Aurobindo USFDA nod for Dasatinib tablets; launch Q1 FY26

What the USFDA approval covers

Aurobindo Pharma said its subsidiary, Eugia Pharma Specialities, has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Dasatinib Tablets. The approval covers multiple strengths: 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg. The company stated the product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Sprycel Tablets, across the same strengths. Sprycel is marketed by Bristol-Myers Squibb Company (BMS). In generic drug filings, such equivalence is central to substitutability in the US market.

Launch timeline and what it signals

The company said the product is expected to be launched in Q1 FY26. While the filing did not provide a revenue estimate for this product, the timing signals continued focus on the US generics opportunity in oncology-linked therapies. A Q1 FY26 launch also indicates the company is aligning supply readiness with commercial planning rather than treating approval as a stand-alone milestone. The approval adds to a long list of ANDA outcomes from Eugia’s facilities, which manufacture both oncology oral and sterile speciality products.

Where Dasatinib is used in treatment

Dasatinib Tablets are indicated for multiple oncology-related conditions, according to the company’s disclosure. These include newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukaemia (CML) in chronic phase. The indications also include adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy, including imatinib. In addition, Dasatinib is indicated for adults with Ph+ acute lymphoblastic leukaemia (ALL) with resistance or intolerance to prior therapy. The indication breadth matters because it frames the set of prescribers and hospital protocols that could influence uptake.

ANDA milestone for Eugia Pharma Specialities

Aurobindo said this Dasatinib approval is the 181st ANDA approval from the Eugia Pharma Specialities Group (EPSG) facilities, including 9 tentative approvals. The company’s statement also highlighted that EPSG manufactures both oncology oral and sterile speciality products. That mix is relevant because sterile oncology injectables and oral oncology products often require different compliance and manufacturing capabilities. A high cumulative ANDA count is typically used by companies to underline breadth and execution track record in regulated markets.

Spectrum oncology injectables deal and US commercial footprint

Separately, Aurobindo has previously highlighted its push into the US oncology market through acquisitions. The company announced an agreement on January 17 to buy a portfolio of 7 FDA-approved branded hematology and oncology drugs from US-based Spectrum Pharmaceuticals. The marketed injectable drugs were to be taken over by Aurobindo Pharma’s New Jersey-based subsidiary, Acrotech Biopharma. Aurobindo said it would pay an upfront purchase price of USD 160 million, along with additional payments of up to USD 140 million on reaching certain regulatory and sales-based milestones. The acquisition also brought an experienced branded commercial infrastructure in the US, according to the company.

Deal expectations and disclosed revenue metrics

Aurobindo said it expects the Spectrum portfolio to create revenue of around USD 100 million during the first 12 months of deal closing. In another disclosure around the same transaction, the revenue of the acquired business was stated as around USD 116.2 million in the year ended December 2017, with estimated revenues in 2018 of USD 105 million. Spectrum’s products involved in the transaction were also described as having generated total sales of USD 76.4 million in the first nine months of 2018. Aurobindo said the acquisition would help it enter the branded oncology market with products well-recognised by the oncology community and support expansion of its US business. The company also stated the transaction would establish a launch pad for Acrotech in the US branded segment.

Acquisition completion and earlier market reference

Aurobindo later said the acquisition of seven marketed oncology injectable products, intellectual property, and commercial infrastructure from Spectrum Pharmaceuticals was completed on March 1 by Acrotech Biopharma. The company repeated the consideration structure as USD 160 million upfront in cash plus up to USD 140 million tied to regulatory and sales-based milestones, with the purchase on a debt-free and cash-free basis. In a separate market reference included in the material, Aurobindo Pharma closed at INR 7,361.0 million (INR 736.10) on 5 February 2019, up 1.54%.

A stalled US acquisition and what it shows

Aurobindo also disclosed that its planned acquisition of the US generic oral solids and dermatology businesses of Sandoz Inc., a unit of Novartis AG, was mutually terminated. The company said the termination occurred because approval from the US Federal Trade Commission was not obtained within anticipated timelines. The transaction involved a cash payment of USD 900 million and potential earn-out payments of USD 100 million on pipeline products. The proposed acquisition was described as covering about 300 products, three manufacturing facilities in the US, and Eon Labs Inc., a wholly-owned unit of Sandoz. The contrast between this termination and the completed Spectrum deal highlights how regulatory clearances can shape inorganic growth outcomes.

Biosimilars licensing from TL Biopharmaceutical

In another disclosed transaction, Aurobindo acquired four cell culture-derived biosimilar products from Swiss-based TL Biopharmaceutical. Under the agreement, TL was to supply all developmental data for four molecules, and the products were to be globally developed, commercialised and marketed by Aurobindo and its affiliates. The company stated that three out of the four biosimilars are monoclonal antibodies in oncology. Regulatory filing for these products was expected during 2020-22. Aurobindo also said it would prepare its lead molecule, a Bevacizumab biosimilar, for clinical trials that year.

Key facts at a glance

Market impact and why this matters

The Dasatinib approval strengthens Aurobindo’s regulated-market oncology-linked portfolio by adding a product positioned against an established RLD, Sprycel. The company’s broader US strategy, as reflected in the Spectrum acquisition, combines product access with commercial infrastructure through Acrotech. Disclosed deal metrics around Spectrum provide a reference point for how Aurobindo frames US oncology opportunities in terms of both portfolio scale and near-term revenue expectations. At the same time, the terminated Sandoz transaction underlines that large US acquisitions remain exposed to antitrust timelines. The biosimilars licensing arrangement with TL adds another layer, focused on longer-horizon biologics development, including oncology monoclonal antibodies.

Conclusion

Aurobindo’s Eugia has secured USFDA final approval for Dasatinib tablets across six strengths, with the company expecting a Q1 FY26 launch. Alongside this, the group’s disclosures around Spectrum, Sandoz, and biosimilars licensing show a multi-track approach to building its US oncology footprint. Future updates are likely to be watched for the Dasatinib launch execution and any further regulatory or commercial milestones tied to the Spectrum portfolio.