Alembic Launches First Branded Drug Pivya in US for UTI Treatment
New Delhi: Alembic Pharmaceuticals Limited has reported the first prescription-based sale of its branded antibiotic Pivya (pivmecillinam) tablets in the United States following the product's commercial launch through its step-down wholly owned subsidiary Alembic Therapeutics LLC.
The company stated that Pivya is an oral prescription antibiotic and represents Alembic’s first branded pharmaceutical product in the US market. The launch marks the company’s entry into the US branded pharmaceuticals segment, expanding its presence beyond its established generics business.
Pivya is indicated as a first-line oral antibiotic option for the treatment of uncomplicated urinary tract infections (uUTIs) in women. The segment has seen limited new product introductions for more than a decade, creating an opportunity for a clinically established therapy with a strong safety and efficacy profile.
Commenting on the milestone, Pranav Amin, Managing Director of Alembic Pharmaceuticals Limited, said the commercial launch of Pivya represents an important step as the company enters the US branded pharmaceuticals market. He added that the product marks the first step in Alembic’s strategy to build a focused branded specialty portfolio in the US and participate in a large and stable therapeutic category.
Uncomplicated urinary tract infections remain among the most common bacterial infections in women in the US, accounting for approximately 30 million antibiotic prescriptions annually. Clinically established agents such as pivmecillinam are expected to play an important role in managing these infections amid increasing emphasis on appropriate antibiotic stewardship.
Pivya contains pivmecillinam, a beta-lactam antibacterial agent with a long history of clinical use internationally. The penicillin-class antibacterial is indicated for the treatment of female patients aged 18 years and older with uncomplicated urinary tract infections caused by susceptible isolates of Escherichia coli, Proteus mirabilis, and Staphylococcus saprophyticus.
As part of its commercial strategy, Alembic has established an initial sales presence across key territories in the US focusing on high-prescribing physicians in women’s health. The company plans a phased expansion of its field force as prescription demand grows, supported by physician education and market access initiatives.
The launch of Pivya is expected to support Alembic’s broader strategy of expanding in the US market through a balanced portfolio across generics, specialty products, and branded pharmaceuticals.
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