deferiprone 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| 4188 | 30652-11-0 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
a chelating agent with an affinity for ferric ion (iron III) indicated for the treatment of patients with transfusional iron overload due to thalassemia syndromes
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
None
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Aug. 25, 1999 | EMA | APOTEX EUROPE BV | |
| Oct. 14, 2011 | FDA | APOPHARMA 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 |
|---|---|---|---|---|---|---|
| Agranulocytosis | 264.04 | 36.07 | 65 | 946 | 21356 | 50582757 |
| Sickle cell anaemia with crisis | 150.41 | 36.07 | 31 | 980 | 4512 | 50599601 |
| Neutropenia | 78.62 | 36.07 | 44 | 967 | 147921 | 50456192 |
| Serum ferritin increased | 59.80 | 36.07 | 15 | 996 | 5187 | 50598926 |
FDA Adverse Event Reporting System (Male)
| 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 |
|---|---|---|---|---|---|---|
| Agranulocytosis | 157.02 | 30.63 | 46 | 797 | 20294 | 29553390 |
| Neutropenia | 56.79 | 30.63 | 39 | 804 | 131672 | 29442012 |
| Death | 51.15 | 30.63 | 55 | 788 | 342029 | 29231655 |
| Sickle cell anaemia with crisis | 49.17 | 30.63 | 12 | 831 | 2596 | 29571088 |
| Serum ferritin increased | 31.61 | 30.63 | 10 | 833 | 5578 | 29568106 |
FDA Adverse Event Reporting System (Geriatric)
| 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 |
|---|---|---|---|---|---|---|
| Agranulocytosis | 390.35 | 32.07 | 104 | 1474 | 38125 | 64459029 |
| Sickle cell anaemia with crisis | 133.55 | 32.07 | 30 | 1548 | 5302 | 64491852 |
| Neutropenia | 128.79 | 32.07 | 77 | 1501 | 239547 | 64257607 |
| Death | 82.48 | 32.07 | 78 | 1500 | 482627 | 64014527 |
| Serum ferritin increased | 58.22 | 32.07 | 17 | 1561 | 8451 | 64488703 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | V03AC02 | VARIOUS ALL OTHER THERAPEUTIC PRODUCTS ALL OTHER THERAPEUTIC PRODUCTS Iron chelating agents |
| FDA MoA | N0000000144 | Iron Chelating Activity |
| FDA EPC | N0000175522 | Iron Chelator |
| MeSH PA | D002614 | Chelating Agents |
| MeSH PA | D007502 | Iron Chelating Agents |
| MeSH PA | D064449 | Sequestering Agents |
| CHEBI has role | CHEBI:38157 | iron chelating agents |
| CHEBI has role | CHEBI:50267 | protective agents |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Iron overload | indication | 60737008 | |
| beta Thalassemia | indication | 65959000 | DOID:12241 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 9.54 | acidic |
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 |
|---|---|---|---|---|---|---|---|---|---|---|
| 100MG/ML | FERRIPROX | CHIESI | N208030 | Sept. 9, 2015 | RX | SOLUTION | ORAL | 8703156 | Oct. 26, 2029 | METHOD OF TREATING TRANSFUSIONAL IRON OVERLOAD |
| 80MG/ML | FERRIPROX | CHIESI | N208030 | April 20, 2018 | DISCN | SOLUTION | ORAL | 8703156 | Oct. 26, 2029 | METHOD OF TREATING TRANSFUSIONAL IRON OVERLOAD |
| 1GM | FERRIPROX | CHIESI | N212269 | May 19, 2020 | RX | TABLET | ORAL | 10780055 | Oct. 25, 2038 | METHOD OF TREATING TRANSFUSIONAL IRON OVERLOAD |
