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tasimelteon 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| 4820 | 609799-22-6 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
an agonist at melatonin MT1 and MT2 receptors, these receptors are thought to be involved in the control of circadian rhythms
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| Vd (Volume of distribution) | 0.33 L/kg | Lombardo F, Berellini G, Obach RS |
| CL (Clearance) | 9.04 mL/min/kg | Lombardo F, Berellini G, Obach RS |
| t_half (Half-life) | 0.75 hours | Lombardo F, Berellini G, Obach RS |
| fu (Fraction unbound in plasma) | 0.12 % | Kawashima H, Watanabe R, Esaki T, Kuroda M, Nagao C, Natsume-Kitatani Y, Ohashi R, Komura H, Mizuguchi K |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| kinase-safety-class | ACVR2B,AXL,BRAF,CAMK2D,CDK5,CDK9,EIF2AK3,ERBB2,GRK2,ITK,MAPKAPK2,PDK1,PDK2,PDK4,PRKDC | 15 | |||
| kinase-selectivity-class | PDK4 | 1 | |||
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Jan. 31, 2014 | FDA | VANDA PHARMS INC |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Drug ineffective | 354.57 | 44.77 | 282 | 2017 | 1384016 | 89242132 |
| Insomnia | 311.99 | 44.77 | 156 | 2143 | 333318 | 90292830 |
| Middle insomnia | 309.45 | 44.77 | 74 | 2225 | 16677 | 90609471 |
| Product dose omission issue | 244.61 | 44.77 | 127 | 2172 | 291560 | 90334588 |
| Incorrect product administration duration | 205.76 | 44.77 | 55 | 2244 | 19267 | 90606881 |
| Nightmare | 185.58 | 44.77 | 52 | 2247 | 21673 | 90604475 |
| Abnormal dreams | 183.42 | 44.77 | 45 | 2254 | 11212 | 90614936 |
| Somnolence | 154.71 | 44.77 | 84 | 2215 | 209000 | 90417148 |
| Initial insomnia | 130.48 | 44.77 | 33 | 2266 | 9277 | 90616871 |
| Therapeutic product effect delayed | 93.15 | 44.77 | 21 | 2278 | 3620 | 90622528 |
| Poor quality sleep | 75.40 | 44.77 | 27 | 2272 | 24666 | 90601482 |
| Therapeutic product effect decreased | 74.05 | 44.77 | 59 | 2240 | 277512 | 90348636 |
| Hypersomnia | 49.06 | 44.77 | 19 | 2280 | 21512 | 90604636 |
| Headache | 45.01 | 44.77 | 79 | 2220 | 862667 | 89763481 |
FDA Adverse Event Reporting System (Male)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Drug ineffective | 424.84 | 55.87 | 270 | 1369 | 629927 | 41989769 |
| Middle insomnia | 335.28 | 55.87 | 74 | 1565 | 7759 | 42611937 |
| Insomnia | 261.56 | 55.87 | 114 | 1525 | 118139 | 42501557 |
| Incorrect product administration duration | 237.31 | 55.87 | 53 | 1586 | 5827 | 42613869 |
| Nightmare | 173.50 | 55.87 | 56 | 1583 | 24956 | 42594740 |
| Product dose omission issue | 151.84 | 55.87 | 86 | 1553 | 154279 | 42465417 |
| Abnormal dreams | 139.72 | 55.87 | 37 | 1602 | 8234 | 42611462 |
| Somnolence | 118.33 | 55.87 | 71 | 1568 | 141034 | 42478662 |
| Therapeutic product effect decreased | 116.87 | 55.87 | 47 | 1592 | 39103 | 42580593 |
| Initial insomnia | 102.43 | 55.87 | 25 | 1614 | 4005 | 42615691 |
| Feeling abnormal | 57.89 | 55.87 | 35 | 1604 | 69751 | 42549945 |
| Poor quality sleep | 56.67 | 55.87 | 19 | 1620 | 9421 | 42610275 |
FDA Adverse Event Reporting System (Geriatric)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Drug ineffective | 446.01 | 53.04 | 319 | 2158 | 1520221 | 109066601 |
| Middle insomnia | 397.78 | 53.04 | 92 | 2385 | 20410 | 110566412 |
| Incorrect product administration duration | 355.46 | 53.04 | 84 | 2393 | 20414 | 110566408 |
| Insomnia | 306.46 | 53.04 | 152 | 2325 | 360438 | 110226384 |
| Nightmare | 261.21 | 53.04 | 75 | 2402 | 38788 | 110548034 |
| Product dose omission issue | 253.39 | 53.04 | 129 | 2348 | 321653 | 110265169 |
| Abnormal dreams | 224.57 | 53.04 | 53 | 2424 | 12727 | 110574095 |
| Somnolence | 163.03 | 53.04 | 94 | 2383 | 297355 | 110289467 |
| Initial insomnia | 121.08 | 53.04 | 31 | 2446 | 10358 | 110576464 |
| Therapeutic product effect decreased | 89.76 | 53.04 | 60 | 2417 | 244256 | 110342566 |
| Therapeutic product effect delayed | 75.58 | 53.04 | 18 | 2459 | 4461 | 110582361 |
| Poor quality sleep | 75.28 | 53.04 | 27 | 2450 | 28050 | 110558772 |
| Headache | 61.13 | 53.04 | 86 | 2391 | 882291 | 109704531 |
| Feeling abnormal | 53.65 | 53.04 | 39 | 2438 | 180672 | 110406150 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | N05CH03 | NERVOUS SYSTEM PSYCHOLEPTICS HYPNOTICS AND SEDATIVES Melatonin receptor agonists |
| FDA MoA | N0000000250 | Melatonin Receptor Agonists |
| FDA EPC | N0000175743 | Melatonin Receptor Agonist |
| CHEBI has role | CHEBI:35469 | antidepressant |
| CHEBI has role | CHEBI:79046 | melatonin receptor agonist |
| CHEBI has role | CHEBI:231911 | renoprotective agent |
Related Drugs by ATC class:
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Non-24 hour sleep-wake cycle | indication | 230496009 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 13.05 | acidic |
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| 20MG | HETLIOZ | VANDA PHARMS INC | N205677 | Jan. 31, 2014 | RX | CAPSULE | ORAL | 10149829 | Jan. 25, 2033 | TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME NON-24 HOUR SLEEP-WAKE DISORDER BY AVOIDING THE USE OF TASIMELTEON IN COMBINATION WITH CYP1A2 STRONG INHIBITORS |
| 20MG | HETLIOZ | VANDA PHARMS INC | N205677 | Jan. 31, 2014 | RX | CAPSULE | ORAL | 10149829 | Jan. 25, 2033 | TREATMENT OF NON-24 HOUR SLEEP-WAKE DISORDER BY AVOIDING THE USE OF TASIMELTEON IN COMBINATION WITH CYP1A2 STRONG INHIBITORS |
| 20MG | HETLIOZ | VANDA PHARMS INC | N205677 | Jan. 31, 2014 | RX | CAPSULE | ORAL | 10449176 | Jan. 25, 2033 | TREATMENT OF NON-24 HOUR SLEEP-WAKE DISORDER BY ADMINISTERING TASIMELTEON |
| 20MG | HETLIOZ | VANDA PHARMS INC | N205677 | Jan. 31, 2014 | RX | CAPSULE | ORAL | 10610510 | Jan. 25, 2033 | TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY ADMINISTERING TASIMELTEON TO PATIENTS WITH A SMOKING HISTORY |
| 20MG | HETLIOZ | VANDA PHARMS INC | N205677 | Jan. 31, 2014 | RX | CAPSULE | ORAL | 10610510 | Jan. 25, 2033 | TREATMENT OF NON-24 HOUR SLEEP-WAKE DISORDER BY ADMINISTERING TASIMELTEON TO PATIENTS WITH A SMOKING HISTORY |
