HETLIOZ Drug Patent Profile
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When do Hetlioz patents expire, and when can generic versions of Hetlioz launch?
Hetlioz is a drug marketed by Vanda Pharms Inc and is included in two NDAs. There are thirty-two patents protecting this drug and one Paragraph IV challenge.
This drug has two hundred and seven patent family members in twenty-four countries.
The generic ingredient in HETLIOZ 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
A generic version of HETLIOZ was approved as tasimelteon by TEVA PHARMS USA INC on December 12th, 2022.
AI Deep Research
Questions you can ask:
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Summary for HETLIOZ
International Patents: | 207 |
US Patents: | 31 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 57 |
Clinical Trials: | 2 |
Patent Applications: | 263 |
Drug Prices: | Drug price information for HETLIOZ |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for HETLIOZ |
What excipients (inactive ingredients) are in HETLIOZ? | HETLIOZ excipients list |
DailyMed Link: | HETLIOZ at DailyMed |


Recent Clinical Trials for HETLIOZ
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Vanda Pharmaceuticals | Phase 1 |
Vanda Pharmaceuticals | Phase 4 |
Pharmacology for HETLIOZ
Drug Class | Melatonin Receptor Agonist |
Mechanism of Action | Melatonin Receptor Agonists |
Paragraph IV (Patent) Challenges for HETLIOZ
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
HETLIOZ | Capsules | tasimelteon | 20 mg | 205677 | 3 | 2018-01-31 |
US Patents and Regulatory Information for HETLIOZ
HETLIOZ is protected by forty-eight 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 | 10,071,977 | ⤷ Try for Free | Y | Y | ⤷ Try for Free | ||
Vanda Pharms Inc | HETLIOZ | tasimelteon | CAPSULE;ORAL | 205677-001 | Jan 31, 2014 | AB | RX | Yes | Yes | 11,285,129 | ⤷ Try for Free | ⤷ Try for Free | |||
Vanda Pharms Inc | HETLIOZ | tasimelteon | CAPSULE;ORAL | 205677-001 | Jan 31, 2014 | AB | RX | Yes | Yes | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | |||
Vanda Pharms Inc | HETLIOZ LQ | tasimelteon | SUSPENSION;ORAL | 214517-001 | Dec 1, 2020 | RX | Yes | Yes | 10,610,511 | ⤷ Try for Free | ⤷ Try for Free | ||||
Vanda Pharms Inc | HETLIOZ | tasimelteon | CAPSULE;ORAL | 205677-001 | Jan 31, 2014 | AB | RX | Yes | Yes | 12,049,457 | ⤷ Try for Free | Y | Y | ⤷ Try for Free | |
>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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Vanda Pharms Inc | HETLIOZ | tasimelteon | CAPSULE;ORAL | 205677-001 | Jan 31, 2014 | 5,856,529 | ⤷ Try for Free |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for HETLIOZ
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
When does loss-of-exclusivity occur for HETLIOZ?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
European Patent Office
Patent: 05212
Patent: TASIMELTÉON DE QUALITÉ PHARMACEUTIQUE, HAUTEMENT PURIFIÉ (HIGHLY PURIFIED PHARMACEUTICAL GRADE TASIMELTEON)
Estimated Expiration: ⤷ Try for Free
Patent: 70405
Patent: TASIMELTEON DE QUALITÉ PHARMACEUTIQUE HAUTEMENT PURIFIÉE (HIGHLY PURIFIED PHARMACEUTICAL GRADE TASIMELTEON)
Estimated Expiration: ⤷ Try for Free
Patent: 23747
Patent: TASIMELTEON DE QUALITÉ PHARMACEUTIQUE HAUTEMENT PURIFIÉ (HIGHLY PURIFIED PHARMACEUTICAL GRADE TASIMELTEON)
Estimated Expiration: ⤷ Try for Free
Japan
Patent: 21534
Estimated Expiration: ⤷ Try for Free
Patent: 17506642
Patent: 高純度医薬品等級タシメルテオン
Estimated Expiration: ⤷ Try for Free
Patent: 20079248
Patent: 高純度医薬品等級タシメルテオン (HIGHLY PURIFIED PHARMACEUTICAL GRADE TASIMELTEON)
Estimated Expiration: ⤷ Try for Free
Patent: 22088624
Patent: 高純度医薬品等級タシメルテオン
Estimated Expiration: ⤷ Try for Free
Patent: 22190155
Patent: 高純度医薬品等級タシメルテオン
Estimated Expiration: ⤷ Try for Free
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 around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Norway | 321450 | ⤷ Try for Free | |
Portugal | 3094322 | ⤷ Try for Free | |
Poland | 333950 | ⤷ Try for Free | |
Australia | 2019219847 | TREATMENT OF CIRCADIAN RHYTHM DISORDERS | ⤷ Try for Free |
Portugal | 1027043 | ⤷ Try for Free | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Market Dynamics and Financial Trajectory for HETLIOZ
More… ↓