hetlioz Drug Patent Profile

Which patents cover Hetlioz, and what generic alternatives are available?

Hetlioz is a drug marketed by Vanda Pharms Inc and is included in two NDAs. There are thirty-three patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and eight patent family members in twenty-four countries.

The generic ingredient in HETLIOZ is tasimelteon. There are three drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the tasimelteon profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Hetlioz

A generic version of hetlioz was approved as tasimelteon by TEVA PHARMS USA INC on December 12^th, 2022.

Summary for hetlioz

International Patents:	208
US Patents:	31
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	58
Clinical Trials:	2
Patent Applications:	310
Drug Prices:	Drug price information for hetlioz
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for hetlioz
What excipients (inactive ingredients) are in hetlioz?	hetlioz excipients list
DailyMed Link:	hetlioz at DailyMed

See drug prices for hetlioz

Recent Clinical Trials for hetlioz

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

Sponsor	Phase
Vanda Pharmaceuticals	Phase 1
Vanda Pharmaceuticals	Phase 4

See all hetlioz clinical trials

Pharmacology for hetlioz

Drug Class	Melatonin Receptor Agonist
Mechanism of Action	Melatonin Receptor Agonists

Paragraph IV (Patent) Challenges for HETLIOZ

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
HETLIOZ	Capsules	tasimelteon	20 mg	205677	3	2018-01-31

US Patents and Regulatory Information for hetlioz

hetlioz is protected by forty-eight US patents and one FDA Regulatory Exclusivity.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Vanda Pharms Inc	HETLIOZ LQ	tasimelteon	SUSPENSION;ORAL	214517-001	Dec 1, 2020		RX	Yes	Yes	10,829,465		Y	Y
Vanda Pharms Inc	HETLIOZ	tasimelteon	CAPSULE;ORAL	205677-001	Jan 31, 2014	AB	RX	Yes	Yes	11,285,129
Vanda Pharms Inc	HETLIOZ	tasimelteon	CAPSULE;ORAL	205677-001	Jan 31, 2014	AB	RX	Yes	Yes

Expired US Patents for hetlioz

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

EU/EMA Drug Approvals for hetlioz

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 hetlioz

When does loss-of-exclusivity occur for hetlioz?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

European Patent Office

Japan

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering hetlioz around the world.

Country	Patent Number	Title	Estimated Expiration
South Korea	20190040102	공복 조건들 하에서의 타시멜테온의 투여 (ADMINISTRATION OF TASIMELTEON UNDER FASTED CONDITIONS)
Israel	246676	מתן של טסימלטיאון תחת תנאי צום (Administration of tasimelteon under fasted conditions)
South Africa	9711051

Market Dynamics and Financial Trajectory for Hetlioz (Tasimelteon)

Last updated: July 27, 2025

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Introduction

Hetlioz (tasimelteon) is a prescription sleep-wake disorder medication developed by Vanda Pharmaceuticals. Approved by the U.S. Food and Drug Administration (FDA) in 2014, Hetlioz is indicated primarily for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24), a condition characterized by the body's inability to maintain a stable circadian rhythm, frequently affecting totally blind individuals. Understanding its market dynamics and financial trajectory requires an analysis of regulatory, clinical, competitive, and commercial factors shaping its growth prospects.

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Market Landscape and Epidemiological Context

Non-24 Disorder:
Non-24 predominantly affects the blind, with prevalence estimates ranging from 50-70% among totally blind individuals lacking light perception [1]. While the overall population affected remains relatively niche (~100,000 globally), the subset of patients suitable for Hetlioz therapy is highly specialized.

Broader Sleep-Wake Disorder Market:
The overall sleep disorders market is expanding, driven by increasing awareness, rising insomnia prevalence, and a growing focus on pharmacological and non-pharmacological interventions. However, Hetlioz's primary indication is limited primarily to a small, defined population segment, constraining its top-line growth potential relative to broader sleep aids.

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Regulatory and Clinical Development

FDA Approval and Labeling:
Vanda’s approval of Hetlioz was based on clinical trials demonstrating efficacy in entraining sleep-wake cycles in Non-24 patients [2]. Post-approval, Vanda has continued to explore expanded indications, including shifts toward broader circadian rhythm disorders, although regulatory hurdles remain.

Off-Label and Expanded Use:
Though initially restricted, there are ongoing academic and clinical explorations of tasimelteon for other circadian-related disorders, including Jet Lag Disorder and DSPD (Delayed Sleep Phase Disorder). However, lack of formal approval limits commercial development beyond the primary indication.

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Market Dynamics

Demand Drivers:

• Unmet Medical Need:
  Currently, limited treatment options exist for Non-24. Melatonin and melatonin receptor agonists have shown limited efficacy, positioning Hetlioz as a significant therapeutic advancement.

• Prescription Adoption:
  Physician familiarity and patient advocacy influence prescribing trends. However, the small patient pool constrains overall sales volume.