| 20MG | HETLIOZ | VANDA PHARMS INC | N205677 | Jan. 31, 2014 | RX | CAPSULE | ORAL | 10945988 | Jan. 25, 2033 | TREATMENT OF NON-24 HOUR SLEEP-WAKE DISORDER BY ADMINISTERING TASIMELTEON |
| 20MG | HETLIOZ | VANDA PHARMS INC | N205677 | Jan. 31, 2014 | RX | CAPSULE | ORAL | 10980770 | Jan. 25, 2033 | TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY AVOIDING THE ADMINISTRATION OF TASIMELTEON TO SMOKERS OR TO PATIENTS BEING TREATED WITH A CYP1A2 INHIBITOR |
| 20MG | HETLIOZ | VANDA PHARMS INC | N205677 | Jan. 31, 2014 | RX | CAPSULE | ORAL | 10980770 | Jan. 25, 2033 | TREATMENT OF NON-24 HOUR SLEEP-WAKE DISORDER BY AVOIDING THE ADMINISTRATION OF TASIMELTEON TO SMOKERS OR TO PATIENTS BEING TREATED WITH A CYP1A2 INHIBITOR |
| 20MG | HETLIOZ | VANDA PHARMS INC | N205677 | Jan. 31, 2014 | RX | CAPSULE | ORAL | 11285129 | Jan. 25, 2033 | TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY AVOIDING THE ADMINISTRATION OF TASIMELTEON WITH BETA-ADRENERGIC RECEPTOR ANTAGONISTS |
| 20MG | HETLIOZ | VANDA PHARMS INC | N205677 | Jan. 31, 2014 | RX | CAPSULE | ORAL | 11285129 | Jan. 25, 2033 | TREATMENT OF NON-24-HOUR SLEEP-WAKE DISORDER BY AVOIDING THE ADMINISTRATION OF TASIMELTEON WITH BETA-ADRENERGIC RECEPTOR ANTAGONISTS |
| 20MG | HETLIOZ | VANDA PHARMS INC | N205677 | Jan. 31, 2014 | RX | CAPSULE | ORAL | 11633377 | Jan. 25, 2033 | TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY ADMINISTERING TASIMELTEON |
| 20MG | HETLIOZ | VANDA PHARMS INC | N205677 | Jan. 31, 2014 | RX | CAPSULE | ORAL | 11633377 | Jan. 25, 2033 | TREATMENT OF NON-24 HOUR SLEEP-WAKE DISORDER BY ADMINISTERING TASIMELTEON |
| 20MG | HETLIOZ | VANDA PHARMS INC | N205677 | Jan. 31, 2014 | RX | CAPSULE | ORAL | 11826339 | Jan. 25, 2033 | TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY AVOIDING THE ADMINISTRATION OF TASIMELTEON WITH BETA-ADRENERGIC RECEPTOR ANTAGONISTS |
| 20MG | HETLIOZ | VANDA PHARMS INC | N205677 | Jan. 31, 2014 | RX | CAPSULE | ORAL | 11826339 | Jan. 25, 2033 | TREATMENT OF NON-24-HOUR SLEEP-WAKE DISORDER BY AVOIDING THE ADMINISTRATION OF TASIMELTEON WITH BETA-ADRENERGIC RECEPTOR ANTAGONISTS |
| 20MG | HETLIOZ | VANDA PHARMS INC | N205677 | Jan. 31, 2014 | RX | CAPSULE | ORAL | 11833130 | Jan. 25, 2033 | TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY ADMINISTERING TASIMELTEON |
| 20MG | HETLIOZ | VANDA PHARMS INC | N205677 | Jan. 31, 2014 | RX | CAPSULE | ORAL | 11833130 | Jan. 25, 2033 | TREATMENT OF NON-24 HOUR SLEEP-WAKE DISORDER BY ADMINISTERING TASIMELTEON |
| 20MG | HETLIOZ | VANDA PHARMS INC | N205677 | Jan. 31, 2014 | RX | CAPSULE | ORAL | 11850229 | Jan. 25, 2033 | TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY AVOIDING THE ADMINISTRATION OF TASIMELTEON WITH BETA-ADRENERGIC RECEPTOR ANTAGONISTS |
| 20MG | HETLIOZ | VANDA PHARMS INC | N205677 | Jan. 31, 2014 | RX | CAPSULE | ORAL | 11850229 | Jan. 25, 2033 | TREATMENT OF NON-24-HOUR SLEEP-WAKE DISORDER BY AVOIDING THE ADMINISTRATION OF TASIMELTEON WITH BETA-ADRENERGIC RECEPTOR ANTAGONISTS |
