Adalvo is submitting its dossier for generic dolutegravir film-coated tablets through the European DCP.
Dolutegravir — marketed as Tivicay (ViiV Healthcare) — is a cornerstone of WHO-recommended first-line HIV treatment regimens.
Adalvo's generic covers 10mg, 25mg, and 50mg strengths, supporting treatment across a broad patient population.
An estimated 39 million people worldwide are living with HIV, with sustained access to affordable antiretroviral therapy remaining a global healthcare priority.
IQVIA data shows dolutegravir generated $478.6M in European sales in 2025, reflecting its continuing clinical and commercial significance.
The completed dossier reflects Adalvo's ability to develop complex, technically demanding therapies, and adds further depth to the company's anti-infectives portfolio.
Adalvo's dolutegravir programme is targeted at Day-1 launch opportunities in European and international markets, with the goal of expanding patient access to a therapy that remains at the heart of HIV care.
To contact us about licensing details, or to view our full range of anti-infective therapies, email us: enquiry@adalvo.com