Eton Pharmaceuticals, Inc. has entered into an exclusive license agreement with Aquestive Therapeutics, Inc. to commercialize LIBERVANT (diazepam) buccal film in the United States. The agreement grants Eton the rights to market the product for the acute treatment of seizure clusters in patients with epilepsy, subject to applicable regulatory approvals.
Under the terms of the deal, Eton paid Aquestive an upfront license fee of $10.0 million. The company is also obligated to pay additional regulatory and commercial milestone payments totaling up to $47.5 million. These payments include $10.0 million upon the first commercial sale in the U.S., reduced to $5.0 million if full FDA approval for patients aged 2 to 5 is not received, $2.5 million upon FDA approval for patients aged 6 to 11, and up to $35 million tied to specific annual net sales targets. Additionally, Eton will pay Aquestive royalties on annual net sales at a mid-teens percentage rate.
In conjunction with the licensing agreement, the companies executed a supply agreement where Aquestive will serve as the exclusive manufacturer and supplier of LIBERVANT. This supply agreement has an initial term of 20 years, with an automatic extension for three-year periods unless either party provides notice at least two years prior to the end of a term.
LIBERVANT has received tentative approval from the U.S. Food and Drug Administration (FDA) for patients aged 2 to 5 and 12 and older. The product is expected to become eligible for full approval for patients aged 12 and above following the expiration of VALTOCO’s orphan drug exclusivity on January 10, 2027. Eton anticipates commercial availability of the product in April 2027, subject to final FDA approval. The product has been granted Orphan Drug Designation and has patent protection extending into 2038.
