DrugPatentWatch Database Preview
HETLIOZ Drug Profile
Which patents cover Hetlioz, and what generic alternatives are available?
Hetlioz is a drug marketed by Vanda Pharms Inc and is included in one NDA. There are ten patents protecting this drug and two Paragraph IV challenges.
This drug has one hundred and twenty-three 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.
Summary for HETLIOZ
| International Patents: | 123 |
| US Patents: | 10 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 39 |
| 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. MSN Pharmaceuticals Inc. | 2019-05-17 |
| Vanda Pharmaceuticals Inc. v. Apotex Inc. | 2019-04-12 |
| Vanda Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc. | 2019-03-22 |
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 |
| 209255-28-7 |
| 609799-22-6 |
| 799T226 |
| AC-6143 |
| ACT06729 |
| AK188029 |
| AKOS025149360 |
| AN-10364 |
| AS-35291 |
| BCP07180 |
| BMS 214778 |
| BMS-214778 |
| CHEBI:79042 |
| CHEMBL2103822 |
| CS-5512 |
| D09388 |
| DB09071 |
| DTXSID70209826 |
| EX-A2729 |
| GTPL7393 |
| Hetlioz (TN) |
| HY-14803 |
| J3.640.465E |
| KS-0000063S |
| MolPort-028-600-027 |
| 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-dihydrobenzofuran-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 |
| SB16782 |
| SCHEMBL3505912 |
| SHS4PU80D9 |
| Tasimelteon |
| Tasimelteon (USAN/INN) |
| Tasimelteon [USAN:INN] |
| Tasimelteon, >=98% (HPLC) |
| tasimelteonum |
| UNII-SHS4PU80D9 |
| VEC 162 |
| VEC-162 |
| X5820 |
| ZINC4392649 |
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 | ||||
| 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 | Y | Y | 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 |
Paragraph IV (Patent) Challenges for HETLIOZ
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Capsules | 20 mg | ➤ Subscribe | Start Trial |
| ➤ Subscribe | Capsules | 20 mg | ➤ Subscribe | Start Trial |
International Patents for HETLIOZ
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Colombia | 7131353 | Start Trial |
| Norway | 992804 | Start Trial |
| China | 107072978 | Start Trial |
| Czech Republic | 297673 | Start Trial |
| Spain | 2230626 | Start Trial |
| Australia | 2018201302 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
