NDAORALTABLET
Approved
Apr 1940
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
5
Data completeness
4/8 — Partial
AMINOPHYLLIN (aminophylline) by Pfizer is mechanism of action: theophylline has two distinct actions in the airways of patients with reversible obstruction; smooth muscle relaxation (i. Approved for chronic obstructive pulmonary disease. First approved in 1940.
Drug data last refreshed 21h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Aminophylline is an oral tablet bronchodilator containing theophylline, approved in 1940 for chronic obstructive pulmonary disease (COPD). It works by inhibiting phosphodiesterase enzymes (PDE III and IV) to relax airway smooth muscle and suppress airway hyperresponsiveness, with therapeutic benefit occurring at serum concentrations between 10–15 mcg/mL.
LOE Approaching
As a legacy product approaching loss of exclusivity with minimal linked opportunities, commercial teams are likely small and focused on managed decline or niche patient populations.
Mechanism of Action
Mechanism of Action: Theophylline has two distinct actions in the airways of patients with reversible obstruction; smooth muscle relaxation (i.e., bronchodilation) and suppression of the response of the airways to stimuli (i.e., nonbronchodilator prophylactic effects). While the mechanisms of…
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.