Zydus Lifesciences gains FDA approval for Darunavir Tablets in HIV-1 treatment

Zydus Lifesciences Limited, a prominent name in the global pharmaceutical industry, has achieved a significant milestone with the United States Food and Drug Administration (FDA) granting final approval for their Darunavir Tablets in 600 mg and 800 mg dosages, and tentative approval for the 75 mg and 150 mg variants. Darunavir is an antiviral medicine belonging to the protease inhibitor class, specifically designed to combat the Human Immunodeficiency Virus (HIV-1) by preventing its multiplication in the body.

Expanding Treatment Options for HIV-1

This medical advancement offers a new avenue for treating HIV-1 infection in adult patients. Additionally, Darunavir is also indicated for pediatric patients aged three years and older. Its administration, however, must be in conjunction with Ritonavir and other antiretroviral agents. The tablets, set to be manufactured at Zydus’s formulation manufacturing facility in the Special Economic Zone (SEZ) of Ahmedabad, India, represent a significant contribution to HIV-1 treatment.

Impressive Market Performance

The Darunavir Tablets, encompassing the 75 mg, 150 mg, 600 mg, and 800 mg variants, have recorded annual sales of USD 275 million in the United States, according to IQVIA MAT data as of October 2023. This figure underscores the medication’s substantial market presence and the potential impact of its availability.

Zydus’s Growing Global Footprint

The approval marks a notable achievement for Zydus Lifesciences, adding to their impressive portfolio of 383 approvals. The company has been actively engaged in filing Abbreviated New Drug Applications (ANDAs) since FY 2003-04, with over 440 submissions to date. The USFDA’s approval of Darunavir Tablets not only enhances Zydus’s standing in the pharmaceutical industry but also signifies their commitment to providing advanced healthcare solutions globally.