Alembic Pharmaceuticals Limited has recorded its first prescription-based sale of Pivya (pivmecillinam) tablets in the United States.

This milestone follows the antibiotic's commercial launch and marks the company's official entry into the U.S. branded pharmaceutical market through its subsidiary, Alembic Therapeutics LLC.

Pivya is Alembic’s first branded pharmaceutica product in the US and is being marketed through Alembic Therapeutics LLC, a step-down wholly owned subsidiary of Alembic.

Pivya (pivmecillinam) is an FDA-approved, first-line oral antibiotic for treating uncomplicated urinary tract infections (uUTIs) in women. As the first new uUTI treatment in over two decades in the U.S., it fills a critical need in a market lacking innovation. With a 40-year history of use in Europe and Canada, Pivya is a clinically proven, safe, and effective therapy for addressing growing antibiotic resistance.

Commenting on the milestone, Pranav Amin, Managing Director, Alembic Pharmaceuticals Limited, said: “The commercial launch of Pivya marks an important milestone for Alembic as we enter the US branded pharmaceuticals market. What began as a strategic acquisition has now translated into a commercial presence in the specialty prescription segment.

Pivya represents the first step in Alembic’s strategy to build a focused branded specialty portfolio in the US, enabling us to participate in a large and stable therapeutic category with a clinically established and differentiated product. Over time, we intend to leverage this platform to build a broader branded portfolio in the US market.”

Uncomplicated urinary tract infections remain among the most common bacterial infections in women in the US, resulting in a significant volume of outpatient antibiotic prescriptions annually.

With increasing emphasis on appropriate antibiotic stewardship and the need for effective firstline therapies, clinically established agents such as pivmecillinam are expected to play an important role in the management of uncomplicated urinary tract infections.  

The therapeutic category represents a large and stable market, accounting for approximately 30 million prescriptions annually in the US.