DrugPatentWatch Database Preview
HETLIOZ LQ Drug Profile
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When do Hetlioz Lq patents expire, and when can generic versions of Hetlioz Lq launch?
Hetlioz Lq is a drug marketed by Vanda Pharms Inc and is included in one NDA. There are ten patents protecting this drug.
This drug has one hundred and sixty-two patent family members in thirty-one countries.
The generic ingredient in HETLIOZ LQ 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 Lq
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 nine 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 is one tentative approval for the generic drug (tasimelteon), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
Summary for HETLIOZ LQ
| International Patents: | 162 |
| US Patents: | 10 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Clinical Trials: | 2 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for HETLIOZ LQ |
| DailyMed Link: | HETLIOZ LQ at DailyMed |
DrugPatentWatch® Estimated Generic Entry Opportunity Date for HETLIOZ LQ
Generic Entry Date for HETLIOZ LQ*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SUSPENSION;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 LQ
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Vanda Pharmaceuticals | Phase 1 |
| Vanda Pharmaceuticals | Phase 4 |
Pharmacology for HETLIOZ LQ
| Drug Class | Melatonin Receptor Agonist |
| Mechanism of Action | Melatonin Receptor Agonists |
US Patents and Regulatory Information for HETLIOZ LQ
| 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 | Start Trial | Start Trial | Start Trial | ||||
| Vanda Pharms Inc | HETLIOZ LQ | tasimelteon | SUSPENSION;ORAL | 214517-001 | Dec 1, 2020 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Vanda Pharms Inc | HETLIOZ LQ | tasimelteon | SUSPENSION;ORAL | 214517-001 | Dec 1, 2020 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Vanda Pharms Inc | HETLIOZ LQ | tasimelteon | SUSPENSION;ORAL | 214517-001 | Dec 1, 2020 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Vanda Pharms Inc | HETLIOZ LQ | tasimelteon | SUSPENSION;ORAL | 214517-001 | Dec 1, 2020 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| >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 LQ
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Chile | 2014001992 | Start Trial |
| Chile | 2015001700 | Start Trial |
| South Korea | 20150093236 | Start Trial |
| Japan | 2020079248 | Start Trial |
| South Korea | 102171965 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
