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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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Events Timeline
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YTD
1Y
2Y
5Y
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FDA approval date
EMA approval date
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Study first post date
Last update post date
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Completion date
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
151 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
InfertilityD007246HP_0000789101129272096
Female infertilityD007247EFO_0008560N975263520
Ovulation inductionD0100621631213
Polycystic ovary syndromeD011085EFO_0000660E28.2153312
Fertilization in vitroD00530715410
SyndromeD01357712339
HypogonadismD007006HP_0000044E23.012429
AnovulationD0008584116
Intracytoplasmic sperm injectionsD020554415
Kallmann syndromeD017436Orphanet_478E23.01135
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AzoospermiaD053713EFO_0000279N46.01113
Assisted reproductive techniquesD027724213
Ovarian hyperstimulation syndromeD016471112
Pituitary diseasesD010900E23.722
Male infertilityD007248EFO_0004248N46112
Embryo transferD00462411
OligospermiaD009845N46.111
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Primary ovarian insufficiencyD016649EFO_0004266E28.311
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
EndometriosisD004715EFO_0001065N80123
Healthy volunteers/patients22
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PregnancyD011247EFO_0002950Z33.155
In vitro oocyte maturation techniquesD05947122
Ovarian pregnancyD065172O00.211
FertilityD00529811
ThrombosisD01392711
Embryo culture techniquesD04614911
AneuploidyD00078211
RecurrenceD01200811
Acupuncture therapyD01567011
Habitual abortionD000026EFO_1000954N9611
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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
Image (chem structure or protein)Loading
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
$
£
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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Number of purchases
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Refill frequency
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Price per prescription (USD)
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 582 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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271 adverse events reported
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