NDAINHALATIONPOWDER
Approved
Jan 2004
Lifecycle
LOE Approaching
Competitive Pressure
25/100
Clinical Trials
20
Data completeness
3/8 — Basic
Drug data last refreshed 3h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SPIRIVA (tiotropium bromide) is a long-acting muscarinic antagonist (LAMA) inhaled powder indicated for maintenance treatment of chronic obstructive pulmonary disease (COPD). It works by blocking M3 muscarinic receptors in airway smooth muscle to produce bronchodilation and reduce airway obstruction. The drug is administered once daily via the HandiHaler device.
LOE Approaching1mo to LOE
The brand faces significant competitive pressure (75% remaining in market) with patent expiration in mid-2026, signaling transition from peak revenue to managed decline and likely smaller field teams focused on retention.
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.