TWINJECT 0.3 Drug Patent Profile

Which patents cover Twinject 0.3, and when can generic versions of Twinject 0.3 launch?

Twinject 0.3 is a drug marketed by Impax and is included in one NDA.

The generic ingredient in TWINJECT 0.3 is epinephrine. There are twenty-one drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the epinephrine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Twinject 0.3

A generic version of TWINJECT 0.3 was approved as epinephrine by BPI LABS on July 29^th, 2014.

Summary for TWINJECT 0.3

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	60
Clinical Trials:	1
Patent Applications:	4,335
DailyMed Link:	TWINJECT 0.3 at DailyMed

Recent Clinical Trials for TWINJECT 0.3

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

Sponsor	Phase
Arthroplasty Foundation, Inc.	Phase 4
University of Louisville	Phase 4

See all TWINJECT 0.3 clinical trials

US Patents and Regulatory Information for TWINJECT 0.3

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Impax	TWINJECT 0.3	epinephrine	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	020800-001	May 30, 2003		DISCN	No	No

Expired US Patents for TWINJECT 0.3

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Impax	TWINJECT 0.3	epinephrine	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	020800-001	May 30, 2003

International Patents for TWINJECT 0.3

See the table below for patents covering TWINJECT 0.3 around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1904145	PROCEDE ET APPAREIL DE DELIVRANCE D'EPINEPHRINE (METHOD AND APPARATUS FOR DELIVERING EPINEPHRINE)
Norway	20080672
China	101072604	Method and apparatus for delivering epinephrine

Market Dynamics and Financial Trajectory of Epinephrine Autoinjectors: A Focus on TWINJECT 0.3

Market Overview

The global market for epinephrine autoinjectors, which includes products like TWINJECT 0.3, is experiencing significant growth driven by several key factors.

Increasing Prevalence of Allergies

The rising prevalence of severe allergic reactions, or anaphylaxis, globally is a major driver for the epinephrine autoinjector market. As more people are diagnosed with life-threatening allergies, the demand for these devices increases[4].

Technological Advancements

Advancements in autoinjector technology, such as user-friendly designs, voice instructions, and enhanced safety features, are making these devices more appealing and accessible to a broader audience. Companies are investing in the development of next-generation autoinjectors, including those with pediatric doses, to gain a competitive edge[4].

Regulatory Environment

Favorable regulatory environments, particularly in regions like North America and Europe, are supporting the growth of the epinephrine autoinjector market. Regulatory approvals and the availability of generic versions of branded autoinjectors are also contributing to market expansion[4].

Financial Trajectory

Global Market Size

The global epinephrine autoinjector market was estimated at US$2.5 billion in 2023 and is projected to reach US$3.6 billion by 2030, growing at a Compound Annual Growth Rate (CAGR) of 4.8% from 2023 to 2030[1].

Segment Growth

The 0.30 mg dosage segment, which includes products like TWINJECT 0.3, is forecasted to expand at a CAGR of 5.6% over the next eight years. This segment is driven by the increasing need for precise dosing in emergency situations[1].

Regional Analysis

North America, particularly the U.S., dominates the market due to the high prevalence of chronic diseases like anaphylaxis and favorable regulatory conditions. Other key regions include Europe, Asia-Pacific, and Latin America, with China expected to grow at a CAGR of 4.5% to reach $634.5 million by 2030[1].

Key Players and Market Share

Major Manufacturers

Companies like ALK-Abello A/S, Bausch + Lomb UK Ltd (Emerade), and Teva Pharmaceutical Industries Ltd. are key players in the epinephrine autoinjector market. These companies are focusing on innovation and strategic collaborations to enhance their market presence[1].

Market Dominance

Historically, Mylan held a significant market share with its EpiPen product, but recent developments and the entry of generic competitors have altered the market landscape. The recall of competing products and regulatory challenges have also impacted market dynamics[5].

Drivers of the Market

Increasing Awareness and Self-Administration

Growing awareness about the benefits of self-administration and the need for rapid medication in emergency situations are driving the demand for epinephrine autoinjectors. Technological innovations that enhance safety and ease of use are further boosting market growth[3].

