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 twenty-five 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 12th, 2022.
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Summary for HETLIOZ LQ
| International Patents: | 197 |
| US Patents: | 25 |
| 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 |
Recent Clinical Trials for HETLIOZ LQ
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Vanda Pharmaceuticals | Phase 1 |
| Vanda Pharmaceuticals | Phase 4 |
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-five US patents and one FDA Regulatory Exclusivity.
Patents protecting HETLIOZ LQ
Highly purifid pharmaceutical grade tasimelteon
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Treatment of circadian rhythm disorders
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY ADMINISTERING TASIMELTEON TO PATIENTS WITH A SMOKING HISTORY
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
Highly purified pharmaceutical grade tasimelteon
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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Patent Expiration: ⤷ Sign Up
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
Method of treatment
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Patent Expiration: ⤷ Sign Up
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
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Method of treatment
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY ADMINISTERING TASIMELTEON
Treatment of circadian rhythm disorders
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY AVOIDING THE ADMINISTRATION OF TASIMELTEON WITH FOOD
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY AVOIDING THE ADMINISTRATION OF TASIMELTEON WITH BETA-ADRENERGIC RECEPTOR ANTAGONISTS
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY ADMINISTERING TASIMELTEON
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY AVOIDING THE ADMINISTRATION OF TASIMELTEON WITH BETA-ADRENERGIC RECEPTOR ANTAGONISTS
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY AVOIDING THE ADMINISTRATION OF TASIMELTEON WITH BETA-ADRENERGIC RECEPTOR ANTAGONISTS
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY ADMINISTERING TASIMELTEON
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Treatment of circadian rhythm disorders
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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
FOR THE TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME (SMS) IN PEDIATRIC PATIENTS 3 TO 15 YEARS OF AGE
Exclusivity Expiration: ⤷ Sign Up
| 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
| 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
| 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)
Estimated Expiration: ⤷ Sign Up
Chile
Patent: 22001546
Patent: Formulaciones líquidas de tasimelteón y métodos para su uso
Estimated Expiration: ⤷ Sign Up
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)
Estimated Expiration: ⤷ Sign Up
Colombia
Patent: 22009691
Patent: Formulaciones líquidas de tasimelteón y métodos para su uso
Estimated Expiration: ⤷ Sign Up
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)
Estimated Expiration: ⤷ Sign Up
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
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 22006577
Patent: FORMULACIONES LIQUIDAS DE TASIMELTEON Y METODOS PARA SU USO. (LIQUID TASIMELTEON FORMULATIONS AND METHODS OF USE THEREOF.)
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 2207188
Patent: LIQUID TASIMELTEON FORMULATIONS AND METHODS OF USE THEREOF
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 2650321
Estimated Expiration: ⤷ Sign Up
Patent: 220113983
Patent: 액체 타시멜테온 제형 및 이의 사용 방법
Estimated Expiration: ⤷ Sign Up
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.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Japan | 2021073222 | 概日リズム障害の治療 (TREATMENT OF CIRCADIAN RHYTHM DISORDERS) | ⤷ Sign Up |
| Australia | 2013211880 | Treatment of circadian rhythm disorders | ⤷ Sign Up |
| Argentina | 010346 | COMPUESTOS DERIVADOS DE BENZOFURANO; SUS USOS, Y COMPOSICIoN FARMACÉUTICA QUE LOS CONTIENE. | ⤷ Sign Up |
| Chile | 2016001794 | Metodo para administrar tasimelteon a un paciente humano que incluye la administración oral de una dosis efectiva en condiciones de ayuno para tratar un trastorno del ritmo circadiano o un trastorno del sueño, como el trastorno del sueño-vigilia diferente a 24 horas no-24 metodo para acortar el tmax del tasimelteon en un paciente humano que está siendo tratado con tasimelteon. | ⤷ Sign Up |
| Japan | 2023071727 | 概日リズム障害の治療 | ⤷ Sign Up |
| Russian Federation | 2015129349 | ЛЕЧЕНИЕ РАССТРОЙСТВ ЦИРКАДНОГО РИТМА | ⤷ Sign Up |
| >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.
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