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Drug ReportsVardenafil
Levitra, Vivanza(vardenafil)
Levitra, Vardenafil (vardenafil) is a small molecule pharmaceutical. Vardenafil was first approved as Vivanza on 2003-03-04. It is used to treat vasculogenic impotence in the USA. It has been approved in Europe to treat erectile dysfunction. The pharmaceutical is active against cGMP-specific 3',5'-cyclic phosphodiesterase.
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FDA approval date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
urogenital diseasesD000091642
mental disordersD001523
Trade Name
FDA
EMA
Vardenafil (discontinued: Levitra, Staxyn, Vardenafil)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Vardenafil hydrochloride
Tradename
Company
Number
Date
Products
LEVITRABayerN-021400 DISCN2003-08-19
4 products, RLD
STAXYNBayerN-200179 DISCN2010-06-17
1 products, RLD
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Labels
FDA
EMA
Brand Name
Status
Last Update
levitraNew Drug Application2011-10-27
staxynNew Drug Application2012-04-23
vardenafilANDA2024-08-14
vardenafil hydrochlorideANDA2024-09-06
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
vasculogenic impotenceEFO_1001234D018783
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Vardenafil Hydrochloride, Staxyn, Bayer Hlthcare
86139502028-12-23DP
Vardenafil Hydrochloride, Levitra, Bayer Hlthcare
82738762027-07-23U-1288
88414462023-07-03DP
ATC Codes
G: Genito urinary system and sex hormones
G04: Urologicals
G04B: Urologicals
G04BE: Drugs used in erectile dysfunction
G04BE09: Vardenafil
HCPCS
No data
Clinical
No data
Drug
General
Drug common nameVardenafil
INNvardenafil
Description
Vardenafil, sold under the brand name Levitra among others, is a medication that is used for treating erectile dysfunction. It is a PDE5 inhibitor. It is taken by mouth.
Classification
Small molecule
Drug classphosphodiesterase type 5 inhibitors (PDE5) inhibitors: (PDE5) inhibitors containing a sulfonamide moiety
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CCCc1nc(C)c2c(=O)nc(-c3cc(S(=O)(=O)N4CCN(CC)CC4)ccc3OCC)[nH]n12
Identifiers
PDB
CAS-ID224785-90-4
RxCUI
ChEMBL IDCHEMBL1520
ChEBI ID46295
PubChem CID110634
DrugBankDB00862
UNII IDUCE6F4125H (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
PDE4B
PDE4B
Organism
Homo sapiens
Gene name
PDE4B
Gene synonyms
DPDE4
NCBI Gene ID
Protein name
cAMP-specific 3',5'-cyclic phosphodiesterase 4B
Protein synonyms
DPDE4, dunce-like phosphodiesterase E4, PDE32, phosphodiesterase 4B, cAMP-specific (phosphodiesterase E4 dunce homolog, Drosophila)
Uniprot ID
Mouse ortholog
Pde4b (18578)
cAMP-specific 3',5'-cyclic phosphodiesterase 4B (Q8VBU5)
Variants
No data
Financial
Revenue by drug
$
£
No data
Estimated US medical usage
Vardenafil
Total medical expenditures per year (USD, in millions)
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Trends
No data
Safety
Black-box Warning
No Black-box warning
Adverse Events
0 adverse events reported
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