NDAINHALATIONPOWDER
Approved
Jan 2004
Lifecycle
Post-LOE
Competitive Pressure
35/100
Clinical Trials
20
Data completeness
3/8 — Basic
Drug data last refreshed 1h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SPIRIVA (tiotropium bromide) is a long-acting anticholinergic bronchodilator delivered via dry powder inhalation for maintenance treatment of chronic obstructive pulmonary disease (COPD). It works by relaxing airway smooth muscle to improve airflow and reduce exacerbations. The drug is indicated for long-term daily maintenance in COPD patients to improve lung function and reduce symptom burden.
Post-LOEPost-LOE
Post-LOE product with 35% competitive pressure indicates defending market share against generics and newer alternatives; team focus shifts from growth to retention and lifecycle extension.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Trial to Assess the Bioequivalence of Tiotropium Bromide Inhalation Powder in Healthy Adult Participants Under Fasting Conditions
Started Jun 2024
186 enrolled
Chronic Obstructive Pulmonary Disease (COPD)
A Trial to Assess the Bioequivalence of Generic Tiotropium Bromide Inhalation Powder and Reference Product in Healthy Adult Participants Under Fasting Conditions (Pilot)
Started Feb 2024
39 enrolled
Chronic Obstructive Pulmonary Disease
Comparison of Tiotropium Absorption From Tiotropium Easyhaler and Spiriva HandiHaler
Started Feb 2022
88 enrolled
Healthy Volunteers
Pharmacokinetic Study Comparing Tiotropium Easyhaler® and Spiriva® HandiHaler®
Started Apr 2021
43 enrolled
Healthy Volunteers
Morbid Rates After Spiriva Chronic Obstructive Pulmonary Disease (COPD) Protocol Change
Started Apr 2021
3,015,000 enrolled
Pulmonary Disease, Chronic Obstructive
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.