Bronchitol Shortage: What Providers and Prescribers Need to Know in 2026

This article is written for pulmonologists, CF care team members, and other prescribers who manage patients on Bronchitol (inhaled mannitol). It provides a current (2026) overview of supply status in the U.S. and EU, common access barriers for U.S. patients, clinical considerations when patients cannot access Bronchitol, and practical strategies for maintaining continuity of care.

U.S. Supply Status: No Formal Shortage, But Access Barriers Are Real

As of 2026, Bronchitol is not on the FDA's drug shortage database. Chiesi USA's U.S. distribution network through specialty pharmacy partners is operating normally. However, providers should be aware that patients frequently encounter significant access friction that can delay or block therapy initiation or continuation:

Prior authorization (PA) delays: Most commercial and Medicaid plans require PA for Bronchitol. PA criteria typically include confirmed CF diagnosis, age ≥18, baseline FEV1 in the specified range, completion of the BTT, and often documentation of trial of standard-of-care therapies.

Step therapy requirements: Some plans require that patients have first tried dornase alfa or hypertonic saline before approving Bronchitol.

Specialty pharmacy routing errors: Prescriptions sent to retail pharmacies will not be filled. Ensure your practice consistently routes Bronchitol prescriptions to specialty pharmacies.

BTT coordination gaps: The Bronchitol Tolerance Test must be completed before prescribing. Ensure BTT results are documented and included with PA requests to avoid delays.

European Supply Status: Shortage and Discontinuation in Multiple Markets

For providers who treat internationally traveling CF patients or who are based in Europe, the situation is more serious. In October 2024, Pharmaxis Europe Limited initiated a distributor change that has led to ongoing shortages in multiple EU/EEA member states. In countries where the transition was unsuccessful, Pharmaxis has decided to discontinue Bronchitol from October 2025 onward.

The European Medicines Agency (EMA) has classified this as an ongoing shortage and recommends that:

No new patients should be initiated on Bronchitol in affected EU countries until supply normalizes

In countries where Bronchitol is being discontinued, existing patients should be transitioned to alternative mucolytic treatments

In Germany, Ireland, Italy, and Spain — where Bronchitol continues to be marketed — supplies remain constrained

Bronchitol Prescribing Requirements: Clinical Summary

For providers new to prescribing Bronchitol, here is a brief clinical summary of key prescribing requirements:

FDA-approved indication: Add-on maintenance therapy to improve pulmonary function in adults ≥18 with CF (FDA approved October 2020)

BTT requirement: Must be performed in-office under supervision with bronchospasm management available; approximately 8% of patients fail

Dosing: 400 mg (10 × 40 mg capsules) twice daily by oral inhalation, morning and evening (evening dose ≥2–3 hours before bedtime)

Pre-medication: Inhaled short-acting bronchodilator 5–15 minutes before every dose

Hypertonic saline: Not permitted concurrently (excluded from clinical trials; safety of combination not established)

Hemoptysis monitoring: Discontinue Bronchitol if hemoptysis occurs; do not use in patients with history of significant hemoptysis (>60 mL) in the prior 3 months

Clinical Alternatives When Bronchitol Is Unavailable

When a patient cannot access Bronchitol, airway clearance goals can be addressed through the following alternatives:

Inhaled hypertonic saline (7% or 3%): The mechanism most comparable to Bronchitol — osmotic airway hydration. CF Foundation guidelines recommend it for patients ≥6. The 2024 European CF Society guidelines explicitly recognize it as an alternative to inhaled mannitol.

Dornase alfa (Pulmozyme): CF Foundation strongly recommends for patients ≥6 with moderate to severe disease; different mechanism (DNase); can be used in combination with airway clearance techniques.

CFTR modulators: For eligible patients, optimizing CFTR modulator therapy (e.g., Trikafta) may reduce the mucus burden and the need for intensive mucolytic therapy over time.

Helping Your Patients Navigate Access Issues

If your patients are struggling to find Bronchitol, medfinder for providers is a resource that calls pharmacies on behalf of patients to identify which ones can fill specialty prescriptions — reducing the burden on your staff and getting patients their medications faster.

For financial assistance, direct patients to the Chiesi CareConnect program and the Cystic Fibrosis Foundation's Compass service (1-844-COMPASS), which can help navigate insurance appeals and identify financial assistance programs.

Also see our companion guide: How to Help Your Patients Find Bronchitol In Stock: A Provider's Guide.