• Reimbursement Landscape:
  Securing insurance coverage remains critical. Vanda's efforts to establish favorable reimbursement channels have been integral to sales expansion.

Competitive Environment:

• Existing Therapies:
  Melatonin supplements, timed light therapy, and behavioral interventions are alternative approaches but lack consistent efficacy [3].

• Potential Competitors:
  The absence of direct competitors with FDA approval sustains Hetlioz’s competitive edge. Nonetheless, generic melatonin products and emerging circadian modulators could challenge its market share.

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Financial Trajectory

Sales Performance:
Since launch, Hetlioz’s sales have experienced gradual growth, driven by increased awareness among sleep medicine specialists and scarce competition. In 2022, Vanda reported worldwide revenues of approximately $88 million from Hetlioz, marking steady growth, although not reaching blockbuster thresholds [4].

Market Penetration Strategy:

• Physician Education:
  Vanda invests in educating sleep medicine practitioners and neurologists to further adoption.

• Regulatory Advances:
  Efforts to expand labels and indications could unlock new revenue streams, though regulatory timelines are protracted.

Margins and Pricing:
Hetlioz commands premium pricing reflective of its targeted indication and clinical benefits. Gross margins are estimated to be high, though reimbursement pressures and negotiations influence net profitability.

Future Outlook:

• Market Expansion:
  Growth hinges on increasing awareness and reimbursement access within the small Non-24 patient population and exploratory indications.

• Orphan Drug Status:
  Hetlioz's orphan designation in the U.S. provides benefits like market exclusivity, incentivizing continued investment.

• Research and Development:
  Ongoing clinical trials may open opportunities for label expansion, further driving financial prospects.

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Challenges and Opportunities

Challenges:

• Limited Patient Population:
  Small target demographics constrain sales volume.

• Reimbursement Hurdles:
  Without broad insurance coverage, patient access remains limited.

• Competition from Non-Pharmacological Therapies:
  Light therapy and behavioral interventions, though less effective, are non-invasive and inexpensive.

Opportunities:

• Extended Indications:
  Broader circadian rhythm disorders could expand market size.

• Pipeline Development:
  New formulations or delivery mechanisms may improve patient compliance.

• Market Education:
  Increased awareness among physicians and patients can elevate sales.

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Regulatory and Patent Landscape

Patent Protection:
Vanda’s patent portfolio provides exclusivity until 2028-2030, supporting revenue continuity. Patent challenges or generic entries post-expiry may impact future pricing and sales.

Regulatory Outlook:
Further approvals for broader circadian rhythm disorders can substantially alter the financial trajectory, contingent upon successful development and market acceptance.

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Summary of Key Market Metrics

Metric	2022 Estimate	Notes
Global Revenue	~$88 million	Small niche market, steady growth
Market Share	Dominant in Non-24	No direct competitors with FDA approval
Patient Population	~100,000 worldwide	Highly specialized market
Pricing Strategy	Premium	Reflects orphan status and clinical benefit

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Key Takeaways

• Limited but Critical Niche: Hetlioz addresses an unmet need in Non-24, serving a small but vital market segment with high treatment significance.

• Growth Likelihood: Sales are expected to gradually increase, supported by ongoing clinical research, healthcare provider education, and potential label expansions.

• Competitive Edge: The absence of direct competitors with regulatory approval sustains Hetlioz’s market position, but emerging therapies and off-label use may influence long-term dynamics.

• Reimbursement and Access: Securing favorable insurance coverage remains essential for expanding market penetration.

• Pipeline and Regulatory Strategy: Strategic investments in clinical trials for broader indications could dramatically influence future revenues and sustain long-term growth.

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FAQs

1. What is the primary therapeutic indication for Hetlioz?
Hetlioz is approved to treat Non-24-Hour Sleep-Wake Disorder, particularly in totally blind individuals lacking light perception.

2. How does Hetlioz’s market size compare to other sleep disorder drugs?
Its market is small, comprising approximately 100,000 globally affected individuals, making it a niche pharmaceutical asset.

3. Are there significant competitors to Hetlioz?
Currently, no direct FDA-approved competitors exist. However, melatonin supplements and behavioral interventions serve as alternative approaches, though with limited efficacy.

4. What are the prospects for Hetlioz’s revenue growth?
Revenue growth is steady but modest, driven by increased awareness, potential label expansions, and broader indications in circadian rhythm disorders.

5. What factors could influence Hetlioz’s long-term financial trajectory?
Regulatory approvals for additional uses, patent protections, reimbursement landscapes, and competition from emerging therapies are critical influences.

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Citations

1. Arendt, J. (2010). "Melatonin and sleep." Endocrine Reviews.
2. Vanda Pharmaceuticals (2014). FDA Approval Letter for Hetlioz.
3. McClung, C. A., et al. (2016). "Circadian disruption and sleep disorders." Annual Review of Pharmacology and Toxicology.
4. Vanda Pharmaceuticals (2022). Annual Financial Report.

[Note: All data points are derived from publicly available sources and company disclosures as of 2023.]