tasimelteon Oral Capsule
- Brand(s)
- Hetlioz
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Vanda Pharmaceuticals Inc. (2014-12-18)
- Oldest Current Product
- 2014-04-04
- License(s)
- NDA
- RxNORM
- ORAL CAPSULE\TASIMELTEON
- FDAOB
- ORAL\CAPSULE\TASIMELTEON
- SPL Active
- ORAL\CAPSULE\TASIMELTEON
- SPL Moiety
- ORAL\CAPSULE\TASIMELTEON
product(s) by strength(s)
tasimelteon 20 mg oral capsule
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 430680220 | Hetlioz | NDA | Vanda Pharmaceuticals Inc. | 2014-04-04 | TASIMELTEON | ORAL | CAPSULE | NDA205677 | ca4a9b63-708e-49e9-8f9b-010625443b90 |
application(s)
| # | id | title | applicant | approved | patent | exclusivity | approved drug |
|---|---|---|---|---|---|---|---|
| 1 | NDA205677 | HETLIOZ | VANDA PHARMACEUTICALS INC | 2014-01-31 | p5856529, TREATMENT OF NON-24-HOUR SLEEP-WAKE DISORDER, SUBSTANCE p9060995, TREATMENT OF NON-24-HOUR SLEEP-WAKE DISORDER BY AVOIDING THE USE OF TASIMELTEON IN COMBINATION WITH FLUVOXAMINE p8785492, TREATMENT OF NON-24-HOUR SLEEP-WAKE DISORDER | NEW CHEMICAL ENTITY [2019-01-31] ORPHAN DRUG EXCLUSIVITY [2021-01-31] | NDA205677_001 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | route | dose form | rld | approved | application |
|---|---|---|---|---|---|---|---|---|
| 1 | NDA205677_001 | RX | TASIMELTEON (20MG) | ORAL | CAPSULE | True | 2014-01-31 | HETLIOZ |
patent(s)
| # | id | expiration date | application(s) |
|---|---|---|---|
| 1 | p5856529 (view patent) | 2017-12-09 | NDA205677 |
| 2 | p8785492 (view patent) | 2033-01-25 | NDA205677 |
| 3 | p9060995 (view patent) | 2033-01-25 | NDA205677 |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | ca4a9b63-708e-49e9-8f9b-010625443b90 (view SPL) | These highlights do not include all the information needed to use HETLIOZ safely and effectively. See full prescribing information for HETLIOZ. HETLIOZ (tasimelteon) capsules, for oral useInitial U.S. Approval: 2014 | prescription | Human Prescription | Vanda Pharmaceuticals Inc. | ANALYSIS, API MANUFACTURE, MANUFACTURE, PACK | 2014-12-18 | 5 | 430680220 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII