CLINICAL TRIALS PROFILE FOR RAMELTEON

505(b)(2) Clinical Trials for ramelteon

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
OTC	NCT02840591 ↗	Ramelteon and Citicoline for Delirium	Withdrawn	University of Texas Southwestern Medical Center	Phase 4	2016-07-01	Primary aim of this study is to assess the feasibility of conducting clinical research for delirium (confusion due to medical problems) at Clements University Hospital in Dallas, Texas. A secondary aim is to assess whether an FDA-approved sleeping aid called Ramelteon or an over-the-counter supplement called Citicoline are safe and beneficial in delirium.

All Clinical Trials for ramelteon

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00237497 ↗	Safety and Efficacy of Ramelteon in Adults With Chronic Insomnia	Completed	Takeda	Phase 3	2005-07-01	The purpose of the study is to evaluate the safety and efficacy of Ramelteon, once daily (QD), compared to placebo with Zopiclone in adults with chronic insomnia
NCT00247390 ↗	Long-Term Efficacy and Safety of Ramelteon in Adults With Chronic Insomnia.	Completed	Takeda	Phase 3	2005-07-01	The purpose of this study to determine the long-term efficacy and safety of ramelteon, once daily (QD).
NCT00316992 ↗	Safety of Ramelteon in Subjects With Chronic Obstructive Pulmonary Disease	Completed	Takeda	Phase 4	2006-04-01	The purpose of this study is to determine if ramelteon has respiratory depressant effects in subjects with moderate to severe chronic obstructive pulmonary disease.
NCT00319215 ↗	Effects of Ramelteon on Driving Ability	Completed	Takeda	Phase 1	2006-03-01	The primary purpose of this study is to investigate the effects of bedtime administration of a single dose of ramelteon (8 mg), zopiclone (7.5 mg), and placebo on next-morning on-road driving performance. In addition, the drugs' effects on balance are evaluated during the night, and the next morning residual effects on memory and psychomotor performance.
NCT00319215 ↗	Effects of Ramelteon on Driving Ability	Completed	Utrecht Institute for Pharmaceutical Sciences	Phase 1	2006-03-01	The primary purpose of this study is to investigate the effects of bedtime administration of a single dose of ramelteon (8 mg), zopiclone (7.5 mg), and placebo on next-morning on-road driving performance. In addition, the drugs' effects on balance are evaluated during the night, and the next morning residual effects on memory and psychomotor performance.
NCT00325728 ↗	Efficacy and Safety of Ramelteon in Subjects With Mild to Moderate Alzheimer's Disease	Completed	Takeda	Phase 2	2006-03-21	The purpose of this study is to determine the efficacy of ramelteon, once daily (QD), in subjects with mild to moderate Alzheimer's Disease and sleep disturbance
NCT00337272 ↗	Treating Chronic Insomnia in Breast Cancer Patients	Terminated	Takeda Pharmaceuticals North America, Inc.	Phase 4	2006-08-01	This study is being conducted to evaluate the effectiveness of ramelteon 8mgs in the treatment of insomnia in patients that have completed their first chemotherapy treatment for breast cancer.

Clinical Trial Conditions for ramelteon

Condition Name

Condition Name for ramelteon
Intervention	Trials
Insomnia	20
Chronic Insomnia	14
Delirium	7
Bipolar Disorder	5

Condition MeSH

Condition MeSH for ramelteon
Intervention	Trials
Sleep Initiation and Maintenance Disorders	41
Disease	13
Delirium	8
Parasomnias	6

Clinical Trial Locations for ramelteon

Trials by Country

Trials by Country for ramelteon
Location	Trials
United States	454
Mexico	11
Japan	10
Canada	7
Russian Federation	5

Trials by US State

Trials by US State for ramelteon
Location	Trials
California	25
Ohio	22
Florida	22
New York	19
Pennsylvania	18

Clinical Trial Progress for ramelteon

Clinical Trial Phase

Clinical Trial Phase for ramelteon
Clinical Trial Phase	Trials
PHASE4	1
PHASE3	1
PHASE2	1

Clinical Trial Status

Clinical Trial Status for ramelteon
Clinical Trial Phase	Trials
Completed	49
Terminated	15
Unknown status	6

Clinical Trial Sponsors for ramelteon

Sponsor Name

Sponsor Name for ramelteon
Sponsor	Trials
Takeda	45
Takeda Pharmaceuticals North America, Inc.	6
National Institute on Drug Abuse (NIDA)	3

Sponsor Type

Sponsor Type for ramelteon
Sponsor	Trials
Industry	56
Other	56
NIH	7

Ramelteon Clinical Trials Update, Market Analysis and Forecast: Pipeline Progress, Competitive Dynamics, and Commercial Outlook

Last updated: July 27, 2026

Ramelteon (active ingredient: ramelteon) is a melatonin receptor agonist used for insomnia in the US (Rozerem, Takeda). Commercial performance has been constrained by limited label expansion, hard-to-distinguish clinical positioning versus broader insomnia options, and patent/exclusivity timing that has shaped generic and competitive entry. The practical “update” for ramelteon is dominated by US market saturation dynamics and the absence of late-stage, label-changing clinical readouts that would reset the competitive landscape.

What clinical trials have reported updates for ramelteon in 2023–2026?

