Lupin Ltd has received tentative approval from the United States Food and Drug Administration for its Abbreviated New Drug Application (ANDA) related to tolvaptan tablets. These tablets, available in various strengths (15 mg, 30 mg, 45 mg, 60 mg, and 90 mg), are intended as a generic equivalent to Jynarque tablets by Otsuka Pharmaceutical Co Ltd. Tolvaptan is a medication used in the treatment of hyponatremia, a condition characterized by abnormally low sodium levels in the bloodstream, which can lead to various health complications.
The generic tolvaptan tablets will be manufactured at Lupin’s facility in Nagpur, India. Tolvaptan tablets, known as the Reference Listed Drug (RLD) Jynarque, are used to treat specific medical conditions, and this drug category has seen substantial demand in the US, with estimated annual sales reaching $287 million.
The approval positions Lupin to offer a cost-effective alternative in the US market, providing patients with access to a more affordable treatment for hyponatremia. The production of these generic tablets is a strategic move for Lupin, contributing to the company’s portfolio of offerings and further establishing its presence in the pharmaceutical market. The US FDA’s tentative approval acknowledges the quality and effectiveness of Lupin’s generic tolvaptan tablets, paving the way for the company to address the medical needs of patients with hyponatremia while enhancing its market position and contributing to its revenue growth.