RAMELTEON - Generic Drug Details

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

Ramelteon is the generic ingredient in two branded drugs marketed by Actavis Labs Fl Inc, Andas 5 Holding, Appco, Aurobindo Pharma Ltd, Dr Reddys Labs Sa, Granules, I3 Pharms, Micro Labs, Xiromed, Zydus Pharms, and Takeda Pharms Usa, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.

There are three drug master file entries for ramelteon. Twenty-six suppliers are listed for this compound.

Summary for RAMELTEON

US Patents:	0
Tradenames:	2
Applicants:	11
NDAs:	11
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	26
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	85
Patent Applications:	3,943
Drug Prices:	Drug price trends for RAMELTEON
What excipients (inactive ingredients) are in RAMELTEON?	RAMELTEON excipients list
DailyMed Link:	RAMELTEON at DailyMed

See drug prices for RAMELTEON

Recent Clinical Trials for RAMELTEON

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

Sponsor	Phase
Sultan Qaboos University	PHASE2
Sultan Qaboos University	PHASE4
Nanjing Chia-tai Tianqing Pharmaceutical	PHASE3

See all RAMELTEON clinical trials

Pharmacology for RAMELTEON

Drug Class	Melatonin Receptor Agonist
Mechanism of Action	Melatonin Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for RAMELTEON

N05CH	Melatonin receptor agonists
N05C	HYPNOTICS AND SEDATIVES
N05	PSYCHOLEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for RAMELTEON

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ROZEREM	Tablets	ramelteon	8 mg	021782	2	2009-07-22

US Patents and Regulatory Information for RAMELTEON

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Granules	RAMELTEON	ramelteon	TABLET;ORAL	213186-001	Aug 21, 2020	AB	RX	No	No
Andas 5 Holding	RAMELTEON	ramelteon	TABLET;ORAL	215435-001	Aug 24, 2022	AB	RX	No	No
Xiromed	RAMELTEON	ramelteon	TABLET;ORAL	216209-001	Nov 25, 2022	BX	RX	No	No

Expired US Patents for RAMELTEON

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	ROZEREM	ramelteon	TABLET;ORAL	021782-001	Jul 22, 2005	10,098,866
Takeda Pharms Usa	ROZEREM	ramelteon	TABLET;ORAL	021782-001	Jul 22, 2005	6,034,239

Market Dynamics and Financial Trajectory for Ramelteon

Last updated: July 27, 2025

Introduction

Ramelteon, sold under the brand name Rozerem among others, is a hypnotic agent targeting insomnia, particularly sleep-onset difficulties. Approved by the FDA in 2005, it functions as a selective melatonin receptor agonist, offering distinct advantages over traditional benzodiazepines and non-benzodiazepine sleep aids by minimizing dependence risks. Its unique mechanism and targeted therapeutic profile position ramelteon within a specialized segment of the sleep disorder pharmacotherapy market. Understanding its market dynamics and financial trajectory is critical for stakeholders assessing growth potential, competitive landscape, and investment viability.

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Market Overview and Key Drivers

The global sleep disorder treatment market is anticipated to grow at a compound annual growth rate (CAGR) of approximately 6% from 2022 to 2029, driven by increasing awareness, aging populations, and rising prevalence of sleep disorders—conditions affecting an estimated 50-70 million Americans alone.[1] Ramelteon, as a non-habit-forming agent, is well-positioned within this expanding market, especially among populations cautious of dependence and adverse effects associated with traditional hypnotics.

Prevalence of Insomnia and Demographic Trends
Insomnia's global prevalence ranges from 10% to 30%, with higher incidence among older adults—an aging demographic more susceptible to chronic sleep issues.[2] The increasing geriatric population worldwide (projected to reach 1.5 billion by 2050) supplies a sustained demand for safe, long-term sleep therapies such as ramelteon.

Regulatory and Prescribing Trends
The favorable safety profile and non-scheduled status (not classified as controlled substance) facilitate prescribing among primary care physicians and specialists. Regulatory encouragement for non-habit-forming sleep aids further enhances its market appeal.

Physician and Patient Acceptance
Ramelteon’s minimal dependency risk and tolerability make it an attractive option for both prescribers and patients, especially in the context of opioid and sedative dependence concerns. However, perceived modest efficacy compared to sedative hypnotics and limited awareness constrain its market penetration.

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Competitive Landscape

Market Positioning and Key Competitors
Ramelteon’s primary competitors include benzodiazepines (e.g., temazepam), non-benzodiazepines (e.g., zolpidem, eszopiclone), and melatonin supplements. While traditional hypnotics dominate sales volumes, safety concerns and regulatory restrictions limit their long-term use, providing space for ramelteon.

