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TIOTROPIUM
STIOLTO RESPIMAT combines tiotropium, an anticholinergic, and olodaterol, a beta-agonist, to achieve bronchodilation through different mechanisms.
STIOLTO RESPIMAT, a combination of tiotropium and olodaterol, is currently marketed for the maintenance treatment of COPD. Its dual mechanism of action, combining an anticholinergic and a beta-agonist, provides a significant competitive advantage in achieving bronchodilation. The primary risk is the key composition patent expiry in 2028, which could lead to increased competition from generics.
At a glance
| Generic name | TIOTROPIUM |
|---|---|
| Target | M3 receptors, beta2-adrenoceptors |
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 2004 |
Mechanism of action
STIOLTO RESPIMAT contains two active ingredients: tiotropium and olodaterol. Tiotropium blocks muscarinic receptors, particularly M3 receptors, in the airways, leading to bronchodilation. Olodaterol activates beta2-adrenoceptors, which increases cAMP levels and relaxes airway smooth muscle, also causing bronchodilation.
Approved indications
- Maintenance treatment of COPD
Common side effects
- Nasopharyngitis
- Cough
- Back Pain
Drug interactions
- Other adrenergic drugs
- Xanthine derivatives, steroids, diuretics, or non-potassium sparing diuretics
- MAO inhibitors, tricyclic antidepressants, and drugs that prolong QTc interval
- Beta-blockers
- Anticholinergics
Key clinical trials
- A Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of TQC3302 Inhalation Spray in Healthy Adult Subjects (PHASE1)
- Tiotropium vs. Inhaled Corticosteroids in Children With Nonatopic Asthma Pilot Study (TioNAAP) (PHASE2)
- Two-period 21 Day Cross-over Study to Compare the Pharmacokinetics of Tiotropium From Two Inhalers (PHASE1)
- Airway Effects of Tiotropium in Patients With COPD (PHASE3)
- ANTES B+ Clinical Trial (PHASE4)
- Asthma Research in Children and Adolescents
- Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM) - Salbutamol vs Long-acting Muscarinic Antagonists
- Acupuncture for Persistent Dyspnea Despite Medical Treatment in COPD (NA)
Patents
| Patent | Expiry | Type |
|---|---|---|
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 |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- TIOTROPIUM CI brief — competitive landscape report
- TIOTROPIUM updates RSS · CI watch RSS