| 1GM | FERRIPROX | CHIESI | N212269 | May 19, 2020 | RX | TABLET | ORAL | 10940115 | Oct. 25, 2038 | METHOD OF TREATING TRANSFUSIONAL IRON OVERLOAD |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 1GM | FERRIPROX | CHIESI | N021825 | July 25, 2019 | RX | TABLET | ORAL | April 30, 2024 | TREATMENT OF PATIENTS WITH TRANSFUSIONAL IRON OVERLOAD DUE TO SICKLE CELL DISEASE OR OTHER ANEMIAS |
| 500MG | FERRIPROX | CHIESI | N021825 | Oct. 14, 2011 | RX | TABLET | ORAL | April 30, 2024 | TREATMENT OF PATIENTS WITH TRANSFUSIONAL IRON OVERLOAD DUE TO SICKLE CELL DISEASE OR OTHER ANEMIAS |
| 100MG/ML | FERRIPROX | CHIESI | N208030 | Sept. 9, 2015 | RX | SOLUTION | ORAL | April 30, 2024 | TREATMENT OF PATIENTS WITH TRANSFUSIONAL IRON OVERLOAD DUE TO SICKLE CELL DISEASE OR OTHER ANEMIAS |
| 80MG/ML | FERRIPROX | CHIESI | N208030 | April 20, 2018 | DISCN | SOLUTION | ORAL | April 30, 2024 | TREATMENT OF PATIENTS WITH TRANSFUSIONAL IRON OVERLOAD DUE TO SICKLE CELL DISEASE OR OTHER ANEMIAS |
| 1GM | FERRIPROX | CHIESI | N212269 | May 19, 2020 | RX | TABLET | ORAL | April 30, 2024 | TREATMENT OF PATIENTS WITH TRANSFUSIONAL IRON OVERLOAD DUE TO SICKLE CELL DISEASE OR OTHER ANEMIAS |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Deoxyhypusine hydroxylase | Enzyme | IC50 | 5.30 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| 4031179 | VUID |
| N0000183921 | NUI |
| D07416 | KEGG_DRUG |
| 4031179 | VANDF |
| C0043832 | UMLSCUI |
| CHEBI:68554 | CHEBI |
| CHEMBL70927 | ChEMBL_ID |
| D000077543 | MESH_DESCRIPTOR_UI |
| DB08826 | DRUGBANK_ID |
| 7456 | IUPHAR_LIGAND_ID |
| 6958 | INN_ID |
| 2BTY8KH53L | UNII |
| 2972 | PUBCHEM_CID |
| 11645 | RXNORM |
| 117386 | MMSL |
| 18035 | MMSL |
| 51626 | MMSL |
| d04976 | MMSL |
| 007561 | NDDF |
| 329482000 | SNOMEDCT_US |
| 396011004 | SNOMEDCT_US |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Deferiprone | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0054-0576 | TABLET, COATED | 500 mg | ORAL | ANDA | 28 sections |
| Deferiprone | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0054-0711 | TABLET, COATED | 1000 mg | ORAL | ANDA | 28 sections |
| FERRIPROX | HUMAN PRESCRIPTION DRUG LABEL | 1 | 10122-100 | TABLET, FILM COATED | 500 mg | ORAL | NDA | 28 sections |
| FERRIPROX | HUMAN PRESCRIPTION DRUG LABEL | 1 | 10122-100 | TABLET, FILM COATED | 500 mg | ORAL | NDA | 28 sections |
| FERRIPROX | HUMAN PRESCRIPTION DRUG LABEL | 1 | 10122-101 | SOLUTION | 100 mg | ORAL | NDA | 29 sections |
| FERRIPROX | HUMAN PRESCRIPTION DRUG LABEL | 1 | 10122-103 | TABLET, FILM COATED | 1000 mg | ORAL | NDA | 28 sections |
| FERRIPROX | HUMAN PRESCRIPTION DRUG LABEL | 1 | 10122-104 | TABLET | 1000 mg | ORAL | NDA | 28 sections |
| Deferiprone | HUMAN PRESCRIPTION DRUG LABEL | 1 | 51672-4196 | TABLET | 500 mg | ORAL | ANDA | 31 sections |
| FERRIPROX | HUMAN PRESCRIPTION DRUG LABEL | 1 | 52609-0006 | TABLET, FILM COATED | 500 mg | ORAL | NDA | 28 sections |
| FERRIPROX | HUMAN PRESCRIPTION DRUG LABEL | 1 | 52609-0007 | TABLET, FILM COATED | 1000 mg | ORAL | NDA | 29 sections |
| FERRIPROX | HUMAN PRESCRIPTION DRUG LABEL | 1 | 52609-4502 | SOLUTION | 100 mg | ORAL | NDA | 29 sections |