Eszopiclone - Generic Drug Details

What are the generic drug sources for eszopiclone and what is the scope of freedom to operate?

Eszopiclone is the generic ingredient in two branded drugs marketed by Aurobindo Pharma, Chartwell Rx, Dr Reddys, Glenmark Pharms Ltd, Hetero Labs Ltd V, Hikma, Ipca Labs Ltd, Lupin Ltd, Macleods Pharms Ltd, Mylan Pharms Inc, Nostrum Labs Inc, Orbion Pharms, Sun Pharm, Teva, and Waylis Therap, and is included in fifteen NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty drug master file entries for eszopiclone. Thirty-four suppliers are listed for this compound.

Summary for eszopiclone

US Patents:	0
Tradenames:	2
Applicants:	15
NDAs:	15
Drug Master File Entries:	20
Finished Product Suppliers / Packagers:	34
Raw Ingredient (Bulk) Api Vendors:	60
Clinical Trials:	71
Patent Applications:	6,618
Drug Prices:	Drug price trends for eszopiclone
Drug Sales Revenues:	Drug sales revenues for eszopiclone
What excipients (inactive ingredients) are in eszopiclone?	eszopiclone excipients list
DailyMed Link:	eszopiclone at DailyMed

See drug prices for eszopiclone

See drug sales revenues for eszopiclone

Recent Clinical Trials for eszopiclone

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

Sponsor	Phase
National Heart, Lung, and Blood Institute (NHLBI)	Phase 2
University of California, Los Angeles	Phase 2
Siriraj Hospital	Phase 4

See all eszopiclone clinical trials

Medical Subject Heading (MeSH) Categories for eszopiclone

Hypnotics and Sedatives

Anatomical Therapeutic Chemical (ATC) Classes for eszopiclone

N05CF	Benzodiazepine related drugs
N05C	HYPNOTICS AND SEDATIVES
N05	PSYCHOLEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for ESZOPICLONE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
LUNESTA	Tablets	eszopiclone	1 mg, 2 mg and 3 mg	021476	10	2008-12-15

US Patents and Regulatory Information for eszopiclone

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hetero Labs Ltd V	ESZOPICLONE	eszopiclone	TABLET;ORAL	205504-003	Jan 4, 2024	AB	RX	No	No
Hetero Labs Ltd V	ESZOPICLONE	eszopiclone	TABLET;ORAL	205504-002	Jan 4, 2024	AB	RX	No	No
Chartwell Rx	ESZOPICLONE	eszopiclone	TABLET;ORAL	091165-001	Jul 14, 2011		DISCN	No	No
Ipca Labs Ltd	ESZOPICLONE	eszopiclone	TABLET;ORAL	206222-003	Dec 29, 2023	AB	RX	No	No
Hetero Labs Ltd V	ESZOPICLONE	eszopiclone	TABLET;ORAL	205504-001	Jan 4, 2024	AB	RX	No	No
Teva	ESZOPICLONE	eszopiclone	TABLET;ORAL	091169-003	May 23, 2011	AB	RX	No	No

Expired US Patents for eszopiclone

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Waylis Therap	LUNESTA	eszopiclone	TABLET;ORAL	021476-003	Dec 15, 2004	6,444,673*PED
Waylis Therap	LUNESTA	eszopiclone	TABLET;ORAL	021476-002	Dec 15, 2004	6,319,926*PED
Waylis Therap	LUNESTA	eszopiclone	TABLET;ORAL	021476-003	Dec 15, 2004	6,319,926*PED
Waylis Therap	LUNESTA	eszopiclone	TABLET;ORAL	021476-001	Dec 15, 2004	6,319,926*PED
Waylis Therap	LUNESTA	eszopiclone	TABLET;ORAL	021476-002	Dec 15, 2004	6,864,257*PED
Waylis Therap	LUNESTA	eszopiclone	TABLET;ORAL	021476-003	Dec 15, 2004	6,864,257*PED

Eszopiclone Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Eszopiclone

Global Market Overview

The eszopiclone market is poised for significant growth, driven by increasing demand for effective sleep aids. As of 2024, the global eszopiclone market size was valued at $2,022.10 million and is projected to reach $2,607.15 million by 2030, growing at a Compound Annual Growth Rate (CAGR) of 4.3% from 2024 to 2031[1].

Regional Market Analysis

North America

North America dominates the eszopiclone market, accounting for 69.63% of the global market share. The region's market size was $1,404.84 million in 2024 and is expected to grow to $1,782.79 million by 2030. This growth is attributed to lifestyle factors such as stress, irregular work schedules, and an aging population, which contribute to a high demand for sleep aids. For instance, according to the Centers for Disease Control and Prevention, 50 million to 70 million U.S. adults suffer from sleep problems[1].

Europe

The European eszopiclone market was valued at $319.55 million in 2024 and is forecasted to reach $417.11 million by 2030, growing at a CAGR of 4.52%. The increasing recognition of the importance of mental health and sleep, coupled with rising stress levels due to contemporary lifestyles, drives this growth. Chronic insomnia affects almost one in ten people in Europe, making it a significant market for eszopiclone[1].

