USFDA Approves Alembic Pharma’s Generic Dasatinib for Leukemia

Alembic Pharmaceuticals Ltd has received final approval from the United States Food and Drug Administration (USFDA) to market its generic version of Dasatinib tablets, a medication used in the treatment of certain types of blood cancer. The approval strengthens the company’s oncology portfolio and enhances its presence in the US generic pharmaceutical market.

Details of the Approval

The USFDA has approved Alembic’s Abbreviated New Drug Application (ANDA) for Dasatinib Tablets in strengths of 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg. These formulations are therapeutically equivalent to Sprycel tablets, the reference listed drug (RLD) developed by Bristol-Myers Squibb Company (BMS). The approval allows Alembic to manufacture and sell the drug for various oncological indications in the US market.

Therapeutic Use and Indications

Dasatinib is a kinase inhibitor used to treat adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukaemia (CML) in the chronic phase. It is also prescribed for those with chronic, accelerated, or blast phase Ph+ CML showing resistance or intolerance to prior therapies such as imatinib. Additionally, it is approved for patients with Philadelphia chromosome-positive acute lymphoblastic leukaemia (Ph+ ALL) with similar resistance conditions.

Pediatric Applications and Market Potential

The approval also extends to the treatment of paediatric patients aged one year and older with Ph+ CML in the chronic phase, marking a significant step in Alembic’s efforts to broaden its oncology reach. According to IQVIA data cited by the company, Dasatinib tablets in these strengths represent a market opportunity of approximately USD 1,017 million for the 12 months ending September 2025.

Exam Oriented Facts

• Dasatinib tablets are used to treat Philadelphia chromosome-positive CML and ALL.
• Alembic’s generic is equivalent to Sprycel by Bristol-Myers Squibb.
• USFDA approved the ANDA for six dosage strengths ranging from 20 mg to 140 mg.
• The drug has an estimated US market size of USD 1.017 billion.

Significance for Alembic Pharmaceuticals

This latest approval reinforces Alembic’s growing footprint in the regulated US market, particularly in high-value oncology segments. The company continues to strengthen its product pipeline, with numerous pending ANDAs aimed at expanding access to affordable generic medicines. The approval is expected to contribute positively to Alembic’s export revenue and global competitiveness in cancer therapeutics.