Stem definition | Drug id | CAS RN |
---|---|---|
opioid receptor antagonists/agonists, morphinan derivates | 5460 | 852626-89-2 |
None
Property | Value | Reference |
---|---|---|
BDDCS (Biopharmaceutical Drug Disposition Classification System) | 1 | Bocci G, Oprea TI, Benet LZ |
Date | Agency | Company | Orphan |
---|---|---|---|
May 28, 2021 | FDA | ALKERMES INC |
None
None
None
None
Source | Code | Description |
---|---|---|
ATC | N05AH53 | NERVOUS SYSTEM PSYCHOLEPTICS ANTIPSYCHOTICS Diazepines, oxazepines, thiazepines and oxepines |
FDA MoA | N0000000154 | Opioid Antagonists |
MeSH PA | D002491 | Central Nervous System Agents |
MeSH PA | D009292 | Narcotic Antagonists |
MeSH PA | D018373 | Peripheral Nervous System Agents |
MeSH PA | D018689 | Sensory System Agents |
FDA EPC | N0000175691 | Opioid Antagonist |
Disease | Relation | SNOMED_ID | DOID |
---|---|---|---|
Schizophrenia | indication | 58214004 | DOID:5419 |
Bipolar I disorder | indication | 371596008 |
None
None
None
Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
---|---|---|---|---|---|---|---|---|---|---|
10MG;EQ 10MG BASE | LYBALVI | ALKERMES INC | N213378 | May 28, 2021 | RX | TABLET | ORAL | 10300054 | Aug. 23, 2031 | METHOD OF TREATING BIPOLAR DISORDER BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN |
10MG;EQ 10MG BASE | LYBALVI | ALKERMES INC | N213378 | May 28, 2021 | RX | TABLET | ORAL | 10300054 | Aug. 23, 2031 | METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN |
10MG;EQ 10MG BASE | LYBALVI | ALKERMES INC | N213378 | May 28, 2021 | RX | TABLET | ORAL | 10716785 | Aug. 23, 2031 | METHOD OF TREATING BIPOLAR DISORDER BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN, WITH REDUCED ANTIPSYCHOTIC INDUCED WEIGHT GAIN |
10MG;EQ 10MG BASE | LYBALVI | ALKERMES INC | N213378 | May 28, 2021 | RX | TABLET | ORAL | 10716785 | Aug. 23, 2031 | METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN, WITH REDUCED ANTIPSYCHOTIC INDUCED WEIGHT GAIN |
10MG;EQ 10MG BASE | LYBALVI | ALKERMES INC | N213378 | May 28, 2021 | RX | TABLET | ORAL | 11185541 | Aug. 23, 2031 | METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN |
10MG;EQ 10MG BASE | LYBALVI | ALKERMES INC | N213378 | May 28, 2021 | RX | TABLET | ORAL | 11241425 | Aug. 23, 2031 | METHOD OF TREATING BIPOLAR DISORDER BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN, WITH REDUCED ANTIPSYCHOTIC INDUCED WEIGHT GAIN |
10MG;EQ 10MG BASE | LYBALVI | ALKERMES INC | N213378 | May 28, 2021 | RX | TABLET | ORAL | 11351166 | Aug. 23, 2031 | METHOD OF TREATING BIPOLAR DISORDER BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN |
10MG;EQ 10MG BASE | LYBALVI | ALKERMES INC | N213378 | May 28, 2021 | RX | TABLET | ORAL | 11351166 | Aug. 23, 2031 | METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN |
10MG;EQ 10MG BASE | LYBALVI | ALKERMES INC | N213378 | May 28, 2021 | RX | TABLET | ORAL | 9126977 | Aug. 23, 2031 | METHOD OF TREATING BIPOLAR DISORDER BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN, WITH REDUCED ANTIPSYCHOTIC INDUCED WEIGHT GAIN |
10MG;EQ 10MG BASE | LYBALVI | ALKERMES INC | N213378 | May 28, 2021 | RX | TABLET | ORAL | 9126977 | Aug. 23, 2031 | METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN, WITH REDUCED ANTIPSYCHOTIC INDUCED WEIGHT GAIN |
