HETLIOZ LQ Drug Patent Profile

When do Hetlioz Lq patents expire, and when can generic versions of Hetlioz Lq launch?

Hetlioz Lq is a drug marketed by Vanda Pharms Inc and is included in one NDA. There are twenty-seven patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in HETLIOZ LQ 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 Lq

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

Summary for HETLIOZ LQ

International Patents:	211
US Patents:	27
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	57
Clinical Trials:	2
Patent Applications:	364
Drug Prices:	Drug price information for HETLIOZ LQ
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for HETLIOZ LQ
DailyMed Link:	HETLIOZ LQ at DailyMed

See drug prices for HETLIOZ LQ

Recent Clinical Trials for HETLIOZ LQ

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

Sponsor	Phase
Vanda Pharmaceuticals	Phase 1
Vanda Pharmaceuticals	Phase 4

See all HETLIOZ LQ clinical trials

Pharmacology for HETLIOZ LQ

Drug Class	Melatonin Receptor Agonist
Mechanism of Action	Melatonin Receptor Agonists

Paragraph IV (Patent) Challenges for HETLIOZ LQ

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
HETLIOZ LQ	Oral Suspension	tasimelteon	4 mg/mL	214517	1	2024-04-01

US Patents and Regulatory Information for HETLIOZ LQ

HETLIOZ LQ is protected by twenty-seven 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
Vanda Pharms Inc	HETLIOZ LQ	tasimelteon	SUSPENSION;ORAL	214517-001	Dec 1, 2020		RX	Yes	Yes
Vanda Pharms Inc	HETLIOZ LQ	tasimelteon	SUSPENSION;ORAL	214517-001	Dec 1, 2020		RX	Yes	Yes

Expired US Patents for HETLIOZ LQ

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Vanda Pharms Inc	HETLIOZ LQ	tasimelteon	SUSPENSION;ORAL	214517-001	Dec 1, 2020

EU/EMA Drug Approvals for HETLIOZ LQ

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 LQ

When does loss-of-exclusivity occur for HETLIOZ LQ?

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

Australia

Canada

Chile

China

Colombia

European Patent Office

Israel

Japan

Mexico

New Zealand

South Africa

South Korea

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 LQ around the world.

Country	Patent Number	Title	Estimated Expiration
New Zealand	749282	Treatment of circadian rhythm disorders
South Korea	20170058464
Mexico	2014009078	TRATAMIENTO DE TRASTORNOS DEL RITMO CIRCADIANO. (TREATMENT OF CIRCADIAN RHYTHM DISORDERS.)

Market Dynamics and Financial Trajectory for HETLIOZ LQ

Last updated: July 28, 2025

Introduction

HETLIOZ LQ (tasimelteon) is an oral, liquid formulation approved for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) in totally blind individuals. Since its approval by the FDA in 2014, the drug has carved a niche addressing a rare but significant disorder primarily affecting the visually impaired. Understanding its market dynamics and financial trajectory provides insights into its commercial viability, growth prospects, and competitive positioning within the pharmaceutical landscape.

Market Overview of Non-24-Hour Sleep-Wake Disorder

Non-24 is characterized by a misalignment of the circadian rhythm, resulting in sleep disturbances and daytime fatigue. It predominantly affects blind individuals lacking light perception, with prevalence rates estimated up to 70-80% among totally blind subjects [1]. The rarity of the disorder classifies it as a orphan condition, influencing regulatory pathways, pricing, and market development strategies.

The global prevalence is limited; however, the unmet medical need remains high due to the lack of approved therapies specifically targeting Non-24. Currently, off-label use of melatonin and melatonin agonists dominates, but these often lack robust evidence and tailored dosing for Non-24.

Market Dynamics Influencing HETLIOZ LQ

Regulatory and Reimbursement Landscape

The orphan status of Non-24 has simplified regulatory approval processes, allowing for expedited pathways and exclusivity benefits. The FDA's orphan drug designation granted to tasimelteon enhances its market exclusivity until 2025 in the U.S., incentivizing investment and commercialization efforts.

Reimbursement policies significantly impact market penetration. The drug’s pricing, set in the therapeutic context of orphan drugs, reflects the high unmet need and limited treatment alternatives. Payers tend to accept higher prices for orphan drugs, but coverage varies, especially for off-label or unapproved uses, emphasizing the importance of managed care negotiations and formulary positioning.

Market Penetration and Adoption

HETLIOZ LQ’s formulation—liquid as opposed to capsule—addresses specific patient needs, especially for those with swallowing difficulties, and may enhance adherence. However, market penetration remains modest due to:

• Limited awareness among clinicians and patients.
• Challenges in diagnosing Non-24, which requires specialized sleep studies.
• Competition from compounding agents and off-label treatments.

