Strides to launch Potassium Chloride Extended-Release tablets in the US market

Strides has announced that its step-down wholly-owned subsidiary, Vensun Pharmaceuticals, Inc USA and its partner Pharmaceutics International, Inc (Pii) have received approval for jointly developed Potassium Chloride Extended-Release tablets USP, 10 mEq (750 mg), 15 mEq (1,125 mg), and 20 mEq (1,500 mg) product from the United States Food & Drug Administration (US FDA). The product is an immediately dispersing extended-release oral dosage form of potassium chloride and is a generic version of Potassium Chloride Extended-Release tablets of Merck, Inc.

The tablet is an electrolyte replenisher and is used in treatment of patients with hypokalemia. It is prescribed to slow the release of potassium so that the likelihood of a high localised concentration of potassium chloride within the gastrointestinal tract is reduced. Extended release tablet is formulated in such a way that the drug is released slowly over time. This has the advantage of taking pills less often and fewer side effects, as the levels of the drug in the body are more consistent.

According to IQVIA MAT data, the US market for Potassium Chloride Extended Release Tablets with the current reference product is approximately US$ 240 Mn. The product will be manufactured by Pii and will be marketed by Strides in the US market. Strides already has an approval for Potassium Chloride Extended-Release tablets USP, 8 mEq (600 mg) and 10 mEq (750 mg) which is a generic version of Klor-Con Extended-Release tablets of Upsher-Smith. The two approvals taken together will help company address a combined opportunity of US$ 300 million per annum, representing 90 per cent of the Potassium Chloride Extended-Release tablet market in the US.

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