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samidorphan 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| opioid receptor antagonists/agonists, morphinan derivates | 5460 | 852626-89-2 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Samidorphan was first approved in combination with olanzapine by the FDA on May 28, 2021, under the name LYBALVI. The mechanism of action of samidorphan could be mediated through opioid receptor antagonism.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 1 | Bocci G, Oprea TI, Benet LZ |
| BA (Bioavailability) | 69 % |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| kinase-safety-class | ACVR2B,CAMK2D,CDK5,EIF2AK3,GRK2,ITK,MAPK7,PDK1,PDK2,PRKDC | 10 | |||
| kinase-selectivity-class | AXL,EIF2AK3,GRK2,MAP2K6,MAP3K14,TEK | 6 | |||
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| May 28, 2021 | FDA | ALKERMES INC |
FDA Adverse Event Reporting System (Female)
None
FDA Adverse Event Reporting System (Male)
None
FDA Adverse Event Reporting System (Geriatric)
None
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| 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 | D002492 | Central Nervous System Depressants |
| MeSH PA | D011619 | Psychotropic Drugs |
| MeSH PA | D014149 | Tranquilizing Agents |
| MeSH PA | D014150 | Antipsychotic Agents |
| MeSH PA | D009292 | Narcotic Antagonists |
| MeSH PA | D018373 | Peripheral Nervous System Agents |
| MeSH PA | D018689 | Sensory System Agents |
| FDA EPC | N0000175691 | Opioid Antagonist |
| CHEBI has role | CHEBI:35476 | antipsychotic agent |
Related Drugs by ATC class:
N05AH Diazepines, oxazepines, thiazepines and oxepines 6 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Schizophrenia | indication | 58214004 | DOID:5419 |
| Bipolar I disorder | indication | 371596008 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
None
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;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 | 11793805 | Aug. 23, 2031 | METHOD OF TREATING SCHIZOPHRENIA IN A PATIENT WHO HAS PREVIOUSLY EXPERIENCED SIGNIFICANT WEIGHT GAIN INDUCED BY OLANZAPINE ALONE BY ADMINISTERING A COMPOSITION COMPRISING OLANZAPINE AND SAMIDORPHAN |
| 10MG;EQ 10MG BASE | LYBALVI | ALKERMES INC | N213378 | May 28, 2021 | RX | TABLET | ORAL | 12194035 | 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 | 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 | 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 | 11793805 | Aug. 23, 2031 | METHOD OF TREATING SCHIZOPHRENIA IN A PATIENT WHO HAS PREVIOUSLY EXPERIENCED SIGNIFICANT WEIGHT GAIN INDUCED BY OLANZAPINE ALONE BY ADMINISTERING A COMPOSITION COMPRISING OLANZAPINE AND SAMIDORPHAN |
| 15MG;EQ 10MG BASE | LYBALVI | ALKERMES INC | N213378 | May 28, 2021 | RX | TABLET | ORAL | 12194035 | 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 | 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 | 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 | 11793805 | Aug. 23, 2031 | METHOD OF TREATING SCHIZOPHRENIA IN A PATIENT WHO HAS PREVIOUSLY EXPERIENCED SIGNIFICANT WEIGHT GAIN INDUCED BY OLANZAPINE ALONE BY ADMINISTERING A COMPOSITION COMPRISING OLANZAPINE AND SAMIDORPHAN |
| 20MG;EQ 10MG BASE | LYBALVI | ALKERMES INC | N213378 | May 28, 2021 | RX | TABLET | ORAL | 12194035 | 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 | 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 | 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 | 11793805 | Aug. 23, 2031 | METHOD OF TREATING SCHIZOPHRENIA IN A PATIENT WHO HAS PREVIOUSLY EXPERIENCED SIGNIFICANT WEIGHT GAIN INDUCED BY OLANZAPINE ALONE BY ADMINISTERING A COMPOSITION COMPRISING OLANZAPINE AND SAMIDORPHAN |
