TASIMELTEON - Generic Drug Details

What are the generic sources for tasimelteon and what is the scope of patent protection?

Tasimelteon is the generic ingredient in three branded drugs marketed by Vanda Pharms Inc, Apotex, MSN, and Teva Pharms Usa Inc, and is included in five NDAs. There are thirty-three patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Tasimelteon has two hundred and eleven patent family members in twenty-four countries.

There are three drug master file entries for tasimelteon. Four suppliers are listed for this compound.

Summary for TASIMELTEON

International Patents:	211
US Patents:	33
Tradenames:	3
Applicants:	4
NDAs:	5
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	58
Clinical Trials:	25
Patent Applications:	575
Drug Prices:	Drug price trends for TASIMELTEON
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TASIMELTEON
What excipients (inactive ingredients) are in TASIMELTEON?	TASIMELTEON excipients list
DailyMed Link:	TASIMELTEON at DailyMed

See drug prices for TASIMELTEON

Recent Clinical Trials for TASIMELTEON

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

Sponsor	Phase
Vanda Pharmaceuticals	PHASE3
Brigham and Women's Hospital	EARLY_PHASE1
Vanda Pharmaceuticals	EARLY_PHASE1

See all TASIMELTEON clinical trials

Pharmacology for TASIMELTEON

Drug Class	Melatonin Receptor Agonist
Mechanism of Action	Melatonin Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for TASIMELTEON

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

Paragraph IV (Patent) Challenges for TASIMELTEON

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
HETLIOZ LQ	Oral Suspension	tasimelteon	4 mg/mL	214517	1	2024-04-01
HETLIOZ	Capsules	tasimelteon	20 mg	205677	3	2018-01-31

US Patents and Regulatory Information for TASIMELTEON

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Msn	TASIMELTEON	tasimelteon	CAPSULE;ORAL	211654-001	Jan 12, 2023	AB	RX	No	No
Vanda Pharms Inc	HETLIOZ	tasimelteon	CAPSULE;ORAL	205677-001	Jan 31, 2014	AB	RX	Yes	Yes	9,060,995
Vanda Pharms Inc	HETLIOZ	tasimelteon	CAPSULE;ORAL	205677-001	Jan 31, 2014	AB	RX	Yes	Yes	12,201,604
Vanda Pharms Inc	HETLIOZ	tasimelteon	CAPSULE;ORAL	205677-001	Jan 31, 2014	AB	RX	Yes	Yes	10,829,465		Y	Y
Vanda Pharms Inc	HETLIOZ LQ	tasimelteon	SUSPENSION;ORAL	214517-001	Dec 1, 2020		RX	Yes	Yes	11,202,770		Y
Vanda Pharms Inc	HETLIOZ LQ	tasimelteon	SUSPENSION;ORAL	214517-001	Dec 1, 2020		RX	Yes	Yes	11,266,622
Vanda Pharms Inc	HETLIOZ	tasimelteon	CAPSULE;ORAL	205677-001	Jan 31, 2014	AB	RX	Yes	Yes	9,855,241

Expired US Patents for TASIMELTEON

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Vanda Pharms Inc	HETLIOZ	tasimelteon	CAPSULE;ORAL	205677-001	Jan 31, 2014	5,856,529
Vanda Pharms Inc	HETLIOZ LQ	tasimelteon	SUSPENSION;ORAL	214517-001	Dec 1, 2020	5,856,529

EU/EMA Drug Approvals for TASIMELTEON

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Vanda Pharmaceuticals Netherlands B.V.	Hetlioz	tasimelteon	EMEA/H/C/003870Hetlioz is indicated for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) in totally blind adults.,	Authorised	no	no	yes	2015-07-03

