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iloperidone 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| antipsychotics, risperidone derivatives | 3294 | 133454-47-4 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
an atypical, negative symptom antipsychotic agent
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 18 | mg | O |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 2 | Benet LZ, Broccatelli F, Oprea TI |
| S (Water solubility) | 0.03 mg/mL | Benet LZ, Broccatelli F, Oprea TI |
| EoM (Fraction excreted unchanged in urine) | 0.50 % | Benet LZ, Broccatelli F, Oprea TI |
| MRTD (Maximum Recommended Therapeutic Daily Dose) | 0.80 µM/kg/day | Contrera JF, Matthews EJ, Kruhlak NL, Benz RD |
| BA (Bioavailability) | 96 % |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| kinase-safety-class | ACVR2A,ACVR2B,AKT2,AKT3,ALK,AURKA,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK4,CDK5,CDK9,CHEK1,DDR1,DYRK1B,EIF2AK3,EPHB4,ERBB2,FLT3,GRK2,ITK,JAK1,JAK2,JAK3,MAP3K21,MAP3K7,MAPK10,MAPK12,MAPK7,MAPK9,MARK4,MET,MTOR,NTRK2,PAK4,PDK2,PDK4,PDPK1,PIK3CB,PIM2,PRKCD,PRKDC,SIK2,SIK3,STK33,SYK,TEK,TTK,ULK1 | 51 | |||
| kinase-selectivity-class | AXL,PDK4,SIK2,TTK | 4 | |||
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| May 6, 2009 | 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 |
|---|---|---|---|---|---|---|
| Orthostatic hypotension | 45.05 | 38.87 | 15 | 597 | 41812 | 90586023 |
| Dizziness | 41.49 | 38.87 | 33 | 579 | 589251 | 90038584 |
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 |
|---|---|---|---|---|---|---|
| Decreased eye contact | 167.51 | 64.90 | 26 | 1229 | 497 | 42619583 |
| Oppositional defiant disorder | 165.18 | 64.90 | 26 | 1229 | 546 | 42619534 |
| Retrograde ejaculation | 137.53 | 64.90 | 22 | 1233 | 513 | 42619567 |
| Bruxism | 130.57 | 64.90 | 26 | 1229 | 2143 | 42617937 |
| Homicidal ideation | 124.00 | 64.90 | 26 | 1229 | 2768 | 42617312 |
| Crying | 102.58 | 64.90 | 26 | 1229 | 6368 | 42613712 |
| Coordination abnormal | 96.64 | 64.90 | 26 | 1229 | 8024 | 42612056 |
| Dyskinesia | 85.59 | 64.90 | 31 | 1224 | 25359 | 42594721 |
| Trismus | 84.03 | 64.90 | 19 | 1236 | 2865 | 42617215 |
| Choreoathetosis | 83.24 | 64.90 | 16 | 1239 | 1093 | 42618987 |
| Priapism | 83.07 | 64.90 | 22 | 1233 | 6385 | 42613695 |
| Speech disorder | 74.29 | 64.90 | 29 | 1226 | 29092 | 42590988 |
| Hyperkinesia | 73.07 | 64.90 | 16 | 1239 | 2082 | 42617998 |
| Streptococcal infection | 69.79 | 64.90 | 19 | 1236 | 6113 | 42613967 |
| Affect lability | 67.57 | 64.90 | 17 | 1238 | 4027 | 42616053 |
| Psychomotor hyperactivity | 67.18 | 64.90 | 21 | 1234 | 10937 | 42609143 |
| Poor quality sleep | 65.95 | 64.90 | 20 | 1235 | 9420 | 42610660 |
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 |
|---|---|---|---|---|---|---|
| Oppositional defiant disorder | 191.92 | 57.42 | 26 | 1259 | 492 | 110587522 |
| Decreased eye contact | 177.13 | 57.42 | 26 | 1259 | 889 | 110587125 |
| Homicidal ideation | 141.35 | 57.42 | 26 | 1259 | 3601 | 110584413 |
| Bruxism | 133.05 | 57.42 | 26 | 1259 | 4968 | 110583046 |
| Coordination abnormal | 104.85 | 57.42 | 29 | 1256 | 25199 | 110562815 |
| Dyskinesia | 104.43 | 57.42 | 34 | 1251 | 51412 | 110536602 |
| Choreoathetosis | 98.03 | 57.42 | 17 | 1268 | 1681 | 110586333 |
| Crying | 90.76 | 57.42 | 26 | 1259 | 25602 | 110562412 |
| Trismus | 85.96 | 57.42 | 19 | 1266 | 6577 | 110581437 |
| Hyperkinesia | 81.25 | 57.42 | 16 | 1269 | 3168 | 110584846 |
| Aggression | 80.50 | 57.42 | 29 | 1256 | 59181 | 110528833 |
| Streptococcal infection | 76.49 | 57.42 | 19 | 1266 | 10871 | 110577143 |
| Speech disorder | 75.69 | 57.42 | 28 | 1257 | 61541 | 110526473 |
| Suicidal ideation | 70.83 | 57.42 | 30 | 1255 | 93907 | 110494107 |
| Psychomotor hyperactivity | 69.22 | 57.42 | 20 | 1265 | 20257 | 110567757 |
| Mood altered | 68.17 | 57.42 | 20 | 1265 | 21355 | 110566659 |
| Retrograde ejaculation | 66.51 | 57.42 | 10 | 1275 | 401 | 110587613 |
| Poor quality sleep | 62.80 | 57.42 | 20 | 1265 | 28057 | 110559957 |
| Affect lability | 57.50 | 57.42 | 17 | 1268 | 18620 | 110569394 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | N05AX14 | NERVOUS SYSTEM PSYCHOLEPTICS ANTIPSYCHOTICS Other antipsychotics |
| FDA EPC | N0000175430 | Atypical Antipsychotic |
| MeSH PA | D002491 | Central Nervous System Agents |
| MeSH PA | D002492 | Central Nervous System Depressants |
| MeSH PA | D011619 | Psychotropic Drugs |
| MeSH PA | D014149 | Tranquilizing Agents |
| MeSH PA | D014150 | Antipsychotic Agents |
| CHEBI has role | CHEBI:35469 | antidepressant |
| CHEBI has role | CHEBI:48279 | serotonergic antagonist |
| CHEBI has role | CHEBI:48561 | dopaminergic antagonist |
| CHEBI has role | CHEBI:65191 | second generation antipsychotic |
