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-six 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 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:	207
US Patents:	26
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	57
Clinical Trials:	2
Patent Applications:	263
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-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
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			Y
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
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/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 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
Denmark	2806863
China	104379135	Treatment of circadian rhythm disorders
Czech Republic	297673	Benzodioxolová, benzofuranová, dihydrobenzofuranová a benzodioxanová melatonergická cinidla (Benzodioxole, benzofuran, dihydrobenzofuran and benzodioxane melatonergic agents)
Brazil	112015014619	tratamento de transtornos do ritmo circadiano
European Patent Office	3188727	TASIMELTEON POUR LE TRAITEMENT DU SYNDROME DE SMITH MAGENIS (TASIMELTEON FOR TREATING SMITH-MAGENIS SYNDROME)
Portugal	2806863
Australia	2021204784	TREATMENT OF CIRCADIAN RHYTHM DISORDERS

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 outlook.

Historical Sales Performance

• Full Year 2022: HETLIOZ net product sales were $159.7 million, a 8% decrease from $173.5 million in 2021, largely due to reimbursement challenges for patients with Non-24[4].
• Full Year 2023: The sales continued to decline, with HETLIOZ net product sales for the first nine months of 2023 being $79.1 million, and for the first nine months of 2024, it dropped to $56.6 million, a 28% decrease. This decline is attributed to the launch of generic versions of HETLIOZ in the U.S.[1][3].

Quarterly Performance

• First Quarter 2024: HETLIOZ net product sales were $20.1 million, a 49% decrease compared to $39.6 million in the first quarter of 2023. This drop was due to lower unit sales and the reduction of elevated inventory levels at specialty pharmacy customers[3].
• Second Quarter 2024: Sales further declined to $18.7 million, a 15% decrease compared to $22.0 million in the second quarter of 2023, again due to continued generic competition[5].

Impact of Generic Competition

The introduction of generic versions of HETLIOZ has significantly impacted its revenue. Generic competition has led to a substantial decline in sales, as generics offer a cheaper alternative, reducing the market share of the branded product. This trend is expected to continue, with HETLIOZ net product sales likely to decline further in future periods[1][3][5].

Reimbursement Challenges

Reimbursement challenges for prescriptions of HETLIOZ have also contributed to the decline in sales. Patients with Non-24-Hour Sleep-Wake Disorder often face difficulties in getting their prescriptions reimbursed, which affects the overall demand for the drug[4].

Regulatory and Expansion Efforts

Despite the current challenges, Vanda Pharmaceuticals is pursuing regulatory approvals for HETLIOZ in additional indications such as insomnia and jet lag disorder. These efforts aim to diversify the revenue streams and mitigate the impact of generic competition[4].

Financial Highlights

• Operating Expenses: The company has seen an increase in operating expenses, particularly in research and development, and selling, general, and administrative costs. For the first nine months of 2024, total operating expenses were $175.9 million, compared to $154.2 million in the same period of 2023[1].
• Net Income/Loss: The financial performance has been affected by the decline in HETLIOZ sales. For the third quarter of 2024, Vanda reported a net loss of $5.3 million, compared to a net income of $0.1 million in the third quarter of 2023[1].

Cash Position

Vanda Pharmaceuticals maintains a strong cash position, which is crucial for navigating the current market challenges. As of June 30, 2024, the company had $387.7 million in cash, cash equivalents, and marketable securities[5].

Future Outlook

• Pipeline Development: Vanda is focused on its robust pipeline, including drugs like tradipitant for motion sickness and gastroparesis, and milsaperidone for schizophrenia and bipolar I disorder. These pipeline developments are expected to contribute to future revenue growth[1][3].
• Market Expansion: The company plans to expand its sales force and marketing activities for its other products, such as Fanapt and PONVORY, to drive revenue growth. The upcoming commercial launches of these products in new indications are anticipated to offset some of the losses from HETLIOZ[3].

Key Takeaways

• Declining Sales: HETLIOZ sales have been declining due to generic competition and reimbursement challenges.
• Regulatory Efforts: Vanda is pursuing additional regulatory approvals to expand HETLIOZ's indications.
• Strong Pipeline: The company has a robust pipeline of new drugs targeting unmet medical needs.
• Cash Position: Vanda maintains a strong cash position to support its operations and pipeline development.
• Market Expansion: The company is focusing on expanding its sales force and marketing activities for other products.

FAQs

1. What is the primary reason for the decline in HETLIOZ sales?

   • The primary reason is the introduction of generic versions of HETLIOZ in the U.S., which has significantly reduced the market share of the branded product[1][3][5].

2. What other indications is Vanda pursuing for HETLIOZ?

   • Vanda is pursuing regulatory approvals for HETLIOZ in the indications of insomnia and jet lag disorder[4].

3. How has the launch of generics affected HETLIOZ sales?

   • The launch of generics has led to a substantial decline in HETLIOZ sales, with a 28% decrease in the first nine months of 2024 compared to the same period in 2023[1].

4. What is Vanda's strategy to offset the decline in HETLIOZ sales?

   • Vanda plans to expand its sales force and marketing activities for other products like Fanapt and PONVORY, and is developing a robust pipeline of new drugs[3].

5. What is Vanda's current cash position?

   • As of June 30, 2024, Vanda had $387.7 million in cash, cash equivalents, and marketable securities[5].

Sources

1. Vanda Pharmaceuticals Reports Third Quarter 2024 Financial Results - PR Newswire
2. Vanda Pharmaceuticals Reports Second Quarter 2024 Financial Results - PR Newswire
3. Earnings call: Vanda Pharmaceuticals reports mixed Q1 results, plans growth - Investing.com
4. Vanda Pharmaceuticals Reports Fourth Quarter and Full Year 2022 Financial Results - Vanda Pharmaceuticals
5. Vanda Pharmaceuticals Reports Second Quarter 2024 Financial Results - Stock Titan

Last updated: 2024-12-17