#USA #HemiClor #West Conshohocken #Ingenus Pharmaceuticals #PRM Pharma

PRM Pharma and Ingenus Pharmaceuticals Announce Patent Listing for HemiClor® Formulation Technology

In a landmark development for hypertension treatment, PRM Pharma, LLC and Ingenus Pharmaceuticals, LLC have announced that the U.S. Food and Drug Administration (FDA) has officially listed U.S. Patent No. 12,667,554 B1 in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book. This patent secures the innovative formulation technology behind HemiClor® (chlorthalidone tablets, 12.5 mg) which is the only FDA-approved low-dose chlorthalidone product available on the market today.

The Orange Book listing, which will protect HemiClor through 2045, offers robust intellectual property support for this essential medication. HemiClor is specifically indicated for adults struggling with hypertension, providing a clinically effective option for lowering blood pressure. Available by prescription at retail pharmacies across the nation, HemiClor not only supports optimal health outcomes for patients but also comes with potential cost-saving benefits through various third-party prescription savings programs.

The Role of Innovation in Established Medications

While chlorthalidone as a medication has been utilized for several decades, the journey to gain FDA approval for a 12.5 mg tablet required overcoming significant hurdles related to formulation challenges, including dissolution rates, particle characteristics, and stability. The proprietary technology developed for HemiClor enabled the creation of a tablet that can be taken whole, eliminating the need for patients to split their doses — a task that alleviates both the risk of dosage errors and user inconvenience.

HemiClor has been designed to provide healthcare professionals with an FDA-approved starting dosage that aligns with the latest hypertension treatment guidelines. Major cardiovascular health guidelines have recognized chlorthalidone as a preferred thiazide-type diuretic due to its long-lasting effects and evidence supporting positive cardiovascular outcomes. Moreover, the latest recommendations have suggested that optimizing chlorthalidone therapy is essential, especially for patients facing resistant hypertension.

Importance of the Orange Book Listing

The Orange Book listing for HemiClor not only reinforces the proprietary formulation technology underlying this critical medication, but it also sets a regulatory framework that impacts future generic applications. Under the Hatch-Waxman Act, any future applicants who aim to gain approvals through the Abbreviated New Drug Application (ANDA) must address the Orange Book-listed patents during their FDA review processes. This stipulation underscores the significance of HemiClor's innovative approach in the realm of pharmaceutical advancements.

Insights from Company Executives

Joe McDevitt, President and CEO of PRM Pharma, emphasized, "HemiClor demonstrates that meaningful innovation remains possible even for well-established medicines." He added that this innovative packaging not only aligns with contemporary hypertension guidelines but also reduces the potential for adverse metabolic side effects that may occur with higher chlorthalidone doses. Mukteeshwar Gande, Chief Scientific Officer of Ingenus Pharmaceuticals, expanded on this by stating that the patented formulation technology addresses essential pharmaceutical challenges while delivering a differentiated product designed to fulfill an essential clinical need.

Indications and Safety Information

HemiClor (12.5 mg chlorthalidone tablets) is indicated primarily for the treatment of hypertension in adults. Effective management of blood pressure is essential in reducing the risk of severe cardiovascular events, such as strokes and heart attacks. Patients are advised to monitor for common adverse effects, including electrolyte imbalances, dizziness, and gastrointestinal discomfort, and should consult their healthcare provider for guidance regarding medication management.

In conclusion, the partnership between PRM Pharma and Ingenus Pharmaceuticals in securing the Orange Book listing for HemiClor marks a significant advancement in the treatment of hypertension. This underlines not only the potential for ongoing innovation in established medicines but also a concerted effort to enhance patient care through effective, guideline-aligned therapeutics. For full prescribing information, patients can visit the official HemiClor website at www.hemiclor.com.