Hetlioz is a drug owned by Vanda Pharmaceuticals Inc. It is protected by 31 US drug patents filed from 2014 to 2024. Out of these, 30 drug patents are active and 1 has expired. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 21, 2041. Details of Hetlioz's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance. | |||
| US5856529 | Benzofuran and dihydrobenzofuran melatonergic agents |
Dec, 2022
(1 year, 7 months ago) |
Expired
|
| US11566011 | Highly purified pharmaceutical grade tasimelteon |
Feb, 2035
(10 years from now) | Active |
| US10829465 | Highly purified pharmaceutical grade tasimelteon |
Feb, 2035
(10 years from now) | Active |
| US11760740 | Highly purified pharmaceutical grade tasimelteon |
Feb, 2035
(10 years from now) | Active |
| US10071977 | Highly purifid pharmaceutical grade tasimelteon |
Feb, 2035
(10 years from now) | Active |
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11633377 | Treatment of circadian rhythm disorders |
Jan, 2033
(8 years from now) | Active |
| US11918557 | Treatment of circadian rhythm disorders |
Jan, 2033
(8 years from now) | Active |
| US10610510 | Treatment of circadian rhythm disorders |
Jan, 2033
(8 years from now) | Active |
| US10980770 | Treatment of circadian rhythm disorders |
Jan, 2033
(8 years from now) | Active |
| US9060995 | Treatment of circadian rhythm disorders |
Jan, 2033
(8 years from now) | Active |
| US11850229 | Treatment of circadian rhythm disorders |
Jan, 2033
(8 years from now) | Active |
| US11833130 | Treatment of circadian rhythm disorders |
Jan, 2033
(8 years from now) | Active |
| US11826339 | Treatment of circadian rhythm disorders |
Jan, 2033
(8 years from now) | Active |
| US11285129 | Treatment of circadian rhythm disorders |
Jan, 2033
(8 years from now) | Active |
| US9549913 | Treatment of circadian rhythm disorders |
Jan, 2033
(8 years from now) | Active |
| US9855241 | Treatment of circadian rhythm disorders |
Jan, 2033
(8 years from now) | Active |
| USRE46604 | Treatment of circadian rhythm disorders |
Jan, 2033
(8 years from now) | Active |
| US10449176 | Treatment of circadian rhythm disorders |
Jan, 2033
(8 years from now) | Active |
| US10945988 | Treatment of circadian rhythm disorders |
Jan, 2033
(8 years from now) | Active |
| US8785492 | Treatment of circadian rhythm disorders |
Jan, 2033
(8 years from now) | Active |
| US9539234 | Treatment of circadian rhythm disorders |
Jan, 2033
(8 years from now) | Active |
| US10149829 | Treatment of circadian rhythm disorders |
Jan, 2033
(8 years from now) | Active |
| US11918556 | Treatment of circadian rhythm disorders |
Apr, 2033
(8 years from now) | Active |
| US9730910 | Treatment of circadian rhythm disorders |
May, 2034
(9 years from now) | Active |
| US11141400 | Method of treatment |
Oct, 2034
(10 years from now) | Active |
| US11786502 | Method of treatment |
Oct, 2034
(10 years from now) | Active |
| US10610511 | Method of treatment |
Oct, 2034
(10 years from now) | Active |
| US10376487 | Method of treatment |
Jul, 2035
(11 years from now) | Active |
| US11266622 | Method of treatment |
Aug, 2035
(11 years from now) | Active |
| US10179119 | Method of treatment |
Aug, 2035
(11 years from now) | Active |
| US11759446 | Liquid tasimelteon formulations and methods of use thereof |
Feb, 2041
(16 years from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Hetlioz's patents.
Latest Legal Activities on Hetlioz's Patents
Given below is the list of recent legal activities going on the following patents of Hetlioz.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 10 Jul, 2024 | US9539234 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 10 May, 2024 | US10829465 |
| Recordation of Patent eCertificate of Correction | 19 Mar, 2024 | US11826339 |
| Patent eCofC Notification | 19 Mar, 2024 | US11826339 |
| Email Notification | 19 Mar, 2024 | US11826339 |
| Mail Patent eCofC Notification | 19 Mar, 2024 | US11826339 |
| Email Notification | 05 Mar, 2024 | US11918556 |
| Mail Patent eGrant Notification | 05 Mar, 2024 | US11918556 |
| Patent eGrant Notification | 05 Mar, 2024 | US11918556 |
| Patent Issue Date Used in PTA Calculation | 05 Mar, 2024 | US11918556 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Hetlioz and ongoing litigations to help you estimate the early arrival of Hetlioz generic.
Hetlioz's Litigations
Hetlioz has been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Dec 29, 2017, against patent number US10376487. The petitioner , challenged the validity or infringement of this patent, with Vanda Pharmaceuticals, Inc. as the respondent. Click below to track the latest information on how companies are challenging Hetlioz's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US10376487 | December, 2017 | Decision | Vanda Pharmaceuticals, Inc. | |
FDA has granted some exclusivities to Hetlioz. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Hetlioz, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Hetlioz.
Exclusivity Information
Hetlioz holds 5 exclusivities out of which 4 have expired. Its last outstanding exclusivity is set to expire in 2027. Details of Hetlioz's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jan 31, 2019 |
| Orphan Drug Exclusivity(ODE) | Jan 31, 2021 |
| Orphan Drug Exclusivity(ODE-59) | Jan 31, 2021 |
| New Indication(I-850) | Dec 01, 2023 |
| Orphan Drug Exclusivity(ODE-330) | Dec 01, 2027 |
US patents provide insights into the exclusivity only within the United States, but Hetlioz is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Hetlioz's family patents as well as insights into ongoing legal events on those patents.
Hetlioz's family patents
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Generic Launch
Generic Release Date:
Hetlioz's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Feb 21, 2041 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Hetlioz Generics:
Tasimelteon is the generic name for the brand Hetlioz. 3 different companies have already filed for the generic of Hetlioz, with Apotex having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Hetlioz's generic
How can I launch a generic of Hetlioz before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Hetlioz's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Hetlioz's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Hetlioz -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 20 mg | 31 Jan, 2018 | 3 | 12 Dec, 2022 | 17 May, 2034 | Eligible Deferred |
About Hetlioz
Hetlioz is a drug owned by Vanda Pharmaceuticals Inc. It is used for treating nighttime sleep disturbances in Smith-Magenis syndrome and non-24-hour sleep-wake disorder with tasimelteon. Hetlioz uses Tasimelteon as an active ingredient. Hetlioz was launched by Vanda Pharms Inc in 2014.
Market Authorisation Date:
Hetlioz was approved by FDA for market use on 31 January, 2014.
NCE-1 date:
NCE-1 date is also known as the four year date as it is four years after the original drug approval. Since the approval date for Hetlioz is 31 January, 2014, its NCE-1 date is estimated to be 31 January, 2018
Active Ingredient:
Hetlioz uses Tasimelteon as the active ingredient. Check out other Drugs and Companies using Tasimelteon ingredient
Treatment:
Hetlioz is used for treating nighttime sleep disturbances in Smith-Magenis syndrome and non-24-hour sleep-wake disorder with tasimelteon.
Dosage:
Hetlioz is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 20MG | CAPSULE | Prescription | ORAL |