Related Drugs by ATC class:
N05AX Other antipsychotics 11 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Schizophrenia | indication | 58214004 | DOID:5419 |
| Depression Treatment Adjunct | off-label use | ||
| Priapism | contraindication | 6273006 | DOID:9286 |
| Weight gain finding | contraindication | 8943002 | |
| Neuroleptic malignant syndrome | contraindication | 15244003 | DOID:14464 |
| Senile dementia | contraindication | 15662003 | |
| Lowered convulsive threshold | contraindication | 19260006 | |
| Myocardial infarction | contraindication | 22298006 | DOID:5844 |
| Orthostatic hypotension | contraindication | 28651003 | |
| Torsades de pointes | contraindication | 31722008 | |
| Dysphagia | contraindication | 40739000 | |
| Hypokalemia | contraindication | 43339004 | |
| Conduction disorder of the heart | contraindication | 44808001 | |
| Bradycardia | contraindication | 48867003 | |
| Diabetes mellitus | contraindication | 73211009 | DOID:9351 |
| Hyperglycemia | contraindication | 80394007 | DOID:4195 |
| Leukopenia | contraindication | 84828003 | DOID:615 |
| Tardive dyskinesia | contraindication | 102449007 | |
| Prolonged QT interval | contraindication | 111975006 | |
| Seizure disorder | contraindication | 128613002 | |
| Hypomagnesemia | contraindication | 190855004 | |
| Disease of liver | contraindication | 235856003 | DOID:409 |
| Hyperprolactinemia | contraindication | 237662005 | DOID:12700 |
| Suicidal | contraindication | 267073005 | |
| Neutropenic disorder | contraindication | 303011007 | DOID:1227 |
| Impaired cognition | contraindication | 386806002 | |
| Breastfeeding (mother) | contraindication | 413712001 | |
| Obesity | contraindication | 414916001 | DOID:9970 |
| Poor metabolizer due to cytochrome p450 CYP2D6 variant | contraindication | 423629005 | |
| Decompensated chronic heart failure | contraindication | 424404003 | |
| Congenital long QT syndrome | contraindication | 442917000 | |
| Carcinoma of female breast | contraindication | 447782002 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 8.55 | Basic |
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 |
|---|---|---|---|---|---|---|---|---|---|---|
| 10MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 8586610 | Nov. 2, 2027 | METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING ILOPERIDONE TO A PATIENT BY REDUCING THE DOSE IN PATIENTS WHO ARE POOR METABOLIZERS OF CYP2D6 |
| 12MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 8586610 | Nov. 2, 2027 | METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING ILOPERIDONE TO A PATIENT BY REDUCING THE DOSE IN PATIENTS WHO ARE POOR METABOLIZERS OF CYP2D6 |
| 1MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 8586610 | Nov. 2, 2027 | METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING ILOPERIDONE TO A PATIENT BY REDUCING THE DOSE IN PATIENTS WHO ARE POOR METABOLIZERS OF CYP2D6 |
| 2MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 8586610 | Nov. 2, 2027 | METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING ILOPERIDONE TO A PATIENT BY REDUCING THE DOSE IN PATIENTS WHO ARE POOR METABOLIZERS OF CYP2D6 |
| 4MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 8586610 | Nov. 2, 2027 | METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING ILOPERIDONE TO A PATIENT BY REDUCING THE DOSE IN PATIENTS WHO ARE POOR METABOLIZERS OF CYP2D6 |
| 6MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 8586610 | Nov. 2, 2027 | METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING ILOPERIDONE TO A PATIENT BY REDUCING THE DOSE IN PATIENTS WHO ARE POOR METABOLIZERS OF CYP2D6 |
| 8MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 8586610 | Nov. 2, 2027 | METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING ILOPERIDONE TO A PATIENT BY REDUCING THE DOSE IN PATIENTS WHO ARE POOR METABOLIZERS OF CYP2D6 |
| 10MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 10570453 | March 28, 2028 | METHOD FOR ACUTE TREATMENT OF MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER IN ADULTS BY ADMINISTERING ILOPERIDONE TO A PATIENT BY LOWERING THE DOSE AFTER DETERMINING THAT THE PATIENT HAS A GENETIC PREDISPOSITION FOR QT PROLONGATION |
| 10MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 10570453 | March 28, 2028 | METHOD FOR TREATMENT OF SCHIZOPHRENIA IN ADULTS BY ADMINISTERING ILOPERIDONE TO A PATIENT BY LOWERING THE DOSE AFTER DETERMINING THAT THE PATIENT HAS A GENETIC PREDISPOSITION FOR QT PROLONGATION |
| 12MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 10570453 | March 28, 2028 | METHOD FOR ACUTE TREATMENT OF MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER IN ADULTS BY ADMINISTERING ILOPERIDONE TO A PATIENT BY LOWERING THE DOSE AFTER DETERMINING THAT THE PATIENT HAS A GENETIC PREDISPOSITION FOR QT PROLONGATION |
