Prescription medicine
Tiotropium Brand names: Spiriva
Tiotropium (Spiriva) is a prescription medicine with an FDA approval on record since 2004. FDA's NDC Directory lists it from 1 generic labeler, and pharmacies paid $11.81 per tiotropium 18 mcg capsule-inhaler in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the tiotropium FDA label on DailyMed (effective November 10, 2025, Boehringer Ingelheim Pharmaceuticals, Inc.); the NDA 21395 record on Drugs@FDA; every tiotropium label on DailyMed.
Highlights of the record
FDA label of November 10, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageSPIRIVA HANDIHALER (tiotropium bromide inhalation powder) is indicated for the long-term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.
Forms and strengths
Capsule; spray (metered).
On the market
- Earliest approval on file
- January 30, 2004 Spiriva, Boehringer Ingelheim; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 1 first June 20, 2023; 1 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 3 of which 1 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- July 19, 2026 Spiriva powder; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $11.81 per capsule Tiotropium 18 mcg capsule-inhaler
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 5 since 2013 0 Class I among all firms' recalls; latest January 26, 2022
- FAERS reports
- 146,625 through July 30, 2026
What is tiotropium used for?
From the label: indications and usageSPIRIVA HANDIHALER (tiotropium bromide inhalation powder) is indicated for the long-term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. SPIRIVA HANDIHALER is indicated to reduce exacerbations in COPD patients. SPIRIVA HANDIHALER is an anticholinergic indicated for the long-term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), and for reducing COPD exacerbations
Conditions named in the indications of tiotropium's FDA labels, with every medicine labeled for each:
From other tiotropium labelsAsthma: Treatment of Asthma SPIRIVA RESPIMAT is a bronchodilator indicated for the long-term, once-daily, maintenance treatment of asthma in patients 6 years of age and older.
FDA pharmacologic class: Anticholinergic.
Source: FDA drug label (Spiriva HandiHaler), Boehringer Ingelheim Pharmaceuticals, Inc., effective November 10, 2025 (SPL set 820839ef-e53d-47e8-a3b9-d911ff92e6a9), via openFDA; the full label on DailyMed
What does the patient leaflet for tiotropium say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What should I avoid while using SPIRIVA HANDIHALER?Do not let the powder from the SPIRIVA capsule get into your eyes. Your vision may get blurry and the pupil in your eye may get larger (dilate). If this happens, call your doctor. SPIRIVA HANDIHALER can cause dizziness and blurred vision. Should you experience these symptoms you should use caution when engaging in activities such as driving a car or operating appliances or other machines.
Source: FDA drug label (Spiriva HandiHaler), Boehringer Ingelheim Pharmaceuticals, Inc., effective November 10, 2025 (SPL set 820839ef-e53d-47e8-a3b9-d911ff92e6a9), via openFDA; the full label on DailyMed
Is there a generic for tiotropium (Spiriva)?
The FDA approved the first generic tiotropium on June 20, 2023. 1 generic application is approved; 1 of it carries a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists tiotropium from 1 labeler under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 1 patent for Spiriva powder, the last expiring on July 19, 2026; a patent listed only for Spiriva Respimat spray runs to April 16, 2031. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2004 earliest approval on file
- 2023 first generic approved
- 2026 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for tiotropium (Spiriva)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $11.81 per Tiotropium 18 mcg capsule-inhaler, down 5% from $12.49 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Tiotropium 18 mcg capsule-inhaler (generic)
- Spiriva handihaler 18 mcg capsule (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Tiotropium 18 mcg capsule-inhaler | Generic | $11.81 per capsule | $354.33 | -5% |
| Spiriva handihaler 18 mcg capsule | Brand | $10.62 per capsule | $318.60 | no change |
| Spiriva respimat 1.25 mcg inhaler | Brand | $126.08 per gram | n/a | -0.1% |
| Spiriva respimat 2.5 mcg inhaler | Brand | $126.12 per gram | n/a | -0.1% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has tiotropium been recalled?
The FDA's Enforcement Report lists 5 recalls naming tiotropium since 2013: 0 Class I (the most serious), 3 Class II, 2 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| January 26, 2022 | Class II | CARDINAL HEALTHCARE | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. |
| March 15, 2021 | Class II | Cardinal Health Inc. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. |
| December 14, 2017 | Class II | Boehringer Ingelheim Pharmaceuticals, Inc. | Failed Stability Specifications |
| March 27, 2014 | Class III | Boehringer Ingelheim Roxane Inc | Defective Delivery System: Potential for dose delivery out of specification due to interation of the drug product powder with the lubricant on the interior of … |
| August 30, 2013 | Class III | Boehringer Ingelheim Roxane Inc | Presence of Foreign Substance: This recall is being conducted due to the potential for extrinsic foreign particles in the API used to manufacture SPIRIVA … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the tiotropium label say about other medicines?
The tiotropium label names 3 other medicines in its interaction, contraindication or warning sections. The labels of 2 other medicines name tiotropium. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Albuterol | warnings and precautions | If this occurs, it should be treated immediately with an inhaled short-acting beta 2 -agonist such as albuterol. |
| Atropine | warnings and precautions | Given the similar structural formula of atropine to tiotropium, patients with a history of hypersensitivity reactions to atropine or its derivatives should be closely monitored for similar hypersensitivity reactions to SPIRIVA HANDIHALER. |
| Ipratropium | contraindications | CONTRAINDICATIONS SPIRIVA HANDIHALER is contraindicated in patients with a hypersensitivity to tiotropium, ipratropium, or any components of this product [see Warnings and Precautions (5.2) ]. |
Source: FDA drug label (Spiriva HandiHaler), Boehringer Ingelheim Pharmaceuticals, Inc., effective November 10, 2025 (SPL set 820839ef-e53d-47e8-a3b9-d911ff92e6a9), via openFDA; the full label on DailyMed
What do FAERS reports show for tiotropium?
The FDA Adverse Event Reporting System holds 146,625 reports that list tiotropium among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 10,513 are coded as a death and 42,641 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as tiotropium?
2 other medicines are given the same way (oral) and in the same FDA class as tiotropium or labeled mainly for the same use (COPD), the same class first. COPD lists all 23 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Umeclidinium | COPD | none listed | $7.35 per inhaler 62.5 mcg inhaler | No current entry |
| Roflumilast | COPD | 16 labelers | $0.311 per tablet 500 mcg tablet | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does tiotropium compare with medicines for the same use?
1 side-by-side page set tiotropium beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Other anticholinergics
- the pharmacologic class, with prices and generics
- Tiotropium side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other