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Spiriva (TIOTROPIUM BROMIDE)
Spiriva works by blocking the action of a chemical called acetylcholine, which causes airway muscles to contract and narrow the airways.
Spiriva (TIOTROPIUM BROMIDE) is a small molecule anticholinergic medication developed by Boehringer Ingelheim, targeting the muscarinic acetylcholine receptor M3. It is used to treat various respiratory conditions, including asthma, chronic obstructive pulmonary disease (COPD), and bronchitis. Spiriva was FDA-approved in 2004 and is currently owned by Boehringer Ingelheim. The medication is available in a generic form, but its commercial status is still under patent. Key safety considerations include potential side effects such as dry mouth and constipation.
At a glance
| Generic name | TIOTROPIUM BROMIDE |
|---|---|
| Sponsor | Boehringer Ingelheim |
| Drug class | Anticholinergic |
| Target | Muscarinic acetylcholine receptor M3 |
| Modality | Small molecule |
| Therapeutic area | Respiratory |
| Phase | FDA-approved |
| First approval | 2004 |
| Annual revenue | 2500 |
Mechanism of action
Tiotropium is long-acting, antimuscarinic agent, which is often referred to as an anticholinergic. It has similar affinity to the subtypes of muscarinic receptors, M1 to M5. In the airways, it exhibits pharmacological effects through inhibition of M3-receptors at the smooth muscle leading to bronchodilation. The competitive and reversible nature of antagonism was shown with human and animal origin receptors and isolated organ preparations. In preclinical in vitro as well as in vivo studies, prevention of methacholine-induced bronchoconstriction effects was dose-dependent and lasted longer than 24 hours. The bronchodilation following inhalation of tiotropium is predominantly site-specific effect.
Approved indications
- Asthma
- Bronchospasm Prevention with COPD
- Chronic Obstructive Pulmonary Disease with Bronchospasms
- Chronic bronchitis
- Pulmonary emphysema
Common side effects
- Upper Respiratory Tract Infection
- Dry Mouth
- Sinusitis
- Pharyngitis
- Chest Pain (non-specific)
- Urinary Tract Infection
- Dyspepsia
- Rhinitis
- Edema, Dependent
- Constipation
- Headache
- Arthralgia
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 |
|---|---|---|
| 7396341 | 2026-10-10 | Formulation |
| 7837235 | 2028-03-13 | Formulation |
| 9027967 | 2027-03-31 | Formulation |
| 8733341 | 2030-10-16 | Formulation |
| 7837235*PED | 2028-09-13 | Compound |
| 7396341*PED | 2027-04-10 | Compound |
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 |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Spiriva CI brief — competitive landscape report
- Spiriva updates RSS · CI watch RSS
- Boehringer Ingelheim portfolio CI