Treats bronchospasm associated with chronic obstructive pulmonary disease (COPD)…. Sold as Spiriva, Spiriva Respimat. Every FDA application for this active ingredient: 3 branded and 1 generic.
As of Nov 15, 2026, FDA lists 4 applications for Tiotropium Bromide (sold as Spiriva, Spiriva Respimat), first approved Jan 30, 2004, with 2 new uses approved and 0 published complete response letters.
| Spiriva Respimat | Part D | $816M | -7% | 297,018 |
| Spiriva Handihaler | Part D | $239M | -51% | 120,839 |
| Tiotropium Bromide | Part D | $94.4M | -3% | 62,428 |
| PREterm Infants With Bronchial Obstruction - Prospective Study of Efficacy and Safety of Inhaled TiotropiumBronchial Obstruction, Premature Birth · General University Hospital, Prague | Phase 4 | Not yet recruiting | Sep 18, 2026 |
| Acupuncture for Persistent Dyspnea Despite Medical Treatment in COPDCOPD (Chronic Obstructive Pulmonary Disease), Acupuncture · Istanbul Medeniyet University | Not applicable | Active, not recruiting | Jul 10, 2025 |
| Evaluating the Impact of Single Dose Tiotropium on Allergen-induced Early Asthmatic ResponseAsthma Bronchiale · University of Saskatchewan | Phase 4 | Not yet recruiting | Nov 7, 2024 |
| Effect on Bronchodilation Response and Ventilation Heterogeneity of Different Inhalation Volumes in COPDCOPD, Lung Injury · University of Milan | — | Not yet recruiting | May 19, 2022 |
| Asthma Research in Children and AdolescentsPersistent Asthma, Asthma in Children · Parc de Salut Mar | — | Active, not recruiting | Jul 21, 2020 |
| Mechanism(s) of Airflow Limitation During Exacerbation of AsthmaAsthma · Gelb, Arthur F., M.D. | Phase 4 | Recruiting | Oct 21, 2010 |
| Mechanism(s)of Airflow Limitation in Moderate-severe Persistent AsthmaAsthma · Gelb, Arthur F., M.D. | — | Recruiting | Dec 18, 2007 |
| Jan 30, 2004 | SpirivaNDA 21395 · New molecular entity | Boehringer Ingelheim | 19 | Marketed |
| Sep 24, 2014 | Spiriva RespimatNDA 21936 · New dosage form | Boehringer Ingelheim | 5 | Marketed |
| Sep 15, 2015 | Spiriva RespimatNDA 207070 · New indication | Boehringer Ingelheim | 0 | Marketed |
| Jun 20, 2023 | Tiotropium BromideANDA 211287 | Lupin | 0 | Marketed |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
Boehringer Ingelheim
Lupin