| 12MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 10570453 | March 28, 2028 | METHOD FOR TREATMENT OF SCHIZOPHRENIA IN ADULTS BY ADMINISTERING ILOPERIDONE TO A PATIENT BY LOWERING THE DOSE AFTER DETERMINING THAT THE PATIENT HAS A GENETIC PREDISPOSITION FOR QT PROLONGATION |
| 1MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 10570453 | March 28, 2028 | METHOD FOR ACUTE TREATMENT OF MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER IN ADULTS BY ADMINISTERING ILOPERIDONE TO A PATIENT BY LOWERING THE DOSE AFTER DETERMINING THAT THE PATIENT HAS A GENETIC PREDISPOSITION FOR QT PROLONGATION |
| 1MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 10570453 | March 28, 2028 | METHOD FOR TREATMENT OF SCHIZOPHRENIA IN ADULTS BY ADMINISTERING ILOPERIDONE TO A PATIENT BY LOWERING THE DOSE AFTER DETERMINING THAT THE PATIENT HAS A GENETIC PREDISPOSITION FOR QT PROLONGATION |
| 2MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 10570453 | March 28, 2028 | METHOD FOR ACUTE TREATMENT OF MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER IN ADULTS BY ADMINISTERING ILOPERIDONE TO A PATIENT BY LOWERING THE DOSE AFTER DETERMINING THAT THE PATIENT HAS A GENETIC PREDISPOSITION FOR QT PROLONGATION |
| 2MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 10570453 | March 28, 2028 | METHOD FOR TREATMENT OF SCHIZOPHRENIA IN ADULTS BY ADMINISTERING ILOPERIDONE TO A PATIENT BY LOWERING THE DOSE AFTER DETERMINING THAT THE PATIENT HAS A GENETIC PREDISPOSITION FOR QT PROLONGATION |
| 4MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 10570453 | March 28, 2028 | METHOD FOR ACUTE TREATMENT OF MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER IN ADULTS BY ADMINISTERING ILOPERIDONE TO A PATIENT BY LOWERING THE DOSE AFTER DETERMINING THAT THE PATIENT HAS A GENETIC PREDISPOSITION FOR QT PROLONGATION |
| 4MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 10570453 | March 28, 2028 | METHOD FOR TREATMENT OF SCHIZOPHRENIA IN ADULTS BY ADMINISTERING ILOPERIDONE TO A PATIENT BY LOWERING THE DOSE AFTER DETERMINING THAT THE PATIENT HAS A GENETIC PREDISPOSITION FOR QT PROLONGATION |
| 6MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 10570453 | March 28, 2028 | METHOD FOR ACUTE TREATMENT OF MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER IN ADULTS BY ADMINISTERING ILOPERIDONE TO A PATIENT BY LOWERING THE DOSE AFTER DETERMINING THAT THE PATIENT HAS A GENETIC PREDISPOSITION FOR QT PROLONGATION |
| 6MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 10570453 | March 28, 2028 | METHOD FOR TREATMENT OF SCHIZOPHRENIA IN ADULTS BY ADMINISTERING ILOPERIDONE TO A PATIENT BY LOWERING THE DOSE AFTER DETERMINING THAT THE PATIENT HAS A GENETIC PREDISPOSITION FOR QT PROLONGATION |
| 8MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 10570453 | March 28, 2028 | METHOD FOR ACUTE TREATMENT OF MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER IN ADULTS BY ADMINISTERING ILOPERIDONE TO A PATIENT BY LOWERING THE DOSE AFTER DETERMINING THAT THE PATIENT HAS A GENETIC PREDISPOSITION FOR QT PROLONGATION |
| 8MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 10570453 | March 28, 2028 | METHOD FOR TREATMENT OF SCHIZOPHRENIA IN ADULTS BY ADMINISTERING ILOPERIDONE TO A PATIENT BY LOWERING THE DOSE AFTER DETERMINING THAT THE PATIENT HAS A GENETIC PREDISPOSITION FOR QT PROLONGATION |
| 10MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 9157121 | April 5, 2030 | DOSAGE MODIFICATION TO REDUCE RISKS ASSOCIATED WITH QT PROLONGATION NOT INDUCED BY OTHER DRUGS DURING TREATMENT WITH ILOPERIDONE |
| 12MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 9157121 | April 5, 2030 | DOSAGE MODIFICATION TO REDUCE RISKS ASSOCIATED WITH QT PROLONGATION NOT INDUCED BY OTHER DRUGS DURING TREATMENT WITH ILOPERIDONE |
| 1MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 9157121 | April 5, 2030 | DOSAGE MODIFICATION TO REDUCE RISKS ASSOCIATED WITH QT PROLONGATION NOT INDUCED BY OTHER DRUGS DURING TREATMENT WITH ILOPERIDONE |
| 2MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 9157121 | April 5, 2030 | DOSAGE MODIFICATION TO REDUCE RISKS ASSOCIATED WITH QT PROLONGATION NOT INDUCED BY OTHER DRUGS DURING TREATMENT WITH ILOPERIDONE |
| 4MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 9157121 | April 5, 2030 | DOSAGE MODIFICATION TO REDUCE RISKS ASSOCIATED WITH QT PROLONGATION NOT INDUCED BY OTHER DRUGS DURING TREATMENT WITH ILOPERIDONE |
| 6MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 9157121 | April 5, 2030 | DOSAGE MODIFICATION TO REDUCE RISKS ASSOCIATED WITH QT PROLONGATION NOT INDUCED BY OTHER DRUGS DURING TREATMENT WITH ILOPERIDONE |
| 8MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 9157121 | April 5, 2030 | DOSAGE MODIFICATION TO REDUCE RISKS ASSOCIATED WITH QT PROLONGATION NOT INDUCED BY OTHER DRUGS DURING TREATMENT WITH ILOPERIDONE |
