LUNESTA Drug Patent Profile

When do Lunesta patents expire, and when can generic versions of Lunesta launch?

Lunesta is a drug marketed by Waylis Therap and is included in one NDA.

The generic ingredient in LUNESTA is eszopiclone. There are twenty drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the eszopiclone profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Lunesta

A generic version of LUNESTA was approved as eszopiclone by TEVA on May 23^rd, 2011.

Summary for LUNESTA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	41
Clinical Trials:	46
Patent Applications:	3,387
Drug Prices:	Drug price information for LUNESTA
What excipients (inactive ingredients) are in LUNESTA?	LUNESTA excipients list
DailyMed Link:	LUNESTA at DailyMed

See drug prices for LUNESTA

See drug sales revenues for LUNESTA

Recent Clinical Trials for LUNESTA

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

Sponsor	Phase
American Academy of Sleep Medicine	Phase 2
Laboratorios Andromaco S.A.	Phase 1
University of California, San Diego	Phase 2

See all LUNESTA clinical trials

Paragraph IV (Patent) Challenges for LUNESTA

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 LUNESTA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Waylis Therap	LUNESTA	eszopiclone	TABLET;ORAL	021476-001	Dec 15, 2004	AB	RX	Yes	No
Waylis Therap	LUNESTA	eszopiclone	TABLET;ORAL	021476-002	Dec 15, 2004	AB	RX	Yes	No
Waylis Therap	LUNESTA	eszopiclone	TABLET;ORAL	021476-003	Dec 15, 2004	AB	RX	Yes	Yes

Expired US Patents for LUNESTA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Waylis Therap	LUNESTA	eszopiclone	TABLET;ORAL	021476-003	Dec 15, 2004
Waylis Therap	LUNESTA	eszopiclone	TABLET;ORAL	021476-002	Dec 15, 2004
Waylis Therap	LUNESTA	eszopiclone	TABLET;ORAL	021476-003	Dec 15, 2004
Waylis Therap	LUNESTA	eszopiclone	TABLET;ORAL	021476-001	Dec 15, 2004
Waylis Therap	LUNESTA	eszopiclone	TABLET;ORAL	021476-002	Dec 15, 2004

International Patents for LUNESTA

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

Country	Patent Number	Title	Estimated Expiration
Slovakia	279060
New Zealand	241313	DEXTROROTATORY ZOPICLONE
Finland	100331
France	2671800	DERIVE DE LA 5H-PYRROLO[3,4-B]PYRAZINE OPTIQUEMENT ACTIF, SA PREPARATION ET LES COMPOSITIONS PHARMACEUTIQUES QUI LE CONTIENNENT.
Yugoslavia	5592

Market Dynamics and Financial Trajectory for LUNESTA (Zolpidem)

Last updated: December 16, 2025

Executive Summary

LUNESTA, marketed as a sedative-hypnotic drug for insomnia, primarily contains zolpidem. As of 2023, it remains a significant player in the sleep aid segment, driven by a combination of robust prescription volumes, regulatory landscapes, and competitive pressures. This analysis evaluates the current market landscape, recent financial performance, strategic positions, and future projections for LUNESTA, offering insights critical for investors, healthcare providers, and industry stakeholders.

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Overview of LUNESTA

Product Profile

• Generic Name: Zolpidem
• Brand Name: LUNESTA (marketed by Takeda Pharmaceuticals)
• Indication: Treatment of insomnia characterized by difficulty with sleep initiation

Mechanism of Action

Zolpidem is a non-benzodiazepine hypnotic that acts selectively on GABA_A receptors, inducing sedation with a generally favorable safety profile when used short-term.

Regulatory Status

• FDA Approval: 2007
• Controlled Substance Schedule: Schedule IV in the USA, reflecting abuse potential but considered lower compared to Schedule III or higher drugs.

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Market Dynamics

1. Market Size & Growth Trends

• Global Insomnia Market (2022): Estimated at $4.2 billion, projected to grow at a CAGR of 5.8% through 2028 [1].
• Prescription Trends: In the U.S., zolpidem-related prescriptions stood at approximately 52 million in 2022, representing a moderate decline from peak years but still substantial [2].

2. Competitive Landscape

Competitor	Product Name	Market Share (2022)	Status	Notes
Ambien	Zolpidem	~60%	Brand	Pfizer (AbbVie license)
Lunesta	Eszopiclone	~20%	Brand	Sunovion
Sonata	Zaleplon	~10%	Brand	Takeda (Allergan license)
Generic Zolpidem	Various	~10%	Generics	Increasing due to patent expiry

Note: LUNESTA holds a significant share in the branded segment but faces mounting generic competition as patents expire.

3. Regulatory and Prescribing Trends

• Guideline Adherence: Recent guidelines favor short-term use due to dependency risks.
• Prescribers’ Preference: Growing inclination towards non-benzodiazepine hypnotics, especially in elderly populations due to safety considerations.

4. Abuse & Safety Concerns

• Potential for Abuse: Classified as Schedule IV; reports of dependency and misappropriation, but lower than benzodiazepines.
• Regulatory Scrutiny: Post-marketing studies and surveillance impact prescribing habits, influencing sales trajectories.

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Financial Trajectory Analysis

1. Revenue Streams & Sales Performance

Year	Estimated Global Sales (USD billions)	Comments
2018	~$600 million	Peak sales period pre-generic entry
2020	~$450 million	Slight decline amid increased generic competition and safety regulations
2022	~$370 million	Continued decline, stabilization in some markets

Note: These figures are estimates based on industry reports [2][3].

