Cingulate Inc. Announces First U.S. Patent for Lead ADHD Asset CTx-1301 – Extends Exclusivity Through 2042
Kansas City, Kan., June 16, 2026 – Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company specializing in next-generation pharmaceutical products using its proprietary Precision Timed Release™ (PTR™) platform, has announced a significant milestone for both its intellectual property portfolio and shareholders. The company has been granted its first wholly owned U.S. patent for its lead asset, CTx-1301 (dexmethylphenidate HCl), designed for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).
Key Highlights for Investors
- Patent Issuance: The United States Patent and Trademark Office (USPTO) issued U.S. Patent No. 12,653,791 on June 16, 2026. This patent provides protection for key aspects of CTx-1301’s formulation and method of use through December 2042.
- Intellectual Property Strengthening: This is the first U.S. patent owned outright by Cingulate covering CTx-1301, significantly bolstering the company’s long-term IP position as it moves towards potential commercialization. The patent, titled “Trimodal, Precision-Timed Pulsatile Release Tablet,” covers composition-of-matter, formulation, structural, and method-of-treatment claims. Notably, it protects the tablet’s unique architecture and the mechanism that enables three distinct medication release phases from a single dose.
- Extended Exclusivity: Patent protection now runs until December 2042, extending the commercial runway for CTx-1301 and potentially increasing its value as a marketable asset.
- Global Patent Portfolio: In addition to the U.S. patent, Cingulate holds patents in 30 European territories (including the UK), Australia, Canada, and Israel, with applications pending in Hong Kong and South Korea.
Potential Share Price Impact
- Potential for Share Price Appreciation: The issuance of a foundational U.S. patent, especially for a lead asset approaching commercialization, is typically viewed as a major value driver for biopharma companies. The patent strengthens Cingulate’s competitive moat against generic competition, increases the asset’s attractiveness for future partnerships, and provides a clear period of market exclusivity.
- Commercialization Pathway: CTx-1301 is being evaluated for ADHD under the FDA’s 505(b)(2) pathway, which may offer an accelerated route to approval and market entry. The company is also advancing CTx-1302 (another ADHD candidate) and CTx-2103 (for anxiety disorders), both leveraging the PTR™ platform.
- Market Opportunity: The U.S. ADHD market represents approximately 100 million prescriptions annually. Over 20 million Americans (12 million adults, over 8 million under 17) have been diagnosed with ADHD. Notably, market trends indicate that adult ADHD prevalence is now larger and growing faster than child/adolescent segments, highlighting a potentially significant, expanding market for CTx-1301.
- Product Differentiation: CTx-1301 is a once-daily, multi-core tablet engineered for three precisely timed releases of dexmethylphenidate. This aims to provide rapid onset and sustained, full-day symptom control from a single dose, a feature that could set it apart from current therapies requiring more frequent dosing.
- Pipeline Expansion: The PTR™ technology is also being applied to the development of CTx-2103 for anxiety disorders, targeting a gap where standard anxiolytics require multiple daily doses. The company envisions expanding the platform into other therapeutic areas with similar unmet needs.
Management Commentary
“This patent represents another important milestone in protecting the technology that differentiates CTx-1301 and underpins our proprietary Precision Timed Release™ Platform. As we advance toward potential commercialization, strengthening our intellectual property portfolio enhances the long-term value of CTx-1301 while supporting our goal of delivering consistent symptom control throughout the entire active day from a single daily dose.”
– Shane J. Schaffer, CEO, Cingulate Inc.
About the Technology
- Precision Timed Release™ (PTR™) Platform: The core technology incorporates a proprietary Erosion Barrier Layer (EBL), which controls the release of the active drug at pre-set times with no premature release. The EBL, licensed from BDD Pharma (Oralogik™), is wrapped around the drug core, creating a tablet-in-tablet structure designed for controlled, multi-phase release.
- Strategic Importance: This platform technology underpins Cingulate’s current pipeline and provides a foundation for future product candidates in other indications with complex dosing requirements.
Forward-Looking Statements
Cingulate’s announcement contains forward-looking statements regarding product development, regulatory timelines, market opportunities, and commercialization plans. Investors should be aware that actual outcomes may differ due to risks highlighted in the company’s SEC filings, including its most recent Annual Report on Form 10-K.
Contact Information
For further information:
Thomas Dalton
Vice President, Corporate and Government Relations, Cingulate
Email: [email protected]
Phone: (480) 529-5434
Disclaimer: This article is for informational purposes only and does not constitute investment advice. All forward-looking statements are subject to risks and uncertainties as outlined in Cingulate Inc.’s SEC filings. Investors should conduct their own due diligence or consult a financial advisor before making investment decisions.
