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Aurobindo Pharma’s subsidiary Eugia Pharma has secured final USFDA approval to manufacture Dasatinib Tablets, a generic of Sprycel. The drug treats leukaemia and is expected to launch in Q1 FY26, tapping into a USD 1.8 billion US market.
Aurobindo Pharma announced that its wholly owned subsidiary, Eugia Pharma Specialities Ltd, has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Dasatinib Tablets in the United States. The product is the generic version of Sprycel, developed by Bristol-Myers Squibb, and is indicated for treating various forms of leukaemia.
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Eugia Pharma gains USFDA approval for generic Dasatinib Tablets.
The drug is used in treating Ph+ CML and ALL in adults and children.
The approved product will be launched in Q1 FY26.
US market size for Dasatinib is estimated at USD 1.8 billion.
Aurobindo Pharma share price rose nearly 3% post-announcement.
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Dasatinib is primarily prescribed for adults and children with Philadelphia chromosome-positive chronic myeloid leukaemia (Ph+ CML) and for Ph+ acute lymphoblastic leukaemia (Ph+ ALL) resistant or intolerant to prior therapies. With the regulatory clearance, Eugia Pharma is set to offer a cost-effective alternative in a key therapeutic segment.
The drug approval covers multiple strengths and is part of Aurobindo’s broader oncology portfolio in the United States. The US market for Dasatinib is valued at approximately USD 1.8 billion for the twelve months ending February 2025, according to IQVIA data. Eugia Pharma aims to launch the product in the first quarter of FY2025–26.
Product Name | Dasatinib Tablets (Generic Sprycel) |
Approved By | USFDA |
Manufacturer | Eugia Pharma (Aurobindo Pharma subsidiary) |
Indication | Ph+ CML and Ph+ ALL |
US Market Size | USD 1.8 billion (Feb 2025) |
Launch Timeline | Q1 FY2025–26 |
Following the announcement, Aurobindo Pharma share price rose 2.88% intraday, reaching Rs.1,222 before settling slightly lower. Despite the recent dip of 15% over six months, the stock showed positive momentum driven by successive USFDA approvals, including for Rivaroxaban earlier this month.
The approval strengthens Aurobindo’s oncology footprint in the US generics market. With an increasing focus on high-value complex generics, the company is positioning itself for long-term growth in regulated markets. Investors are expected to monitor the Q1 FY26 launch closely for its potential influence on Aurobindo Pharma share price performance.
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