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, Aurobindo Pharma Ltd, Dr Reddys Labs Sa, Granules, I3 Pharms, Micro Labs, Upsher Smith 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-four 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:	24
Raw Ingredient (Bulk) Api Vendors:	110
Clinical Trials:	80
Patent Applications:	3,349
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
The University of Hong Kong	Phase 3
University of Sao Paulo	Phase 4
Centennial Medical Center	Phase 4

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
Dr Reddys Labs Sa	RAMELTEON	ramelteon	TABLET;ORAL	091693-001	Jul 26, 2013	AB	RX	No	No
Granules	RAMELTEON	ramelteon	TABLET;ORAL	213186-001	Aug 21, 2020	AB	RX	No	No
Actavis Labs Fl Inc	RAMELTEON	ramelteon	TABLET;ORAL	091610-001	Aug 19, 2015	AB	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
Takeda Pharms Usa	ROZEREM	ramelteon	TABLET;ORAL	021782-001	Jul 22, 2005

RAMELTEON Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ramelteon

Introduction to Ramelteon

Ramelteon, marketed under the brand name Rozerem, is a melatonin receptor agonist used primarily for the treatment of insomnia, particularly in individuals who have difficulty falling asleep. It mimics the action of melatonin, a hormone that regulates the sleep-wake cycle, without the addictive potential associated with many traditional sleep aids[1][3].

Market Outlook and Growth Trends

The Ramelteon market is poised for significant growth, driven by several key factors:

Increasing Awareness of Sleep Disorders

There is a growing awareness of sleep disorders and an increasing prevalence of insomnia worldwide. This trend is fueled by rising stress levels, changing lifestyles, and the impact of technology on sleep quality[1].

Healthcare Priorities

Healthcare systems are emphasizing non-benzodiazepine sleep solutions to avoid dependency issues, making Ramelteon an attractive option for both healthcare providers and patients[1].

Market Segmentation

The Ramelteon market is segmented into brand-name (Rozerem) and generic versions. The generic segment, particularly, is expected to grow due to its cost-effectiveness and wide acceptance. The market is also segmented by region, with North America, Europe, Asia-Pacific, Latin America, and the Middle East & Africa being key regions[1][4].

Financial Trajectory

Revenue and Growth Rate

The Ramelteon market is expected to grow at a compound annual growth rate (CAGR) of 35.10% during the forecast period from 2024 to 2031. This robust growth is driven by increasing demand and innovations in the pharmaceutical sector[1].

Market Size

The global market size for insomnia medications, including Ramelteon, is projected to reach approximately $6 billion by 2025. This indicates a substantial financial opportunity for companies involved in the Ramelteon market[1].

Key Drivers of Growth

Personalized Medicine

Advances in genetic profiling allow for tailored treatments, enhancing the efficacy and reducing side effects of Ramelteon for individual patients. This personalized approach is expected to increase patient adherence and satisfaction[1].

Digital Health Integration

The rise of sleep tracking apps and wearable technology provides valuable insights into sleep patterns, fostering informed decisions about Ramelteon's use. This integration enhances the overall treatment experience and outcomes[1].

Telehealth Growth

Remote consultations have expanded access to sleeping disorder treatments, driving Ramelteon prescriptions among patients who prefer avoiding in-person visits. This trend is particularly significant in the post-COVID-19 era[1].

Natural and Plant-Based Alternatives

A consumer shift towards natural remedies has prompted interest in Ramelteon, which is seen as a preferable option over traditional pharmaceuticals due to its melatonin receptor agonist properties[1].

Competitive Landscape

Key Players

Companies like Takeda and Dr. Reddy's Laboratories are well-positioned to capture a larger share in the evolving landscape of sleep disorder treatments. Dr. Reddy's Laboratories, for example, has entered the Ramelteon market with its generics, capitalizing on the growing demand for cost-effective alternatives[1].

