NDAINHALATIONAEROSOL, METEREDPriority Review
Approved
May 1981
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
Priority Review
PROVENTIL (albuterol) by Merck & Co. is clinical pharmacology the prime action of beta-adrenergic drugs is to stimulate adenyl cyclase, the enzyme which catalyzes the formation of cyclic-3',5'-adenosine monophosphate (cyclic amp) from adenosine triphosphate (atp). First approved in 1981.
Drug data last refreshed 11h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PROVENTIL (albuterol) is a beta-2 adrenergic agonist administered via metered-dose inhaler that relaxes bronchial smooth muscle to treat acute bronchospasm and asthma exacerbations. It works by stimulating adenyl cyclase to increase cyclic AMP, mediating rapid airway dilation with onset within 5 minutes and peak effect at approximately 1 hour. The drug is longer-acting than isoproterenol and produces fewer cardiovascular effects at comparable doses.
LOE Approaching
As an established product approaching loss of exclusivity with moderate competitive pressure (30), brand teams face margin compression and require strategic focus on market share defense and patient loyalty programs.
Mechanism of Action
CLINICAL PHARMACOLOGY The prime action of beta-adrenergic drugs is to stimulate adenyl cyclase, the enzyme which catalyzes the formation of cyclic-3',5'-adenosine monophosphate (cyclic AMP) from adenosine triphosphate (ATP). The cyclic AMP thus formed mediates the cellular responses. In vitro…
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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.