| 10MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 10563259 | July 24, 2030 | METHOD FOR ACUTE TREATMENT OF MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER IN ADULTS BY ADMINISTERING ILOPERIDONE TO A PATIENT BY LOWERING THE DOSE AFTER DETERMINING THAT THE PATIENT HAS A GENETIC PREDISPOSITION FOR QT PROLONGATION |
| 10MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 10563259 | July 24, 2030 | METHOD FOR TREATMENT OF SCHIZOPHRENIA IN ADULTS BY ADMINISTERING ILOPERIDONE TO A PATIENT BY LOWERING THE DOSE AFTER DETERMINING THAT THE PATIENT HAS A GENETIC PREDISPOSITION FOR QT PROLONGATION |
| 12MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 10563259 | July 24, 2030 | METHOD FOR ACUTE TREATMENT OF MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER IN ADULTS BY ADMINISTERING ILOPERIDONE TO A PATIENT BY LOWERING THE DOSE AFTER DETERMINING THAT THE PATIENT HAS A GENETIC PREDISPOSITION FOR QT PROLONGATION |
| 12MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 10563259 | July 24, 2030 | METHOD FOR TREATMENT OF SCHIZOPHRENIA IN ADULTS BY ADMINISTERING ILOPERIDONE TO A PATIENT BY LOWERING THE DOSE AFTER DETERMINING THAT THE PATIENT HAS A GENETIC PREDISPOSITION FOR QT PROLONGATION |
| 1MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 10563259 | July 24, 2030 | METHOD FOR ACUTE TREATMENT OF MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER IN ADULTS BY ADMINISTERING ILOPERIDONE TO A PATIENT BY LOWERING THE DOSE AFTER DETERMINING THAT THE PATIENT HAS A GENETIC PREDISPOSITION FOR QT PROLONGATION |
| 1MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 10563259 | July 24, 2030 | METHOD FOR TREATMENT OF SCHIZOPHRENIA IN ADULTS BY ADMINISTERING ILOPERIDONE TO A PATIENT BY LOWERING THE DOSE AFTER DETERMINING THAT THE PATIENT HAS A GENETIC PREDISPOSITION FOR QT PROLONGATION |
| 2MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 10563259 | July 24, 2030 | METHOD FOR ACUTE TREATMENT OF MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER IN ADULTS BY ADMINISTERING ILOPERIDONE TO A PATIENT BY LOWERING THE DOSE AFTER DETERMINING THAT THE PATIENT HAS A GENETIC PREDISPOSITION FOR QT PROLONGATION |
| 2MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 10563259 | July 24, 2030 | METHOD FOR TREATMENT OF SCHIZOPHRENIA IN ADULTS BY ADMINISTERING ILOPERIDONE TO A PATIENT BY LOWERING THE DOSE AFTER DETERMINING THAT THE PATIENT HAS A GENETIC PREDISPOSITION FOR QT PROLONGATION |
| 4MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 10563259 | July 24, 2030 | METHOD FOR ACUTE TREATMENT OF MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER IN ADULTS BY ADMINISTERING ILOPERIDONE TO A PATIENT BY LOWERING THE DOSE AFTER DETERMINING THAT THE PATIENT HAS A GENETIC PREDISPOSITION FOR QT PROLONGATION |
| 4MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 10563259 | July 24, 2030 | METHOD FOR TREATMENT OF SCHIZOPHRENIA IN ADULTS BY ADMINISTERING ILOPERIDONE TO A PATIENT BY LOWERING THE DOSE AFTER DETERMINING THAT THE PATIENT HAS A GENETIC PREDISPOSITION FOR QT PROLONGATION |
| 6MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 10563259 | July 24, 2030 | METHOD FOR ACUTE TREATMENT OF MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER IN ADULTS BY ADMINISTERING ILOPERIDONE TO A PATIENT BY LOWERING THE DOSE AFTER DETERMINING THAT THE PATIENT HAS A GENETIC PREDISPOSITION FOR QT PROLONGATION |
| 6MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 10563259 | July 24, 2030 | METHOD FOR TREATMENT OF SCHIZOPHRENIA IN ADULTS BY ADMINISTERING ILOPERIDONE TO A PATIENT BY LOWERING THE DOSE AFTER DETERMINING THAT THE PATIENT HAS A GENETIC PREDISPOSITION FOR QT PROLONGATION |
| 8MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 10563259 | July 24, 2030 | METHOD FOR ACUTE TREATMENT OF MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER IN ADULTS BY ADMINISTERING ILOPERIDONE TO A PATIENT BY LOWERING THE DOSE AFTER DETERMINING THAT THE PATIENT HAS A GENETIC PREDISPOSITION FOR QT PROLONGATION |
| 8MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 10563259 | July 24, 2030 | METHOD FOR TREATMENT OF SCHIZOPHRENIA IN ADULTS BY ADMINISTERING ILOPERIDONE TO A PATIENT BY LOWERING THE DOSE AFTER DETERMINING THAT THE PATIENT HAS A GENETIC PREDISPOSITION FOR QT PROLONGATION |
| 10MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 8652776 | Aug. 31, 2030 | DOSAGE MODIFICATION TO REDUCE THE RISK ASSOCIATED WITH QT PROLONGATION NOT INDUCED BY OTHER DRUGS DURING TREATMENT WITH ILOPERIDONE |
| 12MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 8652776 | Aug. 31, 2030 | DOSAGE MODIFICATION TO REDUCE THE RISK ASSOCIATED WITH QT PROLONGATION NOT INDUCED BY OTHER DRUGS DURING TREATMENT WITH ILOPERIDONE |
