Hetlioz is a drug owned by Vanda Pharmaceuticals Inc. It is protected by 33 US drug patents filed from 2014 to 2025. Out of these, 32 drug patents are active and 1 has expired. Hetlioz's patents have been open to challenges since 31 January, 2018. 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 protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US11566011 | Highly purified pharmaceutical grade tasimelteon |
Feb, 2035
(9 years from now) | Active |
| US11760740 | Highly purified pharmaceutical grade tasimelteon |
Feb, 2035
(9 years from now) | Active |
| US12049457 | Highly purified pharmaceutical grade tasimelteon |
Feb, 2035
(9 years from now) | Active |
| US10829465 | Highly purified pharmaceutical grade tasimelteon |
Feb, 2035
(9 years from now) | Active |
| US10071977 | Highly purifid pharmaceutical grade tasimelteon |
Feb, 2035
(9 years from now) | Active |
| US5856529 | Benzofuran and dihydrobenzofuran melatonergic agents |
Dec, 2022
(2 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11759446 | Liquid tasimelteon formulations and methods of use thereof |
Feb, 2041
(15 years from now) | Active |
| US10179119 | Method of treatment |
Aug, 2035
(10 years from now) | Active |
| US11266622 | Method of treatment |
Aug, 2035
(10 years from now) | Active |
| US10376487 | Method of treatment |
Jul, 2035
(10 years from now) | Active |
| US11786502 | Method of treatment |
Oct, 2034
(9 years from now) | Active |
| US10610511 | Method of treatment |
Oct, 2034
(9 years from now) | Active |
| US11141400 | Method of treatment |
Oct, 2034
(9 years from now) | Active |
| US9730910 | Treatment of circadian rhythm disorders |
May, 2034
(8 years from now) | Active |
| US11918556 | Treatment of circadian rhythm disorders |
Apr, 2033
(7 years from now) | Active |
| US10980770 | Treatment of circadian rhythm disorders |
Jan, 2033
(7 years from now) | Active |
| US11285129 | Treatment of circadian rhythm disorders |
Jan, 2033
(7 years from now) | Active |
| US11918557 | Treatment of circadian rhythm disorders |
Jan, 2033
(7 years from now) | Active |
| US11826339 | Treatment of circadian rhythm disorders |
Jan, 2033
(7 years from now) | Active |
| US11633377 | Treatment of circadian rhythm disorders |
Jan, 2033
(7 years from now) | Active |
| US12201604 | Treatment of circadian rhythm disorders |
Jan, 2033
(7 years from now) | Active |
| US9060995 | Treatment of circadian rhythm disorders |
Jan, 2033
(7 years from now) | Active |
| US9539234 | Treatment of circadian rhythm disorders |
Jan, 2033
(7 years from now) | Active |
| US10149829 | Treatment of circadian rhythm disorders |
Jan, 2033
(7 years from now) | Active |
| US9549913 | Treatment of circadian rhythm disorders |
Jan, 2033
(7 years from now) | Active |
| US9855241 | Treatment of circadian rhythm disorders |
Jan, 2033
(7 years from now) | Active |
| USRE46604 | Treatment of circadian rhythm disorders |
Jan, 2033
(7 years from now) | Active |
| US10449176 | Treatment of circadian rhythm disorders |
Jan, 2033
(7 years from now) | Active |
| US10945988 | Treatment of circadian rhythm disorders |
Jan, 2033
(7 years from now) | Active |
| US11850229 | Treatment of circadian rhythm disorders |
Jan, 2033
(7 years from now) | Active |
| US11833130 | Treatment of circadian rhythm disorders |
Jan, 2033
(7 years from now) | Active |
| US10610510 | Treatment of circadian rhythm disorders |
Jan, 2033
(7 years from now) | Active |
| US8785492 | Treatment of circadian rhythm disorders |
Jan, 2033
(7 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.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| 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 Critical | 19 Mar, 2024 | US11826339 |
| Mail Patent eCofC Notification | 19 Mar, 2024 | US11826339 |
| Email Notification Critical | 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 Critical | 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 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 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
(13 Feb, 2019) | 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
Explore Our Curated Drug Screens
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 Generic API suppliers:
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 |
Alternative Brands for Hetlioz
Hetlioz which is used for treating nighttime sleep disturbances in Smith-Magenis syndrome and non-24-hour sleep-wake disorder with tasimelteon., has several other brand drugs in the same treatment category and using the same active ingredient (Tasimelteon). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | Treatment Area | ||
|---|---|---|---|---|
| Vanda Pharms Inc |
| |||
Apart from brand drugs containing the same ingredient, some generics have also been filed for Tasimelteon, Hetlioz's active ingredient. Check the complete list of approved generic manufacturers for Hetlioz
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.
Approval Date:
Hetlioz was approved by FDA for market use on 31 January, 2014.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. 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 |