Product Innovations

The introduction of new formulations and potential expansions in distribution channels are expected to enhance market access and patient adherence. These innovations will likely bolster the financial trajectory of the Ramelteon market[1].

Regional Analysis

Dominant Regions

North America, particularly the United States and Canada, and Europe, including countries like Germany, France, and the U.K., are expected to dominate the global Ramelteon market. The Asia-Pacific region, with countries such as China, Japan, and India, is also anticipated to show significant growth due to increasing healthcare expenditures and a growing awareness of sleep disorders[1][4].

Financial Performance of Key Companies

Dr. Reddy's Laboratories

Dr. Reddy's Laboratories, a global healthcare company, generated revenue of around $2.5 billion in the fiscal year 2022. The company's robust generic product lineup and expansion into regulated markets have been key drivers of its financial success[1].

Challenges and Opportunities

Cost and Insurance Coverage

The cost of Ramelteon can vary based on treatment plans, insurance coverage, and the pharmacy used. However, generic versions tend to be more cost-effective, making them an attractive option for many patients[5].

Regulatory Environment

The approval and regulation of Ramelteon by bodies like the FDA have been crucial in establishing its safety and efficacy. Continued regulatory support and favorable policies will be essential for the market's growth[3].

Emerging Trends

Off-Label Uses

Ramelteon has potential off-label uses, such as treating circadian rhythm sleep disorders like shift-work and jet lag. These additional uses could further expand the market[3].

Pharmacokinetic Profile

Ramelteon's pharmacokinetic profile, including its high affinity for MT1 and MT2 receptors and its extended functional half-life, provides a decisive advantage in promoting sleep initiation and maintenance compared to melatonin[3].

Key Takeaways

• The Ramelteon market is expected to grow significantly, driven by increasing awareness of sleep disorders and a shift towards non-benzodiazepine sleep solutions.
• The market is segmented into brand-name and generic versions, with the generic segment expected to grow due to cost-effectiveness.
• Key drivers include personalized medicine, digital health integration, telehealth growth, and a consumer shift towards natural remedies.
• The competitive landscape is dominated by companies like Takeda and Dr. Reddy's Laboratories.
• Regional growth is anticipated in North America, Europe, and the Asia-Pacific region.

FAQs

What is Ramelteon used for?

Ramelteon is used primarily for the treatment of insomnia, particularly for individuals who have difficulty falling asleep. It mimics the action of melatonin to improve sleep onset without the addictive potential associated with many traditional sleep aids[1][3].

What are the key drivers of the Ramelteon market growth?

Key drivers include increasing awareness of sleep disorders, a shift towards non-benzodiazepine sleep solutions, personalized medicine, digital health integration, telehealth growth, and a consumer shift towards natural remedies[1].

Which regions are expected to dominate the Ramelteon market?

North America, Europe, and the Asia-Pacific region are expected to dominate the global Ramelteon market due to increasing healthcare expenditures and a growing awareness of sleep disorders[1][4].

What is the expected CAGR of the Ramelteon market?

The Ramelteon market is expected to grow at a CAGR of 35.10% during the forecast period from 2024 to 2031[1].

How does Ramelteon compare to melatonin in terms of pharmacokinetics?

Ramelteon has a higher affinity for MT1 and MT2 receptors and an extended functional half-life compared to melatonin, providing a decisive advantage in promoting sleep initiation and maintenance[3].

Sources

1. Ramelteon Market Share & Market Analysis - Growth Trends & Forecasts for period from (2024 - 2031), OpenPR.
2. HEALTHY FUTURES - Annual Reports, AnnualReports.com.
3. Pharmacotherapy of Insomnia with Ramelteon: Safety, Efficacy and Clinical Applications, Journal of Clinical Neuroscience.
4. Ramelteon Market Report 2024 (Global Edition), Cognitive Market Research.
5. Ramelteon cost 2024: Coupons and more, Medical News Today.