| 1MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 8652776 | Aug. 31, 2030 | DOSAGE MODIFICATION TO REDUCE THE RISK ASSOCIATED WITH QT PROLONGATION NOT INDUCED BY OTHER DRUGS DURING TREATMENT WITH ILOPERIDONE |
| 2MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 8652776 | Aug. 31, 2030 | DOSAGE MODIFICATION TO REDUCE THE RISK ASSOCIATED WITH QT PROLONGATION NOT INDUCED BY OTHER DRUGS DURING TREATMENT WITH ILOPERIDONE |
| 4MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 8652776 | Aug. 31, 2030 | DOSAGE MODIFICATION TO REDUCE THE RISK ASSOCIATED WITH QT PROLONGATION NOT INDUCED BY OTHER DRUGS DURING TREATMENT WITH ILOPERIDONE |
| 6MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 8652776 | Aug. 31, 2030 | DOSAGE MODIFICATION TO REDUCE THE RISK ASSOCIATED WITH QT PROLONGATION NOT INDUCED BY OTHER DRUGS DURING TREATMENT WITH ILOPERIDONE |
| 8MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 8652776 | Aug. 31, 2030 | DOSAGE MODIFICATION TO REDUCE THE RISK ASSOCIATED WITH QT PROLONGATION NOT INDUCED BY OTHER DRUGS DURING TREATMENT WITH ILOPERIDONE |
| 10MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 12606869 | Sept. 22, 2030 | METHOD OF TREATING ACUTE EPISODES OF MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER IN ADULTS BY ADMINISTERING ILOPERIDONE TO A PATIENT BY REDUCING THE DOSE IN PATIENTS WHO ARE POOR METABOLIZERS OF CYP2D6 |
| 10MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 12606869 | Sept. 22, 2030 | METHOD OF TREATING SCHIZOPHRENIA IN ADULTS BY ADMINISTERING ILOPERIDONE TO A PATIENT BY REDUCING THE DOSE IN PATIENTS WHO ARE POOR METABOLIZERS OF CYP2D6 |
| 12MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 12606869 | Sept. 22, 2030 | METHOD OF TREATING ACUTE EPISODES OF MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER IN ADULTS BY ADMINISTERING ILOPERIDONE TO A PATIENT BY REDUCING THE DOSE IN PATIENTS WHO ARE POOR METABOLIZERS OF CYP2D6 |
| 12MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 12606869 | Sept. 22, 2030 | METHOD OF TREATING SCHIZOPHRENIA IN ADULTS BY ADMINISTERING ILOPERIDONE TO A PATIENT BY REDUCING THE DOSE IN PATIENTS WHO ARE POOR METABOLIZERS OF CYP2D6 |
| 1MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 12606869 | Sept. 22, 2030 | METHOD OF TREATING ACUTE EPISODES OF MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER IN ADULTS BY ADMINISTERING ILOPERIDONE TO A PATIENT BY REDUCING THE DOSE IN PATIENTS WHO ARE POOR METABOLIZERS OF CYP2D6 |
| 1MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 12606869 | Sept. 22, 2030 | METHOD OF TREATING SCHIZOPHRENIA IN ADULTS BY ADMINISTERING ILOPERIDONE TO A PATIENT BY REDUCING THE DOSE IN PATIENTS WHO ARE POOR METABOLIZERS OF CYP2D6 |
| 2MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 12606869 | Sept. 22, 2030 | METHOD OF TREATING ACUTE EPISODES OF MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER IN ADULTS BY ADMINISTERING ILOPERIDONE TO A PATIENT BY REDUCING THE DOSE IN PATIENTS WHO ARE POOR METABOLIZERS OF CYP2D6 |
| 2MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 12606869 | Sept. 22, 2030 | METHOD OF TREATING SCHIZOPHRENIA IN ADULTS BY ADMINISTERING ILOPERIDONE TO A PATIENT BY REDUCING THE DOSE IN PATIENTS WHO ARE POOR METABOLIZERS OF CYP2D6 |
| 4MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 12606869 | Sept. 22, 2030 | METHOD OF TREATING ACUTE EPISODES OF MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER IN ADULTS BY ADMINISTERING ILOPERIDONE TO A PATIENT BY REDUCING THE DOSE IN PATIENTS WHO ARE POOR METABOLIZERS OF CYP2D6 |
| 4MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 12606869 | Sept. 22, 2030 | METHOD OF TREATING SCHIZOPHRENIA IN ADULTS BY ADMINISTERING ILOPERIDONE TO A PATIENT BY REDUCING THE DOSE IN PATIENTS WHO ARE POOR METABOLIZERS OF CYP2D6 |
| 6MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 12606869 | Sept. 22, 2030 | METHOD OF TREATING ACUTE EPISODES OF MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER IN ADULTS BY ADMINISTERING ILOPERIDONE TO A PATIENT BY REDUCING THE DOSE IN PATIENTS WHO ARE POOR METABOLIZERS OF CYP2D6 |
| 6MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 12606869 | Sept. 22, 2030 | METHOD OF TREATING SCHIZOPHRENIA IN ADULTS BY ADMINISTERING ILOPERIDONE TO A PATIENT BY REDUCING THE DOSE IN PATIENTS WHO ARE POOR METABOLIZERS OF CYP2D6 |
| 8MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 12606869 | Sept. 22, 2030 | METHOD OF TREATING ACUTE EPISODES OF MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER IN ADULTS BY ADMINISTERING ILOPERIDONE TO A PATIENT BY REDUCING THE DOSE IN PATIENTS WHO ARE POOR METABOLIZERS OF CYP2D6 |
| 8MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 12606869 | Sept. 22, 2030 | METHOD OF TREATING SCHIZOPHRENIA IN ADULTS BY ADMINISTERING ILOPERIDONE TO A PATIENT BY REDUCING THE DOSE IN PATIENTS WHO ARE POOR METABOLIZERS OF CYP2D6 |
