Strides Pharma hits 52-week high as arm gets USFDA nod for Dolutegravir tablets

Strides Pharma Science Limited's step-down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received tentative approval for Dolutegravir 50mg tablets from the United States Food & Drug Administration (USFDA).

On Friday morning trade, Strides stock hits 52-week high at Rs522.20 per share on the BSE.

“The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Tivicay Tablets of ViiV Healthcare Company. The approval adds to a list of products that Strides has approved under the PEPFAR pathway taking the total to 13 products”, the company said in a filing to the exchanges.

Further, the Dolutegravir 50mg tablet has a market opportunity in the US of ~US$ 1,345 million per IQVIA. 

Accordingly, the products will be manufactured at the company’s facility in Bengaluru. The conversion of this tentative approval to a full approval is expected upon expiry of the constraining patents.

“Dolutegravir tablets belong to a class of medication knows as antiretrovirals. This medication is the first line of antiretroval therapy (ART) for treatment naïve patients. It works by preventing the multiplication of the virus in human cells”, the company informed.