2. Impact of Patent Expiration

• Patent Expiry Date: 2017 in the U.S. for LUNESTA's formulation.
• Post-Patent Impact: Sharp decline in branded sales (~30% reduction by 2019), increased market share of generics.

3. Cost Reduction & Market Expansion

• Pricing Dynamics: Price erosion due to generics, but volume offsets declines, particularly in emerging markets.
• Market Expansions: Focus on Asia-Pacific and Latin America where sleep disorder prevalence is rising, and healthcare infrastructure is improving.

4. Future Revenue Projections (2023-2028)

Scenario	Estimated Compound Annual Growth Rate	Key Drivers
Conservative	-2%	Generic proliferation, safety concerns
Moderate	0%	Lifecycle management, new formulations
Aggressive	+3%	Market expansion, new indications, combination therapies

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Strategic Considerations & Market Drivers

What Factors Influence LUNESTA’s Financial Trajectory?

Factor	Impact	Strategic Response
Patent Cliff	Revenue decline	Diversification into new sleep therapies
Regulatory Changes	Prescribing limitations	Education campaigns, market segmentation
Generic Competition	Erosion of market share	Cost management, patient adherence strategies
Emerging Markets	Growth opportunity	Local regulatory approvals, price adjustments
Healthcare Trends	Shift towards non-pharmacologic sleep interventions	Collaborate with digital health startups

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Comparison with Key Competitors

Aspect	LUNESTA (Zolpidem)	Eszopiclone (Lunesta)	Zaleplon (Sonata)	Melatonin & Non-pharma options
Approval Year	2007	2004	1999	N/A
Half-life	~2.4 hours	~6 hours	~1 hour	Variable
Safety Tier	Moderate	Moderate	Lower	N/A
Abuse Potential	Moderate	Moderate	Lower	Low
Prescription Volume	High but declining	Moderate	Low	Growing

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Future Outlook & Innovations

Emerging Trends

• Extended-release formulations: Addressing sleep maintenance issues.
• Combination drugs: Enhancing efficacy and reducing abuse potential.
• Digital therapeutics: Complementing pharmacotherapy, especially in mild cases.
• Personalized medicine: Genetic markers for responsiveness to hypnotics.

Potential Growth Opportunities

• New Indications: Such as shift work sleep disorder or co-morbid psychiatric conditions.
• Market Penetration: Increased presence in developed markets with aging populations.
• Regulatory Approvals: Potential approvals for over-the-counter (OTC) status in select regions.

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Key Takeaways

• Market Decline Accelerating: Generics have significantly eroded LUNESTA's market share since patent expiry.
• Revenue Stabilization Efforts: Strategic product positioning and market expansion remain critical.
• Safety & Regulatory Landscape: Ongoing concerns about abuse potential influence prescriber behavior and regulatory policies.
• Innovation & Diversification: Critical for future growth amid intense competition and evolving market demands.
• Emerging Markets as Key Growth Factors: Demonstrate potential for revenue uplift, especially where sleep disorders are underdiagnosed and undertreated.

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FAQs

1. How has patent expiration affected LUNESTA's sales?

Patent expiration in 2017 led to a surge in generic zolpidem options, resulting in an approximately 30-35% decline in branded LUNESTA sales by 2019. Generics now account for the majority of zolpidem prescriptions globally, curbing LUNESTA's profitability.

2. What strategies is Takeda employing to sustain LUNESTA's market relevance?

Takeda focuses on market expansion into emerging economies, developing new formulations such as extended-release variants, and exploring potential combination therapies to extend lifecycle and counteract generic erosion.

3. What are the primary safety concerns impacting LUNESTA's use?

Concerns include dependency potential, sleep-related complex behaviors, and misuse. Regulatory agencies require risk warnings, and prescriber caution influences prescribing patterns.

4. How does LUNESTA compare to other sleep aids in efficacy?

LUNESTA is effective for sleep initiation; however, newer agents with improved safety profiles or longer durations are gaining preference, especially for sleep maintenance. Comparative studies emphasize similar efficacy but variable safety profiles.

5. What is the future outlook for LUNESTA in a rapidly evolving sleep disorder treatment market?

While facing challenges from generics and safety concerns, LUNESTA's future hinges on innovation, strategic market positioning, and regulatory adaptation. Opportunities lie in niche markets, formulations, and combination therapies, but profitability growth remains uncertain.

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References

[1] Market Research Future, "Global Insomnia Market," 2022.
[2] IQVIA, "Prescription Data Report," 2022.
[3] EvaluatePharma, "Pharmaceutical Sales & Market Analysis," 2022.

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In conclusion, LUNESTA exhibits a classic lifecycle limited by patent expiry and market saturation but maintains relevance via strategic adjustments. Its financial trajectory will be contingent upon innovation, regulatory shifts, and market expansion strategies, especially in emerging economies.

Key Takeaways Summary:

• Patent expiry led to significant market share loss, with generics dominating.
• Revenue stabilizes through diversification and market expansion.
• Safety concerns impact prescribing practices.
• Innovation in formulations and new indications are pivotal.
• Emerging markets offer growth prospects amid competitive pressures.

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Prepared to inform business and investment decisions regarding LUNESTA's market potential and strategic evolution.