| 10MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 8999638 | Oct. 28, 2030 | DOSAGE MODIFICATION TO REDUCE RISKS ASSOCIATED WITH QT PROLONGATION NOT INDUCED BY OTHER DRUGS DURING TREATMENT WITH ILOPERIDONE |
| 12MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 8999638 | Oct. 28, 2030 | DOSAGE MODIFICATION TO REDUCE RISKS ASSOCIATED WITH QT PROLONGATION NOT INDUCED BY OTHER DRUGS DURING TREATMENT WITH ILOPERIDONE |
| 1MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 8999638 | Oct. 28, 2030 | DOSAGE MODIFICATION TO REDUCE RISKS ASSOCIATED WITH QT PROLONGATION NOT INDUCED BY OTHER DRUGS DURING TREATMENT WITH ILOPERIDONE |
| 2MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 8999638 | Oct. 28, 2030 | DOSAGE MODIFICATION TO REDUCE RISKS ASSOCIATED WITH QT PROLONGATION NOT INDUCED BY OTHER DRUGS DURING TREATMENT WITH ILOPERIDONE |
| 4MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 8999638 | Oct. 28, 2030 | DOSAGE MODIFICATION TO REDUCE RISKS ASSOCIATED WITH QT PROLONGATION NOT INDUCED BY OTHER DRUGS DURING TREATMENT WITH ILOPERIDONE |
| 6MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 8999638 | Oct. 28, 2030 | DOSAGE MODIFICATION TO REDUCE RISKS ASSOCIATED WITH QT PROLONGATION NOT INDUCED BY OTHER DRUGS DURING TREATMENT WITH ILOPERIDONE |
| 8MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 8999638 | Oct. 28, 2030 | DOSAGE MODIFICATION TO REDUCE RISKS ASSOCIATED WITH QT PROLONGATION NOT INDUCED BY OTHER DRUGS DURING TREATMENT WITH ILOPERIDONE |
| 10MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 9074255 | Dec. 17, 2030 | DOSAGE MODIFICATION TO REDUCE RISKS ASSOCIATED WITH QT PROLONGATION NOT INDUCED BY OTHER DRUGS DURING TREATMENT WITH ILOPERIDONE |
| 12MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 9074255 | Dec. 17, 2030 | DOSAGE MODIFICATION TO REDUCE RISKS ASSOCIATED WITH QT PROLONGATION NOT INDUCED BY OTHER DRUGS DURING TREATMENT WITH ILOPERIDONE |
| 1MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 9074255 | Dec. 17, 2030 | DOSAGE MODIFICATION TO REDUCE RISKS ASSOCIATED WITH QT PROLONGATION NOT INDUCED BY OTHER DRUGS DURING TREATMENT WITH ILOPERIDONE |
| 2MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 9074255 | Dec. 17, 2030 | DOSAGE MODIFICATION TO REDUCE RISKS ASSOCIATED WITH QT PROLONGATION NOT INDUCED BY OTHER DRUGS DURING TREATMENT WITH ILOPERIDONE |
| 4MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 9074255 | Dec. 17, 2030 | DOSAGE MODIFICATION TO REDUCE RISKS ASSOCIATED WITH QT PROLONGATION NOT INDUCED BY OTHER DRUGS DURING TREATMENT WITH ILOPERIDONE |
| 6MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 9074255 | Dec. 17, 2030 | DOSAGE MODIFICATION TO REDUCE RISKS ASSOCIATED WITH QT PROLONGATION NOT INDUCED BY OTHER DRUGS DURING TREATMENT WITH ILOPERIDONE |
| 8MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 9074255 | Dec. 17, 2030 | DOSAGE MODIFICATION TO REDUCE RISKS ASSOCIATED WITH QT PROLONGATION NOT INDUCED BY OTHER DRUGS DURING TREATMENT WITH ILOPERIDONE |
| 10MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 9072742 | Jan. 16, 2031 | DOSAGE MODIFICATION TO REDUCE RISKS ASSOCIATED WITH QT PROLONGATION NOT INDUCED BY OTHER DRUGS DURING TREATMENT WITH ILOPERIDONE |
| 12MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 9072742 | Jan. 16, 2031 | DOSAGE MODIFICATION TO REDUCE RISKS ASSOCIATED WITH QT PROLONGATION NOT INDUCED BY OTHER DRUGS DURING TREATMENT WITH ILOPERIDONE |
| 1MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 9072742 | Jan. 16, 2031 | DOSAGE MODIFICATION TO REDUCE RISKS ASSOCIATED WITH QT PROLONGATION NOT INDUCED BY OTHER DRUGS DURING TREATMENT WITH ILOPERIDONE |
| 2MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 9072742 | Jan. 16, 2031 | DOSAGE MODIFICATION TO REDUCE RISKS ASSOCIATED WITH QT PROLONGATION NOT INDUCED BY OTHER DRUGS DURING TREATMENT WITH ILOPERIDONE |
| 4MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 9072742 | Jan. 16, 2031 | DOSAGE MODIFICATION TO REDUCE RISKS ASSOCIATED WITH QT PROLONGATION NOT INDUCED BY OTHER DRUGS DURING TREATMENT WITH ILOPERIDONE |
| 6MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 9072742 | Jan. 16, 2031 | DOSAGE MODIFICATION TO REDUCE RISKS ASSOCIATED WITH QT PROLONGATION NOT INDUCED BY OTHER DRUGS DURING TREATMENT WITH ILOPERIDONE |
| 8MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 9072742 | Jan. 16, 2031 | DOSAGE MODIFICATION TO REDUCE RISKS ASSOCIATED WITH QT PROLONGATION NOT INDUCED BY OTHER DRUGS DURING TREATMENT WITH ILOPERIDONE |
| 10MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 9074256 | Feb. 10, 2031 | DOSAGE MODIFICATION TO REDUCE RISKS ASSOCIATED WITH QT PROLONGATION NOT INDUCED BY OTHER DRUGS DURING TREATMENT WITH ILOPERIDONE |
