Hetlioz Lq is a drug owned by Vanda Pharmaceuticals Inc. It is protected by 27 US drug patents filed from 2021 to 2025. Out of these, 26 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 Lq'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. | |||
| US10071977 | Highly purifid pharmaceutical grade tasimelteon |
Feb, 2035
(9 years from now) | Active |
| US11566011 | 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 |
| US11760740 | 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 |
| 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 |
| US11202770 | Liquid tasimelteon formulations and methods of use thereof |
Dec, 2040
(15 years from now) | Active |
| US11266622 | Method of treatment |
Aug, 2035
(10 years from now) | Active |
| US10179119 | Method of treatment |
Aug, 2035
(10 years from now) | Active |
| US10376487 | Method of treatment |
Jul, 2035
(10 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 |
| US11786502 | Method of treatment |
Oct, 2034
(9 years from now) | Active |
| US9730910 | Treatment of circadian rhythm disorders |
May, 2034
(9 years from now) | Active |
| US11918556 | Treatment of circadian rhythm disorders |
Apr, 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 |
| US10149829 | 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 |
| US10610510 | 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 |
| US11833130 | 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 |
| US11918557 | 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 |
| US10980770 | 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 Lq's patents.
Latest Legal Activities on Hetlioz Lq's Patents
Given below is the list of recent legal activities going on the following patents of Hetlioz Lq.
| 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 |
| Email Notification Critical | 19 Mar, 2024 | US11826339 |
| Recordation of Patent eCertificate of Correction | 19 Mar, 2024 | US11826339 |
| Mail Patent eCofC Notification | 19 Mar, 2024 | US11826339 |
| 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 Lq and ongoing litigations to help you estimate the early arrival of Hetlioz Lq generic.
Hetlioz Lq's Litigations
Hetlioz Lq 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 Lq'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 Lq. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Hetlioz Lq, 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 Lq.
Exclusivity Information
Hetlioz Lq holds 2 exclusivities out of which 1 have expired. Its last outstanding exclusivity is set to expire in 2027. Details of Hetlioz Lq's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Dec 01, 2023 |
| Orphan Drug Exclusivity(ODE-329) | Dec 01, 2027 |
US patents provide insights into the exclusivity only within the United States, but Hetlioz Lq 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 Lq's family patents as well as insights into ongoing legal events on those patents.
Hetlioz Lq's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Hetlioz Lq'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 Lq Generic API suppliers:
Tasimelteon is the generic name for the brand Hetlioz Lq. 3 different companies have already filed for the generic of Hetlioz Lq, with Apotex having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Hetlioz Lq's generic
Alternative Brands for Hetlioz Lq
Hetlioz Lq which is used for treating nighttime sleep disturbances in Smith-Magenis syndrome and non-24-hour sleep-wake disorder., 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 Lq's active ingredient. Check the complete list of approved generic manufacturers for Hetlioz Lq
About Hetlioz Lq
Hetlioz Lq 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. Hetlioz Lq uses Tasimelteon as an active ingredient. Hetlioz Lq was launched by Vanda Pharms Inc in 2020.
Approval Date:
Hetlioz Lq was approved by FDA for market use on 01 December, 2020.
Active Ingredient:
Hetlioz Lq uses Tasimelteon as the active ingredient. Check out other Drugs and Companies using Tasimelteon ingredient
Treatment:
Hetlioz Lq is used for treating nighttime sleep disturbances in Smith-Magenis syndrome and non-24-hour sleep-wake disorder.
Dosage:
Hetlioz Lq is available in suspension form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 4MG/ML | SUSPENSION | Prescription | ORAL |