PRM PHARMA, LLC

FDA Lists Patent for HemiClor 12.5 mg Chlorthalidone in Orange Book, Securing Formulation Protection Through 2045

- PRM Pharma and Ingenus Pharmaceuticals announced the FDA Orange Book listing of U.S. Patent No. 12,667,554 B1 for HemiClor, the first and only FDA-approved 12.5 mg chlorthalidone tablet. - The patent protects the proprietary formulation technology through 2045, requiring future ANDA applicants to provide patent certifications during FDA review. - HemiClor addresses guideline-recommended starting doses for hypertension and eliminates the need for tablet splitting by delivering a commercially manufactured low-dose tablet. - The formulation overcomes longstanding challenges in dissolution, particle characteristics, stability, and manufacturability for low-dose chlorthalidone.