| 20MG | HETLIOZ | VANDA PHARMS INC | N205677 | Jan. 31, 2014 | RX | CAPSULE | ORAL | 11918557 | Jan. 25, 2033 | TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY ADMINISTERING TASIMELTEON |
| 20MG | HETLIOZ | VANDA PHARMS INC | N205677 | Jan. 31, 2014 | RX | CAPSULE | ORAL | 11918557 | Jan. 25, 2033 | TREATMENT OF NON-24-HOUR SLEEP-WAKE DISORDER BY ADMINISTERING TASIMELTEON |
| 20MG | HETLIOZ | VANDA PHARMS INC | N205677 | Jan. 31, 2014 | RX | CAPSULE | ORAL | 12201604 | Jan. 25, 2033 | TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY ADMINISTERING TASIMELTEON |
| 20MG | HETLIOZ | VANDA PHARMS INC | N205677 | Jan. 31, 2014 | RX | CAPSULE | ORAL | 12201604 | Jan. 25, 2033 | TREATMENT OF NON-24-HOUR SLEEP-WAKE DISORDER BY ADMINISTERING TASIMELTEON |
| 20MG | HETLIOZ | VANDA PHARMS INC | N205677 | Jan. 31, 2014 | RX | CAPSULE | ORAL | 9060995 | Jan. 25, 2033 | TREATMENT OF NON-24-HOUR SLEEP-WAKE DISORDER BY AVOIDING THE USE OF TASIMELTEON IN COMBINATION WITH FLUVOXAMINE |
| 20MG | HETLIOZ | VANDA PHARMS INC | N205677 | Jan. 31, 2014 | RX | CAPSULE | ORAL | 9539234 | Jan. 25, 2033 | TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY AVOIDING THE AVOIDING THE USE OF TASIMELTEON IN COMBINATION WITH A STRONG CYP1A2 INHIBITOR |
| 20MG | HETLIOZ | VANDA PHARMS INC | N205677 | Jan. 31, 2014 | RX | CAPSULE | ORAL | 9539234 | Jan. 25, 2033 | TREATMENT OF NON-24-HOUR SLEEP-WAKE DISORDER BY AVOIDING THE USE OF TASIMELTEON IN COMBINATION WITH A STRONG CYP1A2 INHIBITOR |
| 20MG | HETLIOZ | VANDA PHARMS INC | N205677 | Jan. 31, 2014 | RX | CAPSULE | ORAL | 9549913 | Jan. 25, 2033 | TREATMENT OF NON-24-HOUR SLEEP-WAKE DISORDER |
| 20MG | HETLIOZ | VANDA PHARMS INC | N205677 | Jan. 31, 2014 | RX | CAPSULE | ORAL | 9855241 | Jan. 25, 2033 | TREATMENT OF NON-24 HOUR SLEEP-WAKE DISORDER BY ADMINISTERING TASIMELTEON |
| 20MG | HETLIOZ | VANDA PHARMS INC | N205677 | Jan. 31, 2014 | RX | CAPSULE | ORAL | RE46604 | Jan. 25, 2033 | TREATMENT OF NON-24 HOUR SLEEP-WAKE DISORDER BY ORALLY ADMINISTERING 20MG OF TASIMELTEON ONCE DAILY BEFORE BEDTIME |
| 4MG/ML | HETLIOZ LQ | VANDA PHARMS INC | N214517 | Dec. 1, 2020 | RX | SUSPENSION | ORAL | 10149829 | Jan. 25, 2033 | TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME NON-24 HOUR SLEEP-WAKE DISORDER BY AVOIDING THE USE OF TASIMELTEON IN COMBINATION WITH CYP1A2 STRONG INHIBITORS |
| 4MG/ML | HETLIOZ LQ | VANDA PHARMS INC | N214517 | Dec. 1, 2020 | RX | SUSPENSION | ORAL | 10610510 | Jan. 25, 2033 | TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY ADMINISTERING TASIMELTEON TO PATIENTS WITH A SMOKING HISTORY |
| 4MG/ML | HETLIOZ LQ | VANDA PHARMS INC | N214517 | Dec. 1, 2020 | RX | SUSPENSION | ORAL | 10980770 | Jan. 25, 2033 | TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY AVOIDING THE ADMINISTRATION OF TASIMELTEON TO SMOKERS OR TO PATIENTS BEING TREATED WITH A CYP1A2 INHIBITOR |
| 4MG/ML | HETLIOZ LQ | VANDA PHARMS INC | N214517 | Dec. 1, 2020 | RX | SUSPENSION | ORAL | 11285129 | Jan. 25, 2033 | TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY AVOIDING THE ADMINISTRATION OF TASIMELTEON WITH BETA-ADRENERGIC RECEPTOR ANTAGONISTS |
