SPIRIVA (tiotropium bromide)
Spiriva (tiotropium bromide) is a long-acting antimuscarinic agent used for the long-term, once-daily maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. It is also indicated for the long-term maintenance treatment of asthma in patients 6 years of age and older. Spiriva is
How SPIRIVA Works
This medication works by combining two different mechanisms to relax the smooth muscles in the airways. Tiotropium blocks muscarinic receptors to prevent muscle constriction, while olodaterol stimulates beta-2 receptors to increase levels of a messenger called cAMP, which triggers muscle relaxation. Together, these actions produce a site-specific bronchodilation effect that lasts for more than 24 hours.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2004-01-30
- Patent Cliff
- 2026
- Routes
- INHALATION
- Dosage Forms
- POWDER
SPIRIVA Approval History
What SPIRIVA Treats
3 indicationsSPIRIVA is approved for 3 conditions since its original approval in 2004. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Chronic Obstructive Pulmonary Disease
- Chronic Bronchitis
- Emphysema
SPIRIVA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to SPIRIVA
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
20 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04990167 TioNAAP | 1753113-1 | Ph 2 | terminated | Tiotropium vs. Inhaled Corticosteroids in Children With Nonatopic Asthma Pilot Study (TioNAAP) |
| NCT06282861 ANTES B+ | ANTES B+ 2023-507304-32 | Ph 4 | terminated | ANTES B+ Clinical Trial |
| NCT04061161 ANTIOFLAM | 2018-002173-22 | Ph 4 | completed | Anti-inflammatory Effects of Tiotropium in Patients with Stable COPD |
| NCT03199976 results posted | TFS01 2015-002985-22 | Ph 4 | terminated | Efficacy of Intermittent Tiotropium in Early Childhood Wheezing |
| NCT05113615 | Bio ID 2985 | Ph 4 | completed | Regular Use Tiotropium and Tolerance to Bronchoprotection in Mild Asthma |
| NCT03097380 | D3060C00014 | Ph 1 | completed | PET Study to Determine Muscarinic Receptor Occupancy in Lungs After Inhalation of AZD2115 and Tiotropium |
| NCT02586649 | SCH-14-019 | Ph 2 | completed | 24hr Effects of Tiotropium Bromide in Tetraplegia |
| NCT01662986 results posted | 205.478 | Ph 4 | completed | Investigate the Impact of Early Treatment Initiation With Tiotropium in Patients Recovering From Hospitalization for an Acute COPD Exacerbation 2 |
| NCT01663987 results posted | 205.477 | Ph 4 | completed | Investigate the Impact of Early Treatment Initiation With Tiotropium in Patients Recovering From Hospitalization for an Acute COPD Exacerbation 1 |
| NCT00565266 TALC results posted | 547 U10HL074206, U10HL074208 | Ph 3 | completed | Asthma Clinical Research Network (ACRN) Trial - Tiotropium Bromide as an Alternative to Increased Inhaled Corticosteroid in Patients Inadequately Controlled on a Lower Dose of Inhaled Corticosteroid (TALC) |
| NCT01316900 results posted | 113360 | Ph 3 | completed | 24-week Trial Comparing GSK573719/GW642444 With GW642444 and With Tiotropium in Chronic Obstructive Pulmonary Disease |
| NCT01566773 results posted | PT001003 | Ph 2 | completed | PT001 MDI Versus Spiriva® in Patients With Moderate to Severe COPD |
| NCT01316913 results posted | 113374 | Ph 3 | completed | 24-week Trial Comparing GSK573719/GW642444 With GSK573719 and With Tiotropium in Chronic Obstructive Pulmonary Disease |
| NCT01751113 SCO116572 results posted | 116572 | Ph 4 | completed | A 3 Way Cross-over Study Evaluating the Effects of ADOAIR Twice Daily Plus Tiotropium Bromide Once Daily Compared With the Individual Treatments of Japanese Subjects |
| NCT00784550 ADC111114 results posted | 111114 | Ph 4 | completed | A 24-Week Study to Evaluate the Safety and Efficacy of ADVAIR DISKUS® Inhaler 250/50mcg Plus SPIRIVA HANDIHALER® Inhaler Versus SPIRIVA HANDIHALER® Inhaler Plus Placebo DISKUS® Inhaler in Subjects With Chronic Obstructive Pulmonary Disease (COPD). |
| NCT00696020 results posted | 1237.4 EudraCT No: 2007-005087-26 | Ph 2 | completed | Combination of Orally Inhaled BI1744CL/Tiotropium Bromide in Patients With Chronic Obstructive Pulmonary Disease ( COPD) |
| NCT01383499 results posted | 205.425 2010-022458-18 | Ph 2 | completed | A Study to Evaluate Efficacy and Safety of Tiotropium in Children 6 to 11 Years Old With Moderate Asthma |
| NCT01437748 | 629CEC | Ph 4 | completed | Closing Volume Interpretation and Bronchodilators Effect |
| NCT01122680 results posted | 205.424 2009-017745-55 | Ph 2 | completed | Efficacy and Safety of 3 Doses of Tiotropium Compared to Placebo in Adolescents (12 to 17 Yrs) With Moderate Asthma |
| NCT00563381 results posted | 205.389 EUDRACT2007-001840-33 | Ph 4 | completed | Tiotropium Once Daily 18 Mcg Versus Salmeterol Twice Daily 50 Mcg on Time to First Exacerbation in COPD Patients. |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
SPIRIVA FDA Label Details
Indications & Usage
FDA Label (PDF)SPIRIVA is indicated for the treatment of Chronic Obstructive Pulmonary Disease; Chronic Bronchitis; Emphysema.
SPIRIVA Patents & Exclusivity
Patents (2 active)
Pro Intelligence Preview
Deep insights for SPIRIVA
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2026
- • 2 active patents
Trial Analysis
- • 28 total trials
- • Stage: Declining
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment