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HETLIOZ Drug Profile

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Which patents cover Hetlioz, and what generic alternatives are available?

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.

This drug has ninety-four patent family members in thirty-one countries.

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

International Patents:	94
US Patents:	7
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	33
Clinical Trials:	2
Patent Applications:	29
DailyMed Link:	HETLIOZ at DailyMed

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

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Paragraph IV (Patent) Challenges for HETLIOZ

Drugname	Dosage	Strength	RLD	Submissiondate
	Capsules	20 mg		2018-01-31
	Capsules	20 mg		2018-01-31

Non-Orange Book US Patents for HETLIOZ

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
8,785,492	Treatment of circadian rhythm disorders
5,981,571	Benzodioxa alkylene ethers as melatonergic agents
2,017,087,122
6,060,506	Benzopyran derivatives as melatonergic agents

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International Patents for HETLIOZ

Country	Document Number	Estimated Expiration
Croatia	P20171600
Japan	2015508157
Japan	2016172737
Germany	69731562