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.