Aurobindo Pharma announced that its wholly-owned subsidiary, Eugia Pharma Specialities Limited, has secured final approval from the USFDA to market Everolimus Tablets in four strengths (0.25 mg, 0.5 mg, 0.75 mg, and 1 mg). This generic product is bioequivalent to Novartis’ Zortress Tablets. The product, manufactured at Eugia Unit-I, is expected to launch in Q1FY27 and targets a market estimated at US$ 78 million.
USFDA Approval Secured by Subsidiary
Aurobindo Pharma Limited confirmed the receipt of the final approval from the US Food & Drug Administration (USFDA) for its wholly owned subsidiary, Eugia Pharma Specialities Limited. The approval covers the manufacture and marketing of Everolimus Tablets in dosages of 0.25 mg, 0.5 mg, 0.75 mg, and 1 mg.
This generic version is confirmed to be bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Zortress Tablets, marketed by Novartis Pharmaceuticals Corp. The approval has been secured from Eugia Unit-I, and the commercial launch is anticipated during the first quarter of the Financial Year 2027 (Q1FY27).
Market Potential and Strategic Significance
Market intelligence, derived from IQVIA MAT for the twelve months ending December 2025, estimates the total market size for this product to be approximately US$ 78 million. This marks the 184th ANDA approval (including 10 tentative approvals) achieved by the Eugia Pharma Specialities Group (EPSG) facilities, which handle both oncology oral and sterile specialty products.
Therapeutic Indications
The approved Everolimus Tablets are indicated for specific applications in adult patients:
- Kidney Transplant: Prophylaxis of organ rejection in patients with low-moderate immunologic risk, used alongside basiliximab, cyclosporine (reduced doses), and corticosteroids.
- Liver Transplant: Administered no earlier than 30 days posttransplant, used in combination with tacrolimus (reduced doses) and corticosteroids.
Corporate Context
Aurobindo Pharma Limited is highlighted as an integrated global pharmaceutical company headquartered in Hyderabad, India, developing, manufacturing, and commercializing generics and branded specialty pharmaceuticals in over 150 countries. The company maintains over 30+ manufacturing and packaging facilities approved by major global regulatory agencies, including the USFDA, UK MHRA, and Health Canada.
Source: BSE
