Cingulate secures first US patent on CTx-1301 ADHD tablet
Cingulate Inc. has been issued its first wholly owned US patent covering CTx-1301, its lead candidate for attention deficit hyperactivity disorder. The United States Patent and Trademark Office granted US Patent No. 12,653,791 on 16 June 2026, with protection running to December 2042.
The patent is titled "Trimodal, Precision-Timed Pulsatile Release Tablet" and covers composition-of-matter, formulation, structural and method-of-treatment claims. CTx-1301 contains dexmethylphenidate hydrochloride and is designed to release active medication in three separate pulses across the day from a single daily dose, using Cingulate's proprietary Precision Timed Release (PTR) platform. The platform relies on an Erosion Barrier Layer, marketed as Oralogik and licensed from BDD Pharma, which is engineered to erode at a controlled rate and release drug from a tablet-in-tablet core at pre-defined times.
"This patent represents another important milestone in protecting the technology that differentiates CTx-1301 and underpins our proprietary Precision Timed Release Platform," said Shane J. Schaffer, chief executive of Cingulate. The company is developing CTx-1301 under the FDA's 505(b)(2) regulatory pathway, which allows applicants to reference data from previously approved drugs when seeking approval for a new formulation. A separate ADHD candidate, CTx-1302, is also in development alongside CTx-2103, an anxiolytic product intended to convert a multiple-daily-dose treatment into a once-daily regimen.
IP position and commercial read-across
Beyond the US grant, Cingulate holds patents in 30 European territories including the United Kingdom, as well as in Australia, Canada and Israel. Applications are pending in Hong Kong and South Korea, suggesting the company is building a geographically broad exclusivity position ahead of any commercial launch.
The 505(b)(2) pathway is well established for modified-release reformulations of known active ingredients. It typically shortens development timelines relative to a full new drug application, but it can also attract patent challenges from generic manufacturers, particularly where the active molecule is not itself novel. Dexmethylphenidate is already marketed in several modified-release presentations, most notably Focalin XR from Novartis, meaning Cingulate's commercial differentiation rests substantially on the trimodal release profile and the durability of its formulation patents.
Market context
The ADHD treatment market is large and competitive. Cingulate cites approximately 100 million annual prescriptions in the US alone and notes that more than 20 million patients carry a diagnosis, of whom roughly 12 million are adults. Adult ADHD is the faster-growing segment, driven partly by improved diagnostic recognition and partly by prescribing patterns that have shifted since the pandemic. A number of established stimulant and non-stimulant products are already approved, and several clinical-stage companies are pursuing novel delivery mechanisms or non-stimulant mechanisms of action in the indication.
For Cingulate, a NASDAQ-listed company with a market capitalisation that remains modest, the patent grant provides a more concrete IP foundation as it seeks to advance CTx-1301 toward regulatory submission. The company has not publicly confirmed a PDUFA target date or a named commercial partner, and investors will be watching for those milestones as the next material signals of commercialisation progress.