USFDA Approves Alembic’s Generic Version of Dasatinib for Treating CML and ALL

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 medicine used in the treatment of certain types of blood cancer. This approval marks a major boost to Alembic’s oncology portfolio and strengthens its presence in the US generic drug market.

USFDA Approves Alembic’s Generic Version of Dasatinib for Treating CML and ALL

Details of the Approval

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

Therapeutic Use and Medical Applications

Dasatinib is a kinase inhibitor used to treat:

Adult patients with Philadelphia chromosome-positive (Ph+) Chronic Myeloid Leukaemia (CML) in the chronic phase.
Patients with Ph+ CML in the chronic, accelerated, or blast phase who are resistant or intolerant to imatinib (another cancer drug).
Patients with Philadelphia chromosome-positive Acute Lymphoblastic Leukaemia (Ph+ ALL) showing similar resistance.

These indications make Dasatinib an essential drug in modern oncology treatment protocols.

Pediatric Application and Market Potential

The approval also covers paediatric patients aged one year and above suffering from Ph+ CML in the chronic phase — a key milestone that broadens Alembic’s reach in paediatric oncology care.

According to IQVIA data, the US market for Dasatinib tablets (all strengths combined) is worth around USD 1.017 billion for the 12 months ending September 2025.
This creates a significant market opportunity for Alembic in the global cancer therapeutics sector.

Significance for Alembic Pharmaceuticals

This approval further strengthens Alembic Pharmaceuticals’ presence in the US and underscores its commitment to providing affordable and effective generic medicines.
With several pending ANDA filings, the company continues to expand its oncology and export portfolios, contributing to its global competitiveness and revenue growth in high-value therapeutic segments.

Exam-Oriented Notes

Company: Alembic Pharmaceuticals Ltd
Approval by: USFDA (United States Food and Drug Administration)
Drug Name: Dasatinib Tablets (Generic of Sprycel by BMS)
Dosage Strengths: 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, 140 mg
Used For: Treatment of Philadelphia chromosome-positive CML and ALL
Market Size: Approx. USD 1.017 billion (as of Sept 2025)
Key Benefit: Expands Alembic’s oncology footprint and export revenue

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Question & Answer

Q1. Which company received USFDA approval for its generic version of Dasatinib tablets?
(a) Sun Pharma
(b) Alembic Pharmaceuticals Ltd
(c) Dr. Reddy’s Laboratories
(d) Cipla Ltd
Answer: Alembic Pharmaceuticals Ltd

Q2. Dasatinib tablets are used for the treatment of which type of disease?
(a) Diabetes
(b) Tuberculosis
(c) Blood cancer
(d) Kidney disorder
Answer: Blood cancer

Q3. The reference listed drug (RLD) for Alembic’s Dasatinib tablets is:
(a) Gleevec
(b) Sprycel
(c) Revlimid
(d) Herceptin
Answer: Sprycel

Q4. What is the estimated US market size of Dasatinib tablets for the year ending September 2025?
(a) USD 500 million
(b) USD 750 million
(c) USD 1.017 billion
(d) USD 2 billion
Answer: USD 1.017 billion

Q5. Which phase of chronic myeloid leukaemia (CML) can Dasatinib treat?
(a) Chronic phase
(b) Accelerated phase
(c) Blast phase
(d) All of the above
Answer: All of the above

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