WEST CONSHOHOCKEN, PA — PRM Pharma LLC has strengthened the intellectual property protection surrounding its HemiClor blood pressure medication through 2045 after the U.S. Food and Drug Administration listed a formulation patent in its Orange Book, establishing a patent certification requirement for future generic applicants seeking approval.
PRM Pharma, which holds the drug’s New Drug Application and markets HemiClor, disclosed the listing alongside Ingenus Pharmaceuticals LLC, the medication’s developer, manufacturer and patent owner.
The FDA added U.S. Patent No. 12,667,554 B1 to its Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book.
The patent covers formulation technology used in HemiClor, a 12.5-milligram chlorthalidone tablet approved for treating hypertension in adults.
The listing has implications for potential generic competition under the Hatch-Waxman Act, which governs the approval process for generic prescription drugs.
Companies seeking approval through an Abbreviated New Drug Application must address applicable Orange Book-listed patents through certifications submitted to the FDA.
The requirement can affect the regulatory and legal process for introducing competing products, although an Orange Book listing does not independently establish that a patent is valid or prevent all generic competition.
HemiClor is the first and only FDA-approved 12.5-milligram chlorthalidone tablet, according to the companies.
Chlorthalidone is an established diuretic used to lower blood pressure. The 12.5-milligram strength corresponds to a guideline-recommended starting dose for many adults beginning treatment.
The formulation allows patients to take a whole tablet at that dosage rather than splitting a higher-strength tablet.
Developing the lower-strength product required addressing pharmaceutical manufacturing challenges involving dissolution, particle characteristics, stability and commercial-scale production, the companies said.
“Developing a commercially robust 12.5 mg chlorthalidone tablet required much more than reducing the dose,” said Mukteeshwar Gande, chief scientific officer of RiconPharma and inventor of the patented technology.
The formulation patent provides protection extending to 2045, giving the companies a longer-term intellectual property position for a product based on a medication that has been used for decades.
Joe McDevitt, president and chief executive officer of PRM Pharma, said the product provides a lower-dose option consistent with hypertension treatment guidelines.
He also noted that certain metabolic side effects associated with chlorthalidone are dose-related and may occur more frequently at higher doses.
HemiClor is available by prescription through retail pharmacies nationwide. Patients may qualify for discounts through third-party prescription savings programs, depending on program terms and pharmacy participation.
The Orange Book listing adds a regulatory consideration for prospective generic manufacturers while reinforcing the companies’ patent position in the market for prescription hypertension treatments.
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