NDAINHALATIONAEROSOL, METERED
Approved
Mar 2005
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
XOPENEX HFA (levalbuterol tartrate) by Lupin Ltd. is 2 -adrenergic receptors on airway smooth muscle leads to the activation of adenylate cyclase and to an increase in the intracellular concentration of cyclic-3', 5'-adenosine monophosphate (cyclic amp). First approved in 2005.
Drug data last refreshed 1h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
XOPENEX HFA is a metered-dose inhaler containing levalbuterol tartrate, the active R-enantiomer of albuterol, approved in 2005 for acute bronchospasm relief. It works by binding to beta-2 adrenergic receptors on airway smooth muscle, increasing cyclic AMP and triggering muscle relaxation while inhibiting mast cell mediator release. The drug provides functional antagonism against all bronchoconstrictor challenges regardless of the spasmogen involved.
$0.141BPart D
LOE ApproachingProduct is approaching loss of exclusivity with declining commercial momentum; brand teams should expect resource reallocation and transition planning.
Mechanism of Action
2 -adrenergic receptors on airway smooth muscle leads to the activation of adenylate cyclase and to an increase in the intracellular concentration of cyclic-3', 5'-adenosine monophosphate (cyclic AMP). The increase in cyclic AMP is associated with the activation of protein kinase A, which in turn,…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
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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.