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Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
Johnson and Johnson
Farmers Insurance
Julphar
Federal Trade Commission
Dow
QuintilesIMS
Fish and Richardson
McKesson

Generated: June 18, 2018

DrugPatentWatch Database Preview

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
Drug patent expirations by year for HETLIOZ
Pharmacology for HETLIOZ
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 ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Vanda Pharms Inc HETLIOZ tasimelteon CAPSULE;ORAL 205677-001 Jan 31, 2014 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Vanda Pharms Inc HETLIOZ tasimelteon CAPSULE;ORAL 205677-001 Jan 31, 2014 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Vanda Pharms Inc HETLIOZ tasimelteon CAPSULE;ORAL 205677-001 Jan 31, 2014 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Paragraph IV (Patent) Challenges for HETLIOZ
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Capsules 20 mg ➤ Subscribe 2018-01-31
➤ Subscribe Capsules 20 mg ➤ Subscribe 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 ➤ Try a Free Trial
5,981,571 Benzodioxa alkylene ethers as melatonergic agents ➤ Try a Free Trial
2,017,087,122 ➤ Try a Free Trial
6,060,506 Benzopyran derivatives as melatonergic agents ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
Daiichi Sankyo
Moodys
Chinese Patent Office
Express Scripts
Harvard Business School
UBS
Colorcon
Johnson and Johnson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.