Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Methenamine Hippurate Tablets USP, 1 gram. The approved product is a generic equivalent of Hiprex Tablets, 1 gram, in the United States.
Methenamine Hippurate tablets are indicated for the prophylactic or suppressive treatment of frequently recurring urinary tract infections where long-term therapy is required. The tablets will be manufactured at Zydus Lifesciences Ltd (SEZ) in Ahmedabad.
According to IQVIA MAT data for January 2025, the annual sales of Methenamine Hippurate tablets in the United States were valued at USD 32.6 million.
With this approval, Zydus Lifesciences now has 419 approvals and has filed a total of 483* Abbreviated New Drug Applications (ANDAs) since the filing process began in the financial year 2003-04.
(*As on 31 st December, 2024.)