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-seven patents protecting this drug and one Paragraph IV challenge.
This drug has two hundred and fifteen 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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Questions you can ask:
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Summary for HETLIOZ LQ
| International Patents: | 215 |
| US Patents: | 27 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 57 |
| Clinical Trials: | 2 |
| Patent Applications: | 336 |
| 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-seven US patents and one FDA Regulatory Exclusivity.
| 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 | ⤷ Start Trial | ||||
| 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 | ⤷ Start Trial | ||||
| Vanda Pharms Inc | HETLIOZ LQ | tasimelteon | SUSPENSION;ORAL | 214517-001 | Dec 1, 2020 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start 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 | ⤷ Start Trial | ⤷ Start 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/003870Hetlioz 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: ⤷ Start Trial
Patent: 25205489
Estimated Expiration: ⤷ Start Trial
Patent: 26202446
Estimated Expiration: ⤷ Start Trial
Canada
Patent: 61975
Estimated Expiration: ⤷ Start Trial
Chile
Patent: 22001546
Estimated Expiration: ⤷ Start Trial
China
Patent: 4727978
Estimated Expiration: ⤷ Start Trial
Colombia
Patent: 22009691
Estimated Expiration: ⤷ Start Trial
European Patent Office
Patent: 72542
Estimated Expiration: ⤷ Start Trial
Israel
Patent: 2492
Estimated Expiration: ⤷ Start Trial
Patent: 7244
Estimated Expiration: ⤷ Start Trial
Japan
Patent: 03632
Estimated Expiration: ⤷ Start Trial
Patent: 75899
Estimated Expiration: ⤷ Start Trial
Patent: 23506225
Estimated Expiration: ⤷ Start Trial
Patent: 24084859
Estimated Expiration: ⤷ Start Trial
Patent: 26117039
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: ⤷ Start Trial
Mexico
Patent: 22006577
Patent: FORMULACIONES LIQUIDAS DE TASIMELTEON Y METODOS PARA SU USO. (LIQUID TASIMELTEON FORMULATIONS AND METHODS OF USE THEREOF.)
Estimated Expiration: ⤷ Start Trial
Patent: 26003536
Patent: FORMULACIONES LIQUIDAS DE TASIMELTEON Y METODOS PARA SU USO. (LIQUID TASIMELTEON FORMULATIONS AND METHODS OF USE THEREOF)
Estimated Expiration: ⤷ Start Trial
New Zealand
Patent: 9270
Patent: Liquid tasimelteon formulations and methods of use thereof
Estimated Expiration: ⤷ Start Trial
Patent: 1345
Patent: Liquid tasimelteon formulations and methods of use thereof
Estimated Expiration: ⤷ Start Trial
Patent: 1397
Patent: Liquid tasimelteon formulations and methods of use thereof
Estimated Expiration: ⤷ Start Trial
South Africa
Patent: 2207188
Patent: LIQUID TASIMELTEON FORMULATIONS AND METHODS OF USE THEREOF
Estimated Expiration: ⤷ Start Trial
South Korea
Patent: 2650321
Estimated Expiration: ⤷ Start Trial
Patent: 220113983
Patent: 액체 타시멜테온 제형 및 이의 사용 방법
Estimated Expiration: ⤷ Start 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 |
|---|---|---|---|
| European Patent Office | 3105212 | TASIMELTÉON DE QUALITÉ PHARMACEUTIQUE, HAUTEMENT PURIFIÉ (HIGHLY PURIFIED PHARMACEUTICAL GRADE TASIMELTEON) | ⤷ Start Trial |
| European Patent Office | 3470405 | TASIMELTEON DE QUALITÉ PHARMACEUTIQUE HAUTEMENT PURIFIÉE (HIGHLY PURIFIED PHARMACEUTICAL GRADE TASIMELTEON) | ⤷ Start Trial |
| European Patent Office | 4223747 | TASIMELTEON DE QUALITÉ PHARMACEUTIQUE HAUTEMENT PURIFIÉ (HIGHLY PURIFIED PHARMACEUTICAL GRADE TASIMELTEON) | ⤷ Start Trial |
| Japan | 2017506642 | 高純度医薬品等級タシメルテオン | ⤷ Start Trial |
| Japan | 2020079248 | 高純度医薬品等級タシメルテオン (HIGHLY PURIFIED PHARMACEUTICAL GRADE TASIMELTEON) | ⤷ Start Trial |
| Japan | 2022088624 | 高純度医薬品等級タシメルテオン | ⤷ Start 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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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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