Strides Pharma’s HIV generic drug gets tentative FDA approval

Strides Pharma Science Limited (Strides) announced that its Singapore-based stepdown wholly owned subsidiary, Strides Pharma Global Pte. Limited, has received tentative approval for Dolutegravir 50mg tablets from the United States Food & Drug Administration (FDA). The tentative approval, which deems the Dolutegravir 50mg tablets bioequivalent and therapeutically equivalent to Tivicay Tablets of ViiV Healthcare Company, adds to Strides’ growing list of products under the PEPFAR pathway. The product’s market opportunity in the United States stands at an estimated $ 1.34 billion per IQVIA, and the conversion to full approval is anticipated upon the expiry of constraining patents.

The PEPFAR (President’s Emergency Plan for AIDS Relief) tentative approval allows Strides to participate in global donor-funded programs. This is significant as the Dolutegravir 50mg tablet is a lifesaving medication supplied in 126 countries. Strides’ offerings in HIV treatment are further strengthened by this product, with donor procurement estimated at a value of around 35mn USD for the full year of 2022.

Strides Pharma has an impressive track record with 260 cumulative ANDA (Abbreviated New Drug Application) filings, including recently acquired portfolios. Out of these, more than 230 ANDAs have already received FDA approval. Strides has ambitious plans to launch nearly 60 new products in the U.S. over the next three years. Dolutegravir tablets belong to a class of medications known as antiretrovirals and are considered a first-line antiretroviral therapy (ART) option for treatment-naïve patients. These tablets are manufactured at Strides Pharma’s Bengaluru facility and work by inhibiting the multiplication of the HIV virus in human cells.