A clinical briefing for providers on the Dulera shortage in 2026: timeline, prescribing implications, alternative ICS/LABA options, and patient access tools.
If your patients have been reporting difficulty filling Dulera (Mometasone Furoate/Formoterol Fumarate Dihydrate) prescriptions, the reports are accurate. Organon confirmed supply disruptions for Dulera beginning in September 2025, and the shortage has continued into 2026 with no firm resolution date.
This post provides a clinical overview of the current situation, including the shortage timeline, affected formulations, prescribing implications, therapeutic alternatives, cost considerations, and tools to help your patients access medication during the shortage.
The Dulera shortage was officially reported to the FDA and the American Society of Health-System Pharmacists (ASHP) in September 2025. Key details:
Dulera has experienced intermittent supply issues in previous years, but the current shortage represents the most sustained disruption in the product's history.
The absence of an FDA-approved generic Dulera creates unique challenges during this shortage:
Because no generic Mometasone/Formoterol product exists, pharmacists cannot perform automatic therapeutic substitution. If Dulera is unavailable, a new prescription for an alternative agent is required. This creates additional workflow for both prescribers and patients.
Many payers already position Dulera as a non-preferred brand, requiring step therapy through a preferred ICS/LABA (typically generic Budesonide/Formoterol or Fluticasone/Salmeterol) before authorizing coverage. During the shortage, this may actually work in patients' favor — alternative agents that are preferred on formulary may offer better availability and lower out-of-pocket costs.
However, for patients who have previously failed or are intolerant of preferred alternatives and are specifically maintained on Dulera, the shortage presents a genuine therapeutic gap. In these cases, consider documenting medical necessity for the specific Dulera formulation and engaging with the payer to expedite prior authorization for the available strength (e.g., 200 mcg/5 mcg if 100 mcg/5 mcg is unavailable).
When switching patients from Dulera to an alternative ICS/LABA, approximate dose equivalence should be considered. The following table provides general guidance for the ICS component:
Note: These are approximate equivalencies. Individual patient response may vary, and clinical judgment should guide dosing decisions. The LABA components (Formoterol, Salmeterol, Vilanterol) differ in onset and duration but are generally considered therapeutically comparable for maintenance therapy.
Availability varies significantly by region and pharmacy type:
The most reliable way to assess current pharmacy-level stock is through Medfinder for Providers, which offers real-time availability data across pharmacy networks. This can help your staff direct patients to pharmacies that currently have Dulera in stock.
Dulera's brand-only status contributes to its high cost, which can compound access issues during a shortage:
By comparison, generic alternatives offer significant cost advantages:
For patients facing both availability and cost barriers, switching to a generic ICS/LABA may resolve both issues simultaneously. For detailed savings information, see our provider's guide to helping patients save money on Dulera.
Several resources can help you and your staff manage the Dulera shortage efficiently:
Medfinder provides real-time pharmacy stock data that your team can use to direct patients to pharmacies with available Dulera. This reduces call volume and improves fill rates.
The FDA's drug shortage page provides official updates on the Dulera shortage status, estimated resolution dates, and any new developments from Organon.
ASHP maintains detailed shortage records including clinical alternatives and management strategies for healthcare professionals.
For product-specific questions, Organon's medical information line can be reached at 1-844-674-3200.
The inhaler market is evolving, with several developments worth monitoring:
For practices that have not already diversified their ICS/LABA prescribing beyond Dulera, the current shortage underscores the value of familiarity with multiple agents in this class.
The Dulera shortage is a manageable clinical challenge, but it requires proactive communication with patients, familiarity with therapeutic alternatives, and awareness of the tools available to locate stock when needed.
Key actions for your practice:
For the patient-facing perspective, you may also want to share our Dulera shortage update for patients as a resource. And for guidance on helping patients find the medication, see our provider's guide to helping patients find Dulera in stock.
You focus on staying healthy. We'll handle the rest.
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