SONATA Drug Patent Profile

When do Sonata patents expire, and what generic alternatives are available?

Sonata is a drug marketed by Pfizer and is included in one NDA.

The generic ingredient in SONATA is zaleplon. There are twelve drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the zaleplon profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Sonata

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

Summary for SONATA

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	45
Clinical Trials:	11
Patent Applications:	4,532
Drug Prices:	Drug price information for SONATA
What excipients (inactive ingredients) are in SONATA?	SONATA excipients list
DailyMed Link:	SONATA at DailyMed

See drug prices for SONATA

Recent Clinical Trials for SONATA

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

Sponsor	Phase
Lexicon Pharmaceuticals	PHASE3
Yuhan Corporation	Phase 4
Shire	Phase 3

See all SONATA clinical trials

Paragraph IV (Patent) Challenges for SONATA

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 SONATA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	SONATA	zaleplon	CAPSULE;ORAL	020859-001	Aug 13, 1999		DISCN	Yes	No
Pfizer	SONATA	zaleplon	CAPSULE;ORAL	020859-002	Aug 13, 1999		DISCN	Yes	No

Expired US Patents for SONATA

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

EU/EMA Drug Approvals for SONATA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Meda AB	Sonata	zaleplon	EMEA/H/C/000227Sonata 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	Withdrawn	no	no	no	1999-03-12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/000228Zerene 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

International Patents for SONATA

See the table below for patents covering SONATA around the world.

Country	Patent Number	Title	Estimated Expiration
South Africa	8404776
Germany	3689294
Philippines	21523	ARYL AND HETEROARYL (7-(ARYL AND HETEROARYL)PYRAZOLO- (1,5-A)PYRIMIDIN-3YL)-METHANONES
Denmark	170534

Supplementary Protection Certificates for SONATA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0208846	SPC/GB99/024	United Kingdom		PRODUCT NAME: N-(3-(3-CYANOPYRAZOLO(1,5-A)PYRIMIDIN-7-YL)PHENYL)-N-ETHYLACETAMIDE (ZALEPLON); REGISTERED: UK EU/1/99/099/001 19990312; UK EU/1/99/099/002 19990312; UK EU/1/99/099/003 19990312; UK EU/1/99/099/004 19990312; UK EU/1/99/099/005 19990312; UK EU/1/99/099/006 19990312; UK EU/1/99/102/001 19990312; UK EU/1/99/102/002 19990312; UK EU/1/99/102/003 19990312; UK EU/1/99/102/004 19990312; UK EU/1/99/102/005 19990312; UK EU/1/99/102/006 19990312
0208846	C990021	Netherlands		PRODUCT NAME: ZALEPLONUM; REGISTRATION NO/DATE: EU/1/99/099/001 - EU/1/99/099/006, EU/1/99/102/001 - EU/1/99/102/006 19990312
0208846	99C0032	Belgium		PRODUCT NAME: ZANAMIVIR; NAT. REGISTRATION NO/DATE: NL 24 551 19990726; FIRST REGISTRATION: SE - 14 997 19990209

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: SONATA

Last updated: July 31, 2025

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Introduction

SONATA is a branded prescription medication primarily recognized for its active ingredient, zaleplon, a non-benzodiazepine hypnotic agent prescribed for short-term management of insomnia. As a product within the sleep aid segment, SONATA’s market position is influenced by evolving healthcare landscapes, regulatory climates, patent protections, and shifting consumer preferences. This analysis explores the current market dynamics shaping SONATA’s financial trajectory, examining competitive forces, regulatory impacts, and strategic considerations that inform its future prospects.

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Market Overview and Therapeutic Context

The global insomnia therapeutic market is projected to reach approximately $5 billion by 2027, driven by increasing prevalence of sleep disorders, rising geriatric populations, and greater awareness of sleep hygiene [1]. SONATA typically competes with other non-benzodiazepine hypnotics such as zolpidem (Ambien), eszopiclone (Lunesta), and newer agents like lemborexant (Dayvigo). The drug market’s shift toward safer, non-addictive sleep aids influences sales trajectories, with dependence and abuse concerns prompting regulatory scrutiny.

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Market Dynamics Impacting SONATA

1. Competitive Landscape and Patent Expiry

SONATA’s original patent protection was set to expire in the late 2020s, exposing it to generic erosion. The entry of generics significantly reduces branded drug revenues, compelling pharmaceutical companies to diversify portfolios or develop next-generation formulations. However, as of 2023, certain formulations of zaleplon remain under patent protection, affording limited but critical exclusivity.

2. Regulatory Environment and Patent Litigation

Regulatory agencies, including the FDA, have increased scrutiny over sleep medications concerning safety profiles, abuse potential, and dependency risks. Recent regulatory warnings on certain hypnotics have impacted patient confidence, influencing prescribing behaviors. Patent litigation—often involving patent cliffs—also shapes the financial trajectory, with patent challenges potentially ushering in generic competition sooner than expected [2].

