NDAORALTABLET
Approved
May 1976
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
BRETHINE (terbutaline sulfate) by ANI Pharmaceuticals is clinical pharmacology in vitro and in vivo pharmacologic studies have demonstrated that terbutaline exerts a preferential effect on beta 2 -adrenergic receptors. First approved in 1976.
Drug data last refreshed 9h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Brethine (terbutaline sulfate) is an oral beta-2 adrenergic agonist bronchodilator approved in 1976 for relief of bronchospasm in chronic obstructive pulmonary disease and asthma. It works by stimulating beta-2 receptors in bronchial smooth muscle, increasing intracellular cAMP and relaxing airways, with measurable effects within 30 minutes and maximum effect within 2–3 hours. Duration of action extends 4–8 hours.
LOE Approaching
Long-established generic small molecule with minimal patent protection and moderate competitive pressure (30%); career growth limited to mature, efficiency-focused brand teams.
Mechanism of Action
CLINICAL PHARMACOLOGY In vitro and in vivo pharmacologic studies have demonstrated that terbutaline exerts a preferential effect on beta 2 -adrenergic receptors. While it is recognized that beta 2 -adrenergic receptors are the predominant receptors in bronchial smooth muscle, data indicate that…
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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.