Zaleplon - Generic Drug Details

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

Zaleplon is the generic ingredient in two branded drugs marketed by Pfizer, Aurobindo Pharma, Chartwell Molecular, Hikma, Hikma Pharms, Natco Pharma, Orbion Pharms, Teva Pharms, Unichem, and Upsher Smith Labs, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.

There are twelve drug master file entries for zaleplon. Ten suppliers are listed for this compound.

Summary for zaleplon

US Patents:	0
Tradenames:	2
Applicants:	10
NDAs:	11
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	10
Raw Ingredient (Bulk) Api Vendors:	79
Clinical Trials:	22
Patent Applications:	6,415
Drug Prices:	Drug price trends for zaleplon
What excipients (inactive ingredients) are in zaleplon?	zaleplon excipients list
DailyMed Link:	zaleplon at DailyMed

See drug prices for zaleplon

Recent Clinical Trials for zaleplon

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

Sponsor	Phase
Siriraj Hospital	Phase 4
The University of Hong Kong	Phase 3
Saint-Joseph University	Phase 3

See all zaleplon clinical trials

Pharmacology for zaleplon

Drug Class	gamma-Aminobutyric Acid A Receptor Agonist
Mechanism of Action	GABA A Agonists
Physiological Effect	Central Nervous System Depression

Anatomical Therapeutic Chemical (ATC) Classes for zaleplon

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

Paragraph IV (Patent) Challenges for ZALEPLON

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SONATA	Capsules	zaleplon	5 mg and 10 mg	020859	1	2005-06-21

US Patents and Regulatory Information for zaleplon

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva Pharms	ZALEPLON	zaleplon	CAPSULE;ORAL	077239-001	Jun 6, 2008		DISCN	No	No
Orbion Pharms	ZALEPLON	zaleplon	CAPSULE;ORAL	090374-002	Sep 17, 2009	AB	RX	No	No
Aurobindo Pharma	ZALEPLON	zaleplon	CAPSULE;ORAL	078829-002	Jun 6, 2008	AB	RX	No	No
Upsher Smith Labs	ZALEPLON	zaleplon	CAPSULE;ORAL	078095-002	Jun 6, 2008		DISCN	No	No

Expired US Patents for zaleplon

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	SONATA	zaleplon	CAPSULE;ORAL	020859-001	Aug 13, 1999	4,626,538
Pfizer	SONATA	zaleplon	CAPSULE;ORAL	020859-002	Aug 13, 1999	4,626,538

EU/EMA Drug Approvals for zaleplon

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Meda AB	Sonata	zaleplon	EMEA/H/C/000227 Sonata is indicated for the treatment of patients with insomnia who have difficulty falling asleep. It is indicated only when the disorder is severe, disabling or subjecting the individual to extreme distress.	Withdrawn	no	no	no	1999-03-12
Meda AB	Zerene	zaleplon	EMEA/H/C/000228 Zerene is indicated for the treatment of patients with insomnia who have difficulty falling asleep. It is indicated only when the disorder is severe, disabling or subjecting the individual to extreme distress.	Withdrawn	no	no	no	1999-03-12

Zaleplon Market Analysis and Financial Projection Experimental

Zaleplon Market Dynamics and Financial Trajectory

Introduction to Zaleplon

Zaleplon, marketed under the brand name Sonata, is a nonbenzodiazepine hypnotic drug primarily used to treat insomnia, particularly sleep onset insomnia. It belongs to the class of sedative-hypnotics and is known for reducing the time it takes to fall asleep.

Market Size and Growth

The global Zaleplon market has been experiencing significant growth, driven by several key factors. As of 2023, the global Zaleplon market size was valued at several million dollars, with a projected compound annual growth rate (CAGR) of a notable percentage from 2024 to 2031[1][4].

Market Drivers

Increasing Prevalence of Insomnia

The rising prevalence of insomnia worldwide, coupled with increasing stress levels and growing awareness about treatment options, is a major driver for the Zaleplon market. Insomnia affects a substantial portion of the global population, making Zaleplon a sought-after treatment[4].

Expanding Product Portfolio

Key players such as Aurobindo Pharma, Mylan Pharmaceuticals, and others are focusing on expanding their product portfolios and business through strategic launches, approvals, and partnerships. This expansion helps in capturing a larger market share and driving growth[1][4].

Regional Growth

The market is segmented into five major regions: North America, Europe, Asia-Pacific (APAC), Middle East and Africa (MEA), and South & Central America. Each region offers unique growth opportunities, with APAC and North America expected to be significant contributors to the market's growth due to their large populations and increasing healthcare expenditures[4].

Market Segmentation

Product Type

The Zaleplon market is segmented based on product type, primarily into 5mg and 10mg doses. The 5mg segment has accounted for a noticeable share of the global market and is projected to experience significant growth in the near future[1][4].