| 12MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 9074256 | Feb. 10, 2031 | DOSAGE MODIFICATION TO REDUCE RISKS ASSOCIATED WITH QT PROLONGATION NOT INDUCED BY OTHER DRUGS DURING TREATMENT WITH ILOPERIDONE |
| 1MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 9074256 | Feb. 10, 2031 | DOSAGE MODIFICATION TO REDUCE RISKS ASSOCIATED WITH QT PROLONGATION NOT INDUCED BY OTHER DRUGS DURING TREATMENT WITH ILOPERIDONE |
| 2MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 9074256 | Feb. 10, 2031 | DOSAGE MODIFICATION TO REDUCE RISKS ASSOCIATED WITH QT PROLONGATION NOT INDUCED BY OTHER DRUGS DURING TREATMENT WITH ILOPERIDONE |
| 4MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 9074256 | Feb. 10, 2031 | DOSAGE MODIFICATION TO REDUCE RISKS ASSOCIATED WITH QT PROLONGATION NOT INDUCED BY OTHER DRUGS DURING TREATMENT WITH ILOPERIDONE |
| 6MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 9074256 | Feb. 10, 2031 | DOSAGE MODIFICATION TO REDUCE RISKS ASSOCIATED WITH QT PROLONGATION NOT INDUCED BY OTHER DRUGS DURING TREATMENT WITH ILOPERIDONE |
| 8MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 9074256 | Feb. 10, 2031 | DOSAGE MODIFICATION TO REDUCE RISKS ASSOCIATED WITH QT PROLONGATION NOT INDUCED BY OTHER DRUGS DURING TREATMENT WITH ILOPERIDONE |
| 10MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 9074254 | Dec. 28, 2031 | DOSAGE MODIFICATION TO REDUCE RISKS ASSOCIATED WITH QT PROLONGATION NOT INDUCED BY OTHER DRUGS DURING TREATMENT WITH ILOPERIDONE |
| 12MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 9074254 | Dec. 28, 2031 | DOSAGE MODIFICATION TO REDUCE RISKS ASSOCIATED WITH QT PROLONGATION NOT INDUCED BY OTHER DRUGS DURING TREATMENT WITH ILOPERIDONE |
| 1MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 9074254 | Dec. 28, 2031 | DOSAGE MODIFICATION TO REDUCE RISKS ASSOCIATED WITH QT PROLONGATION NOT INDUCED BY OTHER DRUGS DURING TREATMENT WITH ILOPERIDONE |
| 2MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 9074254 | Dec. 28, 2031 | DOSAGE MODIFICATION TO REDUCE RISKS ASSOCIATED WITH QT PROLONGATION NOT INDUCED BY OTHER DRUGS DURING TREATMENT WITH ILOPERIDONE |
| 4MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 9074254 | Dec. 28, 2031 | DOSAGE MODIFICATION TO REDUCE RISKS ASSOCIATED WITH QT PROLONGATION NOT INDUCED BY OTHER DRUGS DURING TREATMENT WITH ILOPERIDONE |
| 6MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 9074254 | Dec. 28, 2031 | DOSAGE MODIFICATION TO REDUCE RISKS ASSOCIATED WITH QT PROLONGATION NOT INDUCED BY OTHER DRUGS DURING TREATMENT WITH ILOPERIDONE |
| 8MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | 9074254 | Dec. 28, 2031 | DOSAGE MODIFICATION TO REDUCE RISKS ASSOCIATED WITH QT PROLONGATION NOT INDUCED BY OTHER DRUGS DURING TREATMENT WITH ILOPERIDONE |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 10MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | April 2, 2027 | INDICATED FOR ACUTE TREATMENT OF MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER IN ADULTS |
| 12MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | April 2, 2027 | INDICATED FOR ACUTE TREATMENT OF MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER IN ADULTS |
| 1MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | April 2, 2027 | INDICATED FOR ACUTE TREATMENT OF MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER IN ADULTS |
| 2MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | April 2, 2027 | INDICATED FOR ACUTE TREATMENT OF MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER IN ADULTS |
| 4MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | April 2, 2027 | INDICATED FOR ACUTE TREATMENT OF MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER IN ADULTS |
| 6MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | April 2, 2027 | INDICATED FOR ACUTE TREATMENT OF MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER IN ADULTS |
| 8MG | FANAPT | VANDA PHARMS INC | N022192 | May 6, 2009 | RX | TABLET | ORAL | April 2, 2027 | INDICATED FOR ACUTE TREATMENT OF MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER IN ADULTS |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| D(2) dopamine receptor | GPCR | ANTAGONIST | Ki | 8.97 | WOMBAT-PK | CHEMBL | |||
| 5-hydroxytryptamine receptor 2A | GPCR | ANTAGONIST | Ki | 9.86 | WOMBAT-PK | CHEMBL | |||
| Sigma non-opioid intracellular receptor 1 | Membrane receptor | IC50 | 7.19 | CHEMBL | |||||
| Sodium-dependent noradrenaline transporter | Transporter | Ki | 5.83 | WOMBAT-PK | |||||
| 5-hydroxytryptamine receptor 1A | GPCR | Ki | 7.18 | WOMBAT-PK | |||||
| 5-hydroxytryptamine receptor 2C | GPCR | Ki | 7.23 | WOMBAT-PK | |||||
| 5-hydroxytryptamine receptor 6 | GPCR | Ki | 7.37 | WOMBAT-PK | |||||
