WEST CONSHOHOCKEN, PA — The U.S. Food and Drug Administration has listed a patent covering HemiClor, a 12.5-milligram chlorthalidone tablet for treating hypertension, in its Orange Book, extending intellectual property protection for the product through 2045.
PRM Pharma LLC, which markets the drug, and developer Ingenus Pharmaceuticals LLC reported the listing of U.S. Patent No. 12,667,554 B1, which covers the formulation technology used in what the companies describe as the first FDA-approved 12.5 mg chlorthalidone tablet.
The Orange Book listing carries regulatory significance because, under the Hatch-Waxman Act, manufacturers seeking approval for generic versions through an Abbreviated New Drug Application must address patents listed in the FDA publication during the review process.
HemiClor is approved for the treatment of hypertension in adults to lower blood pressure and is available by prescription through retail pharmacies nationwide.
The companies stated that developing the lower-dose tablet required overcoming formulation challenges involving dissolution, particle characteristics, stability and large-scale manufacturing. The resulting product allows patients to take a 12.5 mg tablet without splitting higher-dose tablets.
Joe McDevitt, president and chief executive officer of PRM Pharma, characterized the Orange Book listing as reinforcing the proprietary technology behind the product while providing an FDA-approved treatment option aligned with current hypertension guidelines.
Mukteeshwar Gande, chief scientific officer of RiconPharma and inventor of the patented formulation technology, indicated the development required more than reducing the dosage strength, citing pharmaceutical formulation challenges that differentiated the product from existing chlorthalidone tablets.
Chlorthalidone has been used for decades to treat high blood pressure. According to the companies, major hypertension guidelines identify chlorthalidone as a preferred thiazide-type diuretic because of its long duration of action and cardiovascular outcomes data, with more recent guidelines recommending optimization of chlorthalidone therapy for resistant hypertension.
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