Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: October 22, 2019

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 ten patents protecting this drug and two Paragraph IV challenges.

This drug has one hundred and twenty-three 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.

Drug patent expirations by year for HETLIOZ
Drug Prices for HETLIOZ

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Generic Entry Opportunity Date for HETLIOZ
Generic Entry Date for HETLIOZ*:
Constraining patent/regulatory exclusivity:
NDA:
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.

Recent Clinical Trials for HETLIOZ

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SponsorPhase
Vanda PharmaceuticalsPhase 1
Vanda PharmaceuticalsPhase 4

See all HETLIOZ clinical trials

Recent Litigation for HETLIOZ

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District Court Litigation
Case NameDate
Vanda Pharmaceuticals Inc. v. MSN Pharmaceuticals Inc.2019-05-17
Vanda Pharmaceuticals Inc. v. Apotex Inc.2019-04-12
Vanda Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc.2019-03-22

See all HETLIOZ litigation

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
AS-35291
BCP07180
BMS 214778
BMS-214778
CHEBI:79042
CHEMBL2103822
CS-5512
D09388
DB09071
DTXSID70209826
EX-A2729
GTPL7393
Hetlioz (TN)
HY-14803
J3.640.465E
KS-0000063S
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
SB16782
SCHEMBL3505912
SHS4PU80D9
Tasimelteon
Tasimelteon (USAN/INN)
Tasimelteon [USAN:INN]
Tasimelteon, >=98% (HPLC)
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   Start Trial   Start Trial   Start Trial
Vanda Pharms Inc HETLIOZ tasimelteon CAPSULE;ORAL 205677-001 Jan 31, 2014 RX Yes Yes   Start Trial   Start Trial   Start Trial
Vanda Pharms Inc HETLIOZ tasimelteon CAPSULE;ORAL 205677-001 Jan 31, 2014 RX Yes Yes   Start Trial   Start Trial   Start Trial
Vanda Pharms Inc HETLIOZ tasimelteon CAPSULE;ORAL 205677-001 Jan 31, 2014 RX Yes Yes   Start Trial   Start Trial   Start Trial
Vanda Pharms Inc HETLIOZ tasimelteon CAPSULE;ORAL 205677-001 Jan 31, 2014 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Vanda Pharms Inc HETLIOZ tasimelteon CAPSULE;ORAL 205677-001 Jan 31, 2014 RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration
Paragraph IV (Patent) Challenges for HETLIOZ
Drugname Dosage Strength RLD Date
➤ Subscribe Capsules 20 mg ➤ Subscribe   Start Trial
➤ Subscribe Capsules 20 mg ➤ Subscribe   Start Trial

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Serving leading biopharmaceutical companies globally:

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Moodys
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Medtronic

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