Strides gets tentative USFDA nod for Dolutegravir tablets

Strides Pharma Science announced that its stepdown wholly owned subsidiary, Strides Pharma Global Pte., Singapore, has received tentative approval for Dolutegravir 50mg tablets from the United States Food & Drug Administration (USFDA).

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

The PEPFAR tentative approval for Strides qualifies the Company to participate in global donor funded programs that procure this lifesaving medicine and it is supplied in 126 countries. As of full year 2022, donor procurement for Dolutegravir 50mg tablet is estimated at a value of $35 million. This product further strengthens the available offerings in HIV treatment from Strides.

The company has 260 cumulative ANDA filings (including the recently acquired portfolio from Endo at Chestnut Ridge) with USFDA, of which 230+ ANDAs have been approved. The company has set a target to launch 60 new products over three years in the US.