New Delhi: Alembic Pharmaceuticals Limited (“Alembic”) today announced the first prescription-based sale of Pivya® (pivmecillinam) tablets, an oral prescription antibiotic, following its recent commercial launch in the United States of America (US). Pivya® is Alembic’s first branded pharmaceutical product in the US and is being marketed through Alembic Therapeutics LLC, a step-down wholly owned subsidiary of Alembic.
Pivya® represents 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, Mr. 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.”
Market Context
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 first- line 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.
