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Spiriva (TIOTROPIUM BROMIDE)
Spiriva (generic name: TIOTROPIUM BROMIDE) is a Anticholinergic Small molecule drug developed by Boehringer Ingelheim. It is currently FDA-approved (first approved 2004) for Asthma, Bronchospasm Prevention with COPD, Chronic Obstructive Pulmonary Disease with Bronchospasms.
Spiriva works by blocking the action of a chemical called acetylcholine, which causes airway muscles to contract and narrow the airways.
Spiriva is a small molecule that acts as a muscarinic acetylcholine receptor M3 antagonist. It is used to treat Chronic Obstructive Pulmonary Disease (COPD) when added to tiotropium.
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
Frequently asked questions about Spiriva
What is Spiriva?
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Related
- Drug class: All Anticholinergic drugs
- Target: All drugs targeting Muscarinic acetylcholine receptor M3
- Manufacturer: Boehringer Ingelheim — full pipeline
- Therapeutic area: All drugs in Respiratory
- Indication: Drugs for Asthma
- Indication: Drugs for Bronchospasm Prevention with COPD
- Indication: Drugs for Chronic Obstructive Pulmonary Disease with Bronchospasms
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing