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 nineteen patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred and eighty patent family members in thirty-one countries.
The generic ingredient in HETLIOZ is tasimelteon. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the tasimelteon profile page.
DrugPatentWatch® Generic Entry Outlook for Hetlioz
Hetlioz was eligible for patent challenges on January 31, 2018.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be February 12, 2035. This may change due to patent challenges or generic licensing.
There have been eleven patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
There are two tentative approvals for the generic drug (tasimelteon), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
Summary for HETLIOZ
| International Patents: | 180 |
| US Patents: | 18 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 47 |
| Clinical Trials: | 2 |
| Patent Applications: | 229 |
| 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 |
DrugPatentWatch® Estimated Generic Entry Opportunity Date for HETLIOZ
Generic Entry Date for HETLIOZ*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
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 |
Anatomical Therapeutic Chemical (ATC) Classes for HETLIOZ
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 twenty-seven US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of HETLIOZ is See Plans and Pricing.
This potential generic entry date is based on patent See Plans and Pricing.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting HETLIOZ
Highly purifid pharmaceutical grade tasimelteon
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Treatment of circadian rhythm disorders
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF NON-24 HOUR SLEEP-WAKE DISORDER BY AVOIDING THE USE OF TASIMELTEON IN COMBINATION WITH CYP1A2 STRONG INHIBITORS
Treatment of circadian rhythm disorders
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY ADMINISTERING TASIMELTEON
Method of treatment
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF NON-24 HOUR SLEEP-WAKE DISORDER BY AVOIDING THE ADMINISTRATION OF TASIMELTEON WITH FOOD
Method of treatment
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF NON-24 HOUR SLEEP-WAKE DISORDER BY ADMINISTERING TASIMELTEON
Treatment of circadian rhythm disorders
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY ADMINISTERING TASIMELTEON TO PATIENTS WITH A SMOKING HISTORY
Treatment of circadian rhythm disorders
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF NON-24 HOUR SLEEP-WAKE DISORDER BY ADMINISTERING TASIMELTEON TO PATIENTS WITH A SMOKING HISTORY
Method of treatment
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY AVOIDING THE ADMINISTRATION OF TASIMELTEON WITH FOOD
Method of treatment
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF NON-24 HOUR SLEEP-WAKE DISORDER BY AVOIDING THE ADMINISTRATION OF TASIMELTEON WITH FOOD
Highly purified pharmaceutical grade tasimelteon
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF NON-24 HOUR SLEEP-WAKE DISORDER BY ADMINISTERING TASIMELTEON
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF NON-24 HOUR SLEEP-WAKE DISORDER BY AVOIDING THE ADMINISTRATION OF TASIMELTEON TO SMOKERS OR TO PATIENTS BEING TREATED WITH A CYP1A2 INHIBITOR
Method of treatment
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF NON-24 HOUR SLEEP-WAKE DISORDER BY AVOIDING THE ADMINISTRATION OF TASIMELTEON WITH FOOD
Method of treatment
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY AVOIDING THE ADMINISTRATION OF TASIMELTEON WITH FOOD
Benzofuran and dihydrobenzofuran melatonergic agents
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF NON-24 HOUR SLEEP-WAKE DISORDER BY ADMINISTERING TASIMELTEON
Benzofuran and dihydrobenzofuran melatonergic agents
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY ADMINISTERING TASIMELTEON
Treatment of circadian rhythm disorders
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF NON-24-HOUR SLEEP-WAKE DISORDER BY AVOIDING THE USE OF TASIMELTEON IN COMBINATION WITH FLUVOXAMINE
Treatment of circadian rhythm disorders
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF NON-24-HOUR SLEEP-WAKE DISORDER BY AVOIDING THE USE OF TASIMELTEON IN COMBINATION WITH A STRONG CYP1A2 INHIBITOR
Treatment of circadian rhythm disorders
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF NON-24-HOUR SLEEP-WAKE DISORDER
Treatment of circadian rhythm disorders
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF NON-24-HOUR SLEEP-WAKE DISORDER BY AVOIDING THE USE OF TASIMELTEON IN COMBINATION WITH RIFAMPIN
Treatment of circadian rhythm disorders
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY AVOIDING THE USE OF TASIMELTEON WITH RIFAMPIN
Treatment of circadian rhythm disorders
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF NON-24 HOUR SLEEP-WAKE DISORDER BY ADMINISTERING TASIMELTEON
Treatment of circadian rhythm disorders
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF NON-24 HOUR SLEEP-WAKE DISORDER BY ORALLY ADMINISTERING 20MG OF TASIMELTEON ONCE DAILY BEFORE BEDTIME
FDA Regulatory Exclusivity protecting HETLIOZ
TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME (SMS) IN PATIENTS 16 YEARS OF AGE AND OLDER
Exclusivity Expiration: See Plans and Pricing
THE TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME (SMS) IN PATIENTS 16 YEARS OF AGE AND OLDER
Exclusivity Expiration: See Plans and Pricing
| 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 | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
| Vanda Pharms Inc | HETLIOZ LQ | tasimelteon | SUSPENSION;ORAL | 214517-001 | Dec 1, 2020 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| Vanda Pharms Inc | HETLIOZ | tasimelteon | CAPSULE;ORAL | 205677-001 | Jan 31, 2014 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| Vanda Pharms Inc | HETLIOZ LQ | tasimelteon | SUSPENSION;ORAL | 214517-001 | Dec 1, 2020 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
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
Estimated Expiration: See Plans and Pricing
Patent: 70405
Estimated Expiration: See Plans and Pricing
Japan
Patent: 21534
Estimated Expiration: See Plans and Pricing
Patent: 17506642
Estimated Expiration: See Plans and Pricing
Patent: 20079248
Estimated Expiration: See Plans and Pricing
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 |
|---|---|---|---|
| Japan | 2016172737 | 概日リズム障害の治療 (TREATMENT OF CIRCADIAN RHYTHM DISORDERS) | See Plans and Pricing |
| Norway | 321450 | See Plans and Pricing | |
| World Intellectual Property Organization (WIPO) | 9825606 | See Plans and Pricing | |
| South Korea | 101895653 | See Plans and Pricing | |
| >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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