NDAINHALATIONAEROSOL, METERED
Approved
Oct 2004
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
12
Data completeness
4/8 — Partial
PROAIR HFA (albuterol sulfate) by Teva 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 2004.
Drug data last refreshed 2d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PROAIR HFA is a metered-dose inhaler (MDI) containing albuterol sulfate, a selective beta-2 adrenergic agonist that relaxes bronchial smooth muscle. It is indicated for the treatment and prevention of bronchospasm in patients with asthma and chronic obstructive pulmonary disease (COPD). The drug works by stimulating adenyl cyclase to increase cyclic AMP, producing rapid bronchodilation with onset within 5 minutes and peak effect at approximately 1 hour.
$0.001BPart D
LOE ApproachingProduct is approaching loss of exclusivity with modest Part D spending of $1M (12,038 claims in 2023), indicating a mature, commoditized market with contracting team investment.
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.