Budget impact of dibutepinephrine
4 evidence topics · 3 sources
Summary: projected revenue and addressable market
Aquestive Therapeutics has not announced a price for dibutepinephrine sublingual film, and no budget impact model for the product has been published. The company reports an annual revenue opportunity of more than $1 billion for the product if it is approved, within more than $1.5 billion in potential peak annual net sales across its pipeline assets. In September 2026 the company described the United States epinephrine market as reaching about 7.5 million total prescriptions and about $2.03 billion in value by 2029, citing a commercial market report and Symphony Health prescription data through December 31, 2025. Its February 2026 corporate presentation gave a current market size of about $850 million in 2025 and a projected size of about $2 billion by 2031, citing a different commercial market report, so the two company estimates of current market value differ by source.
For the eligible population, ARS Pharmaceuticals estimates approximately 40 million people in the United States with Type I allergic reactions, approximately 20 million diagnosed with severe reactions that may lead to anaphylaxis, and approximately 6.5 million prescribed an epinephrine auto-injector. At that company's list price for its intranasal epinephrine product, the 6.5 million already prescribed an auto-injector are described as an addressable opportunity of approximately $3.5 billion in annual net sales, and the remaining 13.5 million diagnosed but unprescribed people as approximately $7.0 billion. No independent analyst revenue forecast for dibutepinephrine was identified.