Emerging Alternatives and Innovations
Recent developments include orexin receptor antagonists like suvorexant and lemborexant, which target novel sleep mechanisms. These drugs compete with ramelteon on efficacy but differ in side effect profiles and regulatory status.

Market Penetration Challenges
Ramelteon holds a niche position, often prescribed after other agents if insufficient response or intolerance occurs. Its relatively high cost, lack of rapid onset, and modest efficacy hamper broader adoption.

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Financial Trajectory and Market Performance

Sales Data and Trends
Since approval, ramelteon’s global sales have displayed modest growth. In the U.S., annual sales hovered between $350 million to $500 million in recent years.[3] Growth stagnates due to limited awareness and competition, but steady demand persists among specific patient groups.

Market Share and Revenue Outlook
Ramelteon's market share remains subdued relative to sedative hypnotics, accounting for roughly 5-10% of the insomnia pharmacotherapy market. Nonetheless, the segment of safe, non-habit-forming sleep aids continues to expand, providing incremental revenue opportunities.

Emerging Market Expansion
Interest from emerging economies, driven by rising sleep disorder prevalence, aging populations, and healthcare modernization, offers prospects for revenue growth. Regulatory approvals in countries like China and India are anticipated, contributing to regional sales increases.

Patent and Patent Expiration Impact
As of now, ramelteon’s original patent has already expired or is nearing expiry in several jurisdictions, opening avenues for generic manufacturers to enter the market. This competition is likely to exert downward pressure on prices and margins, influencing the drug’s financial trajectory.

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Regulatory and Policy Influences

Policy shifts favoring non-controlled, non-scheduled sleep agents and increasing emphasis on safety could sustain or enhance ramelteon’s market positioning. Conversely, alterations in reimbursement policies or increased regulation of sleep medications could constrain growth.

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Market Opportunities and Risks

Opportunities:

• Broadened indications for ramelteon, including jet lag and shift work sleep disorder.
• Expansion into emerging markets with high unmet needs.
• Combination therapies or formulations improving onset times and efficacy.

Risks:

• Market saturation with alternative drugs offering superior efficacy.
• Patent expiry leading to generic competition.
• Limited efficacy perceptions among physicians, stalling broader adoption.
• Regulatory hurdles or safety concerns emerging in post-marketing surveillance.

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Conclusion

Ramelteon’s market dynamics are shaped by its positioning as a safe, non-habit-forming sleep aid amid a growing sleep disorder market driven by demographic and lifestyle factors. While current sales are modest and growth moderate, opportunities persist through geographic expansion and product innovation. However, patent expiries and stiff competition from newer agents necessitate strategic adaptations. The drug’s financial trajectory will hinge on its ability to carve out a sustainable niche within the evolving sleep medicine landscape.

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Key Takeaways

• Market Positioning: Ramelteon serves a niche for safety-conscious patients with sleep-onset insomnia, with a stable but limited market share.
• Growth Drivers: Aging populations and increasing awareness of dependence-related issues support its demand, especially in developed markets.
• Competitive Challenges: Dominance of sedative hypnotics and emergence of novel agents pose ongoing threats to market share expansion.
• Revenue Outlook: Sales remain steady but face downward pressure from patent expiration and pricing competition, especially with generics.
• Strategic Opportunities: Geographic expansion, new indications, and combination formulations offer pathways for revenue growth amid competitive pressures.

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FAQs

1. Why is ramelteon positioned as a safer alternative to traditional sleep medications?
Ramelteon’s mechanism as a selective melatonin receptor agonist minimizes dependency, overdose risk, and withdrawal symptoms typical of benzodiazepines and non-benzodiazepines, making it suitable for long-term use.

2. How does patent expiration influence ramelteon’s market prospects?
Patent expiry enables generic manufacturers to produce cost-effective alternatives, which can increase accessibility but also reduce brand-name sales and profit margins for original producers.

3. What emerging therapies threaten ramelteon’s market share?
Orexin receptor antagonists like suvorexant and lemborexant, offering improved efficacy and faster onset, are gaining popularity, encroaching on ramelteon’s niche.

4. Which regional markets present growth opportunities for ramelteon?
Emerging markets such as China, India, and Brazil, with rising sleep disorder prevalence, expanding healthcare infrastructure, and regulatory reforms, are key targets for growth.

5. How can pharmaceutical companies enhance ramelteon’s market performance?
Strategies include developing improved formulations, expanding indications, increasing physician awareness, and tailoring marketing to aging populations and hospital settings.

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References

[1] MarketWatch. "Sleep Disorder Treatment Market Size, Share & Trends." 2022.
[2] Ohayon, M. M., et al. "Prevalence of insomnia among the elderly in the United States." Sleep Medicine, 2011.
[3] IQVIA. "Pharmaceutical Sales Data, 2022."