Cipla gets USFDA approval for generic cancer drug, set to launch in the US

Elara had already factored in approximately $20 million in revenue from gAbraxane in the US for FY26. While 3–4 generic players are currently active in the market and the overall size has eroded, Elara still believes Cipla has the potential to generate up to $50 million from the product.

Drugmaker Cipla Ltd. announced that it has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Paclitaxel, a generic version of Bristol Myers Squibb’s Abraxane. Cipla’s formulation is an AB-rated therapeutic equivalent of Abraxane and is indicated for the treatment of metastatic breast cancer, advanced or metastatic non-small cell lung cancer (NSCLC), and metastatic pancreatic cancer.

The product is expected to be launched in the US during the first half of fiscal year 2025–26, the company said in a filing on Friday, April 9. According to brokerage firm Elara Capital, the approval is a positive surprise, as it comes ahead of the company’s most recent guidance, which had indicated a possible approval in the second half of FY26. Cipla now plans to launch the product in H1FY26.

Elara had already factored in approximately $20 million in revenue from gAbraxane in the US for FY26. While 3–4 generic players are currently active in the market and the overall size has eroded, Elara still believes Cipla has the potential to generate up to $50 million from the product. On the earnings front, Cipla's December quarter results were a beat across parameters.

Net profit for the period also increased by 49% from the year-ago period to ₹1,570 crore. Revenue for the quarter stood at ₹7,073 crore, which is a 7% growth from last year. Earnings Before Interest, Tax, Depreciation and Amortisation (EBITDA) grew by 14% year-on-year to ₹1,989 crore, while margin expanded by 200 basis points to 28% from 26% last year.

For the first nine months of the financial year, Cipla's EBITDA margin 26.9%, which is higher than the management guidance of 24.5% to 25.

5% for the full year. Sales from the US market, where Cipla derives its majority revenue from declined by 2% from last year to $226 million. However, the figure was better than the CNBC-TV18 poll of $218 million.

Out of the 37 analysts that have coverage on Cipla, 24 of them have a 'Buy' rating on the stock, eight of them said 'Hold', while five of them have a 'Sell' rating on the counter. Shares of Cipla settled 1.16% lower on Wednesday at ₹1,416.

The stock is down 7% so far on 2025..