Alembic Pharmaceuticals Limited (Alembic) 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, 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 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.
Pivya contains pivmecillinam, a beta-lactam antibacterial agent with a long history of clinical use internationally. Pivya is a penicillin-class antibacterial indicated for the treatment of female patients (18 years of age and older) with uncomplicated urinary tract infections (uUTI) caused by susceptible isolates of Escherichia coli, Proteus mirabilis, and Staphylococcus saprophyticus. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Pivya and other antibacterial drugs, Pivya should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
Alembic has established an initial sales footprint across key territories in the US, with each territory focusing on high-prescribing physicians in women’s health and engaging a targeted base of prescribers. The company plans a phased expansion of field force as prescription momentum builds, supported by targeted physician education and market access initiatives.
Alembic continues to expand its presence in the US, one of the world’s largest pharmaceutical markets, through a balanced approach across generics, specialty products, and branded pharmaceuticals. The launch of Pivya represents an important step in building a focused branded business platform in the US, complementing the company’s established generics franchise.
Alembic remains committed to disciplined investments that support sustainable growth and long-term value creation.
Alembic Therapeutics LLC is committed to providing high-quality prescription medicines to support patient care and healthcare delivery. The launch of Pivya reflects our ongoing focus on quality, reliability, and access.
Alembic Pharmaceuticals Limited, a vertically integrated research and development pharmaceutical company, has been at the forefront of healthcare since 1907. Headquartered in India, Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world.
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