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-one patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and ninety-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:	198
US Patents:	30
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	57
Clinical Trials:	2
Patent Applications:	153
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-six 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			Y	Y
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
Vanda Pharms Inc	HETLIOZ LQ	tasimelteon	SUSPENSION;ORAL	214517-001	Dec 1, 2020		RX	Yes	Yes
Vanda Pharms Inc	HETLIOZ	tasimelteon	CAPSULE;ORAL	205677-001	Jan 31, 2014	AB	RX	Yes	Yes			Y	Y
Vanda Pharms Inc	HETLIOZ LQ	tasimelteon	SUSPENSION;ORAL	214517-001	Dec 1, 2020		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

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
South Korea	20160106735
South Korea	20150093236
South Korea	20170058463
Japan	2020097602
South Korea	20170058464
South Korea	102317399

HETLIOZ Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for HETLIOZ

Introduction

HETLIOZ (tasimelteon) is a prescription medication developed by Vanda Pharmaceuticals, primarily used to treat Non-24-Hour Sleep-Wake Disorder (Non-24). Here, we will delve into the market dynamics and financial trajectory of HETLIOZ, highlighting key trends, challenges, and future prospects.

Market Overview

HETLIOZ was approved by the U.S. Food and Drug Administration (FDA) in 2014 for the treatment of Non-24, a condition affecting individuals who are blind and have no light perception. The drug has been a significant contributor to Vanda Pharmaceuticals' revenue stream.

Sales Performance

Quarterly and Annual Sales

In the fourth quarter of 2023, HETLIOZ net product sales were $21.1 million, a 47% decrease compared to $40.1 million in the fourth quarter of 2022. This decline was largely due to the at-risk launch of generic versions of HETLIOZ in the U.S.[2][3].

For the full year 2023, HETLIOZ net product sales were $100.2 million, a 37% decrease from $159.7 million in 2022. This reduction is also attributed to the introduction of generic competitors[2][3].

Comparative Analysis

In contrast to the decline in 2023, HETLIOZ sales in 2022 were $159.7 million, an 8% decrease from $173.5 million in 2021. The decrease in 2022 was partly due to continued reimbursement challenges for prescriptions[4].

Impact of Generic Competition

The launch of generic versions of HETLIOZ has significantly impacted its sales. Generic competition has led to a substantial decrease in sales revenue, as patients and healthcare providers opt for more affordable generic alternatives. This trend is expected to continue, affecting the financial performance of HETLIOZ.

Regulatory and Clinical Developments

New Indications

Vanda Pharmaceuticals is pursuing additional regulatory approvals for HETLIOZ, including its use in treating insomnia and jet lag disorder. The supplemental New Drug Application (sNDA) for HETLIOZ in the treatment of insomnia is currently under review by the FDA, with a Prescription Drug User Fee Act (PDUFA) target action date of March 4, 2024[2].

Patent Litigation

In December 2022, the U.S. District Court for the District of Delaware ruled in favor of defendants Teva Pharmaceuticals USA, Inc. and Apotex Inc. and Apotex Corp. in the consolidated HETLIOZ patent lawsuit. This ruling has further complicated the market landscape for HETLIOZ by allowing generic competitors to enter the market sooner[3].

Financial Impact

Revenue and Net Income

The decline in HETLIOZ sales has had a direct impact on Vanda Pharmaceuticals' overall revenue and net income. For the full year 2023, the company reported a net income of $2.5 million, down from $6.3 million in 2022. The net loss in the fourth quarter of 2023 was $2.4 million, compared to a net income of $6.9 million in the fourth quarter of 2022[2][3].

Cash and Marketable Securities

As of December 31, 2023, Vanda Pharmaceuticals had $388.3 million in cash, cash equivalents, and marketable securities, representing a decrease of $78.6 million or 17% compared to December 31, 2022. This decrease is partly due to the $100 million spent on acquiring PONVORY from Actelion Pharmaceuticals Ltd. (Janssen), a Johnson & Johnson Company[2].

Market Challenges

Reimbursement Issues

HETLIOZ has faced ongoing reimbursement challenges, which have affected its sales. These issues have made it difficult for some patients to access the medication, further impacting its market performance[4].

Competition and Pricing

The entry of generic competitors has not only reduced sales but also forced Vanda Pharmaceuticals to consider pricing strategies to remain competitive. This competitive landscape is likely to continue shaping the market dynamics for HETLIOZ.

Future Prospects

Expanding Indications

The potential approval of HETLIOZ for new indications such as insomnia and jet lag disorder could provide a significant boost to its sales. However, this is contingent on favorable regulatory outcomes and successful market penetration.

Strategic Acquisitions

Vanda Pharmaceuticals' acquisition of PONVORY from Janssen for $100 million is part of its strategy to diversify its product portfolio and mitigate the impact of declining HETLIOZ sales. This move indicates the company's commitment to advancing its clinical development pipeline and strengthening its commercial presence[2].

Key Takeaways

• Sales Decline: HETLIOZ sales have declined significantly due to generic competition and reimbursement challenges.
• Regulatory Efforts: Vanda Pharmaceuticals is pursuing additional indications for HETLIOZ, including insomnia and jet lag disorder.
• Financial Impact: The decline in HETLIOZ sales has affected Vanda Pharmaceuticals' revenue and net income.
• Strategic Moves: The company is diversifying its product portfolio through acquisitions like PONVORY.

FAQs

What is HETLIOZ used for?

HETLIOZ (tasimelteon) is primarily used to treat Non-24-Hour Sleep-Wake Disorder (Non-24) in individuals who are blind and have no light perception.

Why have HETLIOZ sales declined?

HETLIOZ sales have declined due to the at-risk launch of generic versions in the U.S. and ongoing reimbursement challenges for prescriptions.

What are the potential new indications for HETLIOZ?

Vanda Pharmaceuticals is pursuing regulatory approvals for HETLIOZ in the treatment of insomnia and jet lag disorder.

How has the acquisition of PONVORY impacted Vanda Pharmaceuticals?

The acquisition of PONVORY is part of Vanda Pharmaceuticals' strategy to diversify its product portfolio and mitigate the impact of declining HETLIOZ sales.

What is the current financial status of Vanda Pharmaceuticals?

As of December 31, 2023, Vanda Pharmaceuticals had $388.3 million in cash, cash equivalents, and marketable securities, representing a decrease of $78.6 million or 17% compared to December 31, 2022.

Sources

1. Vanda Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results - Vanda Pharmaceuticals Inc.[1]
2. Vanda Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results - PR Newswire[2]
3. Vanda Pharmaceuticals Reports Fourth Quarter and Full Year 2022 Financial Results - Vanda Pharmaceuticals Inc.[4]
4. Hetlioz / Minnesota Department of Human Services - Minnesota Department of Human Services[3]