DrugPatentWatch Database Preview
HETLIOZ Drug Profile
» See Plans and Pricing
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 fifteen patents protecting this drug and two Paragraph IV challenges.
This drug has one hundred and sixty 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.
US ANDA Litigation and 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 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
| International Patents: | 160 |
| US Patents: | 15 |
| Applicants: | 1 |
| NDAs: | 2 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 47 |
| Clinical Trials: | 2 |
| Patent Applications: | 208 |
| 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 |
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 |
Paragraph IV (Patent) Challenges for HETLIOZ
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| HETLIOZ | CAPSULE;ORAL | tasimelteon | 205677 | 2018-01-31 |
US Patents and Regulatory Information for HETLIOZ
| 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 | Y | Y | 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 | ||
| >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
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 2934509 | Start Trial |
| Canada | 2957588 | Start Trial |
| Mexico | 2017002796 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
