amifampridine 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| 4336 | 54-96-6 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
4-Aminopyridine derivative that acts as a POTASSIUM CHANNEL blocker to increase release of ACETYLCHOLINE from nerve terminals. It is used in the treatment of CONGENITAL MYASTHENIC SYNDROMES.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 40 | mg | O |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| S (Water solubility) | 24 mg/mL | Bocci G, Oprea TI, Benet LZ |
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 1 | Bocci G, Oprea TI, Benet LZ |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Dec. 23, 2009 | EMA | BioMarin Europe Ltd | |
| Nov. 28, 2018 | FDA | CATALYST PHARMS |
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 |
|---|---|---|---|---|---|---|
| Asthenia | 28.87 | 28.84 | 21 | 347 | 383583 | 63105071 |
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 | N07XX05 | NERVOUS SYSTEM OTHER NERVOUS SYSTEM DRUGS OTHER NERVOUS SYSTEM DRUGS Other nervous system drugs |
| FDA MoA | N0000175448 | Potassium Channel Antagonists |
| MeSH PA | D002317 | Cardiovascular Agents |
| MeSH PA | D049990 | Membrane Transport Modulators |
| MeSH PA | D009465 | Neuromuscular Agents |
| MeSH PA | D018373 | Peripheral Nervous System Agents |
| MeSH PA | D026902 | Potassium Channel Blockers |
| FDA EPC | N0000192795 | Potassium Channel Blocker |
| CHEBI has role | CHEBI:76971 | Escherichia coli metabolites |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Eaton-Lambert syndrome | indication | 56989000 | DOID:0050214 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 8.89 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|
| EQ 10MG BASE | FIRDAPSE | CATALYST PHARMS | N208078 | Nov. 28, 2018 | RX | TABLET | ORAL | 11060128 | June 29, 2032 | METHOD OF TREATING LAMBERT-EATON MYASTHENIC SYNDROME WITH AMIFAMPRIDINE |
| EQ 10MG BASE | FIRDAPSE | CATALYST PHARMS | N208078 | Nov. 28, 2018 | RX | TABLET | ORAL | 11268128 | June 29, 2032 | METHOD OF TREATING LAMBERT-EATON MYASTHENIC SYNDROME WITH AMIFAMPRIDINE |
| EQ 10MG BASE | FIRDAPSE | CATALYST PHARMS | N208078 | Nov. 28, 2018 | RX | TABLET | ORAL | 11274331 | June 29, 2032 | METHOD OF TREATING LAMBERT-EATON MYASTHENIC SYNDROME WITH AMIFAMPRIDINE |
| EQ 10MG BASE | FIRDAPSE | CATALYST PHARMS | N208078 | Nov. 28, 2018 | RX | TABLET | ORAL | 11274332 | June 29, 2032 | METHOD OF TREATING LAMBERT-EATON MYASTHENIC SYNDROME WITH AMIFAMPRIDINE |
| EQ 10MG BASE | FIRDAPSE | CATALYST PHARMS | N208078 | Nov. 28, 2018 | RX | TABLET | ORAL | 10793893 | May 26, 2034 | METHOD OF TREATING LAMBERT-EATON MYASTHENIC SYNDROME WITH AMIFAMPRIDINE |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| EQ 10MG BASE | FIRDAPSE | CATALYST PHARMS | N208078 | Nov. 28, 2018 | RX | TABLET | ORAL | Nov. 28, 2023 | NEW CHEMICAL ENTITY |
| EQ 10MG BASE | FIRDAPSE | CATALYST PHARMS | N208078 | Nov. 28, 2018 | RX | TABLET | ORAL | Sept. 29, 2025 | NEW PATIENT POPULATION |
| EQ 10MG BASE | FIRDAPSE | CATALYST PHARMS | N208078 | Nov. 28, 2018 | RX | TABLET | ORAL | Nov. 28, 2025 | TREATMENT OF LAMBERT-EATON MYASTHENIC SYNDROME (LEMS) |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Voltage-gated potassium channel | Ion channel | BLOCKER | SCIENTIFIC LITERATURE | SCIENTIFIC LITERATURE |
External reference:
| ID | Source |
|---|---|
| D10228 | KEGG_DRUG |
| 4027572 | VANDF |
| 4038075 | VANDF |
| C0046948 | UMLSCUI |
| CHEBI:135948 | CHEBI |
| L89 | PDB_CHEM_ID |
| CHEMBL354077 | ChEMBL_ID |
| CHEMBL3301611 | ChEMBL_ID |
| D000077770 | MESH_DESCRIPTOR_UI |
| DB11640 | DRUGBANK_ID |
| 8032 | IUPHAR_LIGAND_ID |
| 8804 | INN_ID |
| 446254-47-3 | SECONDARY_CAS_RN |
| RU4S6E2G0J | UNII |
| 5918 | PUBCHEM_CID |
| 2106337 | RXNORM |
| 177374 | MMSL |
| 23312 | MMSL |
| NOCODE | MMSL |
| d06641 | MMSL |
| 011806 | NDDF |
| 013406 | NDDF |
| 422654000 | SNOMEDCT_US |
| 782983000 | SNOMEDCT_US |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Ruzurgi | HUMAN PRESCRIPTION DRUG LABEL | 1 | 49938-110 | TABLET | 10 mg | ORAL | NDA | 28 sections |
| Ruzurgi | HUMAN PRESCRIPTION DRUG LABEL | 1 | 49938-110 | TABLET | 10 mg | ORAL | NDA | 28 sections |
| Firdapse | HUMAN PRESCRIPTION DRUG LABEL | 1 | 69616-211 | TABLET | 10 mg | ORAL | NDA | 33 sections |
| Firdapse | HUMAN PRESCRIPTION DRUG LABEL | 1 | 69616-211 | TABLET | 10 mg | ORAL | NDA | 33 sections |
| Firdapse | HUMAN PRESCRIPTION DRUG LABEL | 1 | 69616-211 | TABLET | 10 mg | ORAL | NDA | 33 sections |