Shares of Aurobindo Pharma Ltd. gained as much as 2% on Thursday, February 26, after the company announced that its wholly owned subsidiary, Eugia Pharma Specialities, received final approval from the US Food and Drug Administration for Everolimus Tablets.
The approval allows Eugia Unit I to manufacture and market Everolimus Tablets in strengths of 0.25 mg, 0.5 mg, 0.75 mg, and 1 mg. The product is the generic version of Zortress and is expected to be launched in the first quarter of FY27.
Approval Details and Market Opportunity
The approved formulation is bioequivalent and therapeutically equivalent to the reference listed drug, Zortress Tablets, marketed by Novartis Pharmaceuticals Corp.According to IQVIA MAT data, the approved product recorded an estimated market size of 78 million dollars for the 12 months ending December 2025. The approval strengthens Eugia Pharma Specialities’ oncology and speciality portfolio in the US market.
With this clearance, Eugia Pharma Specialities Group has secured its 184th ANDA approval, including 10 tentative approvals, across facilities focused on oncology oral and sterile speciality products.
Indications and Therapeutic Use
Everolimus Tablets are indicated for the prophylaxis of organ rejection in adult patients undergoing kidney transplant who are at low to moderate immunologic risk. The drug is to be used in combination with basiliximab, reduced dose cyclosporine, and corticosteroids.It is also indicated for use in liver transplant patients.
Recent Financial Performance
Aurobindo Pharma recently reported December quarter earnings that were largely ahead of estimates, with operating margins remaining in line.Growth during the quarter was supported by strong performance in Europe, where revenues increased 27% year on year. The ARV segment expanded 22.5% year on year, while the US business also exceeded analyst expectations.
Research and development spending stood at 4.7% of sales, amounting to ₹409 crore.
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