Alembic Pharmaceuticals has announced the first prescription-based sale of Pivya (pivmecillinam) tablets in the United States, following the recent commercial launch of the oral antibiotic in the country.

Pivya is the company’s first branded pharmaceutical product introduced in the US market and is being commercialised through Alembic Therapeutics LLC, a step-down wholly owned subsidiary of Alembic.

The antibiotic is positioned as a first-line oral treatment for uncomplicated Urinary Tract Infections (uUTIs) in women. The therapeutic segment has witnessed limited innovation over the past decade, creating an opportunity for clinically proven treatments with established safety and efficacy.

Pranav Amin, Managing Director, Alembic Pharmaceuticals, said the launch marks a strategic milestone as the company expands into the US branded pharmaceutical space. He noted that the product originated from a strategic acquisition and now represents Alembic’s first step toward building a focused specialty branded portfolio in the US market.

Uncomplicated UTI are among the most common bacterial infections affecting women in the United States, generating a significant number of outpatient antibiotic prescriptions each year. The category accounts for nearly 30 million prescriptions annually, making it a large and stable therapeutic market.

Pivya contains pivmecillinam, a beta-lactam antibacterial agent with a long track record of international clinical use. The medicine is indicated for adult female patients aged 18 years and above suffering from uncomplicated urinary tract infections caused by susceptible bacterial strains including Escherichia coli, Proteus mirabilis and Staphylococcus saprophyticus. As with other antibiotics, the treatment is recommended only for infections confirmed or strongly suspected to be bacterial in origin to help limit antimicrobial resistance.

To support the launch, Alembic has established an initial commercial footprint across key US territories. The company’s field teams are focusing on physicians who frequently prescribe treatments in women’s health, while also engaging a targeted group of healthcare providers. Alembic plans to gradually expand its field force as prescription demand grows, supported by physician education initiatives and improved market access.

The introduction of Pivya reflects Alembic’s broader strategy to strengthen its presence in the US pharmaceutical market through a balanced portfolio spanning generics, specialty medicines and branded products. The company views the launch as a foundational step toward building a stronger branded business platform alongside its established generics operations.