| 4MG/ML | HETLIOZ LQ | VANDA PHARMS INC | N214517 | Dec. 1, 2020 | RX | SUSPENSION | ORAL | 11633377 | Jan. 25, 2033 | TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY ADMINISTERING TASIMELTEON |
| 4MG/ML | HETLIOZ LQ | VANDA PHARMS INC | N214517 | Dec. 1, 2020 | RX | SUSPENSION | ORAL | 11826339 | Jan. 25, 2033 | TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY AVOIDING THE ADMINISTRATION OF TASIMELTEON WITH BETA-ADRENERGIC RECEPTOR ANTAGONISTS |
| 4MG/ML | HETLIOZ LQ | VANDA PHARMS INC | N214517 | Dec. 1, 2020 | RX | SUSPENSION | ORAL | 11833130 | Jan. 25, 2033 | TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY ADMINISTERING TASIMELTEON |
| 4MG/ML | HETLIOZ LQ | VANDA PHARMS INC | N214517 | Dec. 1, 2020 | RX | SUSPENSION | ORAL | 11850229 | Jan. 25, 2033 | TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY AVOIDING THE ADMINISTRATION OF TASIMELTEON WITH BETA-ADRENERGIC RECEPTOR ANTAGONISTS |
| 4MG/ML | HETLIOZ LQ | VANDA PHARMS INC | N214517 | Dec. 1, 2020 | RX | SUSPENSION | ORAL | 11918557 | Jan. 25, 2033 | TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY ADMINISTERING TASIMELTEON |
| 4MG/ML | HETLIOZ LQ | VANDA PHARMS INC | N214517 | Dec. 1, 2020 | RX | SUSPENSION | ORAL | 12201604 | Jan. 25, 2033 | TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY ADMINISTERING TASIMELTEON |
| 4MG/ML | HETLIOZ LQ | VANDA PHARMS INC | N214517 | Dec. 1, 2020 | RX | SUSPENSION | ORAL | 9539234 | Jan. 25, 2033 | TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY AVOIDING THE AVOIDING THE USE OF TASIMELTEON IN COMBINATION WITH A STRONG CYP1A2 INHIBITOR |
| 20MG | HETLIOZ | VANDA PHARMS INC | N205677 | Jan. 31, 2014 | RX | CAPSULE | ORAL | 11918556 | April 7, 2033 | TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY AVOIDING THE ADMINISTRATION OF TASIMELTEON WITH BETA-ADRENERGIC RECEPTOR ANTAGONISTS |
| 20MG | HETLIOZ | VANDA PHARMS INC | N205677 | Jan. 31, 2014 | RX | CAPSULE | ORAL | 11918556 | April 7, 2033 | TREATMENT OF NON-24-HOUR SLEEP-WAKE DISORDER BY AVOIDING THE ADMINISTRATION OF TASIMELTEON WITH BETA-ADRENERGIC RECEPTOR ANTAGONISTS |
| 4MG/ML | HETLIOZ LQ | VANDA PHARMS INC | N214517 | Dec. 1, 2020 | RX | SUSPENSION | ORAL | 11918556 | April 7, 2033 | TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY AVOIDING THE ADMINISTRATION OF TASIMELTEON WITH BETA-ADRENERGIC RECEPTOR ANTAGONISTS |
| 20MG | HETLIOZ | VANDA PHARMS INC | N205677 | Jan. 31, 2014 | RX | CAPSULE | ORAL | 9730910 | May 17, 2034 | TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY AVOIDING THE USE OF TASIMELTEON WITH RIFAMPIN |
| 20MG | HETLIOZ | VANDA PHARMS INC | N205677 | Jan. 31, 2014 | RX | CAPSULE | ORAL | 9730910 | May 17, 2034 | TREATMENT OF NON-24-HOUR SLEEP-WAKE DISORDER BY AVOIDING THE USE OF TASIMELTEON IN COMBINATION WITH RIFAMPIN |
| 4MG/ML | HETLIOZ LQ | VANDA PHARMS INC | N214517 | Dec. 1, 2020 | RX | SUSPENSION | ORAL | 9730910 | May 17, 2034 | TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY AVOIDING THE USE OF TASIMELTEON WITH RIFAMPIN |
