Aurobindo arm’s copy of Novartis drug gets U.S. FDA nod

Aurobindo Pharma subsidiary Eugia Pharma Specialities has received final approval from the U.S. Food and Drug Administration (U.S. FDA) to manufacture and market Everolimus Tablets in different strengths.

The product is bioequivalent and therapeutically equivalent to reference listed drug Zortress Tablets of Novartis Pharmaceuticals Corp. The approval is for Eugia Unit-I and the product is expected to be launched in first quarter of FY27, Aurobindo Pharma said on Thursday.

The approved product has an estimated market size of $78 million for the 12 months ending December 2025, it said citing IQVIA MAT numbers.

Everolimus Tablets are indicated for the prophylaxis of organ rejection in adult patients receiving kidney or liver transplants. Aurobindo Pharma said this is the 184th ANDA approval, including 10 tentative approvals received, out of Eugia Pharma Specialities Group (EPSG) facilities, manufacturing both oncology oral and sterile specialty products.