LEVITRA
LOE ApproachingNDAORALTABLET
Approved
Aug 2003
Lifecycle
LOE Approaching
Competitive Pressure
25/100
Clinical Trials
7
Data completeness
5/8 — Partial
LEVITRA by Bayer is mechanism of action penile erection is a hemodynamic process initiated by the relaxation of smooth muscle in the corpus cavernosum and its associated arterioles. Approved for erectile dysfunction. First approved in 2003.
Drug data last refreshed 3h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LEVITRA (vardenafil) is an oral small-molecule phosphodiesterase type 5 (PDE5) inhibitor approved for the treatment of erectile dysfunction. It works by inhibiting PDE5 in the corpus cavernosum, thereby increasing cGMP levels and promoting smooth muscle relaxation and increased blood flow to enable penile erection during sexual stimulation. The drug requires sexual stimulation to be effective and has demonstrated >15-fold selectivity for PDE5 over other phosphodiesterase isoforms.
LOE Approaching10mo to LOE
Product faces approaching loss of exclusivity in July 2027; commercial teams should expect significant market contraction and consolidation.
Mechanism of Action
Mechanism of Action Penile erection is a hemodynamic process initiated by the relaxation of smooth muscle in the corpus cavernosum and its associated arterioles. During sexual stimulation, nitric oxide is released from nerve endings and endothelial cells in the corpus cavernosum. Nitric oxide…
Indications (1)
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.