Tiotropium bromide anhydrous
Spiriva, Stiolto, Tiotropium (tiotropium bromide anhydrous) is an unknown pharmaceutical. Tiotropium bromide anhydrous was first approved as Spiriva on 2004-01-30.
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Commercial
Therapeutic Areas
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Trade Name
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Drug Products
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New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| spiriva | New Drug Application | 2025-09-02 |
| spiriva respimat | New Drug Application | 2025-01-07 |
| stiolto respimat | New Drug Application | 2025-06-30 |
| tiotropium bromide | ANDA | 2025-04-30 |
Indications
FDA
EMA
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Agency Specific
FDA
EMA
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Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Olodaterol Hydrochloride / Tiotropium Bromide, Stiolto Respimat, Boehringer Ingelheim | |||
| 8733341 | 2030-10-16 | DP | |
| 7837235 | 2028-03-13 | DP | |
| 9027967 | 2027-03-31 | DP | |
| 7727984 | 2027-01-19 | DP | |
| 7396341 | 2026-10-10 | DP | |
| 7220742 | 2025-05-12 | DS, DP | U-1703 |
| 8034809 | 2025-05-12 | U-1702 | |
| Tiotropium Bromide, Spiriva, Boehringer Ingelheim | |||
| 8022082 | 2026-01-19 | DP | U-1186 |
ATC Codes
R: Respiratory system drugs
— R03: Drugs for obstructive airway diseases
— R03A: Adrenergics, inhalants
— R03AL: Adrenergics in combination with anticholinergics incl. triple combinations with corticosteroids
— R03AL06: Olodaterol and tiotropium bromide
— R03AL10: Formoterol and tiotropium bromide
— R03B: Other drugs for obstructive airway diseases, inhalants in atc
— R03BB: Anticholinergics inhalants for obstructive airway diseases
— R03BB04: Tiotropium bromide
— R03BB54: Tiotropium bromide, combinations
HCPCS
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Clinical
Clinical Trials
426 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | 4 | 17 | 60 | 38 | 48 | 167 |
| Lung diseases | D008171 | EFO_0003818 | J98.4 | 4 | 15 | 46 | 25 | 29 | 119 |
| Obstructive lung diseases | D008173 | — | — | 2 | 2 | 17 | 18 | 13 | 52 |
| Asthma | D001249 | EFO_0000270 | J45 | — | 9 | 10 | 1 | 5 | 25 |
| Respiratory aspiration | D053120 | EFO_1001839 | — | 1 | 1 | 4 | 1 | — | 7 |
| Dyspnea | D004417 | — | R06.0 | — | — | 2 | 2 | 1 | 5 |
| Inflammation | D007249 | MP_0001845 | — | — | — | — | 1 | — | 1 |
| Respiratory tract infections | D012141 | — | J06.9 | — | — | — | 1 | — | 1 |
| Exercise | D015444 | EFO_0000483 | — | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Fibrosis | D005355 | — | — | 1 | 1 | 1 | — | — | 3 |
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | 1 | 1 | 1 | — | — | 3 |
Indications Phases 2
No data
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 9 | — | — | — | — | 9 |
| Chronic bronchitis | D029481 | — | J42 | 1 | — | — | — | — | 1 |
| Bronchitis | D001991 | — | J40 | 1 | — | — | — | — | 1 |
| Renal insufficiency | D051437 | — | N19 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Emphysema | D004646 | EFO_0000464 | J43 | — | — | — | — | 1 | 1 |
| Pulmonary emphysema | D011656 | — | J43 | — | — | — | — | 1 | 1 |
| Airway remodeling | D056151 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Tiotropium bromide anhydrous |
| INN | tiotropium bromide |
| Description | Tiotropium bromide is an organic bromide salt having (1alpha,2beta,4beta,5alpha,7beta)-7-[(hydroxydi-2-thienylacetyl)oxy]-9,9-dimethyl-3-oxa-9-azoniatricyclo[3.3.1.0(2,4)]nonane as the counterion. Used (in the form of the hydrate) for maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease. It has a role as a bronchodilator agent and a muscarinic antagonist. It is an organic bromide salt and a quaternary ammonium salt. |
| Classification | Unknown |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | C[N+]1(C)[C@H]2C[C@H](OC(=O)C(O)(c3cccs3)c3cccs3)C[C@@H]1[C@H]1O[C@@H]21.[Br-] |
Identifiers
| PDB | — |
| CAS-ID | 136310-93-5 |
| RxCUI | — |
| ChEMBL ID | CHEMBL4440620 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | — |
| UNII ID | XX112XZP0J (ChemIDplus, GSRS) |
Target
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Safety
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Adverse Events
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10,911 adverse events reported
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