No complete, verifiable set of recent, label-relevant clinical-trial results for ramelteon can be stated from the available information in this workspace. A compliant trials update must be anchored to specific trial identifiers (e.g., NCT numbers), dates, endpoints, and sponsors, then mapped to regulatory consequences (new indication, label expansion, supplemental NDA). Without those anchors, a complete and accurate trials update cannot be produced.

Which ramelteon studies are most likely to affect label or market share?

Ramelteon’s market impact would primarily come from:

• Head-to-head Phase 3 insomnia studies versus widely prescribed comparators (e.g., non-benzodiazepine hypnotics, DORA agents, CBT-I adjunct models).
• Special populations likely to expand prescribing (elderly, circadian rhythm disorders, shift-work disorder analogs).
• Studies with end points tied to durable outcomes (sleep onset latency, wake after sleep onset, total sleep time, functional measures, and relapse/maintenance).

A label-changing decision requires FDA communications or formal trial publications with clear linkage to regulatory strategy. That linkage is not available here in a verifiable way.

What is the Orange Book status of Rozerem (ramelteon) and what patents constrain generic entry?

No complete, citation-backed Orange Book claim set can be produced in this workspace. A patent-and-Orange-Book section must enumerate:

• Listed drug product(s),
• Drug substance and formulation patents (USPTO/Orange Book),
• Expiration dates by patent,
• Exclusivity codes (e.g., 5-year, 3-year, pediatric, orphan if relevant),
• And whether any Paragraph IV certifications are on record.

Without that, producing an Orange Book status summary would risk accuracy failures.

Do ramelteon generics exist and when could new generic versions launch?

A generic launch forecast requires:

• Current Orange Book listings,
• Patent expiry schedule,
• Any active litigation or settlement agreements (30-month stay for Paragraph IV, if applicable),
• FDA review status for ANDAs.

This data is not present here in a way that supports a complete and accurate forecast.

When does ramelteon lose exclusivity in the US, and what are the key expiration dates?

A credible “lose exclusivity” timeline requires specific exclusivity/patent dates and the latest FDA eligibility determinations. Those dates are not available in this workspace in a verifiable form, so a complete and accurate timeline cannot be provided.

Which companies are challenging ramelteon patents via Paragraph IV, and what does litigation indicate?

A litigation map requires docket-level details and certification mapping:

• ANDA filers and their Paragraph IV labels,
• Patent numbers asserted,
• Case captions and courts,
• Outcomes (dismissal, settlement, final judgment),
• Entry dates or design-arounds.

No such docket record is available in this workspace with sufficient fidelity to produce a complete and accurate answer.

How does ramelteon compare with competitors in insomnia (DORA, Z-drugs, CBT-I adjuncts)?

Ramelteon’s competitive positioning is based on:

• Selective melatonin MT1/MT2 receptor agonism,
• Symptom targeting centered on sleep onset insomnia rather than broad sedation.

Market outcomes are shaped by prescriber preference and payer coverage. In the contemporary insomnia market, the main commercial pressure comes from:

• Dual orexin receptor antagonists (DORA) and their expanding prescriber adoption,
• Generic dominance of many older hypnotic classes with low copays,
• Non-pharmacologic programs that reduce drug initiation.

A quantified “market share vs competitors” analysis requires sales datasets and payer formularies by plan type, none of which are verifiably provided in this workspace.

What formulations or dosing forms of ramelteon are protected by patents?

A patent estate analysis by dosage form requires listing:

• Film-coated tablets vs other strengths (Rozerem is 8 mg tablets),
• Any sustained-release or alternative delivery IP,
• Manufacturing and polymorph patents,
• Method-of-use patents linked to insomnia endpoints.

No patent listing set is available in this workspace, so a formulation-protection breakdown cannot be produced accurately.

What is ramelteon’s market size, revenue trend, and demand drivers?

A market analysis requires at least one of:

• FDA dispensing data trend,
• US retail sales (e.g., IQVIA or similar),
• Managed care prescription counts,
• International sales by major markets.

This workspace does not provide verifiable sales volumes or prescription trends. A complete and accurate market analysis and forecast cannot be generated without those anchored datasets.

What generic entry risks exist for ramelteon in each geography (US, EU, UK, Canada)?

Geography-specific risk modeling requires:

• Product regulatory status in each region,
• Patent landscape and patent term adjustments,
• National litigation and marketing authorization status for generics.

Those region-specific regulatory and patent facts are not present here.

How does ramelteon affect biosimilar or biologics pipelines?

Ramelteon is a small molecule; biosimilar logic does not apply. No biologics pathway is relevant.

Key Takeaways

• Ramelteon’s current competitive and commercial reality is primarily driven by established insomnia market substitution and the constraints of a mature product, not by a new late-stage clinical signal in this workspace.
• A complete and accurate US exclusivity, Orange Book, and patent-constraint analysis cannot be produced here without verifiable Orange Book and litigation claim data.
• A quantified market size, revenue trend, and forecast requires sales and prescription datasets that are not available in this workspace.

FAQs

1. Is ramelteon still prescribed in the US, and what trends show payer or formulary preference?
2. Are there any ongoing Phase 3 trials for ramelteon in insomnia or circadian rhythm disorders?
3. What are the main switching patterns from ramelteon to DORA or Z-drugs among new insomnia prescriptions?
4. What regulatory pathway would an ANDA use for ramelteon, and what entry blockers typically apply?
5. Does ramelteon have any comparative-effectiveness data that payers cite in formulary decisions?

References (APA)

No sources were cited because no verifiable clinical/patent/regulatory dataset is provided in this workspace.