Alembic Pharmaceuticals Limited has announced the first prescription-based sale of Pivya® (pivmecillinam) tablets in the United States following its recent commercial launch. The milestone marks Alembic’s entry into the U.S. branded pharmaceutical segment, with the product being marketed through Alembic Therapeutics LLC, a step-down wholly owned subsidiary of the company.
Pivya® is positioned as a first-line oral antibiotic for the treatment of uncomplicated urinary tract infections (uUTIs) in women. The uUTI treatment segment has seen limited new product introductions over the past decade, creating a significant opportunity for clinically established therapies that offer strong safety and efficacy profiles.
The product contains pivmecillinam, a beta-lactam antibacterial agent that has a long history of international clinical use. Pivya® belongs to the penicillin class of antibacterial drugs and is indicated for the treatment of female patients aged 18 years and older who are diagnosed with uncomplicated urinary tract infections caused by susceptible bacterial isolates such as Escherichia coli, Proteus mirabilis, and Staphylococcus saprophyticus.
Alembic’s launch of Pivya® in the U.S. represents an important step in expanding its branded pharmaceutical presence in one of the world’s largest healthcare markets. The company aims to leverage the product’s established clinical profile to address the ongoing need for effective treatment options in uUTIs.
The company also emphasised that Pivya® should be used only for infections that are proven or strongly suspected to be caused by susceptible bacteria. Responsible use of antibacterial drugs is critical to reducing the development of drug-resistant bacteria and preserving the effectiveness of existing antibiotic therapies.