ZURNAI (AUTOINJECTOR) Drug Patent Profile

When do Zurnai (autoinjector) patents expire, and when can generic versions of Zurnai (autoinjector) launch?

Zurnai (autoinjector) is a drug marketed by Purdue Pharma Lp and is included in one NDA. There are twenty-one patents protecting this drug.

This drug has seventy patent family members in fourteen countries.

The generic ingredient in ZURNAI (AUTOINJECTOR) is nalmefene hydrochloride. There are four drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the nalmefene hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Zurnai (autoinjector)

A generic version of ZURNAI (AUTOINJECTOR) was approved as nalmefene hydrochloride by PURDUE PHARMA LP on February 8^th, 2022.

Summary for ZURNAI (AUTOINJECTOR)

International Patents:	70
US Patents:	21
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ZURNAI (AUTOINJECTOR)
DailyMed Link:	ZURNAI (AUTOINJECTOR) at DailyMed

US Patents and Regulatory Information for ZURNAI (AUTOINJECTOR)

ZURNAI (AUTOINJECTOR) is protected by twenty-one US patents and one FDA Regulatory Exclusivity.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Purdue Pharma Lp	ZURNAI (AUTOINJECTOR)	nalmefene hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	218590-001	Aug 7, 2024		DISCN	Yes	No			Y
Purdue Pharma Lp	ZURNAI (AUTOINJECTOR)	nalmefene hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	218590-001	Aug 7, 2024		DISCN	Yes	No			Y
Purdue Pharma Lp	ZURNAI (AUTOINJECTOR)	nalmefene hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	218590-001	Aug 7, 2024		DISCN	Yes	No			Y
Purdue Pharma Lp	ZURNAI (AUTOINJECTOR)	nalmefene hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	218590-001	Aug 7, 2024		DISCN	Yes	No			Y
Purdue Pharma Lp	ZURNAI (AUTOINJECTOR)	nalmefene hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	218590-001	Aug 7, 2024		DISCN	Yes	No			Y

International Patents for ZURNAI (AUTOINJECTOR)

See the table below for patents covering ZURNAI (AUTOINJECTOR) around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	2900672	DISPOSITIF D'INJECTION A JET ASSISTEE PAR AIGUILLE AYANT UNE FORCE DE DECLENCHEMENT REDUITE (NEEDLE ASSISTED JET INJECTION DEVICE HAVING REDUCED TRIGGER FORCE)
European Patent Office	2731645	DISPOSITIF D'INJECTION AVEC ENSEMBLE-VÉRIN À CAME (INJECTION DEVICE WITH CAMMED RAM ASSEMBLY)
Japan	2016507305	トリガ力を低減した針支援式ジェット注射装置
Japan	7103996
World Intellectual Property Organization (WIPO)	2014124464

Market Dynamics and Financial Trajectory for Autoinjectors: A Focus on ZURNAI and Similar Products

Introduction to Autoinjectors

Autoinjectors are medical devices designed to administer a specific dose of a drug, often used for chronic and emergency conditions such as diabetes, anaphylaxis, and rheumatoid arthritis. These devices have revolutionized the way patients manage their medications, offering ease of use, safety, and precision.

Global Autoinjectors Market Overview

The global autoinjectors market is experiencing rapid growth, driven by several key factors:

• Increasing Prevalence of Chronic Diseases: Conditions like diabetes, anaphylaxis, and rheumatoid arthritis are on the rise, necessitating the use of user-friendly medication delivery systems[1][3][4].
• Technological Advancements: Innovations in autoinjector design, including connectivity features for data tracking and dosage reminders, are enhancing safety and ease of use[4].
• Growing Adoption of Biologics and Biosimilars: The increasing use of biologics and biosimilars, which often require frequent injections, is a significant driver of the market[1][3][4].

Market Size and Growth Projections

The global autoinjectors market was estimated at USD 8.35 billion in 2023 and is projected to grow at a CAGR of 14.4% from 2024 to 2030[1].

• By 2030, the market is expected to reach USD 3.02 billion for autoinjector devices and USD 134.27 billion for finished formulations, growing at CAGRs of 13.6% and 12.2%, respectively[4].

Regional Market Dynamics

North America

North America dominates the global autoinjectors market, accounting for 45.27% of the revenue share in 2023. This is due to the high prevalence of chronic diseases, advanced healthcare infrastructure, and increased awareness about self-administration of drugs[1].