| 5-hydroxytryptamine receptor 7 | GPCR | Ki | 7.66 | WOMBAT-PK | |||||
| Alpha-1A adrenergic receptor | GPCR | Ki | 7.44 | WOMBAT-PK | |||||
| Alpha-2B adrenergic receptor | GPCR | Ki | 6.79 | WOMBAT-PK | |||||
| D(3) dopamine receptor | GPCR | Ki | 8.15 | WOMBAT-PK | |||||
| D(1B) dopamine receptor | GPCR | Ki | 6.50 | WOMBAT-PK | |||||
| Histamine H1 receptor | GPCR | Ki | 7.91 | WOMBAT-PK | |||||
| Muscarinic acetylcholine receptor M1 | GPCR | Ki | 5.31 | PDSP | |||||
| Muscarinic acetylcholine receptor M2 | GPCR | Ki | 5.48 | PDSP | |||||
| Muscarinic acetylcholine receptor M4 | GPCR | Ki | 5.08 | PDSP | |||||
| 5-hydroxytryptamine receptor 1B | GPCR | Ki | 7.05 | WOMBAT-PK | |||||
| 5-hydroxytryptamine receptor 1D | GPCR | Ki | 7.82 | WOMBAT-PK | |||||
| Alpha-2C adrenergic receptor | GPCR | Ki | 7.79 | WOMBAT-PK | |||||
| Sodium-dependent dopamine transporter | Transporter | Ki | 5.53 | WOMBAT-PK | |||||
| D(4) dopamine receptor | GPCR | Ki | 7.60 | WOMBAT-PK | |||||
| Gastrin/cholecystokinin type B receptor | GPCR | Ki | 5.03 | PDSP | |||||
| D(1A) dopamine receptor | GPCR | Ki | 6.67 | WOMBAT-PK | |||||
| Alpha-2A adrenergic receptor | GPCR | Ki | 6.79 | WOMBAT-PK | |||||
| D(2) dopamine receptor | GPCR | IC50 | 6.96 | CHEMBL | |||||
| 5-hydroxytryptamine receptor 1A | GPCR | ANTAGONIST | Ki | 6.80 | IUPHAR | ||||
| 5-hydroxytryptamine receptor 7 | GPCR | ANTAGONIST | Ki | 7.70 | IUPHAR | ||||
| Alpha-2A adrenergic receptor | GPCR | IC50 | 9.40 | CHEMBL | |||||
| 5-hydroxytryptamine receptor 1A | GPCR | IC50 | 6.68 | CHEMBL | |||||
| D(1A) dopamine receptor | GPCR | IC50 | 6.12 | CHEMBL | |||||
| 5-hydroxytryptamine receptor 2A | GPCR | IC50 | 8.05 | CHEMBL | |||||
| 5-hydroxytryptamine receptor 6 | GPCR | ANTAGONIST | Ki | 7.40 | IUPHAR | ||||
| Serotonin 2 (5-HT2) receptor | GPCR | IC50 | 8.05 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| 4028716 | VUID |
| N0000178412 | NUI |
| D02666 | KEGG_DRUG |
| 4028716 | VANDF |
| C0247194 | UMLSCUI |
| CHEBI:65173 | CHEBI |
| CHEMBL14376 | ChEMBL_ID |
| DB04946 | DRUGBANK_ID |
| C081732 | MESH_SUPPLEMENTAL_RECORD_UI |
| 71360 | PUBCHEM_CID |
| 87 | IUPHAR_LIGAND_ID |
| 7045 | INN_ID |
| VPO7KJ050N | UNII |
| 73178 | RXNORM |
| 164543 | MMSL |
| 26436 | MMSL |
| d07441 | MMSL |
| 013338 | NDDF |
| 442849001 | SNOMEDCT_US |
| 442910003 | SNOMEDCT_US |
| VPO7KJ050N | INXIGHT DRUGS |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| ILOPERIDONE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0378-0630 | TABLET | 1 mg | ORAL | ANDA | 29 sections |
| ILOPERIDONE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0378-0631 | TABLET | 2 mg | ORAL | ANDA | 29 sections |
| ILOPERIDONE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0378-0632 | TABLET | 4 mg | ORAL | ANDA | 29 sections |
| ILOPERIDONE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0378-0633 | TABLET | 6 mg | ORAL | ANDA | 29 sections |
| ILOPERIDONE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0378-0634 | TABLET | 8 mg | ORAL | ANDA | 29 sections |
| ILOPERIDONE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0378-0635 | TABLET | 10 mg | ORAL | ANDA | 29 sections |
| ILOPERIDONE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0378-0636 | TABLET | 12 mg | ORAL | ANDA | 29 sections |
| FANAPT | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43068-101 | TABLET | 1 mg | ORAL | NDA | 31 sections |
| FANAPT | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43068-102 | TABLET | 2 mg | ORAL | NDA | 31 sections |
| FANAPT | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43068-104 | TABLET | 4 mg | ORAL | NDA | 31 sections |
| FANAPT | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43068-106 | TABLET | 6 mg | ORAL | NDA | 31 sections |
| FANAPT | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43068-108 | TABLET | 8 mg | ORAL | NDA | 31 sections |
| FANAPT | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43068-110 | TABLET | 10 mg | ORAL | NDA | 31 sections |
| FANAPT | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43068-112 | TABLET | 12 mg | ORAL | NDA | 31 sections |
| FANAPT | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43068-901 | TABLET | 6 mg | ORAL | NDA | 31 sections |
| FANAPT | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43068-902 | TABLET | 8 mg | ORAL | NDA | 31 sections |
| FANAPT | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43068-904 | TABLET | 2 mg | ORAL | NDA | 31 sections |
| FANAPT | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43068-905 | TABLET | 1 mg | ORAL | NDA | 31 sections |
| FANAPT | HUMAN PRESCRIPTION DRUG LABEL | 1 | 69189-0597 | TABLET | 4 mg | ORAL | NDA | 31 sections |
| Fanapt | HUMAN PRESCRIPTION DRUG LABEL | 1 | 69189-0665 | TABLET | 4 mg | ORAL | NDA | 31 sections |