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Last Updated: December 22, 2024

RAMELTEON Drug Patent Profile


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

Ramelteon is a drug 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, and Zydus Pharms. and is included in ten NDAs.

The generic ingredient in RAMELTEON is ramelteon. There are three drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the ramelteon profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Ramelteon

A generic version of RAMELTEON was approved as ramelteon by DR REDDYS LABS SA on July 26th, 2013.

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Drug patent expirations by year for RAMELTEON
Drug Prices for RAMELTEON

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Recent Clinical Trials for RAMELTEON

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

SponsorPhase
The University of Hong KongPhase 3
University of Sao PauloPhase 4
Centennial Medical CenterPhase 4

See all RAMELTEON clinical trials

Pharmacology for RAMELTEON
Anatomical Therapeutic Chemical (ATC) Classes for RAMELTEON
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
Actavis Labs Fl Inc RAMELTEON ramelteon TABLET;ORAL 091610-001 Aug 19, 2015 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Micro Labs RAMELTEON ramelteon TABLET;ORAL 215243-001 Feb 9, 2023 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Dr Reddys Labs Sa RAMELTEON ramelteon TABLET;ORAL 091693-001 Jul 26, 2013 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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.

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