Asia Pacific

The Asia Pacific region is experiencing significant growth, driven by the rising prevalence of chronic diseases, improvements in healthcare infrastructure, and economic growth in countries like China, India, and Japan. This region is projected to grow at the highest CAGR during the forecast period[1][3][4].

Key Drivers and Opportunities

• Patient Preference for Self-Administration: The rise in patient preference for self-administration of medication is a key driver, as it enhances patient compliance and convenience[1][3][4].
• Technological Innovations: Advanced features such as Bluetooth connectivity, dosage tracking, and multi-dose capabilities are increasing the adoption of autoinjectors[4].
• Regulatory and Reimbursement Policies: Favorable regulatory and reimbursement policies in regions like North America and Europe are boosting market growth[4].

Competitive Landscape

The autoinjectors market is highly competitive, with key players including AbbVie Inc., Amgen Inc., Becton, Dickinson and Company (BD), Eli Lilly and Company, Johnson & Johnson, and others. These companies are investing heavily in research and development to introduce user-friendly and efficient autoinjectors[3].

Financial Trajectory for Autoinjector Manufacturers

Companies involved in the autoinjectors market are experiencing significant financial growth:

• Revenue Growth: Companies like Servier are reporting substantial revenue growth, with Servier aiming for €6 billion in revenue and an EBITDA of €1.3 billion by 2025[2].
• Investments in R&D: Major investments in research and development are driving innovation and market expansion. For example, Blueprint Medicines has seen a significant increase in net product revenues, reflecting the growing demand for advanced medical treatments[5].

Impact of Technological Advancements

Technological advancements are a crucial factor in the growth of the autoinjectors market:

• Connectivity Features: The inclusion of features like Bluetooth connectivity and dosage reminders has improved disease management by allowing for real-time data tracking and exchange[4].
• User-Friendly Designs: Improved designs have made autoinjectors more user-friendly, reducing the complexity of self-administration and enhancing patient safety[1][4].

Challenges and Opportunities

Challenges

• Regulatory Hurdles: Navigating regulatory approvals can be challenging, but favorable regulatory scenarios in regions like North America and Europe are mitigating these challenges[4].
• Cost Considerations: While reusable autoinjectors offer cost-effectiveness over time, the initial cost can be a barrier for some patients[4].

Opportunities

• Emerging Markets: The Asia Pacific region offers significant growth opportunities due to its large population, rising healthcare infrastructure, and growing demand for self-administration options[1][3][4].
• Patent Expiry of Biologics: The expiry of patents for biologics is expected to drive the adoption of biosimilars, further boosting the demand for autoinjectors[4].

Key Takeaways

• The global autoinjectors market is driven by the increasing prevalence of chronic diseases, technological advancements, and growing adoption of biologics.
• North America and the Asia Pacific region are key markets, with the latter expected to grow at the highest CAGR.
• Technological innovations and favorable regulatory policies are significant drivers of market growth.
• Major companies are investing heavily in R&D to introduce user-friendly and efficient autoinjectors.

FAQs

Q: What is the projected growth rate of the global autoinjectors market? A: The global autoinjectors market is projected to grow at a CAGR of 14.4% from 2024 to 2030[1].

Q: Which region dominates the global autoinjectors market? A: North America dominates the global autoinjectors market, accounting for 45.27% of the revenue share in 2023[1].

Q: What are the key drivers of the autoinjectors market? A: Key drivers include the increasing prevalence of chronic diseases, technological advancements, and growing adoption of biologics and biosimilars[1][3][4].

Q: Which companies are major players in the autoinjectors market? A: Major players include AbbVie Inc., Amgen Inc., Becton, Dickinson and Company (BD), Eli Lilly and Company, and Johnson & Johnson, among others[3].

Q: How are technological advancements impacting the autoinjectors market? A: Technological advancements such as connectivity features and improved designs are enhancing safety, ease of use, and patient compliance[4].

Cited Sources

1. Grand View Research: Auto-Injectors Market Size, Share, & Trends Report, 2030.
2. Servier: Servier confirms its 2025 trajectory to achieve its 2030 ambition.
3. Meditech Insights: Autoinjectors Market is Projected Growth at a CAGR of 14-16% from 2023 to 2028.
4. MarketsandMarkets: Autoinjectors Market Growth, Drivers, and Opportunities.
5. Blueprint Medicines: Blueprint Medicines Reports Second Quarter 2024 Results and Raises AYVAKIT®/AYVAKYT® (avapritinib) Full Year Revenue Guidance.