Lupin bags tentative FDA approval for Tolvaptan Tablets, a generic of Jynarque

Lupin Limited, a global pharmaceutical powerhouse, proudly announces that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Tolvaptan Tablets, encompassing strengths of 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg. These tablets serve as a generic equivalent to Otsuka Pharmaceutical Co., Ltd.’s Jynarque Tablets and will be produced at Lupin‘s state-of-the-art Nagpur facility in India.

Tolvaptan Tablets, serving as the reference listed drug Jynarque®, exhibit robust market potential. With estimated annual sales of USD 287 million in the U.S., as reported by IQVIA in August 2023, Lupin’s venture into this segment is poised to make a significant impact.

The U.S. FDA’s tentative approval signifies that Lupin is on track to introduce a compelling generic alternative, expanding affordable treatment options while maintaining strict adherence to regulatory standards.

Lupin’s choice to manufacture Tolvaptan Tablets at its Nagpur facility underscores the company’s commitment to quality and cost-effectiveness, aligning with its mission to provide accessible healthcare solutions.

Lupin Limited’s tentative FDA approval for Tolvaptan Tablets represents a noteworthy development in the pharmaceutical landscape. By offering a generic alternative to Jynarque®, Lupin aims to bolster the accessibility of vital medications, ultimately benefiting patients and healthcare providers alike.