hetlioz lq Drug Patent Profile

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When do Hetlioz Lq patents expire, and what generic alternatives are available?

Hetlioz Lq is a drug marketed by Vanda Pharms Inc and is included in one NDA. There are twenty-four patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and ninety-seven patent family members in twenty-four countries.

The generic ingredient in HETLIOZ LQ is tasimelteon. There are three drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the tasimelteon profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Hetlioz Lq

A generic version of hetlioz lq was approved as tasimelteon by TEVA PHARMS USA INC on December 12^th, 2022.

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Summary for hetlioz lq

International Patents:	197
US Patents:	24
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	57
Clinical Trials:	2
Patent Applications:	153
Drug Prices:	Drug price information for hetlioz lq
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for hetlioz lq
DailyMed Link:	hetlioz lq at DailyMed

Drug patent expirations by year for hetlioz lq

Recent Clinical Trials for hetlioz lq

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

Sponsor	Phase
Vanda Pharmaceuticals	Phase 1
Vanda Pharmaceuticals	Phase 4

See all hetlioz lq clinical trials

Pharmacology for hetlioz lq

Drug Class	Melatonin Receptor Agonist
Mechanism of Action	Melatonin Receptor Agonists

Paragraph IV (Patent) Challenges for HETLIOZ LQ

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
HETLIOZ LQ	Oral Suspension	tasimelteon	4 mg/mL	214517	1	2024-04-01

US Patents and Regulatory Information for hetlioz lq

hetlioz lq is protected by twenty-four US patents and one FDA Regulatory Exclusivity.

Patents protecting hetlioz lq

Highly purifid pharmaceutical grade tasimelteon
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Treatment of circadian rhythm disorders
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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
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Patented Use: TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY ADMINISTERING TASIMELTEON

Method of treatment
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Patented Use: TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY AVOIDING THE ADMINISTRATION OF TASIMELTEON WITH FOOD

Treatment of circadian rhythm disorders
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Patented Use: TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY ADMINISTERING TASIMELTEON TO PATIENTS WITH A SMOKING HISTORY

Highly purified pharmaceutical grade tasimelteon
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Patented Use: TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY AVOIDING THE ADMINISTRATION OF TASIMELTEON TO SMOKERS OR TO PATIENTS BEING TREATED WITH A CYP1A2 INHIBITOR

Liquid tasimelteon formulations and methods of use thereof
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Treatment of circadian rhythm disorders
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Patented Use: TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY AVOIDING THE ADMINISTRATION OF TASIMELTEON WITH BETA-ADRENERGIC RECEPTOR ANTAGONISTS

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Patented Use: TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY ADMINISTERING TASIMELTEON

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Patented Use: TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY ADMINISTERING TASIMELTEON

Treatment of circadian rhythm disorders
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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

FDA Regulatory Exclusivity protecting hetlioz lq

FOR THE TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME (SMS) IN PEDIATRIC PATIENTS 3 TO 15 YEARS OF AGE
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Glossary

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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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Vanda Pharms Inc	HETLIOZ LQ	tasimelteon	SUSPENSION;ORAL	214517-001	Dec 1, 2020		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Vanda Pharms Inc	HETLIOZ LQ	tasimelteon	SUSPENSION;ORAL	214517-001	Dec 1, 2020		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Vanda Pharms Inc	HETLIOZ LQ	tasimelteon	SUSPENSION;ORAL	214517-001	Dec 1, 2020		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Vanda Pharms Inc	HETLIOZ LQ	tasimelteon	SUSPENSION;ORAL	214517-001	Dec 1, 2020		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Vanda Pharms Inc	HETLIOZ LQ	tasimelteon	SUSPENSION;ORAL	214517-001	Dec 1, 2020		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for hetlioz lq

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Vanda Pharms Inc	HETLIOZ LQ	tasimelteon	SUSPENSION;ORAL	214517-001	Dec 1, 2020	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for hetlioz lq

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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 hetlioz lq

When does loss-of-exclusivity occur for hetlioz lq?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 20400065
Patent: Liquid tasimelteon formulations and methods of use thereof
Estimated Expiration: ⤷ Sign Up

Canada

Patent: 61975
Patent: FORMULATIONS LIQUIDES DE TASIMELTEON ET LEURS PROCEDES D'UTILISATION (LIQUID TASIMELTEON FORMULATIONS AND METHODS OF USE THEREOF)
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Chile

Patent: 22001546
Patent: Formulaciones líquidas de tasimelteón y métodos para su uso
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China

Patent: 4727978
Patent: 液体他司美琼制剂及其使用方法 (Liquid tasimelteon formulations and methods of use thereof)
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Colombia

Patent: 22009691
Patent: Formulaciones líquidas de tasimelteón y métodos para su uso
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European Patent Office

Patent: 72542
Patent: FORMULATIONS LIQUIDES DE TASIMELTÉON ET LEURS PROCÉDÉS D'UTILISATION (LIQUID TASIMELTEON FORMULATIONS AND METHODS OF USE THEREOF)
Estimated Expiration: ⤷ Sign Up

Israel

Patent: 2492
Patent: פורמולציות נוזליות של טזימלטיון ושיטות שימוש בהם (Liquid tasimelteon formulations and methods of use thereof)
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Japan

Patent: 23506225
Patent: 液体タシメルテオン製剤及びそれを使用する方法
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Mexico

Patent: 22006577
Patent: FORMULACIONES LIQUIDAS DE TASIMELTEON Y METODOS PARA SU USO. (LIQUID TASIMELTEON FORMULATIONS AND METHODS OF USE THEREOF.)
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South Africa

Patent: 2207188
Patent: LIQUID TASIMELTEON FORMULATIONS AND METHODS OF USE THEREOF
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South Korea

Patent: 2650321
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Patent: 220113983
Patent: 액체 타시멜테온 제형 및 이의 사용 방법
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Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering hetlioz lq around the world.

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Country	Patent Number	Title	Estimated Expiration
South Korea	102171965		⤷ Sign Up
China	1239886		⤷ Sign Up
China	104379135	Treatment of circadian rhythm disorders	⤷ Sign Up
European Patent Office	3470405	TASIMELTEON DE QUALITÉ PHARMACEUTIQUE HAUTEMENT PURIFIÉE (HIGHLY PURIFIED PHARMACEUTICAL GRADE TASIMELTEON)	⤷ Sign Up
Mexico	2020007448	TRATAMIENTO DE TRASTORNOS DEL RITMO CIRCADIANO. (TREATMENT OF CIRCADIAN RHYTHM DISORDERS.)	⤷ Sign Up
South Korea	102593047		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration