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HETLIOZ Drug Profile

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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 one NDA. There are seven patents protecting this drug and two Paragraph IV challenges.

The generic ingredient in HETLIOZ is tasimelteon. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the tasimelteon profile page.

Summary for HETLIOZ

US Patents:	7
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	34
Clinical Trials:	2
Patent Applications:	30
Drug Prices:	Drug price information for HETLIOZ
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for HETLIOZ
DailyMed Link:	HETLIOZ at DailyMed

Generic Entry Opportunity Date for HETLIOZ

Constraining patent/regulatory exclusivity:

TREATMENT OF NON-24-HOUR SLEEP-WAKE DISORDER

NDA:

205677

Dosage:

CAPSULE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for HETLIOZ

Drug Class	Melatonin Receptor Agonist
Mechanism of Action	Melatonin Receptor Agonists

Synonyms for HETLIOZ

(-)-(trans)-N-[[2-(2,3-Dihydrobenzofuran-4-yl)cycloprop-1-yl] methyl]propanamide

(trans)-N-[[2-(2,3-dihydrobenzofuran-4-yl) cyclopropyl]methyl]propanamide

(trans)-N-[[2-(2,3-dihydrobenzofuran-4-yl)cyclopropyl]methyl]propanamide

209255-28-7

609799-22-6

799T226

AC-6143

ACT06729

AK188029

AKOS025149360

AN-10364

BMS 214778

BMS-214778

CHEBI:79042

CHEMBL2103822

CS-5512

D09388

D0Q5MQ

DB09071

DTXSID70209826

GTPL7393

Hetlioz (TN)

HY-14803

KS-0000063S

MA 1

MFCD09033789

MolPort-028-600-027

N-(((1R,2R)-2-(2,3-Dihydro-1-benzofuran-4-yl)cyclopropyl)methyl)propanamide

N-(((1R,2R)-2-(2,3-dihydrobenzofuran-4-yl)cyclopropyl)methyl)propionamide

N-([(1r,2r)-2-(2,3-dihydro-1-benzofuran-4-yl)cyclopropyl]methyl)propanamide

N-[[(1R,2R)-2-(2,3-dihydro-1-benzofuran-4-yl)cyclopropyl]methyl]propanamide

N-[[(1R,2R)-2-(2,3-dihydrobenzofuran-4-yl)cyclopropyl]methyl]propanamide

N-{[(1R,2R)-2-(2,3-dihydro-1-benzofuran-4-yl)cyclopropyl]methyl}propanamide

Propanamide, N-(((1R,2R)-2-(2,3-dihydro-4-benzofuranyl)cyclopropyl)methyl)-

PTOIAAWZLUQTIO-GXFFZTMASA-N

SCHEMBL3505912

SHS4PU80D9

Tasimelteon

Tasimelteon (USAN/INN)

Tasimelteon [USAN:INN]

tasimelteonum

UNII-SHS4PU80D9

VEC 162

VEC-162

X5820

ZINC4392649

US Patents and Regulatory Information for HETLIOZ

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	tasimelteon	CAPSULE;ORAL	205677-001	Jan 31, 2014		RX	Yes	Yes
Vanda Pharms Inc	HETLIOZ	tasimelteon	CAPSULE;ORAL	205677-001	Jan 31, 2014		RX	Yes	Yes			Y	Y
Vanda Pharms Inc	HETLIOZ	tasimelteon	CAPSULE;ORAL	205677-001	Jan 31, 2014		RX	Yes	Yes
Vanda Pharms Inc	HETLIOZ	tasimelteon	CAPSULE;ORAL	205677-001	Jan 31, 2014		RX	Yes	Yes

Paragraph IV (Patent) Challenges for HETLIOZ

Drugname	Dosage	Strength	RLD	Date
	Capsules	20 mg
	Capsules	20 mg

International Patents for HETLIOZ

Country	Document Number	Estimated Expiration
Chile	2014001992
World Intellectual Property Organization (WIPO)	2013112949
New Zealand	335910
Canada	2861111