atogepant 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| calcitonin gene-related peptide receptor antagonists | 5472 | 1374248-81-3 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Atogepant is a calcitonin gene-related peptide (CGRP) receptor antagonist.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
None
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Sept. 28, 2021 | FDA | ABBVIE 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 |
|---|---|---|---|---|---|---|
| Constipation | 97.11 | 50.49 | 42 | 427 | 224901 | 63263652 |
| Nausea | 73.04 | 50.49 | 55 | 414 | 854416 | 62634137 |
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 | N02CD07 | NERVOUS SYSTEM ANALGESICS ANTIMIGRAINE PREPARATIONS Calcitonin gene-related peptide (CGRP) antagonists |
| FDA EPC | N0000193917 | Calcitonin Gene-related Peptide Receptor Antagonist |
| FDA MoA | N0000193918 | Calcitonin Gene-related Peptide Receptor Antagonists |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Preventive treatment of episodic migraine in adults | indication | 408381007 |
🐶 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 | QULIPTA | ABBVIE | N215206 | Sept. 28, 2021 | RX | TABLET | ORAL | 9499545 | Nov. 10, 2031 | PREVENTIVE TREATMENT OF MIGRAINE IN ADULTS |
| 30MG | QULIPTA | ABBVIE | N215206 | Sept. 28, 2021 | RX | TABLET | ORAL | 9499545 | Nov. 10, 2031 | PREVENTIVE TREATMENT OF MIGRAINE IN ADULTS |
| 60MG | QULIPTA | ABBVIE | N215206 | Sept. 28, 2021 | RX | TABLET | ORAL | 9499545 | Nov. 10, 2031 | PREVENTIVE TREATMENT OF MIGRAINE IN ADULTS |
| 10MG | QULIPTA | ABBVIE | N215206 | Sept. 28, 2021 | RX | TABLET | ORAL | 8754096 | July 19, 2032 | PREVENTIVE TREATMENT OF MIGRAINE IN ADULTS |
| 30MG | QULIPTA | ABBVIE | N215206 | Sept. 28, 2021 | RX | TABLET | ORAL | 8754096 | July 19, 2032 | PREVENTIVE TREATMENT OF MIGRAINE IN ADULTS |
| 60MG | QULIPTA | ABBVIE | N215206 | Sept. 28, 2021 | RX | TABLET | ORAL | 8754096 | July 19, 2032 | PREVENTIVE TREATMENT OF MIGRAINE IN ADULTS |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 10MG | QULIPTA | ABBVIE | N215206 | Sept. 28, 2021 | RX | TABLET | ORAL | April 17, 2026 | PREVENTIVE TREATMENT OF MIGRAINE IN ADULTS |
| 30MG | QULIPTA | ABBVIE | N215206 | Sept. 28, 2021 | RX | TABLET | ORAL | April 17, 2026 | PREVENTIVE TREATMENT OF MIGRAINE IN ADULTS |
| 60MG | QULIPTA | ABBVIE | N215206 | Sept. 28, 2021 | RX | TABLET | ORAL | April 17, 2026 | PREVENTIVE TREATMENT OF MIGRAINE IN ADULTS |
| 10MG | QULIPTA | ABBVIE | N215206 | Sept. 28, 2021 | RX | TABLET | ORAL | Sept. 28, 2026 | NEW CHEMICAL ENTITY |
| 30MG | QULIPTA | ABBVIE | N215206 | Sept. 28, 2021 | RX | TABLET | ORAL | Sept. 28, 2026 | NEW CHEMICAL ENTITY |
| 60MG | QULIPTA | ABBVIE | N215206 | Sept. 28, 2021 | RX | TABLET | ORAL | Sept. 28, 2026 | NEW CHEMICAL ENTITY |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Calcitonin gene-related peptide type 1 receptor | GPCR | ANTAGONIST | Ki | 10.82 | SCIENTIFIC LITERATURE | DRUG LABEL |
External reference:
| ID | Source |
|---|---|
| 7CRV8RR151 | UNII |
| C5238205 | UMLSCUI |
| CHEMBL3991065 | ChEMBL_ID |
| 72163100 | PUBCHEM_CID |
| DB16098 | DRUGBANK_ID |
| D11313 | KEGG_DRUG |
| 10510 | INN_ID |
| 9730 | IUPHAR_LIGAND_ID |
| 018859 | NDDF |
| 4040846 | VANDF |
| 2571813 | RXNORM |
| 350582 | MMSL |
| 39917 | MMSL |
| d09812 | MMSL |
| C000718987 | MESH_SUPPLEMENTAL_RECORD_UI |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Qulipta | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0074-7094 | TABLET | 60 mg | ORAL | NDA | 31 sections |
| Qulipta | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0074-7094 | TABLET | 60 mg | ORAL | NDA | 31 sections |
| Qulipta | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0074-7094 | TABLET | 60 mg | ORAL | NDA | 31 sections |
| Qulipta | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0074-7095 | TABLET | 10 mg | ORAL | NDA | 31 sections |
| Qulipta | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0074-7095 | TABLET | 10 mg | ORAL | NDA | 31 sections |
| Qulipta | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0074-7095 | TABLET | 10 mg | ORAL | NDA | 31 sections |
| Qulipta | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0074-7096 | TABLET | 30 mg | ORAL | NDA | 31 sections |
| Qulipta | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0074-7096 | TABLET | 30 mg | ORAL | NDA | 31 sections |
| Qulipta | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0074-7096 | TABLET | 30 mg | ORAL | NDA | 31 sections |