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- 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.
- A Delaware federal judge dismissed Ingenus Pharmaceuticals' patent infringement lawsuit against Hetero Labs over generic cyclophosphamide, ruling the company cannot pursue claims on a previously invalidated patent. - The court found that Ingenus already had a fair opportunity to defend US Patent No. 10,993,952's validity in a separate Illinois case against Nexus Pharmaceuticals and lost. - Judge Jennifer L. Hall granted summary judgment in favor of Hetero Labs, effectively barring Ingenus from relitigating the patent's validity in the Delaware case. - The ruling highlights the legal principle that prevents patent holders from repeatedly challenging generic drug makers over patents that have already been deemed invalid in prior litigation.
