Spiriva
(Tiotropium)ApprovedSmall molecule
Boehringer IngelheimTiotropium is used to treat chronic obstructive pulmonary disease (COPD) and asthma by helping to open airways and make breathing easier. It is a long-acting maintenance medication that people inhale once daily to prevent symptoms.[2] Spiriva is currently approved and in use across 10 indications[4].[1]
Spiriva is one of 246 small molecule programs targeting Emphysema. It is currently in Approved.
10
Indications
161
Total Trials
1
Active Trials
245
Competitors
2
FDA Applications
NDA/BLA/ANDA regulatory filings
7
Patents
Pipeline
Status by Indication[4][1]
Indication
Competition
Competitive Landscape
1639 competitors in Non-Small Cell Lung Cancer
#DrugCompanyPhaseTrials
1Spiriva
Boehringer IngelheimApproved
Yervoy
Bristol-Myers SquibbPreclinical
PORTRAZZA
Eli LillyPreclinical
Imjudo
AstraZenecaPreclinical
Vizimpro
PfizerPreclinical
Gilotrif
Boehringer IngelheimPreclinical
Ofev
Boehringer IngelheimPreclinical
PD-1 Inhibitor
Johnson & JohnsonPreclinical
Ftorafur
TThe First Affiliated Hospital with Nanjing Medical University
Preclinical
Vibramycin
PPfizer's Upjohn has merged with Mylan to form Viatris Inc.
Preclinical
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
Chronic Obstructive Pulmonary Disease70 trials
Show 67 more trials
Tiotropium In Early Chronic Obstructive Pulmonary Disease Patients in China
Completed·TThe First Affiliated Hospital of Guangzhou Medical University·Phase 4·NCT01455129·841 enrolled
Effects of Long Acting Bronchodilators on CARDiac Autonomic Control in Chronic Obstructive Pulmonary Disease (COPD)
Completed·—·Phase 4·NCT02872090·42 enrolled
COPD13 trials
Show 10 more trials
Asthma8 trials
Show 5 more trials
Efficacy and Safety8 trials
Show 5 more trials
Salmeterol5 trials
35 more indications
Moderate to Severe COPD4 trials
Treatment4 trials
Trial3 trials
Replication of the INSPIRE Trial in Healthcare Claims Data
Completed·—··NCT05179512·98,278 enrolled
Replication of the POET-COPD Trial in Healthcare Claims Data
Completed·—··NCT05083429·8,716 enrolled
Liver3 trials
Efficacy3 trials
Exercise3 trials
Function2 trials
Tics2 trials
MPA2 trials
Arterial Stiffness1 trial
Respiratory Disorders1 trial
Female1 trial
Pulmonary Function1 trial
Quality of Life1 trial
Monotherapy1 trial
Inflammation1 trial
Effect of Tiotropium on Inflammation and Exacerbations in COPD
Completed·—·Phase 4·NCT00405236·220 enrolled
Safety and Efficacy1 trial
Physical Activity1 trial
Chronic Lung Disease1 trial
Satisfaction1 trial
Patient Preference1 trial
Sts1 trial
Blacks and Exacerbations on Long Acting Beta Agonists (LABA) vs. Tiotropium (BELT)
Completed·—·Phase 3·NCT01290874·1,070 enrolled
CHOP1 trial
Non-Small Cell Lung Cancer1 trial
Chronic1 trial
Corticosteroids1 trial
Unspecified6 trials
Regulatory
FDA Approval Timeline[5]
Jan 30, 2004
SPIRIVA
NDA NDA021395
Sep 15, 2015
SPIRIVA RESPIMAT
NDA NDA021936
Sources
References
- [1]
- [2]MedlinePlus Drug Information — Spiriva drug information. U.S. National Library of Medicine, National Institutes of Health.
- [3]
- [4]Open Targets Platform — Drug–disease associations for Tiotropium. EMBL-EBI & Wellcome Sanger Institute.
- [5]
- [6]
- [7]
Details
Drug Info
Quick Facts
- Mechanism of Action
- Muscarinic Acetylcholine Receptor M3 Antagonist[3]
- Modality
- Small molecule[3]
- Highest Phase
- Approved[1]
- Company
Patent Landscape[6]
Patent Cliff
Jul 19, 2026
Earliest patent expiration — generic entry possible after this date
Patent #Expires
8022082Jan 19, 2026
8022082*PEDJul 19, 2026
9027967Mar 31, 2027
7396341*PEDApr 10, 2027
9027967*PEDSep 30, 2027
2 more patents
7837235*PEDSep 13, 2028
8733341*PEDApr 16, 2031