Tradename | Company | Number | Date | Products |
---|---|---|---|---|
KUVAN | BioMarin Pharmaceutical | N-022181 RX | 2007-12-13 | 1 products, RLD, RS |
KUVAN | BioMarin Pharmaceutical | N-205065 RX | 2013-12-19 | 2 products, RLD, RS |
Brand Name | Status | Last Update |
---|---|---|
javygtor | ANDA | 2024-10-22 |
kuvan | New Drug Application | 2024-08-26 |
sapropterin dihydrochloride | ANDA | 2025-01-06 |
Indication | Ontology | MeSH | ICD-10 |
---|---|---|---|
phenylketonurias | — | D010661 | E70.0 |
Patent | Expires | Flag | FDA Information |
---|---|---|---|
Sapropterin Dihydrochloride, Kuvan, Biomarin Pharm | |||
9216178 | 2032-11-01 | DP | |
7566462 | 2025-11-16 | DP | |
8003126 | 2025-11-16 | ||
RE43797 | 2024-11-17 | U-1156, U-1590 | |
7566714 | 2024-11-17 | U-989, U-1589 | |
7612073 | 2024-11-17 | U-1010 | |
7727987 | 2024-11-17 | DP | |
8067416 | 2024-11-17 | U-989, U-1589 | |
8318745 | 2024-11-17 | DP | |
9433624 | 2024-11-17 | U-1589 |
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Phenylketonurias | D010661 | — | E70.0 | 1 | 3 | 7 | 4 | 16 | 31 |
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Autistic disorder | D001321 | EFO_0003758 | F84.0 | — | 2 | 1 | — | — | 2 |
Oral manifestations | D009912 | — | — | — | 1 | 1 | — | — | 1 |
Lesch-nyhan syndrome | D007926 | Orphanet_510 | E79.1 | — | 1 | 1 | — | — | 1 |
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Hypertension | D006973 | EFO_0000537 | I10 | 1 | 2 | — | — | — | 3 |
Peripheral arterial disease | D058729 | EFO_0004265 | — | 1 | 1 | — | — | — | 2 |
Intermittent claudication | D007383 | EFO_0003876 | I73.9 | 1 | 1 | — | — | — | 2 |
Peripheral vascular diseases | D016491 | EFO_0003875 | I73.9 | 1 | 1 | — | — | — | 2 |
Chronic renal insufficiency | D051436 | — | N18 | — | 1 | — | — | — | 1 |
Kidney diseases | D007674 | EFO_0003086 | N08 | — | 1 | — | — | — | 1 |
Albuminuria | D000419 | EFO_0004285 | R80.9 | — | 1 | — | — | — | 1 |
Coronary disease | D003327 | — | — | — | 1 | — | — | — | 1 |
Coronary artery disease | D003324 | — | I25.1 | — | 1 | — | — | — | 1 |
Myocardial ischemia | D017202 | EFO_1001375 | I20-I25 | — | 1 | — | — | — | 1 |
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Vascular diseases | D014652 | EFO_0004264 | I77 | 1 | — | — | — | — | 1 |
Pulmonary arterial hypertension | D000081029 | — | — | 1 | — | — | — | — | 1 |
Familial primary pulmonary hypertension | D065627 | — | I27.0 | 1 | — | — | — | — | 1 |
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Behavior and behavior mechanisms | D001520 | — | — | — | — | — | — | 1 | 1 |
Developmental disabilities | D002658 | EFO_0003852 | F89 | — | — | — | — | 1 | 1 |
Autism spectrum disorder | D000067877 | — | F84.0 | — | — | — | — | 1 | 1 |
Heart failure | D006333 | EFO_0003144 | I50 | — | — | — | — | 1 | 1 |
Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | — | — | — | 1 | 1 |
Drug common name | Sapropterin |
INN | sapropterin |
Description | Sapropterin is a tetrahydropterin that is 2-amino-5,6,7,8-tetrahydropteridin-4(3H)-one in which a hydrogen at position 6 is substituted by a 1,2-dihydroxypropyl group (6R,1'R,2'S-enantiomer). It has a role as a coenzyme, a diagnostic agent, a human metabolite and a cofactor. |
Classification | Small molecule |
Drug class | pteridine derivatives |
Image (chem structure or protein) | ![]() |
Structure (InChI/SMILES or Protein Sequence) | C[C@H](O)[C@H](O)[C@H]1CNc2nc(N)[nH]c(=O)c2N1 |
PDB | — |
CAS-ID | 17528-72-2 |
RxCUI | — |
ChEMBL ID | CHEMBL1201774 |
ChEBI ID | 59560 |
PubChem CID | 135398654 |
DrugBank | DB00360 |
UNII ID | EGX657432I (ChemIDplus, GSRS) |