International Patents for TASIMELTEON

Country	Patent Number	Title	Estimated Expiration
Australia	2020400065	Liquid tasimelteon formulations and methods of use thereof
Chile	2016001794	Metodo para administrar tasimelteon a un paciente humano que incluye la administración oral de una dosis efectiva en condiciones de ayuno para tratar un trastorno del ritmo circadiano o un trastorno del sueño, como el trastorno del sueño-vigilia diferente a 24 horas no-24 metodo para acortar el tmax del tasimelteon en un paciente humano que está siendo tratado con tasimelteon.
Japan	2017165742	概日リズム障害の治療 (TREATMENT OF CIRCADIAN RHYTHM DISORDERS)
China	110200958
Israel	239246
South Korea	20180100450	일주기 리듬 장애의 치료 (TREATMENT OF CIRCADIAN RHYTHM DISORDERS)
Israel	269054

Last updated: July 27, 2025

rket Dynamics and Financial Trajectory for TASIMELTEON: A Comprehensive Overview

Introduction

Tasimelteon, marketed under the brand name Hetlioz, is a novel oral melatonin receptor agonist primarily indicated for the treatment of non-24-hour sleep-wake disorder (Non-24) in totally blind individuals. Originally developed by Vanda Pharmaceuticals, tasimelteon represents a promising therapeutic agent in the sleep disorder landscape, with its unique mechanism targeting circadian rhythm regulation. This article delineates the current market dynamics influencing tasimelteon and scrutinizes its financial trajectory based on clinical, regulatory, and commercial developments.

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Pharmacological Profile and Clinical Position

Tasimelteon acts as a selective agonist at melatonin receptors MT1 and MT2, which play critical roles in circadian rhythm entrainment. Its FDA approval in 2014 for Non-24 marked a milestone, granting it exclusivity in an area with no other targeted therapies. The drug’s efficacy hinges on realigning circadian rhythms in blind individuals lacking light perception, thus filling a crucial unmet medical need.

However, despite its targeted mechanism, the clinical adoption of tasimelteon faces hurdles. The rarity of non-24, affecting approximately 8,000 to 10,000 patients in the U.S., constrains its immediate market. Yet, the high unmet need affirms its value proposition, particularly within niche sleep disorders and circadian rhythm management.

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Current Market Dynamics

1. Demographics and Patient Population:
Non-24 primarily affects totally blind individuals, representing a small but significant market segment. The limited prevalence constrains drug sales but establishes a high-value niche, especially given the lack of alternative treatments. Growth in diagnosed cases, driven by increased awareness and improved diagnostic protocols, could gradually expand the market.

2. Regulatory Environment:
The FDA granted tasimelteon Orphan Drug Designation, boosting its stature by providing benefits such as market exclusivity for seven years. Additionally, the potential for breakthrough therapy designation or additional indications, such as shift work disorder or delayed sleep phase syndrome, remains a strategic consideration.

3. Competition and Market Fragmentation:
The sleep disorder market is highly competitive with established treatments like melatonin supplements and behavioral therapies. However, these lack circadian rhythm resetting capabilities. Currently, no direct competitors to tasimelteon exist explicitly targeting non-24, although off-label melatonin and other chronobiological agents are used.

4. Clinical Expansion and Off-label Opportunities:
Efforts to demonstrate efficacy in other circadian-related conditions could bolster demand. Vanda’s ongoing or proposed trials to extend indications could significantly influence market penetration.

5. Market Penetration Challenges:
Limited awareness among physicians and patients, coupled with high treatment costs and reimbursement issues, impede widespread adoption. Moreover, the narrow indication confines revenue streams, emphasizing the importance of expanding approved uses.

Financial Trajectory and Revenue Outlook

1. Revenue Generation and Sales Trends:
Since its FDA approval, tasimelteon has seen steady, yet modest, revenue growth. Vanda Pharmaceuticals reported revenues of approximately $82 million in 2021, with a significant portion derived from Hetlioz sales. The growth trajectory remains sensitive to factors like new indications, expanded patient access, and market penetration efficiency.

2. Pricing and Reimbursement:
Tasimelteon’s high cost, driven by its orphan status and specialized formulation, positions it as a premium therapy. Securing reimbursement from insurers is essential; however, coverage varies by region and payer policies. As access improves, revenue prospects could rise proportionally.