| 20MG | HETLIOZ | VANDA PHARMS INC | N205677 | Jan. 31, 2014 | RX | CAPSULE | ORAL | 10610511 | Oct. 10, 2034 | TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY AVOIDING THE ADMINISTRATION OF TASIMELTEON WITH FOOD |
| 20MG | HETLIOZ | VANDA PHARMS INC | N205677 | Jan. 31, 2014 | RX | CAPSULE | ORAL | 10610511 | Oct. 10, 2034 | TREATMENT OF NON-24 HOUR SLEEP-WAKE DISORDER BY AVOIDING THE ADMINISTRATION OF TASIMELTEON WITH FOOD |
| 20MG | HETLIOZ | VANDA PHARMS INC | N205677 | Jan. 31, 2014 | RX | CAPSULE | ORAL | 11141400 | Oct. 10, 2034 | TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY AVOIDING THE ADMINISTRATION OF TASIMELTEON WITH FOOD |
| 20MG | HETLIOZ | VANDA PHARMS INC | N205677 | Jan. 31, 2014 | RX | CAPSULE | ORAL | 11141400 | Oct. 10, 2034 | TREATMENT OF NON-24 HOUR SLEEP-WAKE DISORDER BY AVOIDING THE ADMINISTRATION OF TASIMELTEON WITH FOOD |
| 20MG | HETLIOZ | VANDA PHARMS INC | N205677 | Jan. 31, 2014 | RX | CAPSULE | ORAL | 11786502 | Oct. 10, 2034 | TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY AVOIDING THE ADMINISTRATION OF TASIMELTEON WITH FOOD |
| 20MG | HETLIOZ | VANDA PHARMS INC | N205677 | Jan. 31, 2014 | RX | CAPSULE | ORAL | 11786502 | Oct. 10, 2034 | TREATMENT OF NON-24-HOUR SLEEP-WAKE DISORDER BY AVOIDING THE ADMINISTRATION OF TASIMELTEON WITH FOOD |
| 4MG/ML | HETLIOZ LQ | VANDA PHARMS INC | N214517 | Dec. 1, 2020 | RX | SUSPENSION | ORAL | 10610511 | Oct. 10, 2034 | TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY AVOIDING THE ADMINISTRATION OF TASIMELTEON WITH FOOD |
| 4MG/ML | HETLIOZ LQ | VANDA PHARMS INC | N214517 | Dec. 1, 2020 | RX | SUSPENSION | ORAL | 11141400 | Oct. 10, 2034 | TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY AVOIDING THE ADMINISTRATION OF TASIMELTEON WITH FOOD |
| 4MG/ML | HETLIOZ LQ | VANDA PHARMS INC | N214517 | Dec. 1, 2020 | RX | SUSPENSION | ORAL | 11786502 | Oct. 10, 2034 | TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY AVOIDING THE ADMINISTRATION OF TASIMELTEON WITH FOOD |
| 20MG | HETLIOZ | VANDA PHARMS INC | N205677 | Jan. 31, 2014 | RX | CAPSULE | ORAL | 10376487 | July 27, 2035 | TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY AVOIDING THE ADMINISTRATION OF TASIMELTEON WITH FOOD |
| 20MG | HETLIOZ | VANDA PHARMS INC | N205677 | Jan. 31, 2014 | RX | CAPSULE | ORAL | 10376487 | July 27, 2035 | TREATMENT OF NON-24 HOUR SLEEP-WAKE DISORDER BY AVOIDING THE ADMINISTRATION OF TASIMELTEON WITH FOOD |
| 4MG/ML | HETLIOZ LQ | VANDA PHARMS INC | N214517 | Dec. 1, 2020 | RX | SUSPENSION | ORAL | 10376487 | July 27, 2035 | TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY AVOIDING THE ADMINISTRATION OF TASIMELTEON WITH FOOD |
| 20MG | HETLIOZ | VANDA PHARMS INC | N205677 | Jan. 31, 2014 | RX | CAPSULE | ORAL | 10179119 | Aug. 29, 2035 | TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY ADMINISTERING TASIMELTEON |
| 20MG | HETLIOZ | VANDA PHARMS INC | N205677 | Jan. 31, 2014 | RX | CAPSULE | ORAL | 11266622 | Aug. 29, 2035 | TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY ADMINISTERING TASIMELTEON |
