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Last Updated: December 22, 2024

ZALEPLON Drug Patent Profile


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DrugPatentWatch® Litigation and Generic Entry Outlook for Zaleplon

A generic version of ZALEPLON was approved as zaleplon by AUROBINDO PHARMA on June 6th, 2008.

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Summary for ZALEPLON
Drug patent expirations by year for ZALEPLON
Drug Prices for ZALEPLON

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Recent Clinical Trials for ZALEPLON

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

SponsorPhase
Siriraj HospitalPhase 4
The University of Hong KongPhase 3
Saint-Joseph UniversityPhase 3

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Pharmacology for ZALEPLON
Anatomical Therapeutic Chemical (ATC) Classes for ZALEPLON
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
Aurobindo Pharma ZALEPLON zaleplon CAPSULE;ORAL 078829-001 Jun 6, 2008 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Upsher Smith Labs ZALEPLON zaleplon CAPSULE;ORAL 078706-001 Jun 6, 2008 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hikma Pharms ZALEPLON zaleplon CAPSULE;ORAL 078147-001 Nov 25, 2008 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Chartwell Molecular ZALEPLON zaleplon CAPSULE;ORAL 077505-002 Jun 20, 2008 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Orbion Pharms ZALEPLON zaleplon CAPSULE;ORAL 090374-002 Sep 17, 2009 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Upsher Smith Labs ZALEPLON zaleplon CAPSULE;ORAL 078706-002 Jun 6, 2008 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hikma Pharms ZALEPLON zaleplon CAPSULE;ORAL 078147-002 Nov 25, 2008 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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

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