10MG;EQ 10MG BASE | LYBALVI | ALKERMES INC | N213378 | May 28, 2021 | RX | TABLET | ORAL | 9517235 | Aug. 23, 2031 | METHOD OF TREATING BIPOLAR DISORDER BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN, WITH REDUCTION OF THE ADVERSE METABOLIC PROFILE |
10MG;EQ 10MG BASE | LYBALVI | ALKERMES INC | N213378 | May 28, 2021 | RX | TABLET | ORAL | 9517235 | Aug. 23, 2031 | METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN, WITH REDUCTION OF THE ADVERSE METABOLIC PROFILE |
15MG;EQ 10MG BASE | LYBALVI | ALKERMES INC | N213378 | May 28, 2021 | RX | TABLET | ORAL | 10300054 | Aug. 23, 2031 | METHOD OF TREATING BIPOLAR DISORDER BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN |
15MG;EQ 10MG BASE | LYBALVI | ALKERMES INC | N213378 | May 28, 2021 | RX | TABLET | ORAL | 10300054 | Aug. 23, 2031 | METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN |
15MG;EQ 10MG BASE | LYBALVI | ALKERMES INC | N213378 | May 28, 2021 | RX | TABLET | ORAL | 10716785 | Aug. 23, 2031 | METHOD OF TREATING BIPOLAR DISORDER BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN, WITH REDUCED ANTIPSYCHOTIC INDUCED WEIGHT GAIN |
15MG;EQ 10MG BASE | LYBALVI | ALKERMES INC | N213378 | May 28, 2021 | RX | TABLET | ORAL | 10716785 | Aug. 23, 2031 | METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN, WITH REDUCED ANTIPSYCHOTIC INDUCED WEIGHT GAIN |
15MG;EQ 10MG BASE | LYBALVI | ALKERMES INC | N213378 | May 28, 2021 | RX | TABLET | ORAL | 11185541 | Aug. 23, 2031 | METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN |
15MG;EQ 10MG BASE | LYBALVI | ALKERMES INC | N213378 | May 28, 2021 | RX | TABLET | ORAL | 11241425 | Aug. 23, 2031 | METHOD OF TREATING BIPOLAR DISORDER BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN, WITH REDUCED ANTIPSYCHOTIC INDUCED WEIGHT GAIN |
15MG;EQ 10MG BASE | LYBALVI | ALKERMES INC | N213378 | May 28, 2021 | RX | TABLET | ORAL | 11351166 | Aug. 23, 2031 | METHOD OF TREATING BIPOLAR DISORDER BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN |
15MG;EQ 10MG BASE | LYBALVI | ALKERMES INC | N213378 | May 28, 2021 | RX | TABLET | ORAL | 11351166 | Aug. 23, 2031 | METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN |
15MG;EQ 10MG BASE | LYBALVI | ALKERMES INC | N213378 | May 28, 2021 | RX | TABLET | ORAL | 9126977 | Aug. 23, 2031 | METHOD OF TREATING BIPOLAR DISORDER BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN, WITH REDUCED ANTIPSYCHOTIC INDUCED WEIGHT GAIN |
15MG;EQ 10MG BASE | LYBALVI | ALKERMES INC | N213378 | May 28, 2021 | RX | TABLET | ORAL | 9126977 | Aug. 23, 2031 | METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN, WITH REDUCED ANTIPSYCHOTIC INDUCED WEIGHT GAIN |
15MG;EQ 10MG BASE | LYBALVI | ALKERMES INC | N213378 | May 28, 2021 | RX | TABLET | ORAL | 9517235 | Aug. 23, 2031 | METHOD OF TREATING BIPOLAR DISORDER BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN, WITH REDUCTION OF THE ADVERSE METABOLIC PROFILE |
15MG;EQ 10MG BASE | LYBALVI | ALKERMES INC | N213378 | May 28, 2021 | RX | TABLET | ORAL | 9517235 | Aug. 23, 2031 | METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN, WITH REDUCTION OF THE ADVERSE METABOLIC PROFILE |