| 4MG/ML | HETLIOZ LQ | VANDA PHARMS INC | N214517 | Dec. 1, 2020 | RX | SUSPENSION | ORAL | 10179119 | Aug. 29, 2035 | TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY ADMINISTERING TASIMELTEON |
| 4MG/ML | HETLIOZ LQ | VANDA PHARMS INC | N214517 | Dec. 1, 2020 | RX | SUSPENSION | ORAL | 11266622 | Aug. 29, 2035 | TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY ADMINISTERING TASIMELTEON |
| 4MG/ML | HETLIOZ LQ | VANDA PHARMS INC | N214517 | Dec. 1, 2020 | RX | SUSPENSION | ORAL | 12447141 | Dec. 11, 2040 | TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY ADMINISTERING TASIMELTEON |
| 20MG | HETLIOZ | VANDA PHARMS INC | N205677 | Jan. 31, 2014 | RX | CAPSULE | ORAL | 11759446 | Feb. 21, 2041 | TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY ADMINISTERING TASIMELTEON |
| 4MG/ML | HETLIOZ LQ | VANDA PHARMS INC | N214517 | Dec. 1, 2020 | RX | SUSPENSION | ORAL | 11759446 | Feb. 21, 2041 | TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY ADMINISTERING TASIMELTEON |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 20MG | HETLIOZ | VANDA PHARMS INC | N205677 | Jan. 31, 2014 | RX | CAPSULE | ORAL | Dec. 1, 2027 | THE TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME (SMS) IN PATIENTS 16 YEARS OF AGE AND OLDER |
| 4MG/ML | HETLIOZ LQ | VANDA PHARMS INC | N214517 | Dec. 1, 2020 | RX | SUSPENSION | ORAL | Dec. 1, 2027 | FOR THE TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME (SMS) IN PEDIATRIC PATIENTS 3 TO 15 YEARS OF AGE |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Melatonin receptor type 1A | GPCR | AGONIST | Ki | 9.45 | SCIENTIFIC LITERATURE | SCIENTIFIC LITERATURE | |||
| Melatonin receptor type 1B | GPCR | AGONIST | Ki | 9.80 | SCIENTIFIC LITERATURE | SCIENTIFIC LITERATURE |
External reference:
| ID | Source |
|---|---|
| D09388 | KEGG_DRUG |
| 4033173 | VUID |
| N0000190488 | NUI |
| 4033173 | VANDF |
| CHEBI:79042 | CHEBI |
| CHEMBL2103822 | ChEMBL_ID |
| C478745 | MESH_SUPPLEMENTAL_RECORD_UI |
| 7393 | IUPHAR_LIGAND_ID |
| DB09071 | DRUGBANK_ID |
| 1490468 | RXNORM |
| 211275 | MMSL |
| 30166 | MMSL |
| 364462 | MMSL |
| d08240 | MMSL |
| 015295 | NDDF |
| 702394009 | SNOMEDCT_US |
| 704468000 | SNOMEDCT_US |
| C1313052 | UMLSCUI |
| 8985 | INN_ID |
| 10220503 | PUBCHEM_CID |
| SHS4PU80D9 | UNII |
| SHS4PU80D9 | INXIGHT DRUGS |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Tasimelteon | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0480-4490 | CAPSULE, GELATIN COATED | 20 mg | ORAL | ANDA | 27 sections |
| Hetlioz | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43068-220 | CAPSULE | 20 mg | ORAL | NDA | 34 sections |
| HetliozLQ | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43068-304 | SUSPENSION | 4 mg | ORAL | NDA | 34 sections |
| Tasimelteon | HUMAN PRESCRIPTION DRUG LABEL | 1 | 60505-4665 | CAPSULE | 20 mg | ORAL | ANDA | 29 sections |
| Tasimelteon | HUMAN PRESCRIPTION DRUG LABEL | 1 | 69238-2548 | CAPSULE | 20 mg | ORAL | ANDA | 31 sections |