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Last Updated: March 4, 2024

Tasimelteon - Generic Drug Details


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What are the generic drug sources for tasimelteon and what is the scope of patent protection?

Tasimelteon is the generic ingredient in three branded drugs marketed by Vanda Pharms Inc, Apotex, MSN, and Teva Pharms Usa Inc, and is included in five NDAs. There are twenty-seven patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Tasimelteon has one hundred and ninety-five patent family members in twenty-four countries.

There are three drug master file entries for tasimelteon. Four suppliers are listed for this compound.

Summary for tasimelteon
Recent Clinical Trials for tasimelteon

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Saint-Joseph UniversityPhase 3
Vanda PharmaceuticalsPhase 2
Vanda PharmaceuticalsPhase 4

See all tasimelteon clinical trials

Pharmacology for tasimelteon
Paragraph IV (Patent) Challenges for TASIMELTEON
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
HETLIOZ Capsules tasimelteon 20 mg 205677 3 2018-01-31

US Patents and Regulatory Information for tasimelteon

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 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Vanda Pharms Inc HETLIOZ tasimelteon CAPSULE;ORAL 205677-001 Jan 31, 2014 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Vanda Pharms Inc HETLIOZ tasimelteon CAPSULE;ORAL 205677-001 Jan 31, 2014 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Vanda Pharms Inc HETLIOZ tasimelteon CAPSULE;ORAL 205677-001 Jan 31, 2014 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Vanda Pharms Inc HETLIOZ LQ tasimelteon SUSPENSION;ORAL 214517-001 Dec 1, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for tasimelteon

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Vanda Pharmaceuticals Netherlands B.V. Hetlioz tasimelteon EMEA/H/C/003870
Hetlioz is indicated for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) in totally blind adults.,
Authorised no no yes 2015-07-03
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for tasimelteon

Country Patent Number Title Estimated Expiration
South Korea 20140117537 TREATMENT OF CIRCADIAN RHYTHM DISORDERS ⤷  Try a Trial
Croatia P20171600 ⤷  Try a Trial
South Korea 102411809 ⤷  Try a Trial
European Patent Office 3767297 TRAITEMENT DES TROUBLES DU RYTHME CIRCADIEN (METHOD OF DETERMINING TAU AND THEREBY DETERMINING WHETHER A PATIENT HAS A FREE-RUNNING CIRCADIAN RHYTHM) ⤷  Try a Trial
Australia 2019219847 TREATMENT OF CIRCADIAN RHYTHM DISORDERS ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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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 verification 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.