20MG;EQ 10MG BASE | LYBALVI | ALKERMES INC | N213378 | May 28, 2021 | RX | TABLET | ORAL | 10300054 | Aug. 23, 2031 | METHOD OF TREATING BIPOLAR DISORDER BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN |
20MG;EQ 10MG BASE | LYBALVI | ALKERMES INC | N213378 | May 28, 2021 | RX | TABLET | ORAL | 10300054 | Aug. 23, 2031 | METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN |
20MG;EQ 10MG BASE | LYBALVI | ALKERMES INC | N213378 | May 28, 2021 | RX | TABLET | ORAL | 10716785 | Aug. 23, 2031 | METHOD OF TREATING BIPOLAR DISORDER BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN, WITH REDUCED ANTIPSYCHOTIC INDUCED WEIGHT GAIN |
20MG;EQ 10MG BASE | LYBALVI | ALKERMES INC | N213378 | May 28, 2021 | RX | TABLET | ORAL | 10716785 | Aug. 23, 2031 | METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN, WITH REDUCED ANTIPSYCHOTIC INDUCED WEIGHT GAIN |
20MG;EQ 10MG BASE | LYBALVI | ALKERMES INC | N213378 | May 28, 2021 | RX | TABLET | ORAL | 11185541 | Aug. 23, 2031 | METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN |
20MG;EQ 10MG BASE | LYBALVI | ALKERMES INC | N213378 | May 28, 2021 | RX | TABLET | ORAL | 11241425 | Aug. 23, 2031 | METHOD OF TREATING BIPOLAR DISORDER BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN, WITH REDUCED ANTIPSYCHOTIC INDUCED WEIGHT GAIN |
20MG;EQ 10MG BASE | LYBALVI | ALKERMES INC | N213378 | May 28, 2021 | RX | TABLET | ORAL | 11351166 | Aug. 23, 2031 | METHOD OF TREATING BIPOLAR DISORDER BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN |
20MG;EQ 10MG BASE | LYBALVI | ALKERMES INC | N213378 | May 28, 2021 | RX | TABLET | ORAL | 11351166 | Aug. 23, 2031 | METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN |
20MG;EQ 10MG BASE | LYBALVI | ALKERMES INC | N213378 | May 28, 2021 | RX | TABLET | ORAL | 9126977 | Aug. 23, 2031 | METHOD OF TREATING BIPOLAR DISORDER BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN, WITH REDUCED ANTIPSYCHOTIC INDUCED WEIGHT GAIN |
20MG;EQ 10MG BASE | LYBALVI | ALKERMES INC | N213378 | May 28, 2021 | RX | TABLET | ORAL | 9126977 | Aug. 23, 2031 | METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN, WITH REDUCED ANTIPSYCHOTIC INDUCED WEIGHT GAIN |
20MG;EQ 10MG BASE | LYBALVI | ALKERMES INC | N213378 | May 28, 2021 | RX | TABLET | ORAL | 9517235 | Aug. 23, 2031 | METHOD OF TREATING BIPOLAR DISORDER BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN, WITH REDUCTION OF THE ADVERSE METABOLIC PROFILE |
20MG;EQ 10MG BASE | LYBALVI | ALKERMES INC | N213378 | May 28, 2021 | RX | TABLET | ORAL | 9517235 | Aug. 23, 2031 | METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN, WITH REDUCTION OF THE ADVERSE METABOLIC PROFILE |
5MG;EQ 10MG BASE | LYBALVI | ALKERMES INC | N213378 | May 28, 2021 | RX | TABLET | ORAL | 10300054 | Aug. 23, 2031 | METHOD OF TREATING BIPOLAR DISORDER BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN |
5MG;EQ 10MG BASE | LYBALVI | ALKERMES INC | N213378 | May 28, 2021 | RX | TABLET | ORAL | 10300054 | Aug. 23, 2031 | METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN |
5MG;EQ 10MG BASE | LYBALVI | ALKERMES INC | N213378 | May 28, 2021 | RX | TABLET | ORAL | 10716785 | Aug. 23, 2031 | METHOD OF TREATING BIPOLAR DISORDER BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN, WITH REDUCED ANTIPSYCHOTIC INDUCED WEIGHT GAIN |
