Prescription medicine

Olodaterol and tiotropium Brand names: Stiolto; first approved as Stiolto Respimat

Olodaterol and tiotropium (Stiolto Respimat) is a prescription medicine with an FDA approval on record since 2015. No generic is listed; pharmacies paid $115.80 per gram (Stiolto respimat inhaler (60)) in the October 7, 2026 NADAC survey.

No generic listed

Check it at the source: the olodaterol and tiotropium FDA label on DailyMed (effective June 30, 2025, Boehringer Ingelheim Pharmaceuticals, Inc.); the NDA 206756 record on Drugs@FDA; every olodaterol and tiotropium label on DailyMed.

Highlights of the record

FDA label of June 30, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026

Used for

From the label: indications and usage
STIOLTO RESPIMAT is a combination of tiotropium bromide, an anticholinergic and olodaterol, a long-acting beta 2 -adrenergic agonist (LABA) indicated for the long-term, once-daily maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).

Forms and strengths

Spray (metered).

On the market

Earliest approval on file: May 21, 2015 Stiolto Respimat, Boehringer Ingelheim; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals: No generic approved
Labelers listed (NDC): 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Last listed patent: October 16, 2030 Stiolto Respimat spray; not a generic launch date

Supply and safety

Pharmacy cost (NADAC): $115.80 per gram Stiolto respimat inhaler (60)
Shortage (FDA): No current entry
Recalls by its makers (FDA): No recall recorded
FAERS reports: 4,990 through July 30, 2026

What is olodaterol and tiotropium used for?

From the label: indications and usage
STIOLTO RESPIMAT is a combination of tiotropium bromide, an anticholinergic and olodaterol, a long-acting beta 2 -adrenergic agonist (LABA) indicated for the long-term, once-daily maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). ( 1.1 ) Important limitations: STIOLTO RESPIMAT is NOT indicated to treat acute deterioration of COPD. ( 1.1 ) STIOLTO RESPIMAT is NOT indicated to treat asthma. […]

Conditions named in the indications of olodaterol and tiotropium's FDA labels, with every medicine labeled for each:

COPD

FDA pharmacologic class: Anticholinergic and beta2-Adrenergic Agonist.

Source: FDA drug label (Stiolto Respimat), Boehringer Ingelheim Pharmaceuticals, Inc., effective June 30, 2025 (SPL set 01e15aee-40e0-23f3-537f-c96dd63e2cb1), via openFDA; the full label on DailyMed

Is there a generic for olodaterol and tiotropium (Stiolto Respimat)?

No generic olodaterol and tiotropium is approved (Drugs@FDA, October 8, 2026).

The Orange Book lists 5 patents for Stiolto Respimat spray: the compound patent runs to January 19, 2027, and the last listed entry to October 16, 2030. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.

2015 earliest approval on file
2030 last listed patent

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What do pharmacies pay for olodaterol and tiotropium (Stiolto Respimat)?

In CMS's NADAC survey of October 7, 2026, pharmacies paid $115.80 per gram (Stiolto respimat inhaler (60)), about the same as a year earlier. 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.

Stiolto respimat inhaler (60) (brand)

$116.12

$115.79

February 2024October 2026

NADAC per unit, October 7, 2026
Strength and form	Brand or generic	Pharmacy cost	30 tablets, or one pen or vial	12-month change
Stiolto respimat inhaler (60)	Brand	$115.80 per gram	n/a	no change

Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price

What does the olodaterol and tiotropium label say about other medicines?

The olodaterol and tiotropium label names 5 other medicines in its interaction, contraindication or warning sections. 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	Doses of the related beta 2 -agonist albuterol, when administered intravenously, have been reported to aggravate pre-existing diabetes mellitus and ketoacidosis.
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 STIOLTO RESPIMAT.
Ipratropium	contraindications	STIOLTO RESPIMAT is contraindicated in patients with a hypersensitivity to tiotropium, ipratropium, olodaterol, or any component of this product [see Warnings and Precautions (5.4) ].
Ketoconazole	drug interactions	In a drug interaction study using the strong dual CYP and P-gp inhibitor ketoconazole, a 1.7-fold increase of olodaterol maximum plasma concentrations and AUC was observed [see Pharmacokinetics (12.3) ].
Salmeterol	warnings and precautions	A 28-week, placebo-controlled US study comparing the safety of another LABA (salmeterol) with placebo, each added to usual asthma therapy, showed an increase in asthma-related deaths in patients receiving salmeterol (13/13,176 in patients treated with salmeterol vs. 3/13,179 in patients treated with placebo;

Check olodaterol and tiotropium against other medicines

What do FAERS reports show for olodaterol and tiotropium?

The FDA Adverse Event Reporting System holds 4,990 reports that list olodaterol and tiotropium among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 356 are coded as a death and 1,032 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

Dyspnoea910
Cough (named in the label)405
Drug Ineffective (a use or a product term, not a reaction)335
Off Label Use (a use or a product term, not a reaction)295
Fatigue243
Headache (named in the label)232
Death (an outcome recorded in the report)214
Diarrhoea210

Side effects: the label's list and every FAERS reaction

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What else is labeled for the same conditions as olodaterol and tiotropium?

15 other medicines are given the same way (respiratory (inhalation)) and in the same FDA class as olodaterol and tiotropium or labeled mainly for the same use (COPD), the same class first. COPD lists all 23 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.

Medicine	Shared indication	Generic labelers (respiratory (inhalation))	Pharmacy cost	Shortage
Fluticasone and salmeterol	COPD	8 labelers	$1.07 per unit 100-50	A presentation being discontinued
Albuterol and ipratropium	COPD	14 labelers	$0.0787 per mL 0.5-3(2.5) mg/3 mL	No current entry
Budesonide and formoterol	COPD	2 labelers	$17.26 per gram 160-4.5	No current entry
Ipratropium	COPD	13 labelers	$0.111 per mL 0.02% solution	No current entry
Arformoterol	COPD	15 labelers	$0.633 per mL 15 mcg/2 mL solution	No current entry
Formoterol	COPD	11 labelers	$1.30 per mL 20 mcg/2 mL neb vial	No current entry
Fluticasone and vilanterol	COPD	none listed	$3.90 per unit 100-25	No current entry
Budesonide and formoterol and glycopyrrolate	COPD	none listed	$61.41 per gram 160-9-4.8 mcg	No current entry

Every medicine labeled for the same conditions as olodaterol and tiotropium

Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)

What next?

Alternatives to olodaterol and tiotropium: 15 medicines for the same use
Other anticholinergics: the pharmacologic class, with prices and generics
Olodaterol and tiotropium side effects: the label's list beside FAERS reports
Check an interaction: what two or more labels say about each other