Tasimelteon - Generic Drug Details

What are the generic drug sources for tasimelteon and what is the scope of patent protection?

Tasimelteon is the generic ingredient in three branded drugs marketed by Vanda Pharms Inc, Apotex, MSN, and Teva Pharms Usa Inc, and is included in five NDAs. There are thirty-one patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Tasimelteon has one hundred and ninety-eight patent family members in twenty-four countries.

There are three drug master file entries for tasimelteon. Four suppliers are listed for this compound.

Summary for tasimelteon

International Patents:	198
US Patents:	31
Tradenames:	3
Applicants:	4
NDAs:	5
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	57
Clinical Trials:	21
Patent Applications:	290
Drug Prices:	Drug price trends for tasimelteon
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for tasimelteon
What excipients (inactive ingredients) are in tasimelteon?	tasimelteon excipients list
DailyMed Link:	tasimelteon at DailyMed

See drug prices for tasimelteon

Recent Clinical Trials for tasimelteon

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

Sponsor	Phase
Saint-Joseph University	Phase 3
Vanda Pharmaceuticals	Phase 2
Vanda Pharmaceuticals	Phase 4

See all tasimelteon clinical trials

Pharmacology for tasimelteon

Drug Class	Melatonin Receptor Agonist
Mechanism of Action	Melatonin Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for tasimelteon

N05CH	Melatonin receptor agonists
N05C	HYPNOTICS AND SEDATIVES
N05	PSYCHOLEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for TASIMELTEON

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
HETLIOZ LQ	Oral Suspension	tasimelteon	4 mg/mL	214517	1	2024-04-01
HETLIOZ	Capsules	tasimelteon	20 mg	205677	3	2018-01-31

US Patents and Regulatory Information for tasimelteon

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 LQ	tasimelteon	SUSPENSION;ORAL	214517-001	Dec 1, 2020		RX	Yes	Yes	11,850,229
Vanda Pharms Inc	HETLIOZ LQ	tasimelteon	SUSPENSION;ORAL	214517-001	Dec 1, 2020		RX	Yes	Yes	11,285,129
Vanda Pharms Inc	HETLIOZ	tasimelteon	CAPSULE;ORAL	205677-001	Jan 31, 2014	AB	RX	Yes	Yes	10,149,829
Vanda Pharms Inc	HETLIOZ	tasimelteon	CAPSULE;ORAL	205677-001	Jan 31, 2014	AB	RX	Yes	Yes	11,633,377
Vanda Pharms Inc	HETLIOZ	tasimelteon	CAPSULE;ORAL	205677-001	Jan 31, 2014	AB	RX	Yes	Yes	11,566,011		Y	Y
Vanda Pharms Inc	HETLIOZ LQ	tasimelteon	SUSPENSION;ORAL	214517-001	Dec 1, 2020		RX	Yes	Yes	11,566,011		Y	Y

Expired US Patents for tasimelteon

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
Vanda Pharms Inc	HETLIOZ LQ	tasimelteon	SUSPENSION;ORAL	214517-001	Dec 1, 2020	5,856,529

EU/EMA Drug Approvals for tasimelteon

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 tasimelteon

Country	Patent Number	Title	Estimated Expiration
South Korea	20160106735
South Korea	20150093236
South Korea	20170058463
Japan	2020097602
South Korea	20170058464
South Korea	102317399
Mexico	2016009231

Tasimelteon Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Tasimelteon

Introduction

Tasimelteon, marketed under the brand name HETLIOZ®, is a circadian regulator developed by Vanda Pharmaceuticals Inc. for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) in totally blind individuals. Here, we will delve into the market dynamics and financial trajectory of tasimelteon, highlighting its performance, challenges, and future outlook.

Market Need and Target Population

Tasimelteon addresses a specific and significant medical need for individuals with Non-24, a condition prevalent among the totally blind population. This disorder disrupts the body's natural sleep-wake cycle, leading to severe sleep disturbances and related health issues. The orphan drug designation for tasimelteon provides potential financial and regulatory incentives, including tax credits and waiver of FDA user fees, which can be beneficial for its commercialization[3].

Commercial Performance

Historical Sales

In the fourth quarter of 2020, HETLIOZ® net product sales were $44.2 million, representing a 14% increase compared to $38.6 million in the fourth quarter of 2019. For the full year 2020, HETLIOZ® sales reached $160.7 million, a 12% increase from $143.0 million in 2019. This growth indicated strong market acceptance and increasing demand for the drug[1].

