TWINJECT 0.15 Drug Patent Profile

When do Twinject 0.15 patents expire, and when can generic versions of Twinject 0.15 launch?

Twinject 0.15 is a drug marketed by Impax and is included in one NDA.

The generic ingredient in TWINJECT 0.15 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 0.15

A generic version of TWINJECT 0.15 was approved as epinephrine by BPI LABS on July 29^th, 2014.

Summary for TWINJECT 0.15

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	60
Clinical Trials:	1
Patent Applications:	4,017
DailyMed Link:	TWINJECT 0.15 at DailyMed

Recent Clinical Trials for TWINJECT 0.15

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

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

See all TWINJECT 0.15 clinical trials

US Patents and Regulatory Information for TWINJECT 0.15

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Impax	TWINJECT 0.15	epinephrine	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	020800-002	May 28, 2004		DISCN	No	No

International Patents for TWINJECT 0.15

See the table below for patents covering TWINJECT 0.15 around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2009256717
South Africa	200704516	Medicine injection devices and methods
Russian Federation	2131748	AUTOMATIC OR MANUAL DEVICE FOR INJECTIONS OF LIQUID MEDICINAL AGENT
Japan	H08507239

Market Dynamics and Financial Trajectory of Epinephrine Autoinjectors: A Focus on Twinject 0.15mg

Introduction

The epinephrine autoinjector market has been experiencing significant growth, driven by increasing prevalence of allergies, technological advancements, and strategic activities by major players. This article delves into the market dynamics and financial trajectory of epinephrine autoinjectors, with a specific focus on the Twinject 0.15mg product.

Global Epinephrine Autoinjector Market Overview

The global epinephrine autoinjector market is projected to grow substantially over the forecast period. By 2027, the market is estimated to reach $2.7 billion, growing at a CAGR of 5.6% from 2020 to 2027[3].

Market Drivers

Several factors are driving the growth of the epinephrine autoinjector market:

• Increasing Prevalence of Allergies: The rising incidence of anaphylaxis and other severe allergic reactions is a key driver[4].
• Technological Advances: Innovations in device design and functionality, such as easier-to-use devices and color-coded indicators for color-blind users, are enhancing market growth[5].
• Strategic Activities: New product launches, mergers, acquisitions, joint ventures, and collaborations among major players are also contributing to market expansion[1].

Market Segmentation

The market is segmented by dosage, end-user, and geography:

• Dosage Segments: The 0.15mg, 0.30mg, and 0.50mg dosages are key segments. The 0.15mg dosage segment is projected to record a 6% CAGR and reach $1.9 billion by 2027[3].
• End-Users: Hospitals, clinics, and individual consumers are the primary end-users. Individual consumers are a significant segment due to the increasing need for personal emergency treatment options[4].
• Geography: The U.S., China, Japan, and Canada are among the leading markets. The U.S. market was estimated at $535 million in 2020, while China is forecast to grow at a CAGR of 5.2% over the analysis period[3].

Twinject 0.15mg: Product Overview

Twinject is an epinephrine autoinjector product that comes in 0.15mg and 0.30mg dosages. It was approved by the FDA in 2003 and is known for its unique design, which includes a second dose that can be administered if the first dose is not effective[2].

Key Features

• Dual Dose Capability: Twinject allows for a second dose to be administered after a short interval, which is particularly useful in cases where the first dose may not be sufficient.
• Ease of Use: The device is designed to be user-friendly, making it easier for individuals to administer the dose in emergency situations.

Financial Trajectory

The financial performance of the Twinject 0.15mg, like other epinephrine autoinjectors, is influenced by several factors:

• Market Growth: The overall growth of the epinephrine autoinjector market benefits products like Twinject. The market is expected to grow by $762.51 million from 2020 to 2024, with a CAGR of over 7% during this period[4].
• Competitive Landscape: The market is competitive, with several key players including Adamis Pharmaceuticals, ALK-Abello AS, Antares Pharma, Inc., and Mylan N.V. among others. This competition can impact pricing and market share[3].
• Regulatory and Cost Factors: Regulatory constraints and the high cost of epinephrine autoinjectors can impede market growth. However, new product launches and strategic activities are expected to mitigate these challenges[1].

Regional Performance

The performance of Twinject 0.15mg varies by region:

• U.S. Market: The U.S. is a significant market for epinephrine autoinjectors, with an estimated value of $535 million in 2020. Products like Twinject benefit from the strong demand in this region[3].
• Asia-Pacific: Countries like China, Japan, and Australia are also key markets. China, in particular, is forecast to grow at a CAGR of 5.2%, making it an important region for market expansion[3].

Challenges and Opportunities

Despite the growth potential, the market faces several challenges:

• Regulatory Constraints: Strict regulatory requirements can delay product approvals and affect market growth[1].
• High Costs: The inflated cost of epinephrine autoinjectors is a significant barrier to entry for many consumers. However, efforts to improve affordability and access are ongoing[1].

Opportunities

• Technological Innovations: Continuous innovations in device design and functionality offer opportunities for market differentiation and growth.
• Expanding Market Reach: Growing awareness and increasing prevalence of allergies in emerging markets present opportunities for expansion.

Key Players and Competitive Insights

The market is highly competitive, with several key players:

• Adamis Pharmaceuticals Corporation
• ALK-Abello AS
• Antares Pharma, Inc.
• Mylan N.V.
• Teva Pharmaceutical Industries Ltd.

These companies engage in various strategic activities such as new product launches, mergers, and collaborations to maintain market share and drive growth[3].

Conclusion

The epinephrine autoinjector market, including products like Twinject 0.15mg, is poised for significant growth driven by increasing allergy prevalence, technological advancements, and strategic market activities. Despite regulatory and cost challenges, the market is expected to expand substantially over the forecast period.

Key Takeaways

• The global epinephrine autoinjector market is projected to reach $2.7 billion by 2027.
• The 0.15mg dosage segment is expected to record a 6% CAGR.
• Technological innovations and increasing allergy prevalence are key drivers.
• Regulatory constraints and high costs are significant challenges.
• The U.S. and China are among the leading markets.

FAQs

Q: What is the projected CAGR for the 0.15mg dosage segment of epinephrine autoinjectors? A: The 0.15mg dosage segment is projected to record a 6% CAGR[3].

Q: Which regions are expected to drive the growth of the epinephrine autoinjector market? A: The U.S., China, Japan, and Canada are among the leading regions driving market growth[3].

Q: What are the key challenges facing the epinephrine autoinjector market? A: Regulatory constraints and the high cost of epinephrine autoinjectors are significant challenges[1].

Q: Who are some of the major players in the epinephrine autoinjector market? A: Major players include Adamis Pharmaceuticals Corporation, ALK-Abello AS, Antares Pharma, Inc., Mylan N.V., and Teva Pharmaceutical Industries Ltd.[3].

Q: How does the Twinject 0.15mg differ from other epinephrine autoinjectors? A: Twinject 0.15mg has a unique dual dose capability, allowing for a second dose to be administered if the first dose is not effective[2].

Sources

1. Mordor Intelligence: Epinephrine Autoinjector Market Size & Share Analysis
2. FDA: 201739Orig1s000 - accessdata.fda.gov
3. PR Newswire: Global $2.7 Billion Epinephrine Auto-injector Market Trajectory & Analytics
4. Business Wire: $762.51 Million Growth in Epinephrine Autoinjector Market During 2020-2024
5. U.S. District Court for the District of Kansas: EpiPen (Epinephrine Injection, USP) Marketing, MDL No