising Prevalence of Allergies

The increasing incidence of food allergies, asthma, and other allergic conditions is a major driver of the market. According to the World Health Organization (WHO), the global prevalence of food allergy is about 4% in children and 1% in adults, showing an increase over the past two decades[3].

Growing Consumer Preference for Self-Administration

There is a growing preference for self-administration devices, which is boosting the sales of epinephrine autoinjectors. Patients and caregivers are increasingly seeking convenient and easy-to-use devices for emergency situations[1].

Increasing Patient Awareness and Generic Versions

Increased patient awareness about anaphylaxis and the availability of generic versions of branded autoinjectors are also propelling market growth. Generic alternatives offer more affordable options, making these life-saving devices more accessible[1].

Expanding Healthcare Infrastructure

The expansion of healthcare infrastructure in emerging markets is another significant factor. Developing countries are investing heavily in their healthcare sectors, including emergency medical treatment, which is driving the demand for epinephrine injectors[3].

Regional Market Dynamics

North America

North America, particularly the U.S., is expected to continue dominating the market. The strong demand for epinephrine autoinjectors in this region is fueled by the growing burden of allergies and a favorable regulatory environment[1].

Europe and Asia Pacific

Europe and the Asia Pacific are emerging as highly lucrative markets. These regions are experiencing surging healthcare investments and an increasing rate of diagnosis of allergic disorders, which is driving market growth[1].

Financial Performance and Trends

Revenue and Sales

The sales of epinephrine autoinjectors have seen significant growth over the years. For example, EpiPen sales, which were acquired by Mylan in 2007, have risen from $200 million to over $1 billion, largely due to price increases, new policies, and changes in the auto-injector marketplace[4].

Pricing and Affordability

Despite the growth, the market faces challenges related to pricing. The inflated cost of epinephrine autoinjectors is a significant barrier to access. Regulatory and market changes, such as the introduction of generic versions, are aimed at making these devices more affordable[5].

Regulatory Environment

Favorable reimbursement policies in developed countries are also fueling market growth. However, regulatory constraints and product recalls due to technical defects can impede market expansion[1][5].

Product Innovations and Strategic Activities

New Product Launches

The market is witnessing new product launches and strategic activities such as mergers, acquisitions, and collaborations. For instance, Catalent's agreement to manufacture SYMJEPI for Adamis Pharmaceuticals Co. highlights the ongoing innovation and partnership activities in the industry[5].

Convenience and Acceptance

The convenience of use and disposal of autoinjectors is another factor driving market growth. Autoinjectors are increasingly accepted due to their ease of use in emergency situations, which is accelerating market expansion[5].

Challenges and Limitations

Regulatory Constraints

Regulatory constraints and the high cost of epinephrine autoinjectors are significant challenges. Product recalls due to technical defects also pose a risk to market growth[1][5].

Public and Policy Response

Public and policy responses, such as state laws requiring schools to stock epinephrine-delivery devices, have contributed to increased demand but also highlight the need for more affordable and accessible solutions[4].

Quotes from Industry Experts

"The increasing demand for epinephrine autoinjectors, including EpiPen, is likely to boost the market growth. The rising incidence of allergic conditions and expanding healthcare infrastructure in emerging markets are major factors creating immense opportunities in the market."[3]

Illustrative Statistics

• The global epinephrine autoinjector market is expected to reach $3.91 billion by 2030, growing at a CAGR of 8.6%[1].
• The number of EpiPen prescriptions in the U.S. rose from approximately 2.5 million to more than 3.5 million between 2011 and 2015[4].
• Over 16 billion injections were administered annually worldwide in 2021, stimulating the autoinjector market[5].

Highlight: Regulatory Impact

"Some states have passed laws requiring schools to stock epinephrine-delivery devices. This has contributed to the increased demand for epinephrine autoinjectors, but it also underscores the need for more affordable and accessible solutions."[4]

Key Takeaways

• The global epinephrine autoinjector market is expected to grow significantly due to rising allergies and consumer preference for self-administration devices.
• North America, particularly the U.S., will continue to dominate the market.
• Expanding healthcare infrastructure in emerging markets is a key growth driver.
• Regulatory constraints and high costs are significant challenges.
• New product launches and strategic activities are driving innovation and market growth.

FAQs

Q: What is the projected market size for epinephrine autoinjectors by 2030?

A: The global epinephrine autoinjector market is expected to reach approximately $3.91 billion by 2030[1].

Q: What are the main drivers of the epinephrine autoinjector market?

A: The main drivers include the rising prevalence of allergies, growing consumer preference for self-administration devices, increasing patient awareness, and expanding healthcare infrastructure[1][3].

Q: Which region is expected to dominate the epinephrine autoinjector market?

A: North America, particularly the U.S., is expected to continue dominating the market due to strong demand and a favorable regulatory environment[1].

Q: What are the challenges facing the epinephrine autoinjector market?

A: Regulatory constraints, high costs, and product recalls due to technical defects are significant challenges[1][5].

Q: How have public policies impacted the demand for epinephrine autoinjectors?

A: Public policies, such as state laws requiring schools to stock epinephrine-delivery devices, have increased demand but also highlight the need for more affordable solutions[4].

Sources:

1. Coherent Market Insights - Global Epinephrine Autoinjector Market Size & Share Analysis
2. Mylan - Mylan Reports Full Year and Fourth Quarter 2017 Results and ...
3. GlobeNewswire - Epinephrine Market Size Expected to Attain USD 6.93 Bn by 2034
4. Pew Trusts - Beyond EpiPen: Prices of Lifesaving Epinephrine Products Soar
5. Mordor Intelligence - Epinephrine Autoinjector Market Size & Share Analysis