Clinical endorsement from sleep disorder specialists and progressive awareness campaigns are expected to improve prescribing rates.

Competitive Environment

HETLIOZ’s main competitor is off-label melatonin therapy, which suffers from inconsistent pharmacokinetics and lack of approval-specific dosing guidance. No direct FDA-approved competitors currently exist in the U.S., giving HETLIOZ a first-mover advantage. Nonetheless, biopharma firms exploring circadian rhythm modulators or sleep aids could pose future threats or opportunities.

Pricing and Revenue Assumptions

HETLIOZ is priced higher than typical sleep aids, given its orphan status and specialized indication. The average wholesale price (AWP) per dose ranges around $70-$100, translating to annual treatment costs upward of $20,000 per patient. As reimbursement cycles gain momentum, revenue growth hinges on the number of diagnosed and treated patients, which remains limited.

Market Expansion Opportunities

Although initially focused on the U.S., international markets—particularly Europe and Japan—present growth channels. Regulatory alignment with EMA and PMDA, respectively, could facilitate broader access. Additionally, expanding indications, such as in other circadian rhythm sleep disorders, could broaden the addressable market, pending clinical data.

Financial Trajectory Analysis

Historical Revenue Performance

Since its launch, HETLIOZ LQ’s revenue trajectory reflects the typical pattern of orphan drugs. Initial sales were modest, attributed to limited awareness and diagnostic challenges. Year-over-year growth has been steady but conservative, averaging single-digit percentage increases as awareness improves.

Future Revenue Projections

Assumptions for future financial modeling include:

• Increasing diagnosis rates among eligible patients.
• Greater prescriber awareness and insurance coverage.
• Stable pricing within the orphan drug framework.

Under these assumptions, revenue estimates suggest a compound annual growth rate (CAGR) of approximately 10-12% over the next five years, reaching potentially $100-$150 million globally by 2027.

Cost Considerations and Profitability

Production costs for liquid formulations typically exceed those of capsules due to formulation complexity, but scale benefits and limited patient populations keep margins favorable. Marketing and education expenses are projected to increase modestly, supporting the expanded adoption.

Strategic Partnerships and Licensing

Collaborations with healthcare providers, research institutions, and payers bolster market acceptance. Licensing agreements could unlock territories with high unmet need, accelerating revenue.

Key Market Drivers and Challenges

Drivers	Challenges
Orphan drug incentives	Limited patient pool
Lack of competitors	Diagnostic complexity
Liquid formulation benefits	Pricing and reimbursement hurdles
Expanding awareness	Potential future entrants

Conclusion

HETLIOZ LQ’s market outlook is cautiously optimistic, driven by its unique positioning for a rare disorder with significant unmet needs. Its financial trajectory depends on effective market access strategies, clinician education, and continued advocacy for diagnosis and treatment adherence. As awareness grows and targeted expansion efforts are implemented, the drug can capitalize on its first-mover advantage within an increasingly supportive regulatory and reimbursement environment.

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Key Takeaways

• HETLIOZ LQ benefits from orphan drug exclusivity, shaping a protected market niche for Non-24.
• Revenue growth hinges on expanding the diagnosed patient base and improving healthcare provider awareness.
• Pricing remains premium due to orphan status, with reimbursement negotiations pivotal to market penetration.
• Opportunities exist in international markets and potential label expansions into related circadian rhythm disorders.
• The competitive landscape is limited but may evolve with novel therapies targeting sleep and circadian disorders.

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FAQs

1. What is the primary therapeutic indication for HETLIOZ LQ?
HETLIOZ LQ is indicated for the treatment of Non-24-Hour Sleep-Wake Disorder in completely blind individuals lacking light perception.

2. How does the liquid formulation benefit patients over capsules?
The liquid formulation offers easier administration for patients with swallowing difficulties and may enhance adherence, especially critical in managing sleep disorders.

3. What are the main factors influencing its market growth?
Market growth depends on increased diagnosis, prescriber adoption, reimbursement policies, and international expansion efforts.

4. Are there any significant competitors to HETLIOZ LQ?
Currently, no direct FDA-approved competitors exist; off-label melatonin is used but lacks standardization and approval-specific dosing.

5. What are critical hurdles for HETLIOZ LQ’s commercial success?
Major hurdles include diagnostic challenges, limited awareness, reimbursement negotiations, and potential future entrants developing alternative therapies.

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References

[1] National Organization for Rare Disorders (NORD). Non-24-Hour Sleep-Wake Disorder. 2022.