FDA Grants Patent Protection to HemiClor Formulation Through 2045
The U.S. Food and Drug Administration has listed U.S. Patent No. 12,667,554 B1 in the Orange Book, securing intellectual property rights for HemiClor’s proprietary 12.5 mg chlorthalidone formulation. This regulatory milestone protects the hypertension medication’s unique delivery technology until 2045, shielding it from generic competition for the next two decades.
Developed by Ingenus Pharmaceuticals and marketed by PRM Pharma, HemiClor represents a shift in how clinicians approach hypertension. While chlorthalidone has been a standard treatment for decades, manufacturers historically struggled to produce a stable 12.5 mg tablet that did not require splitting. The patented technology solves these dissolution and stability challenges, allowing for a whole-tablet dose that aligns with modern clinical guidelines.
Under the Hatch-Waxman Act, this Orange Book listing forces future generic applicants to address the patent during their own FDA review processes. Joe McDevitt, CEO of PRM Pharma, noted that the listing validates the innovation required to improve an established medicine. Mukteeshwar Gande, the patent's inventor, added that the technology was specifically engineered to meet precise clinical needs, moving beyond simple dose reduction to ensure a commercially robust product.
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