5MG;EQ 10MG BASE | LYBALVI | ALKERMES INC | N213378 | May 28, 2021 | RX | TABLET | ORAL | 10716785 | Aug. 23, 2031 | METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN, WITH REDUCED ANTIPSYCHOTIC INDUCED WEIGHT GAIN |
5MG;EQ 10MG BASE | LYBALVI | ALKERMES INC | N213378 | May 28, 2021 | RX | TABLET | ORAL | 11185541 | Aug. 23, 2031 | METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN |
5MG;EQ 10MG BASE | LYBALVI | ALKERMES INC | N213378 | May 28, 2021 | RX | TABLET | ORAL | 11241425 | Aug. 23, 2031 | METHOD OF TREATING BIPOLAR DISORDER BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN, WITH REDUCED ANTIPSYCHOTIC INDUCED WEIGHT GAIN |
5MG;EQ 10MG BASE | LYBALVI | ALKERMES INC | N213378 | May 28, 2021 | RX | TABLET | ORAL | 11351166 | Aug. 23, 2031 | METHOD OF TREATING BIPOLAR DISORDER BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN |
5MG;EQ 10MG BASE | LYBALVI | ALKERMES INC | N213378 | May 28, 2021 | RX | TABLET | ORAL | 11351166 | Aug. 23, 2031 | METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN |
5MG;EQ 10MG BASE | LYBALVI | ALKERMES INC | N213378 | May 28, 2021 | RX | TABLET | ORAL | 9126977 | Aug. 23, 2031 | METHOD OF TREATING BIPOLAR DISORDER BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN, WITH REDUCED ANTIPSYCHOTIC INDUCED WEIGHT GAIN |
5MG;EQ 10MG BASE | LYBALVI | ALKERMES INC | N213378 | May 28, 2021 | RX | TABLET | ORAL | 9126977 | Aug. 23, 2031 | METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN, WITH REDUCED ANTIPSYCHOTIC INDUCED WEIGHT GAIN |
5MG;EQ 10MG BASE | LYBALVI | ALKERMES INC | N213378 | May 28, 2021 | RX | TABLET | ORAL | 9517235 | Aug. 23, 2031 | METHOD OF TREATING BIPOLAR DISORDER BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN, WITH REDUCTION OF THE ADVERSE METABOLIC PROFILE |
5MG;EQ 10MG BASE | LYBALVI | ALKERMES INC | N213378 | May 28, 2021 | RX | TABLET | ORAL | 9517235 | Aug. 23, 2031 | METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN, WITH REDUCTION OF THE ADVERSE METABOLIC PROFILE |
10MG;EQ 10MG BASE | LYBALVI | ALKERMES INC | N213378 | May 28, 2021 | RX | TABLET | ORAL | 8778960 | Feb. 13, 2032 | METHOD OF TREATING BIPOLAR DISORDER BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN, WITH REDUCED ANTIPSYCHOTIC INDUCED WEIGHT GAIN |
10MG;EQ 10MG BASE | LYBALVI | ALKERMES INC | N213378 | May 28, 2021 | RX | TABLET | ORAL | 8778960 | Feb. 13, 2032 | METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN, WITH REDUCED ANTIPSYCHOTIC INDUCED WEIGHT GAIN |
15MG;EQ 10MG BASE | LYBALVI | ALKERMES INC | N213378 | May 28, 2021 | RX | TABLET | ORAL | 8778960 | Feb. 13, 2032 | METHOD OF TREATING BIPOLAR DISORDER BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN, WITH REDUCED ANTIPSYCHOTIC INDUCED WEIGHT GAIN |
15MG;EQ 10MG BASE | LYBALVI | ALKERMES INC | N213378 | May 28, 2021 | RX | TABLET | ORAL | 8778960 | Feb. 13, 2032 | METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN, WITH REDUCED ANTIPSYCHOTIC INDUCED WEIGHT GAIN |
20MG;EQ 10MG BASE | LYBALVI | ALKERMES INC | N213378 | May 28, 2021 | RX | TABLET | ORAL | 8778960 | Feb. 13, 2032 | METHOD OF TREATING BIPOLAR DISORDER BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN, WITH REDUCED ANTIPSYCHOTIC INDUCED WEIGHT GAIN |
