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

PRM Pharma and Ingenus Pharmaceuticals Announce Orange Book Listing for HemiClor®

On October 5, 2026, PRM Pharma, LLC, along with Ingenus Pharmaceuticals, LLC, made a notable announcement regarding their product HemiClor® (chlorthalidone tablets, 12.5 mg). The drug has officially been listed in the U.S. Food and Drug Administration's (FDA) Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book. This listing serves a crucial role in protecting the proprietary formulation technology used in HemiClor, set to remain under protection until 2045.

Significance of the Orange Book Listing

The inclusion of U.S. Patent No. 12,667,554 B1 in the Orange Book is more than just a procedural formality; it fortifies the intellectual property surrounding HemiClor, a first-of-its-kind FDA-approved 12.5 mg chlorthalidone tablet. This unique formulation is specifically designed to treat hypertension in adults, lowering blood pressure effectively. The Orange Book listing implies that any future applications for similar medications will be subjected to a review process concerning the listed patents, as mandated by the Hatch-Waxman Act.

Innovative Approach to Established Medication

HemiClor’s formulation represents a significant innovation in a well-known medication. Though chlorthalidone has been used for hypertension treatment for several decades, the development of a 12.5 mg tablet that complies with FDA standards involved overcoming various formulation hurdles related to dissolution, stability, and manufacturability. The patented technology employed in HemiClor enables healthcare providers to prescribe a commercially manufactured 12.5 mg tablet that can be taken whole, avoiding the common practice of splitting tablets, which can be both inconvenient and impractical for patients.

Aligning with Hypertension Guidelines

Health guidelines suggest that HemiClor is closely aligned with the recommended starting dose for adults beginning chlorthalidone therapy. Many of the major hypertension treatment guidelines advocate for chlorthalidone as a preferred thiazide-type diuretic due to its long-term effectiveness and favorable cardiovascular outcomes. In fact, the latest treatment strategies for resistant hypertension emphasize the optimization of chlorthalidone therapy, underpinning the importance of HemiClor in contemporary hypertension management practices.

Voices from Leadership

Joe McDevitt, President and CEO of PRM Pharma, commented, "HemiClor demonstrates that meaningful innovation is achievable even with long-established medications. By providing a 12.5 mg treatment option, we are aligning our product with the current guidelines for hypertension management." He further highlighted that certain side effects associated with chlorthalidone are dose-dependent and may be less frequent when using this lower dose option.

Mukteeshwar Gande, Chief Scientific Officer of Ingenus Pharmaceuticals, explained the complexities involved in developing HemiClor: "Creating a commercially viable 12.5 mg tablet was not merely a matter of reducing the dose. Our patented formulation technology tackles significant pharmaceutical challenges while delivering a differentiated product designed to meet a pressing clinical demand. The Orange Book listing showcases the innovative effort behind HemiClor and our commitment to the advancement of pharmaceutical sciences."

Product Indication

HemiClor (chlorthalidone tablets, 12.5 mg) is indicated for lowering blood pressure in adults with hypertension, which can subsequently diminish the risk of life-threatening cardiovascular incidents such as strokes and heart attacks.

Important Safety Information

Contraindications: HemiClor is not recommended for individuals suffering from anuria or those with known hypersensitivity to chlorthalidone or sulfonamide-derived medications.

Adverse Reactions: Potential side effects may include electrolyte imbalances (most notably hypokalemia), dizziness, and gastrointestinal disturbance, requiring careful monitoring of serum electrolytes.

Monitoring: Regular monitoring is advised, as chlorthalidone might influence blood sugar levels, affecting diabetes management.

Drug Interactions: Caution should be taken when combining chlorthalidone with other antihypertensives, lithium, antidiabetic agents, or NSAIDs.

For detailed prescribing information, please visit HemiClor's prescribing information page.

About the Companies

PRM Pharma, LLC, located in Pennsylvania, is dedicated to introducing low-dose therapies that align with clinical guidelines to enhance patient care.
Ingenus Pharmaceuticals, LLC focus on the development, manufacturing, and management of pharmaceutical products, proudly holding the patent for HemiClor.