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Drug ReportsUrofollitropin
Urofollitropin
Bravelle (urofollitropin) is an unknown pharmaceutical. Urofollitropin was first approved as Bravelle on 2002-05-06. It is used to treat female infertility and polycystic ovary syndrome in the USA. The pharmaceutical is active against follicle-stimulating hormone receptor.
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YTD
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FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
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Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
urogenital diseasesD000091642
endocrine system diseasesD004700
Trade Name
FDA
EMA
No data
Drug Products
FDA
EMA
Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
Interchangeable product - 351(k)
Biosimilar product - 351(k)
Biosimilar product - 351(k)
Urofollitropin
Tradename
Proper name
Company
Number
Date
Products
BravelleurofollitropinFerring PharmaceuticalsN-21289 DISCN2002-05-06
1 products
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Labels
FDA
EMA
No data
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
polycystic ovary syndromeEFO_0000660D011085E28.2
female infertilityEFO_0008560D007247N97
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
G: Genito urinary system and sex hormones
— G03: Sex hormones and modulators of the genital system
— G03G: Gonadotropins and other ovulation stimulants
— G03GA: Gonadotropins
— G03GA04: Urofollitropin
HCPCS
Code
Description
J3355
Injection, urofollitropin, 75 iu
Clinical
Clinical Trials
157 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
InfertilityD007246EFO_0000545———5319
Polycystic ovary syndromeD011085EFO_0000660E28.2———1—1
SyndromeD013577—————1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AnovulationD000858————1——1
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
FertilityD005298——————11
Female infertilityD007247EFO_0008560N97————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameUrofollitropin
INNurofollitropin
Description
Follitropin beta chain precursor (Follicle-stimulating hormone beta subunit) (FSH-beta)
Classification
Protein
Drug classtricyclic compounds; atropine derivatives
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Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID—
RxCUI—
ChEMBL IDCHEMBL1201520
ChEBI ID—
PubChem CID—
DrugBankDB00094
UNII IDW9BB98U6HP (ChemIDplus, GSRS)
Target
Agency Approved
FSHR
FSHR
Organism
Homo sapiens
Gene name
FSHR
Gene synonyms
LGR1
NCBI Gene ID
Protein name
follicle-stimulating hormone receptor
Protein synonyms
Follitropin receptor, FSH receptor
Uniprot ID
Mouse ortholog
Fshr (14309)
follicle-stimulating hormone receptor (Q9QWV8)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
No data
Estimated US medical usage
Urofollitropin
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 591 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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281 adverse events reported
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