Recent Trends

However, the financial performance of HETLIOZ® has faced challenges in recent years. In 2023, the net product sales for HETLIOZ® decreased by 4% to $90.9 million compared to $94.7 million in 2022. This decline is primarily attributed to generic competition, which has impacted the drug's revenue streams significantly[2].

Competitive Landscape

Generic Competition

The introduction of generic versions of tasimelteon has significantly impacted its sales. The 30% decrease in Q4 sales year-over-year in 2023 highlights the competitive pressure from generics. This competition not only affects the revenue but also poses a challenge for Vanda Pharmaceuticals to maintain market share and pricing power[2].

Market Positioning

Despite the competition, HETLIOZ® remains a unique treatment option for Non-24, with its specific mechanism of action as a potent agonist of the human MT1 and MT2 receptors. This differentiation helps in maintaining a loyal patient base and healthcare provider support, although it may not be enough to completely mitigate the effects of generic competition[4].

Financial Impact

Revenue and Profitability

The decline in HETLIOZ® sales has had a direct impact on Vanda Pharmaceuticals' overall revenue and profitability. The company reported a net income of $2.5 million for the full year 2023, down from $6.3 million in 2022. This contraction in profitability is a critical concern for investors and indicates the need for strategic adjustments to maintain financial health[2].

Cash Reserves and Liquidity

The acquisition of PONVORY® from Janssen for $100 million in 2023, while strategically important, has reduced Vanda Pharmaceuticals' cash reserves. As of December 31, 2023, the company's cash, cash equivalents, and marketable securities decreased by $78.6 million compared to the previous year. This reduction raises questions about the company's liquidity and financial resilience, especially in the face of ongoing patent litigation uncertainties[2].

Regulatory and Intellectual Property

Patent Litigation

The ongoing patent litigation surrounding HETLIOZ® is a significant risk factor for Vanda Pharmaceuticals. The outcome of these litigations can impact the drug's market exclusivity and, consequently, its revenue streams. The lack of 2024 financial guidance due to these uncertainties adds to the volatility in the company's financial trajectory[2].

Regulatory Approvals

Vanda Pharmaceuticals' ability to maintain and expand regulatory approvals is crucial for the continued commercial success of HETLIOZ®. The company must navigate regulatory challenges and ensure compliance with FDA requirements to sustain its market position[3].

Future Outlook

Strategic Acquisitions and Diversification

The acquisition of PONVORY® is part of Vanda Pharmaceuticals' strategy to diversify its product portfolio and mitigate the risks associated with reliance on a single product. This move could help stabilize revenue and provide growth opportunities in the future[2].

Clinical Development

Vanda Pharmaceuticals is also investing in the clinical development of other products, including tradipitant and VQW-765. These pipeline products hold potential for treating various conditions and could contribute to the company's future revenue growth[3].

Market Awareness and Acceptance

Increasing market awareness of Non-24 and the benefits of HETLIOZ® remains a key strategy for Vanda Pharmaceuticals. Efforts to educate healthcare providers and patients about the condition and the drug's efficacy are essential for maintaining and expanding its market share[3].

Key Takeaways

• Sales Performance: HETLIOZ® has shown strong sales growth in the past but faces current challenges due to generic competition.
• Financial Impact: The decline in sales has affected Vanda Pharmaceuticals' revenue and profitability.
• Regulatory and Intellectual Property: Ongoing patent litigation and regulatory compliance are critical factors influencing the drug's market exclusivity and revenue.
• Future Outlook: Strategic acquisitions, diversification, and clinical development of new products are key to the company's future growth.

FAQs

What is tasimelteon used for?

Tasimelteon, marketed as HETLIOZ®, is used for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) in totally blind individuals.

How has the sales performance of HETLIOZ® been in recent years?

In recent years, HETLIOZ® sales have faced a decline due to generic competition, with a 4% decrease in full-year 2023 sales compared to 2022.

What are the main challenges facing HETLIOZ® in the market?

The main challenges include generic competition, ongoing patent litigation, and the need to maintain regulatory approvals.

How is Vanda Pharmaceuticals addressing the decline in HETLIOZ® sales?

Vanda Pharmaceuticals is diversifying its product portfolio through strategic acquisitions, such as the acquisition of PONVORY®, and investing in the clinical development of new products.

What is the impact of generic competition on Vanda Pharmaceuticals' financial health?

Generic competition has led to a decline in revenue and profitability for Vanda Pharmaceuticals, raising concerns about the company's liquidity and financial resilience.