Aurobindo Pharma gains FDA approval for Darunavir Tablets

Aurobindo Pharma Limited has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Darunavir Tablets, 600 mg and 800 mg. These tablets are bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Prezista Tablets, of Janssen Products, L.P. The product is scheduled for launch on November 29, 2023.

Estimated Market Size and ANDA Approvals

The approved Darunavir Tablets hold an estimated market size of US$ 274.8 million for the twelve months ending October 2023, according to data from IQVIA. With this approval, Aurobindo Pharma now boasts a total of 500 Abbreviated New Drug Application (ANDA) approvals from the USFDA, including 478 final approvals and 22 tentative approvals.

Indication and Treatment for HIV-1 Infection

Darunavir Tablets, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus (HIV-1) infection in adult and pediatric patients aged 3 years and older. This marks a significant advancement in the availability of treatment options for HIV-1.

Impact on the Healthcare Industry

Aurobindo Pharma’s latest approval underscores its commitment to expanding treatment options in the healthcare sector, particularly in antiretroviral therapy. The launch of Darunavir Tablets is poised to make a substantial impact on the HIV-1 treatment landscape, providing a valuable alternative for patients and healthcare providers.

With this development, Aurobindo Pharma Limited continues to strengthen its position in the pharmaceutical market, showcasing its dedication to addressing critical healthcare needs through effective and accessible medication solutions.