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 fifteen patents protecting this drug.
This drug has two hundred and twenty patent family members in thirty-two countries.
The generic ingredient in HETLIOZ LQ is tasimelteon. There are three drug master file entries for this compound. Two 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.
Summary for HETLIOZ LQ
| International Patents: | 220 |
| US Patents: | 15 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 55 |
| Clinical Trials: | 2 |
| Patent Applications: | 266 |
| 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 |
Anatomical Therapeutic Chemical (ATC) Classes for HETLIOZ LQ
US Patents and Regulatory Information for HETLIOZ LQ
HETLIOZ LQ is protected by fifteen US patents and two FDA Regulatory Exclusivities.
Patents protecting HETLIOZ LQ
Highly purifid pharmaceutical grade tasimelteon
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Treatment of circadian rhythm disorders
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY ADMINISTERING TASIMELTEON
Method of treatment
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Method of treatment
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY ADMINISTERING TASIMELTEON
Treatment of circadian rhythm disorders
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY AVOIDING THE ADMINISTRATION OF TASIMELTEON WITH BETA-ADRENERGIC RECEPTOR ANTAGONISTS
Benzofuran and dihydrobenzofuran melatonergic agents
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY ADMINISTERING TASIMELTEON
Treatment of circadian rhythm disorders
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
FOR THE TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME (SMS) IN PEDIATRIC PATIENTS 3 TO 15 YEARS OF AGE
Exclusivity Expiration: ⤷ Try a Trial
| 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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Vanda Pharms Inc | HETLIOZ LQ | tasimelteon | SUSPENSION;ORAL | 214517-001 | Dec 1, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Vanda Pharms Inc | HETLIOZ LQ | tasimelteon | SUSPENSION;ORAL | 214517-001 | Dec 1, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Vanda Pharms Inc | HETLIOZ LQ | tasimelteon | SUSPENSION;ORAL | 214517-001 | Dec 1, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Vanda Pharms Inc | HETLIOZ LQ | tasimelteon | SUSPENSION;ORAL | 214517-001 | Dec 1, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Vanda Pharms Inc | HETLIOZ LQ | tasimelteon | SUSPENSION;ORAL | 214517-001 | Dec 1, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >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 | ⤷ Try a Trial | ⤷ Try a Trial |
| >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
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 61975
Estimated Expiration: ⤷ Try a Trial
Chile
Patent: 22001546
Estimated Expiration: ⤷ Try a Trial
China
Patent: 4727978
Estimated Expiration: ⤷ Try a Trial
Colombia
Patent: 22009691
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 72542
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 2492
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 23506225
Estimated Expiration: ⤷ Try a Trial
South Africa
Patent: 2207188
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 220113983
Estimated Expiration: ⤷ Try a Trial
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 |
|---|---|---|---|
| Czech Republic | 9901991 | ⤷ Try a Trial | |
| Canada | 3161975 | FORMULATIONS LIQUIDES DE TASIMELTEON ET LEURS PROCEDES D'UTILISATION (LIQUID TASIMELTEON FORMULATIONS AND METHODS OF USE THEREOF) | ⤷ Try a Trial |
| Brazil | 112017003644 | métodos de tratamento de distúrbios do sono e para regular produção de melatonina. | ⤷ Try a Trial |
| European Patent Office | 3300728 | TRAITEMENT DES TROUBLES DU RYTHME CIRCADIEN (TREATMENT OF CIRCADIAN RHYTHM DISORDERS) | ⤷ Try a Trial |
| Poland | 333950 | ⤷ Try a Trial | |
| Cyprus | 2501 | Benzodioxole, benzofuran, dihydrobenzofuran, and benzodioxane melatonergic agents. | ⤷ Try a Trial |
| >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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