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Drug ReportsSomatropin
Humatrope, Nutropinaq(somatropin)
Genotropin, Humatrope, Norditropin, Nutropin, NutropinAq, Omnitrope, Serostim, Zomacton (somatropin) is a protein pharmaceutical. Somatropin was first approved as Humatrope on 1986-10-16. It is used to treat cachexia, dwarfism, heart failure, noonan syndrome, and prader-willi syndrome amongst others in the USA. It has been approved in Europe to treat growth, pituitary dwarfism, prader-willi syndrome, and turner syndrome. The pharmaceutical is active against growth hormone receptor.
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Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
musculoskeletal diseasesD009140
nervous system diseasesD009422
urogenital diseasesD000091642
cardiovascular diseasesD002318
hereditary congenital and neonatal diseases and abnormalitiesD009358
skin and connective tissue diseasesD017437
nutritional and metabolic diseasesD009750
endocrine system diseasesD004700
signs and symptoms pathological conditionsD013568
physiological phenomenaD010829
Trade Name
FDA
EMA
Genotropin, Humatrope, Norditropin, Nutropin, Omnitrope, Serostim, Zomacton (discontinued: Accretropin, Genotropin, Humatrope, Norditropin, Nutropin, Omnitrope, Saizen, Serostim, Zomacton)
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)
Somatropin
Tradename
Proper name
Company
Number
Date
Products
Nutropin AQsomatropinGenentechN-20522 RX2008-01-03
3 products
SerostimsomatropinEMD SeronoN-20604 RX1996-08-23
3 products
HumatropesomatropinEli LillyN-19640 RX1999-02-04
3 products
ZomactonsomatropinFerring PharmaceuticalsN-19774 RX2002-01-04
2 products
NorditropinsomatropinNovo NordiskN-21148 RX2010-03-01
4 products
GenotropinsomatropinPharmacia & Upjohn Company LLCN-20280 RX1995-08-24
12 products
OmnitropesomatropinSandozN-21426 RX2006-05-30
3 products
Show 11 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
genotropinBiologic Licensing Application2024-08-28
humatropeBiologic Licensing Application2024-11-13
norditropinBiologic Licensing Application2020-03-09
norditropin norditropin nordiflex2008-11-10
nutropin aq2006-07-11
nutropin aq nuspin 10 nutropin aq nuspin 20 nutropin aq nuspin 5Biologic Licensing Application2024-11-19
nutropin aq nuspin 10 nutropin aq nuspin 20 nutropin aq nuspin 5 nutropin aq pen 10 nutropin aq pen 20New Drug Application2019-12-17
nutropin aq nutropin aq nuspin 10 nutropin aq nuspin 20 nutropin aq nuspin 5 nutropin aq pen 10 nutropin aq pen 20New Drug Application2013-10-29
omnitropeBiologic Licensing Application2024-11-14
serostimBiologic Licensing Application2022-02-02
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Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
heart failureEFO_0003144D006333I50
prader-willi syndromeOrphanet_739D011218Q87.11
cachexia—D002100R64
turner syndromeOrphanet_881D014424Q96
noonan syndromeOrphanet_648D009634Q87.19
dwarfism—D004392E34.31
Agency Specific
FDA
EMA
Expiration
Code
somatropin, Norditropin, Novo Nordisk Inc.
2114-05-31Orphan excl.
somatropin, Humatrope, Eli Lilly and Company
2113-11-01Orphan excl.
somatropin, Genotropin, Pharmacia & Upjohn Company LLC
2108-07-25Orphan excl.
somatropin, Nutropin, Genentech, Inc.
2103-12-30Orphan excl.
somatropin, Serostim, EMD Serono, Inc.
2103-08-23Orphan excl.
Patent Expiration
No data
ATC Codes
H: Systemic hormonal preparations, excl. sex hormones and insulins
— H01: Pituitary and hypothalamic hormones and analogues
— H01A: Anterior pituitary lobe hormones and analogues
— H01AC: Somatropin and somatropin agonists
— H01AC01: Somatropin
HCPCS
Code
Description
J2941
Injection, somatropin, 1 mg
Clinical
Clinical Trials
2119 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Laron syndromeD046150Orphanet_633E34.321—14——4
Endocrine system diseasesD004700EFO_0001379E34.9——2——2
Pituitary dwarfismD004393EFO_1001109E23.0——2——2
Pituitary diseasesD010900—E23.7——2——2
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameSomatropin
INNsomatropin
Description
Accretropin, Genotropin, Humatrope, Norditropin, Nutropin, Nutropin AQ, Omnitrope, Saizen, Serostim, Zomacton, Zorbtive/Serostim, NutropinAq (somatropin) is a protein pharmaceutical. Somatropin was first approved as Accretropin on 2001-02-15. It is used to treat cachexia, dwarfism, heart failure, noonan syndrome, and prader-willi syndrome amongst others in the USA. It has been approved in Europe to treat pituitary dwarfism, prader-willi syndrome, and turner syndrome. The pharmaceutical is active against growth hormone receptor.
Classification
Protein
Drug classtricyclic compounds; growth hormone derivatives; atropine derivatives
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID—
RxCUI—
ChEMBL IDCHEMBL1201621
ChEBI ID—
PubChem CID—
DrugBank—
UNII IDNQX9KB6PCL (ChemIDplus, GSRS)
Target
Agency Approved
GHR
GHR
Organism
Homo sapiens
Gene name
GHR
Gene synonyms
NCBI Gene ID
2690
Protein name
growth hormone receptor
Protein synonyms
GH receptor, growth hormone binding protein, mutant growth hormone receptor, serum binding protein, Somatotropin receptor
Uniprot ID
Q9HCX2
Mouse ortholog
Ghr (14600)
growth hormone receptor (P16882)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Genotropin – Pfizer
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Estimated US medical usage
Somatropin
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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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 6,449 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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72,990 adverse events reported
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