Trial	Phase	Status	Sponsor	Enrollment	Dates
Evaluating the Effects of Tasimelteon vs. Placebo in Delayed Sleep-Wake Phase Disorder (DSWPD)NCT04652882	Phase 3	Active	Vanda Pharmaceuticals	70	2020-12-09 → 2026-09
Pharmacokinetics of Tasimelteon in Subjects With Renal Impairment and Matched Control Subjects With Relatively Normal Renal Function NCT01526746	Phase 1	Completed	Vanda Pharmaceuticals	32	2012-02 → 2012-06
Pharmacokinetics of Tasimelteon Alone and in Combination With a CYP3A4 Inhibitor, Ketoconazole, or a CYP3A4 Inducer, Rifampin.NCT01637636	Phase 1	Completed	Vanda Pharmaceuticals	48	2012-06 → 2012-08
Withdrawal Study to Demonstrate the Maintenance Effect in the Treatment of Non-24-Hour Sleep-Wake Disorder NCT01430754	Phase 3	Completed	Vanda Pharmaceuticals	20	2011-09 → 2012-12
A Study to Assess the Effect Tasimelteon on the Cytochrome P450 3A4 and 2C8 Enzymes in Healthy Subjects NCT01402076	Phase 1	Completed	Vanda Pharmaceuticals	24	2011-08 → 2011-08
Tasimelteon for the Treatment of Non-24-hour Sleep-Wake Disorder (N24HSWD) in Blind Individuals With no Light Perception NCT01429116	Phase 3	Completed	Vanda Pharmaceuticals	200	2011-10 → 2015-01
A Proof of Concept Study to Evaluate the Effects of Tasimelteon and Placebo in Travelers With Jet Lag Disorder NCT03291041	Phase 2	Completed	Vanda Pharmaceuticals	25	2016-07 → 2017-11
Effects of Smoking, Age and Body Size on Pharmacokinetics, Safety and Tolerability on Tasimelteon in Healthy Subjects NCT01477619	Phase 1	Completed	Vanda Pharmaceuticals	60	2011-11 → 2012-01
Pharmacokinetics of Tasimelteon Alone and in Combination With CYP1A2 Inhibitor, Fluvoxamine NCT01540500	Phase 1	Completed	Vanda Pharmaceuticals	24	2012-02 → 2012-03
Melatonin Agonist Effects of Tasimelteon Versus Placebo in Patients With Major Depressive Disorder NCT01428661	Phase 2/3	Completed	Vanda Pharmaceuticals	507	2011-09 → 2013-05

Source: ClinicalTrials.gov. Trials matched by ingredient name; data refreshed each weekday and may lag the registry.

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$5567.71

Highest Price

$24700.71

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
43068-0304-02HETLIOZ LQ 4MG/ML SUSP,ORAL	$5567.71	Big4	Vanda Pharmaceuticals, Inc.	08/31/2029
43068-0304-02HETLIOZ LQ 4MG/ML SUSP,ORAL	$7504.01	FSS	Vanda Pharmaceuticals, Inc.	08/31/2029
43068-0304-06HETLIOZ LQ 4MG/ML SUSP,ORAL	$18430.04	Big4	Vanda Pharmaceuticals, Inc.	08/31/2029
43068-0304-06HETLIOZ LQ 4MG/ML SUSP,ORAL	$24700.71	FSS	Vanda Pharmaceuticals, Inc.	08/31/2029

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Hetlioz Lq (2024)

Total Spending

$1.3M

Total Claims

Beneficiaries

—

Avg Cost/Unit

$152.06

Spending Trend

$437K(2022)→$843K(2023)→$1.3M(2024)

YoY Change:-5.8%

5yr CAGR:+0.6%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain3 active DMFs

3 active API suppliers hold Drug Master Files for this ingredient.

APOTEX INCTASIMELTEON

DMF 318432017

MSN LIFE SCIENCES PRIVATE LTDTASIMELTEON

DMF 319482017

ZHEJIANG AUSUN PHARMACEUTICAL CO LTDTASIMELTEON

DMF 320772017

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Dec 2, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 4MG/ML

RLD

27 patents1 exclusivity▴

SUSPENSION;ORAL | Approved: Dec 1, 2020

Patents (27) · 21 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
9539234	Jan 25, 2033	—	—	—		—
9730910	May 17, 2034	—	—	—		—
10071977	Feb 12, 2035	—	Yes	Yes	—	—
10149829	Jan 25, 2033	—	—	—		—
10179119	Aug 29, 2035	—	—	—		—
10376487	Jul 27, 2035	—	—	—		—
10610510	Jan 25, 2033	—	—	—		—
10610511	Oct 10, 2034	—	—	—		—
10829465	Feb 12, 2035	—	Yes	Yes	—	—
10980770	Jan 25, 2033	—	—	—		—
11141400	Oct 10, 2034	—	—	—		—
11202770	Dec 11, 2040	—	—	Yes	—	—
11266622	Aug 29, 2035	—	—	—		—
11285129	Jan 25, 2033	—	—	—		—
11566011	Feb 12, 2035	—	Yes	Yes	—	—
11633377	Jan 25, 2033	—	—	—		—
11759446	Feb 21, 2041	—	—	—		—
11760740	Feb 12, 2035	—	Yes	Yes	—	—
11786502	Oct 10, 2034	—	—	—		—
11826339	Jan 25, 2033	—	—	—		—
11833130	Jan 25, 2033	—	—	—		—
11850229	Jan 25, 2033	—	—	—		—
11918556	Apr 7, 2033	—	—	—		—
11918557	Jan 25, 2033	—	—	—		—
12049457	Feb 12, 2035	—	Yes	Yes	—	—
12201604	Jan 25, 2033	—	—	—		—
12447141	Dec 11, 2040	—	—	—		—

Exclusivities (1)

Code	Date	Status
ODE-329	Dec 1, 2027	Active