3. Patent and Market Exclusivity:
Vanda holds patents protecting tasimelteon until 2029, preserving competitive advantage. Patent expirations could open opportunities for generics, which would significantly impact revenue potential.

4. Strategic Partnerships and Licensing:
Potential licensing deals for broader indications and geographic expansion could accelerate sales. Moreover, collaborations with biosimilar manufacturers may influence long-term pricing strategies.

5. Market Expansion and Future Revenue Streams:
Identifying new indications, such as circadian rhythm disorders in shift workers or jet lag, could diversify revenue streams. Additionally, exploring pediatric applications and other sleep-related conditions may augment market size.

Emerging Trends and Future Outlook

• Pipeline Development: There is ongoing interest in developing next-generation melatonin receptor agents, which could either complement or challenge tasimelteon’s market position.
• Regulatory Pathways: Expedited review programs, including Orphan Drug and Fast Track designations, could hasten market access for new indications.
• Digital Health Integration: Incorporating pharmacogenomics and digital health tools may enhance treatment adherence and efficacy assessment, potentially boosting commercial success.

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Challenges and Opportunities

Challenges:

• Limited patient population and narrow indication restrict revenue potential.
• Competition from over-the-counter melatonin supplements, despite their inferior pharmacological profile.
• Pricing and reimbursement barriers hinder accessibility.
• Patent expirations threaten future exclusivity.

Opportunities:

• Expanding to broader circadian rhythm disorder markets.
• Developing combination therapies for sleep disorders.
• Strategic collaborations to enhance global market reach.
• Investment into personalized medicine approaches to identify optimal responders.

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Conclusion

Tasimelteon’s market dynamics are characterized by a high-value niche with limited but steady growth potential. Its future financial trajectory depends on successful indication expansion, regulatory support, effective commercialization, and strategic positioning against emerging competitors. Despite these challenges, its unique mechanism and FDA approval provide a solid foundation for continued relevance in the sleep disorder market, with room for growth as awareness and clinical applications evolve.

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Key Takeaways

• Limited Market, High Value: Tasimelteon’s focus on non-24 positions it as a specialized therapy with significant unmet needs but constrained patient access.
• Regulatory Advantages: Orphan designation and patent protection underpin its market exclusivity, supporting sustained revenue.
• Growth Potential in Indication Expansion: Introducing tasimelteon into additional circadian disorders can diversify income streams.
• Pricing and Reimbursement Crucial: High costs necessitate proactive payer engagement to facilitate patient access.
• Patent Expiry Risks and Competition: The potential rise of generics post-2029 calls for strategic planning to maintain market share.

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FAQs

1. What is the primary therapeutic use of tasimelteon?
Tasimelteon is approved for the treatment of non-24-hour sleep-wake disorder in totally blind individuals, aiding circadian rhythm entrainment.

2. Are there any other indications for tasimelteon under investigation?
Yes, clinical trials are exploring its efficacy for other circadian rhythm disorders such as shift work disorder and delayed sleep phase syndrome.

3. How does tasimelteon differentiate itself from over-the-counter melatonin supplements?
Tasimelteon selectively targets melatonin receptors MT1 and MT2 with pharmacokinetic properties designed for therapeutic efficacy, unlike generic melatonin, which varies in absorption and receptor affinity.

4. What are the main challenges to tasimelteon’s market growth?
Limited patient population, high treatment costs, reimbursement hurdles, and impending patent expirations pose significant obstacles.

5. What is the outlook for tasimelteon’s revenue in the coming years?
Revenue growth remains steady but moderate, contingent upon indication expansion, increased market awareness, and strategic collaborations, with potential risk from patent expirations around 2029.

Sources

[1] Vanda Pharmaceuticals Annual Reports, 2021.
[2] FDA Drug Approvals Database, 2014.
[3] MarketResearch.com, Sleep Disorder Therapeutics Market Analysis, 2022.
[4] ClinicalTrials.gov, Tasimelteon Trials and Indications Tracker, 2022.
[5] IQVIA Prescription Data, 2021.