Asia Pacific

The Asia Pacific region held a market share of 10.28% in 2024, with a market size of $213.55 million, and is expected to grow to $298.34 million by 2030 at a CAGR of 5.71%. The growing need for pharmacological treatments for sleep disorders, along with increasing stress and lifestyle changes in urbanizing economies, fuels this growth. High rates of depression, anxiety, and distress in the region also contribute to the demand for eszopiclone[1].

South America and Middle East & Africa

While smaller, these regions also show potential for growth. The Latin American market is expanding due to increased marketing and distribution efforts by pharmaceutical companies, while the Middle East and Africa are seeing growth driven by improvements in healthcare infrastructure and increased government and private sector investments in healthcare[1].

Market Drivers

Increasing Demand for Sleep Aids

The global demand for sleep aids is on the rise due to factors such as stress, irregular work schedules, and an aging population. This demand is particularly high in regions like North America and Europe, where lifestyle changes and mental health concerns are more prevalent[1].

Recognition of Mental Health

There is a growing recognition of the importance of mental health and sleep quality, leading to increased seeking of medical treatments for sleep disorders. This trend is evident in Europe, where chronic insomnia is a common issue[1].

Economic and Healthcare Developments

Improvements in healthcare infrastructure and increased investments in healthcare facilities, drugs, and medical services in regions like the Middle East and Africa are making eszopiclone more accessible and contributing to market growth[1].

Market Restraints

Despite the positive growth trajectory, there are several restraints that could impact the eszopiclone market. These include:

Side Effects and Safety Concerns

Eszopiclone, like other sleep aids, can have side effects such as dizziness, headache, and nausea, which may deter some patients. Additionally, concerns about long-term safety and potential for dependency can also restrain market growth[3].

Regulatory Challenges

Pharmaceutical markets are heavily regulated, and changes in regulatory policies can impact the availability and pricing of eszopiclone. This can create uncertainty and challenges for manufacturers and distributors[3].

Cost Effectiveness and Economic Impact

Healthcare and Productivity Costs

Studies have shown that long-term treatment with eszopiclone can be cost-effective, particularly when considering the impact on productivity costs. A six-month treatment period reduced direct healthcare costs by $245.13 and indirect productivity costs by $184.19 per patient[2].

Quality of Life

Eszopiclone treatment has been associated with a net gain in quality-adjusted life-years (QALYs), indicating an improvement in the quality of life for patients. This translates into a cost-effectiveness ratio that makes eszopiclone a viable treatment option from both a healthcare and societal perspective[2].

Competitive Landscape

The eszopiclone market is competitive, with key players such as Sunovion and Dr. Reddy's Laboratories focusing on strategy building and product portfolio expansion. These companies are actively increasing their presence in various regions and customizing their plans to meet local preferences and requirements[3].

Future Market Opportunities

Growing Demand in Emerging Markets

Emerging markets, particularly in Latin America and the Middle East & Africa, offer significant growth opportunities due to their expanding healthcare infrastructure and increasing demand for sleep aids[1].

Technological and Pharmaceutical Advancements

Advancements in pharmaceutical technology and the development of new sleep disorder treatments could further drive the market. However, eszopiclone's established presence and efficacy make it a strong contender in the sleep solutions market[4].

Key Takeaways

• The global eszopiclone market is projected to grow from $2,022.10 million in 2024 to $2,607.15 million by 2030.
• North America dominates the market due to high demand for sleep aids driven by lifestyle factors.
• Europe and Asia Pacific regions are also experiencing significant growth due to increasing recognition of mental health and sleep quality.
• Eszopiclone is cost-effective, reducing healthcare and productivity costs while improving quality of life.
• Emerging markets and technological advancements present future growth opportunities.

Frequently Asked Questions (FAQs)

Q: What is the projected global market size of eszopiclone by 2030? A: The global eszopiclone market is expected to reach $2,607.15 million by 2030[1].

Q: Which region dominates the eszopiclone market? A: North America dominates the eszopiclone market, accounting for 69.63% of the global market share[1].

Q: What are the primary drivers of the eszopiclone market growth? A: The primary drivers include increasing demand for sleep aids, recognition of mental health, and economic and healthcare developments[1].

Q: Is eszopiclone treatment cost-effective? A: Yes, long-term eszopiclone treatment has been shown to be cost-effective, reducing healthcare and productivity costs while improving quality of life[2].

Q: Which companies are key players in the eszopiclone market? A: Key players include Sunovion and Dr. Reddy's Laboratories, among others[3].

Citations

[1] https://www.cognitivemarketresearch.com/eszopiclone-market-report [2] https://pubmed.ncbi.nlm.nih.gov/17381185/ [3] https://www.cognitivemarketresearch.com/eszopiclone-drug-market-report [4] https://www.marketresearchintellect.com/blog/eszopiclone-drug-market-navigating-the-sleep-solutions-revolution/