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Last Updated: February 28, 2021

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HETLIOZ Drug Profile

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When do Hetlioz patents expire, and when can generic versions of Hetlioz launch?

Hetlioz is a drug marketed by Vanda Pharms Inc and is included in two NDAs. There are fifteen patents protecting this drug and two Paragraph IV challenges.

This drug has one hundred and sixty 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.

US ANDA Litigation and Generic Entry Outlook for Hetlioz

Hetlioz was eligible for patent challenges on January 31, 2018.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 12, 2035. This may change due to patent challenges or generic licensing.

There have been eleven patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (tasimelteon), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Summary for HETLIOZ
Drug patent expirations by year for HETLIOZ
Drug Prices for HETLIOZ

See drug prices for HETLIOZ

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

*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

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

Vanda PharmaceuticalsPhase 1
Vanda PharmaceuticalsPhase 4

See all HETLIOZ clinical trials

Pharmacology for HETLIOZ
Paragraph IV (Patent) Challenges for HETLIOZ
Tradename Dosage Ingredient NDA Submissiondate
HETLIOZ CAPSULE;ORAL tasimelteon 205677 2018-01-31

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 LQ tasimelteon SUSPENSION;ORAL 214517-001 Dec 1, 2020 RX Yes Yes   Start Trial   Start Trial   Start Trial
Vanda Pharms Inc HETLIOZ LQ tasimelteon SUSPENSION;ORAL 214517-001 Dec 1, 2020 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Vanda Pharms Inc HETLIOZ LQ tasimelteon SUSPENSION;ORAL 214517-001 Dec 1, 2020 RX Yes Yes   Start Trial   Start Trial Y Y   Start 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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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Express Scripts

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