NDAORALTABLET
Approved
May 1976
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
4/8 — Partial
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. Approved for chronic obstructive pulmonary disease. First approved in 1976.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BRETHINE (terbutaline sulfate) is an oral beta-2 adrenergic agonist bronchodilator approved in 1976 for chronic obstructive pulmonary disease (COPD). It works by stimulating beta-2 receptors in bronchial smooth muscle, increasing cAMP and producing airway relaxation with measurable onset within 30 minutes and clinically significant improvement by 60-120 minutes.
LOE Approaching
As an approaching loss-of-exclusivity product, the BRETHINE team is likely transitioning to generic defense and cost management strategies with reduced headcount compared to peak-stage products.
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.