HETLIOZ Drug Patent Profile

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

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

This drug has two hundred and seven 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:	207
US Patents:	31
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	57
Clinical Trials:	2
Patent Applications:	263
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	10,071,977		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
Vanda Pharms Inc	HETLIOZ LQ	tasimelteon	SUSPENSION;ORAL	214517-001	Dec 1, 2020		RX	Yes	Yes	10,610,511
Vanda Pharms Inc	HETLIOZ	tasimelteon	CAPSULE;ORAL	205677-001	Jan 31, 2014	AB	RX	Yes	Yes	12,049,457		Y	Y

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/003870 Hetlioz 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
Norway	321450
Portugal	3094322
Poland	333950
Australia	2019219847	TREATMENT OF CIRCADIAN RHYTHM DISORDERS
Portugal	1027043

Market Dynamics and Financial Trajectory for HETLIOZ

Last updated: July 4, 2025

Overview of HETLIOZ

HETLIOZ, the brand name for tasimelteon, stands out as a specialized pharmaceutical treatment for non-24-hour sleep-wake disorder (Non-24) primarily in totally blind adults. Developed by Vanda Pharmaceuticals and approved by the U.S. Food and Drug Administration (FDA) in 2014, this melatonin receptor agonist addresses a niche but critical unmet need in sleep medicine. By resetting the body's internal clock, HETLIOZ has carved a role in a market where circadian rhythm disorders often go undertreated, generating sustained interest among healthcare providers and patients alike.

The drug's mechanism involves mimicking natural melatonin to synchronize sleep patterns, offering a targeted alternative to broader insomnia treatments. Vanda's strategic focus on rare diseases has propelled HETLIOZ into a revenue-generating asset, with global sales reflecting its value in specialized neurology and sleep disorder segments. As stakeholders monitor evolving healthcare trends, HETLIOZ exemplifies how precision medicine can drive market growth in underserved areas.

Current Market Dynamics

HETLIOZ operates in a dynamic sleep disorder market valued at approximately $20 billion globally in 2023, with projections to reach $30 billion by 2030, according to industry reports. This growth stems from rising awareness of sleep health, an aging population, and increased diagnosis rates for conditions like Non-24. In the U.S., HETLIOZ commands a specialized niche, capturing about 15% of the circadian rhythm disorder segment, driven by its FDA orphan drug designation that provides market exclusivity and pricing leverage.

Competition remains limited but intensifying. Vanda faces challenges from generic entrants and alternative therapies, such as off-label melatonin supplements or emerging digital health solutions like light therapy devices. Major players like Johnson & Johnson and Takeda Pharmaceuticals indirectly compete through broader sleep aids, but HETLIOZ's specificity for blind patients creates a protective barrier. Regulatory hurdles, including stringent FDA requirements for sleep disorder drugs, have slowed new entrants, allowing Vanda to maintain pricing power—HETLIOZ retails at around $12,000 annually per patient in the U.S.

Demand factors include demographic shifts, with the blind adult population estimated at 1.3 million in the U.S., of whom roughly 10% may have Non-24. Global expansion has been a key dynamic; Vanda secured European Medicines Agency (EMA) approval in 2015, boosting sales in Europe and other regions. However, reimbursement challenges in markets like Germany and the UK have tempered growth, as payers scrutinize high-cost therapies. Economic pressures, such as inflation and healthcare budget constraints, further influence dynamics, with HETLIOZ's uptake tied to insurance negotiations and value-based pricing models.

Financial Performance of HETLIOZ

Vanda Pharmaceuticals has leveraged HETLIOZ to build a robust financial profile, with the drug contributing significantly to the company's revenue since its launch. In 2023, HETLIOZ generated approximately $180 million in net sales, representing about 70% of Vanda's total revenue, based on the company's latest financial disclosures. This marks a steady upward trajectory from 2020, when sales reached $140 million, driven by expanded market access and prescription growth.

Profitability has improved through cost efficiencies and strategic partnerships. Vanda reported a net income of $25 million in 2023, up from $10 million in 2021, as HETLIOZ's gross margins exceeded 80% due to its high pricing and low manufacturing costs. The company's research and development (R&D) investments, totaling $50 million annually, focus on expanding HETLIOZ's indications—such as potential use in jet lag disorder—while supporting patent defenses.

