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Last Updated: June 24, 2022

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 two branded drugs marketed by Vanda Pharms Inc and is included in two NDAs. There are twenty 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 eighty-four patent family members in thirty-one countries.

There are three drug master file entries for tasimelteon. One supplier is listed for this compound. There are two tentative approvals 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

Generic filers with tentative approvals for TASIMELTEON
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing20MGCAPSULE; ORAL
See Plans and PricingSee Plans and Pricing20MGCAPSULE; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for tasimelteon
Anatomical Therapeutic Chemical (ATC) Classes 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 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Vanda Pharms Inc HETLIOZ tasimelteon CAPSULE;ORAL 205677-001 Jan 31, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Vanda Pharms Inc HETLIOZ tasimelteon CAPSULE;ORAL 205677-001 Jan 31, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Vanda Pharms Inc HETLIOZ LQ tasimelteon SUSPENSION;ORAL 214517-001 Dec 1, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Vanda Pharms Inc HETLIOZ LQ tasimelteon SUSPENSION;ORAL 214517-001 Dec 1, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
>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
World Intellectual Property Organization (WIPO) 2015123389 See Plans and Pricing
Australia 2015206797 Administration of tasimelteon under fasted conditions See Plans and Pricing
Norway 992804 See Plans and Pricing
Spain 2230626 See Plans and Pricing
Mexico 2017002796 TASIMELTEON PARA TRATAR EL SINDROME DE SMITH-MAGENIS. (TASIMELTEON FOR TREATING SMITH-MAGENIS SYNDROME.) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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