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Last Updated: May 26, 2022

HETLIOZ LQ Drug Patent Profile


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

Hetlioz Lq is a drug marketed by Vanda Pharms Inc and is included in one NDA. There are thirteen patents protecting this drug.

This drug has one hundred and eighty-one patent family members in thirty-one countries.

The generic ingredient in HETLIOZ LQ 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.

DrugPatentWatch® Generic Entry Outlook for Hetlioz Lq

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 11, 2040. This may change due to patent challenges or generic licensing.

There have been nine 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.

Indicators of Generic Entry

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

See drug prices for HETLIOZ LQ

DrugPatentWatch® Estimated Generic Entry Opportunity Date for HETLIOZ LQ
Generic Entry Date for HETLIOZ LQ*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SUSPENSION;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 LQ

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

SponsorPhase
Vanda PharmaceuticalsPhase 1
Vanda PharmaceuticalsPhase 4

See all HETLIOZ LQ clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for HETLIOZ LQ

US Patents and Regulatory Information for HETLIOZ LQ

HETLIOZ LQ is protected by thirteen US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of HETLIOZ LQ is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting HETLIOZ LQ

Highly purifid pharmaceutical grade tasimelteon
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Treatment of circadian rhythm disorders
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME NON-24 HOUR SLEEP-WAKE DISORDER BY AVOIDING THE USE OF TASIMELTEON IN COMBINATION WITH CYP1A2 STRONG INHIBITORS

Method of treatment
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY ADMINISTERING TASIMELTEON

Method of treatment
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY AVOIDING THE ADMINISTRATION OF TASIMELTEON WITH FOOD

Treatment of circadian rhythm disorders
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY ADMINISTERING TASIMELTEON TO PATIENTS WITH A SMOKING HISTORY

Method of treatment
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY AVOIDING THE ADMINISTRATION OF TASIMELTEON WITH FOOD

Highly purified pharmaceutical grade tasimelteon
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing


Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENISSYNDROME BY AVOIDING THE ADMINISTRATION OF TASIMELTEON TO SMOKERS OR TO PATIENTS BEING TREATED WITH A CYP1A2 INHIBITOR

Method of treatment
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY AVOIDING THE ADMINISTRATION OF TASIMELTEON WITH FOOD

Liquid tasimelteon formulations and methods of use thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Benzofuran and dihydrobenzofuran melatonergic agents
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY ADMINISTERING TASIMELTEON

Treatment of circadian rhythm disorders
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY AVOIDING THE AVOIDING THE USE OF TASIMELTEON IN COMBINATION WITH A STRONG CYP1A2 INHIBITOR

Treatment of circadian rhythm disorders
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY AVOIDING THE USE OF TASIMELTEON WITH RIFAMPIN

FDA Regulatory Exclusivity protecting HETLIOZ LQ

NEW PRODUCT
Exclusivity Expiration: See Plans and Pricing

FOR THE TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME (SMS) IN PEDIATRIC PATIENTS 3 TO 15 YEARS OF AGE
Exclusivity Expiration: 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
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 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 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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for HETLIOZ LQ

See the table below for patents covering HETLIOZ LQ around the world.

Country Patent Number Title Estimated Expiration
Canada 2861111 TRAITEMENT DE TROUBLES DU RYTHME CIRCADIEN (TREATMENT OF CIRCADIAN RHYTHM DISORDERS) See Plans and Pricing
Japan 4290765 See Plans and Pricing
Australia 2019204306 TREATMENT OF CIRCADIAN RHYTHM DISORDERS See Plans and Pricing
Japan 2020079248 高純度医薬品等級タシメルテオン (HIGHLY PURIFIED PHARMACEUTICAL GRADE TASIMELTEON) See Plans and Pricing
Spain 2230626 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Colorcon
Boehringer Ingelheim
Johnson and Johnson
Harvard Business School
Express Scripts
McKesson

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.