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Brethine (TERBUTALINE)
Terbutaline (Brethine) is a marketed beta-2 adrenergic agonist used primarily for the prevention and reversal of bronchospasm, competing in a crowded market with other same-class drugs such as salbutamol, isoetarine, pirbuterol, salmeterol, and formoterol. A key strength of Terbutaline is its well-established mechanism of action and long-standing use, supported by a key composition patent expiring in 2028. The primary risk is the strong competition from off-patent alternatives like formoterol, which has 10 generics available, potentially eroding market share.
At a glance
| Generic name | TERBUTALINE |
|---|---|
| Sponsor | Pharmacare |
| Drug class | terbutaline |
| Target | Beta-2 adrenergic receptor |
| Modality | Small molecule |
| Therapeutic area | Respiratory |
| Phase | FDA-approved |
| First approval | 1974 |
Approved indications
- Prevention and reversal of bronchospasm
Boxed warnings
- WARNING: TOCOLYSIS Oral terbutaline sulfate has not been approved and should not be used for acute or maintenance tocolysis. In particular, terbutaline sulfate should not be used for maintenance tocolysis in the outpatient or home setting. Serious adverse reactions, including death, have been reported after administration of terbutaline sulfate to pregnant women. In the mother, these adverse reactions include increased heart rate, transient hyperglycemia, hypokalemia, cardiac arrhythmias, pulmonary edema and myocardial ischemia. Increased fetal heart rate and neonatal hypoglycemia may occur as a result of maternal administration. [see Contraindications, Tocolysis . ]
Common side effects
- Tremor
- Nervousness
- Palpitations
- Dizziness
- Headache
- Nausea/vomiting
- Drowsiness
- Tachycardia
- Weakness
- Chest discomfort
- Dyspnea
- Sweating
Drug interactions
- other sympathomimetic agents
Key clinical trials
- Terbutaline Sulfate in Adults With Asthma (PHASE2,PHASE3)
- Patient Perspective on Climate Impact of Inhalers (NA)
- Hot Flashes and Neurovascular Function in Women (NA)
- Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)
- Randomized Controlled Trial of Intravenous Magnesium Sulfate Versus Terbutaline for Children in the Management of Acute Exacerbation of Asthma (PHASE3)
- The Impact of Airway Allergic Diseases on Children's and Parents' Quality of Life
- Airway Microbiota Based Treatment of Asthma in Preschool Children (PHASE4)
- Umbilical Cord Mesenchymal Stem Cells Transplantation in the Treatment of Chronic Obstructive Pulmonary Disease (PHASE1,PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Brethine CI brief — competitive landscape report
- Brethine updates RSS · CI watch RSS