20MG;EQ 10MG BASE | LYBALVI | ALKERMES INC | N213378 | May 28, 2021 | RX | TABLET | ORAL | 8778960 | Feb. 13, 2032 | METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN, WITH REDUCED ANTIPSYCHOTIC INDUCED WEIGHT GAIN |
5MG;EQ 10MG BASE | LYBALVI | ALKERMES INC | N213378 | May 28, 2021 | RX | TABLET | ORAL | 8778960 | Feb. 13, 2032 | METHOD OF TREATING BIPOLAR DISORDER BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN, WITH REDUCED ANTIPSYCHOTIC INDUCED WEIGHT GAIN |
5MG;EQ 10MG BASE | LYBALVI | ALKERMES INC | N213378 | May 28, 2021 | RX | TABLET | ORAL | 8778960 | Feb. 13, 2032 | METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN, WITH REDUCED ANTIPSYCHOTIC INDUCED WEIGHT GAIN |
Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
---|---|---|---|---|---|---|---|---|---|
10MG;EQ 10MG BASE | LYBALVI | ALKERMES INC | N213378 | May 28, 2021 | RX | TABLET | ORAL | May 28, 2026 | NEW CHEMICAL ENTITY |
15MG;EQ 10MG BASE | LYBALVI | ALKERMES INC | N213378 | May 28, 2021 | RX | TABLET | ORAL | May 28, 2026 | NEW CHEMICAL ENTITY |
20MG;EQ 10MG BASE | LYBALVI | ALKERMES INC | N213378 | May 28, 2021 | RX | TABLET | ORAL | May 28, 2026 | NEW CHEMICAL ENTITY |
5MG;EQ 10MG BASE | LYBALVI | ALKERMES INC | N213378 | May 28, 2021 | RX | TABLET | ORAL | May 28, 2026 | NEW CHEMICAL ENTITY |
Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
---|---|---|---|---|---|---|---|---|---|
Mu-type opioid receptor | GPCR | ANTAGONIST | Ki | 10.28 | DRUG LABEL | ||||
Kappa-type opioid receptor | GPCR | PARTIAL AGONIST | Ki | 9.64 | DRUG LABEL | ||||
Delta-type opioid receptor | GPCR | PARTIAL AGONIST | Ki | 8.59 | DRUG LABEL |
ID | Source |
---|---|
D10162 | KEGG_DRUG |
7W2581Z5L8 | UNII |
1204592-75-5 | SECONDARY_CAS_RN |
C4277369 | UMLSCUI |
CHEMBL426084 | ChEMBL_ID |
11667832 | PUBCHEM_CID |
DB12543 | DRUGBANK_ID |
CHEMBL2105749 | ChEMBL_ID |
9515 | INN_ID |
C000722611 | MESH_SUPPLEMENTAL_RECORD_UI |
C583425 | MESH_SUPPLEMENTAL_RECORD_UI |
10651 | IUPHAR_LIGAND_ID |
018753 | NDDF |
4040827 | VANDF |
2559612 | RXNORM |
347116 | MMSL |
39562 | MMSL |
d09753 | MMSL |
Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
---|---|---|---|---|---|---|---|---|
LYBALVI | HUMAN PRESCRIPTION DRUG LABEL | 2 | 65757-651 | TABLET, FILM COATED | 10 mg | ORAL | NDA | 29 sections |
LYBALVI | HUMAN PRESCRIPTION DRUG LABEL | 2 | 65757-651 | TABLET, FILM COATED | 10 mg | ORAL | NDA | 29 sections |
LYBALVI | HUMAN PRESCRIPTION DRUG LABEL | 2 | 65757-652 | TABLET, FILM COATED | 10 mg | ORAL | NDA | 29 sections |
LYBALVI | HUMAN PRESCRIPTION DRUG LABEL | 2 | 65757-652 | TABLET, FILM COATED | 10 mg | ORAL | NDA | 29 sections |
LYBALVI | HUMAN PRESCRIPTION DRUG LABEL | 2 | 65757-653 | TABLET, FILM COATED | 10 mg | ORAL | NDA | 29 sections |
LYBALVI | HUMAN PRESCRIPTION DRUG LABEL | 2 | 65757-653 | TABLET, FILM COATED | 10 mg | ORAL | NDA | 29 sections |
LYBALVI | HUMAN PRESCRIPTION DRUG LABEL | 2 | 65757-654 | TABLET, FILM COATED | 10 mg | ORAL | NDA | 29 sections |
LYBALVI | HUMAN PRESCRIPTION DRUG LABEL | 2 | 65757-654 | TABLET, FILM COATED | 10 mg | ORAL | NDA | 29 sections |