Stem definition | Drug id | CAS RN |
---|---|---|
orexin receptor antagonists | 5493 | 1505484-82-1 |
None
None
Date | Agency | Company | Orphan |
---|---|---|---|
April 29, 2022 | EMA | IDORSIA PHARMACEUTICALS DEUTSCHLAND GMBH | |
Jan. 1, 2022 | FDA | IDORSIA PHARMACEUTICALS LTD |
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 |
---|---|---|---|---|---|---|
Nightmare | 118.60 | 74.28 | 20 | 55 | 19174 | 63469773 |
None
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 |
---|---|---|---|---|---|---|
Nightmare | 112.71 | 97.08 | 19 | 48 | 25842 | 79718479 |
None
Source | Code | Description |
---|---|---|
FDA MoA | N0000190998 | Orexin Receptor Antagonists |
FDA EPC | N0000191000 | Orexin Receptor Antagonist |
Disease | Relation | SNOMED_ID | DOID |
---|---|---|---|
Insomnia | indication | 193462001 | |
Narcolepsy | contraindication | 60380001 | DOID:8986 |
None
None
None
Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
---|---|---|---|---|---|---|---|---|---|---|
EQ 25MG BASE | QUVIVIQ | IDORSIA | N214985 | April 7, 2022 | RX | TABLET | ORAL | 9732075 | June 12, 2033 | TREATMENT OF INSOMNIA |
EQ 50MG BASE | QUVIVIQ | IDORSIA | N214985 | April 7, 2022 | RX | TABLET | ORAL | 9732075 | June 12, 2033 | TREATMENT OF INSOMNIA |
EQ 25MG BASE | QUVIVIQ | IDORSIA | N214985 | April 7, 2022 | RX | TABLET | ORAL | 10023560 | Dec. 2, 2034 | TREATMENT OF INSOMNIA |
EQ 50MG BASE | QUVIVIQ | IDORSIA | N214985 | April 7, 2022 | RX | TABLET | ORAL | 10023560 | Dec. 2, 2034 | TREATMENT OF INSOMNIA |
Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
---|---|---|---|---|---|---|---|---|---|
EQ 25MG BASE | QUVIVIQ | IDORSIA | N214985 | April 7, 2022 | RX | TABLET | ORAL | April 7, 2027 | NEW CHEMICAL ENTITY |
EQ 50MG BASE | QUVIVIQ | IDORSIA | N214985 | April 7, 2022 | RX | TABLET | ORAL | April 7, 2027 | NEW CHEMICAL ENTITY |
Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
---|---|---|---|---|---|---|---|---|---|
Orexin receptor type 1 | GPCR | ANTAGONIST | Ki | 9.33 | DRUG LABEL | ||||
Orexin receptor type 2 | GPCR | ANTAGONIST | Ki | 9.03 | DRUG LABEL |
ID | Source |
---|---|
NS2 | PDB_CHEM_ID |
CHEMBL4297590 | ChEMBL_ID |
C000634383 | MESH_SUPPLEMENTAL_RECORD_UI |
11648 | IUPHAR_LIGAND_ID |
1792993-84-0 | SECONDARY_CAS_RN |
DB15031 | DRUGBANK_ID |
018928 | NDDF |
018929 | NDDF |
4041355 | VANDF |
D11886 | KEGG_DRUG |
C5227711 | UMLSCUI |
CHEMBL4650216 | ChEMBL_ID |
10679 | INN_ID |
91801202 | PUBCHEM_CID |
2591496 | RXNORM |
358453 | MMSL |
40618 | MMSL |
d09879 | MMSL |
LMQ24G57E9 | UNII |
Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
---|---|---|---|---|---|---|---|---|
QUVIVIQ | HUMAN PRESCRIPTION DRUG LABEL | 1 | 80491-7825 | TABLET, FILM COATED | 25 mg | ORAL | NDA | 35 sections |
QUVIVIQ | HUMAN PRESCRIPTION DRUG LABEL | 1 | 80491-7825 | TABLET, FILM COATED | 25 mg | ORAL | NDA | 35 sections |
QUVIVIQ | HUMAN PRESCRIPTION DRUG LABEL | 1 | 80491-7825 | TABLET, FILM COATED | 25 mg | ORAL | NDA | 35 sections |
QUVIVIQ | HUMAN PRESCRIPTION DRUG LABEL | 1 | 80491-7850 | TABLET, FILM COATED | 50 mg | ORAL | NDA | 35 sections |
QUVIVIQ | HUMAN PRESCRIPTION DRUG LABEL | 1 | 80491-7850 | TABLET, FILM COATED | 50 mg | ORAL | NDA | 35 sections |
QUVIVIQ | HUMAN PRESCRIPTION DRUG LABEL | 1 | 80491-7850 | TABLET, FILM COATED | 50 mg | ORAL | NDA | 35 sections |