Eton licenses LIBERVANT buccal film from Aquestive for U.S. epilepsy market

On October 13, 2026, Eton Pharmaceuticals and Aquestive Therapeutics entered into an exclusive U.S. license and supply agreement for LIBERVANT (diazepam) buccal film, which grants Eton exclusive U.S. rights to commercialize the product for acute treatment of seizure clusters in patients with epilepsy, subject to regulatory approvals.¹ The companies disclosed the deal in matching 8-K filings dated October 14, 2026.

Eton paid Aquestive an upfront license fee of $10.0 million.¹ Eton is also responsible for up to $47.5 million in regulatory and commercial milestones: $10.0 million upon first U.S. commercial sale, reduced to $5.0 million if full FDA approval for ages 2-5 has not been received; $2.5 million upon FDA approval for ages 6-11; and up to $35 million tied to annual net sales levels, plus mid-teens percentage royalties on net sales.¹

The companies also signed a supply deal under which Aquestive will serve as exclusive manufacturer and supplier of the product under a 20-year initial term, subject to automatic three-year renewals unless either party gives at least two years' notice not to renew.¹

On regulatory status, LIBERVANT currently has tentative FDA approval for acute treatment of seizure clusters in patients ages 2 to 5 and 12 and older.¹ Full approval for ages 12 and up is expected to become available following the scheduled expiration of VALTOCO's orphan drug exclusivity on January 10, 2027.¹ A separate Type 9 NDA to add ages 6 to 11 to the label is under FDA review, with a PDUFA target action date of March 29, 2027.¹ The FDA granted LIBERVANT orphan drug designation in November 2016.¹ The product has issued patent protection extending into 2038, with additional applications pending.¹

Eton anticipates the product becoming commercially available in April 2027, subject to final FDA approval.¹