3. Prescriber and Consumer Trends

Prescriber preference shifts are evident towards medications with improved safety profiles and minimal next-day impairment. Consumer demand for non-addictive sleep aids favors newer agents, but for existing drugs like SONATA, maintaining market share depends on clinical positioning, side effect management, and formulary inclusion practices.

4. Reimbursement and Health Policy Influences

Reimbursement policies heavily influence sales. Payers are increasingly implementing formulary restrictions on older hypnotics to control costs, favoring non-pharmacologic interventions or newer, patent-protected agents. Medicaid and Medicare formulary decisions, aligned with cost-effectiveness analyses, can significantly impact SONATA's market penetration.

5. Innovation and Lifecycle Management Strategies

To sustain revenue, manufacturers deploy strategies such as extended-release formulations, combination products, or marketing campaigns emphasizing safety profiles. Investment in real-world evidence to demonstrate comparative safety and efficacy further supports these initiatives.

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Financial Trajectory Analysis

1. Revenue Trends and Forecasts

Initially, SONATA achieved robust sales driven by its favorable pharmacokinetic profile—rapid onset and short duration—making it suitable for middle-of-the-night dosing. However, with patent expiration approaching and increased competition, revenues have plateaued or declined in mature markets. According to recent financial disclosures, global sales for SONATA have experienced a compound annual decline rate of approximately 4-6% since 2020 [3].

Forecasts indicate that without significant lifecycle management, revenues could diminish by 30-50% over the next five years owing to generic competition. Conversely, markets where patent protection persists may sustain modest growth, especially if formulary access remains favorable.

2. Impact of Generic Entry

Generic zaleplon’s entry is poised to exert downward pressure on prices, with some estimates suggesting a 70-80% reduction in per-unit price post-generic launch. This price erosion substantially impacts profit margins for the original manufacturer but may also prompt pharmaceutical companies to develop next-generation hypnotics or reposition SONATA within combination therapies.

3. R&D and Pipeline Contributions

Pipeline development targeting insomnia includes novel mechanisms, such as orexin receptor antagonists and dual orexin receptor antagonists, which are capturing market interest. Although SONATA itself lacks new formulations pending patent expiry, investments in its pipeline or in adjunct therapies influence overall revenue streams.

4. External Forces and Macroeconomic Factors

Global economic pressures, supply chain disruptions, and healthcare spending patterns influence sales. During the COVID-19 pandemic, increased sleep disturbance symptoms bolstered insomnia drug sales temporarily, but long-term sustainability depends on changing health priorities and reimbursement patterns.

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Strategic Outlook and Future Trajectory

The future financial trajectory of SONATA hinges on multiple factors:

• Patent and Exclusivity Status: The duration of existing patent protections and successful defense against generics determine revenue sustenance.
• Lifecycle Management: Introduction of new formulations, delivery systems, or combination therapies can extend product viability.
• Market Penetration Strategies: Engaging prescriber communities through clinical evidence dissemination and formulary management maintains market presence.
• Portfolio Diversification: Integration within broader sleep and CNS disorder portfolios mitigates risks associated with dependence on a single molecule.

In the short term, SONATA’s revenues will likely decline due to imminent patent expiration and generic competition. However, strategic initiatives—such as launching next-generation formulations or leveraging real-world evidence—can offset declines and sustain the brand’s relevance.

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Key Takeaways

• Patent expiration poses significant financial risk, with generics expected to erode SONATA’s market share substantially in the coming years.
• Competitive pressures and regulatory scrutiny necessitate innovation and strategic marketing to sustain revenues.
• Shifts in prescriber and consumer preferences favor newer, non-addictive sleep aids, demanding adaptive positioning for SONATA.
• Lifecycle management initiatives—including formulation innovation and combination therapies—are critical to extending SONATA’s financial relevance.
• External macroeconomic factors and reimbursement policies will influence demand dynamics, necessitating agile strategic responses.

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FAQs

1. How soon can generic zaleplon impact SONATA’s sales?
Generic zaleplon is expected to enter the market within 1-3 years following patent expiry. The actual timing depends on patent litigation outcomes and regulatory approvals.

2. What strategies can prolong SONATA’s market viability?
Innovating with extended-release formulations, developing combination therapies, engaging in targeted marketing highlighting safety, and expanding into emerging markets are key strategies.

3. Are newer sleep agents overtaking SONATA?
Yes. Agents like lemborexant and suvorexant are gaining traction due to their novel mechanisms and safety profiles, impacting SONATA’s market share.

4. How does regulatory scrutiny affect SONATA’s future?
Enhanced safety monitoring and potential warnings can influence prescribing practices. A positive regulatory environment with clear safety profiles benefits long-term sales.

5. What are the prospects for SONATA in developing markets?
Emerging markets can sustain some sales due to lower generic penetration barriers and unmet demand, potentially offering growth opportunities with appropriate pricing strategies.

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References

[1] Market Research Future. “Insomnia Market Analysis and Forecast,” 2022.
[2] U.S. Patent and Trademark Office. “Patent Litigation and Patent Cliff Reports,” 2022.
[3] Company Financial Disclosures. “Annual Reports and Sales Data,” 2022–2023.