Dosage Form

Zaleplon is available in oral and intranasal forms. The oral segment is expected to expand at a significant CAGR, retaining its dominant position throughout the forecast period[1][4].

Market Restraints

Safety and Efficacy Concerns

Despite its efficacy, Zaleplon faces challenges related to its safety and efficacy profile. Long-term use can lead to side effects such as gastrointestinal distress, impaired motor coordination, and liver stress. These concerns can hamper market growth as patients and clinicians seek alternative treatments with better safety profiles[3][4].

Demand for Cost-Effective Alternatives

The rise in demand for cost-effective over-the-counter (OTC) sleep aids is another restraint. Patients often opt for cheaper alternatives, which can reduce the demand for prescription drugs like Zaleplon[4].

Financial Analysis

Revenue and Market Share

Key players in the Zaleplon market, such as Aurobindo Pharma, Cipla, and Mylan Pharmaceuticals, have significant revenue and market share. The financial analysis includes revenue (in USD million), gross margin percentage, and market share percentage from 2019 to 2023. This data helps in understanding the competitive landscape and financial health of the market leaders[1][4].

SWOT Analysis

A detailed SWOT analysis (Strengths, Weaknesses, Opportunities, and Threats) is crucial for understanding the strategic position of companies in the Zaleplon market. This analysis highlights the strengths of market leaders, such as their extensive product portfolios and strategic partnerships, as well as weaknesses like safety concerns and competition from OTC alternatives[1][4].

Competitive Landscape

The competitive landscape of the Zaleplon market is highly competitive, with several key players vying for market share. Companies are adopting both organic and inorganic growth strategies, including product launches, approvals, acquisitions, and partnerships. This competitive environment drives innovation and expansion in the market[1][4].

Regional Framework

The Zaleplon market is analyzed across five major regions, each with its own set of opportunities and challenges. The report provides a detailed overview of the industry, including both qualitative and quantitative information, and forecasts market size and growth for each region from 2021 to 2031[4].

PEST Analysis

A PEST analysis (Political, Economic, Social, and Technological) is essential for understanding the external factors affecting the Zaleplon market. This analysis evaluates factors such as government regulations, economic conditions, social trends, and technological advancements that impact market dynamics[4].

Future Trends and Opportunities

Increasing Awareness and Treatment Options

The growing awareness about insomnia and its treatment options is expected to drive the demand for Zaleplon. As more people seek medical help for sleep disorders, the market is likely to see significant growth[4].

Technological Advancements

Advancements in pharmaceutical technology and the development of new dosage forms, such as intranasal delivery, are expected to enhance the market's growth prospects. These innovations can improve the efficacy and safety profile of Zaleplon, making it more appealing to patients and clinicians[1][4].

Clinical Practice and Recommendations

Clinical practice guidelines suggest the use of Zaleplon for sleep onset insomnia, particularly at the 10mg dose. However, these recommendations are often weak due to the limited quality of evidence and the risk of publication bias. Clinicians must consider individual patient circumstances and available diagnostic tools when prescribing Zaleplon[2].

Conclusion

The Zaleplon market is poised for significant growth driven by increasing prevalence of insomnia, expanding product portfolios, and regional expansion. However, it faces challenges related to safety and efficacy concerns and the demand for cost-effective alternatives. Understanding the market dynamics, financial trajectory, and competitive landscape is crucial for stakeholders to make informed decisions.

Key Takeaways

• The global Zaleplon market is expected to grow at a notable CAGR from 2024 to 2031.
• The market is driven by the increasing prevalence of insomnia and expanding product portfolios.
• Safety and efficacy concerns, along with the demand for cost-effective alternatives, are significant restraints.
• The competitive landscape is highly competitive, with key players adopting various growth strategies.
• Regional analysis highlights significant growth opportunities in APAC and North America.

FAQs

What is Zaleplon used for?

Zaleplon is primarily used to treat sleep onset insomnia, helping to reduce the time it takes to fall asleep.

What are the common side effects of Zaleplon?

Common side effects include gastrointestinal distress, impaired motor coordination, and liver stress. High doses can also lead to respiratory depression and overdose risks.

Which companies are key players in the Zaleplon market?

Key players include Aurobindo Pharma, Cipla, Mylan Pharmaceuticals, Roxane Laboratories, and others.

What are the market segments for Zaleplon?

The market is segmented by product type (5mg and 10mg) and dosage form (oral and intranasal).

What is the forecasted growth rate for the Zaleplon market?

The market is expected to grow at a notable CAGR from 2024 to 2031, driven by increasing demand and regional expansion.

Sources

1. Cognitive Market Research: Zaleplon Market Report 2024 (Global Edition)
2. Journal of Clinical Sleep Medicine: Clinical Practice Guideline for the Pharmacologic Treatment of Chronic Insomnia in Adults
3. Sanctuary Lodge: Zaleplon Addiction: Signs, Symptoms & Effects
4. The Insight Partners: Zaleplon Market Dynamics 2021-2031