| 5MG;EQ 10MG BASE | LYBALVI | ALKERMES INC | N213378 | May 28, 2021 | RX | TABLET | ORAL | 12194035 | 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 | 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 |
| 10MG;EQ 10MG BASE | LYBALVI | ALKERMES INC | N213378 | May 28, 2021 | RX | TABLET | ORAL | 10300054 | May 31, 2033 | 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 | May 31, 2033 | 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 | 10300054 | May 31, 2033 | 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 | May 31, 2033 | 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 | 10300054 | May 31, 2033 | 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 | May 31, 2033 | 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 | 10300054 | May 31, 2033 | 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 | May 31, 2033 | 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 | 11951111 | Nov. 12, 2041 | METHOD OF TREATING BIPOLAR DISORDER BY ADMINISTERING A BILAYER TABLET COMPRISING OLANZAPINE AND SAMIDORPHAN |
| 10MG;EQ 10MG BASE | LYBALVI | ALKERMES INC | N213378 | May 28, 2021 | RX | TABLET | ORAL | 11951111 | Nov. 12, 2041 | METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING A BILAYER TABLET COMPRISING OLANZAPINE AND SAMIDORPHAN |
| 15MG;EQ 10MG BASE | LYBALVI | ALKERMES INC | N213378 | May 28, 2021 | RX | TABLET | ORAL | 11951111 | Nov. 12, 2041 | METHOD OF TREATING BIPOLAR DISORDER BY ADMINISTERING A BILAYER TABLET COMPRISING OLANZAPINE AND SAMIDORPHAN |
| 15MG;EQ 10MG BASE | LYBALVI | ALKERMES INC | N213378 | May 28, 2021 | RX | TABLET | ORAL | 11951111 | Nov. 12, 2041 | METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING A BILAYER TABLET COMPRISING OLANZAPINE AND SAMIDORPHAN |
| 20MG;EQ 10MG BASE | LYBALVI | ALKERMES INC | N213378 | May 28, 2021 | RX | TABLET | ORAL | 11951111 | Nov. 12, 2041 | METHOD OF TREATING BIPOLAR DISORDER BY ADMINISTERING A BILAYER TABLET COMPRISING OLANZAPINE AND SAMIDORPHAN |
| 20MG;EQ 10MG BASE | LYBALVI | ALKERMES INC | N213378 | May 28, 2021 | RX | TABLET | ORAL | 11951111 | Nov. 12, 2041 | METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING A BILAYER TABLET COMPRISING OLANZAPINE AND SAMIDORPHAN |
| 5MG;EQ 10MG BASE | LYBALVI | ALKERMES INC | N213378 | May 28, 2021 | RX | TABLET | ORAL | 11951111 | Nov. 12, 2041 | METHOD OF TREATING BIPOLAR DISORDER BY ADMINISTERING A BILAYER TABLET COMPRISING OLANZAPINE AND SAMIDORPHAN |
| 5MG;EQ 10MG BASE | LYBALVI | ALKERMES INC | N213378 | May 28, 2021 | RX | TABLET | ORAL | 11951111 | Nov. 12, 2041 | METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING A BILAYER TABLET COMPRISING OLANZAPINE AND SAMIDORPHAN |
Orange Book exclusivity data (new drug applications)
| 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 |
Bioactivity Summary:
| 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 |
External reference:
| ID | Source |
|---|---|
| D10162 | KEGG_DRUG |
| 7W2581Z5L8 | UNII |
| 1204592-75-5 | SECONDARY_CAS_RN |
| C4277369 | UMLSCUI |
| CHEBI:177605 | CHEBI |
| CHEMBL426084 | ChEMBL_ID |
| 11667832 | PUBCHEM_CID |
| DB12543 | DRUGBANK_ID |
| CHEMBL2105749 | ChEMBL_ID |
| 9515 | INN_ID |
| C000606131 | MESH_SUPPLEMENTAL_RECORD_UI |
| C000722611 | MESH_SUPPLEMENTAL_RECORD_UI |
| C583425 | MESH_SUPPLEMENTAL_RECORD_UI |
| 10651 | IUPHAR_LIGAND_ID |
| 4040827 | VANDF |
| 347116 | MMSL |
| 39562 | MMSL |
| d09753 | MMSL |
| 018753 | NDDF |
| 2559612 | RXNORM |
| 7W2581Z5L8 | INXIGHT DRUGS |
Pharmaceutical products:
| 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 | 65757-652 | 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 | 65757-654 | TABLET, FILM COATED | 10 mg | ORAL | NDA | 29 sections |