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HETLIOZ Drug Profile
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» See Plans and PricingWhen 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 one NDA. There are eleven patents protecting this drug and two Paragraph IV challenges.
This drug has one hundred and twenty-eight 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 ten 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.
Indicators of Generic Entry
Summary for HETLIOZ
| International Patents: | 128 |
| US Patents: | 11 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 43 |
| Clinical Trials: | 2 |
| Patent Applications: | 37 |
| Drug Prices: | Drug price information for HETLIOZ |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for HETLIOZ |
| 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 |
Recent Litigation for HETLIOZ
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Vanda Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc. | 2020-01-22 |
| Vanda Pharmaceuticals Inc. v. Apotex Inc. | 2020-01-21 |
| Vanda Pharmaceuticals Inc. v. Apotex Inc. | 2019-12-30 |
Pharmacology for HETLIOZ
| Drug Class | Melatonin Receptor Agonist |
| Mechanism of Action | Melatonin Receptor Agonists |
Synonyms for HETLIOZ
| (-)-(trans)-N-[[2-(2,3-Dihydrobenzofuran-4-yl)cycloprop-1-yl] methyl]propanamide |
| (trans)-N-[[2-(2,3-dihydrobenzofuran-4-yl) cyclopropyl]methyl]propanamide |
| (trans)-N-[[2-(2,3-dihydrobenzofuran-4-yl)cyclopropyl]methyl]propanamide |
| 609799-22-6 |
| 799T226 |
| AC-6143 |
| ACT06729 |
| AK188029 |
| AKOS025149360 |
| AS-35291 |
| BCP07180 |
| BMS 214778 |
| BMS-214,778 |
| BMS-214778 |
| CHEBI:79042 |
| CHEMBL2103822 |
| CS-5512 |
| D09388 |
| DB09071 |
| DTXSID70209826 |
| EX-A2729 |
| GTPL7393 |
| Hetlioz (TN) |
| HY-14803 |
| J3.640.465E |
| KS-0000063S |
| N-(((1R,2R)-2-(2,3-Dihydro-1-benzofuran-4-yl)cyclopropyl)methyl)propanamide |
| N-(((1R,2R)-2-(2,3-dihydrobenzofuran-4-yl)cyclopropyl)methyl)propionamide |
| N-([(1r,2r)-2-(2,3-dihydro-1-benzofuran-4-yl)cyclopropyl]methyl)propanamide |
| N-[[(1R,2R)-2-(2,3-dihydro-1-benzofuran-4-yl)cyclopropyl]methyl]propanamide |
| N-{[(1R,2R)-2-(2,3-dihydro-1-benzofuran-4-yl)cyclopropyl]methyl}propanamide |
| Propanamide, N-(((1R,2R)-2-(2,3-dihydro-4-benzofuranyl)cyclopropyl)methyl)- |
| PTOIAAWZLUQTIO-GXFFZTMASA-N |
| Q7687250 |
| s4281 |
| SB16782 |
| SCHEMBL3505912 |
| SHS4PU80D9 |
| Tasimelteon |
| Tasimelteon (USAN/INN) |
| Tasimelteon [USAN:INN] |
| Tasimelteon, >=98% (HPLC) |
| tasimelteonum |
| UNII-SHS4PU80D9 |
| VEC 162 |
| VEC-162 |
| X5820 |
| ZINC4392649 |
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 | tasimelteon | CAPSULE;ORAL | 205677-001 | Jan 31, 2014 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Vanda Pharms Inc | HETLIOZ | tasimelteon | CAPSULE;ORAL | 205677-001 | Jan 31, 2014 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Vanda Pharms Inc | HETLIOZ | tasimelteon | CAPSULE;ORAL | 205677-001 | Jan 31, 2014 | 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
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| China | 110200958 | Start Trial |
| Spain | 2646197 | Start Trial |
| South Korea | 20160106735 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