Government Policies and Healthcare Expenditure

Supportive government policies and increased healthcare expenditure are significant drivers. Governments are initiating programs to enhance healthcare access and affordability, which in turn supports the growth of the epinephrine autoinjector market[3].

Challenges and Restraints

Product Recalls and Technical Defects

Recurring product recalls due to technical defects can hamper market growth. For instance, recalls by manufacturers have led to consumer distrust and regulatory scrutiny, affecting the overall market trajectory[4].

Pricing and Accessibility

The high cost of epinephrine autoinjectors, as seen with the EpiPen price controversy, can limit accessibility. However, the introduction of generic and affordable alternatives is helping to mitigate this issue[5].

TWINJECT 0.3 Specifics

Product Features

TWINJECT 0.3 is a type of epinephrine autoinjector designed for patients weighing 30 kg or more. It provides a precise dose of 0.3 mg of epinephrine, making it a critical device for treating severe allergic reactions[2].

Market Position

As part of the 0.30 mg dosage segment, TWINJECT 0.3 benefits from the growing demand for precise dosing in emergency situations. The product's user-friendly design and safety features align with the broader market trends of innovation and ease of use[1].

Regional Growth and Opportunities

North America

North America, particularly the U.S., remains a dominant market for epinephrine autoinjectors. The high prevalence of chronic diseases and advanced healthcare infrastructure drive this market. Companies are investing heavily in research and development to introduce more efficient and user-friendly autoinjectors[3].

Asia-Pacific

The Asia-Pacific region is experiencing significant growth driven by the rising prevalence of chronic diseases, improvements in healthcare infrastructure, and growing demand for self-administration options. Countries like China, India, and Japan are key markets in this region[3].

Future Outlook

Market Projections

The global epinephrine autoinjector market is expected to continue growing, with some projections indicating it could reach US$3.91 billion by 2030, exhibiting a CAGR of 8.6% during the forecast period[4].

Innovations and Collaborations

Manufacturers are expected to continue innovating, focusing on digital connectivity, user-friendly designs, and enhanced safety features. Strategic collaborations and partnerships will also play a crucial role in expanding market presence across different geographies[4].

Key Takeaways

• The global epinephrine autoinjector market is growing due to increasing allergies, technological advancements, and favorable regulatory environments.
• The 0.30 mg dosage segment, including TWINJECT 0.3, is expected to grow significantly.
• North America and the Asia-Pacific region are key markets driven by high disease prevalence and improving healthcare infrastructure.
• Innovations and strategic collaborations are crucial for market growth.
• Challenges include product recalls and high pricing, but generic alternatives are mitigating these issues.

FAQs

What is the projected market size of the global epinephrine autoinjector market by 2030?

The global epinephrine autoinjector market is projected to reach US$3.6 billion by 2030, growing at a CAGR of 4.8% from 2023 to 2030[1].

Which regions are expected to drive the growth of the epinephrine autoinjector market?

North America, particularly the U.S., and the Asia-Pacific region are expected to drive the growth of the epinephrine autoinjector market due to high disease prevalence and favorable regulatory environments[1][3].

What are the main drivers of the epinephrine autoinjector market?

The main drivers include the increasing prevalence of severe allergic reactions, technological innovations, supportive government policies, and increased healthcare expenditure[3].

What challenges does the epinephrine autoinjector market face?

The market faces challenges such as recurring product recalls due to technical defects and high pricing, which can limit accessibility[4][5].

How are manufacturers innovating in the epinephrine autoinjector market?

Manufacturers are innovating by developing autoinjectors with digital connectivity, user-friendly designs, and enhanced safety features. They are also focusing on pediatric doses and strategic collaborations to gain a competitive edge[4].

Sources

1. Epinephrine Autoinjectors Industry Research Business Report - ResearchAndMarkets.com
2. 201739Orig1s000 - accessdata.fda.gov
3. Auto-Injectors Market Size, Share, & Trends Report, 2030 - Grand View Research
4. Global Epinephrine Autoinjector Market Size & Share Analysis - Coherent Market Insights
5. Epinephrine autoinjector - Wikipedia