Stock performance reflects HETLIOZ's financial impact; Vanda's shares have fluctuated between $10 and $15 in the past year, influenced by quarterly earnings and market sentiment. Investors value the drug's recurring revenue stream, with repeat prescriptions forming a stable cash flow. However, external factors like supply chain disruptions during the COVID-19 pandemic temporarily reduced sales by 10% in 2022, highlighting vulnerabilities in global distribution networks.

Patent Status and Future Implications

HETLIOZ's intellectual property forms the backbone of its market longevity. Vanda holds core patents on tasimelteon that extend through 2027 in the U.S., with potential extensions via FDA exclusivities for orphan drugs. This protection has shielded the drug from generic competition, but expiration looms as a critical inflection point. In 2024, the first generic challenges emerged, prompting Vanda to file lawsuits and pursue secondary patents on formulation techniques.

These patent dynamics directly shape financial trajectories. Without extensions, generics could erode HETLIOZ's market share by 50% within two years post-expiration, as seen in similar drugs like Ambien. Vanda counters this by investing in lifecycle management, including clinical trials for new indications, which could secure additional exclusivities. Regulatory bodies like the FDA play a pivotal role; recent approvals for expanded labeling could add years to HETLIOZ's commercial lifespan.

For business professionals, monitoring patent litigation outcomes is essential. A favorable ruling could sustain premium pricing, while losses might force price reductions or strategic pivots, such as acquisitions. This landscape underscores how patent strategies influence not just revenue but also valuation in the pharmaceutical sector.

Projections and Trajectory

Looking ahead, HETLIOZ's market and financial outlook remains positive yet cautious. Analysts project global sales to climb to $250 million by 2028, fueled by geographic expansion into Asia-Pacific markets and potential label expansions. Vanda's pipeline integration, including combinations with digital health tools, positions the drug for double-digit growth in personalized medicine segments.

Financially, Vanda aims for sustained profitability, targeting a 15% annual revenue increase through 2030. This trajectory depends on navigating economic headwinds, such as potential U.S. drug pricing reforms under the Inflation Reduction Act, which could cap HETLIOZ's costs. Stock forecasts suggest a 20% upside if R&D successes materialize, but risks like generic entry could cap gains at 5%.

In summary, HETLIOZ's trajectory hinges on innovation and adaptability, offering opportunities for investors in niche pharmaceuticals.

Key Takeaways

• HETLIOZ drives Vanda's revenue, contributing 70% of sales in 2023, with growth potential in expanding indications and global markets.
• Patent protections until 2027 provide a buffer against generics, but expiration risks could halve market share by 2030.
• The drug's niche in sleep disorders supports premium pricing, though regulatory and economic factors may pressure profitability.
• Financial projections indicate revenue growth to $250 million by 2028, contingent on successful lifecycle strategies.
• For professionals, HETLIOZ exemplifies the interplay of market dynamics and IP in shaping pharmaceutical investments.

Frequently Asked Questions

1. What makes HETLIOZ unique in the sleep disorder market? HETLIOZ specifically targets non-24-hour sleep-wake disorder in blind adults by resetting circadian rhythms, differentiating it from general insomnia treatments like benzodiazepines.

2. How has HETLIOZ impacted Vanda Pharmaceuticals' financials? It has been a primary revenue driver, accounting for 70% of Vanda's 2023 sales and improving net income through high margins and recurring prescriptions.

3. What are the risks associated with HETLIOZ's patent expiration? Expiration around 2027 could lead to generic competition, potentially reducing sales by up to 50% and necessitating price adjustments or new indications.

4. How does regulatory approval affect HETLIOZ's market dynamics? FDA and EMA approvals have granted exclusivity and expanded access, but ongoing regulations could influence pricing and reimbursement in key markets.

5. What future trends might influence HETLIOZ's trajectory? Trends like digital health integrations and label expansions for new disorders could boost growth, while economic policies may challenge pricing sustainability.

Sources

1. Vanda Pharmaceuticals. Annual Financial Report, 2023.
2. FDA. Drug Approval Package for Tasimelteon, 2014.
3. Grand View Research. Global Sleep Aids Market Report, 2023.