Zydus Lifesciences Gets Tentative US FDA Approval for Its Generic Version of Ibrutinib

Ahmedabad, July 24, 2025 – Zydus Lifesciences Limited (NSE: Zyduslife, BSE: 532321) has secured tentative approval from the United States Food and Drug Administration (USFDA) for its generic version of Ibrutinib tablets in 140 mg, 280 mg, and 420 mg strengths.

Key Product Details and Market Impact

The approval pertains to the generic version of Imbruvica®, a blockbuster drug used in treating:

• Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL) with 17p deletion
• Waldenstrom’s Macroglobulinemia (WM)

Ibrutinib, a kinase inhibitor, is a targeted therapy widely used in oncology. The tablets will be manufactured at Zydus’s SEZ facility in Ahmedabad. According to IQVIA MAT May 2025 data, Ibrutinib tablets clocked annual U.S. sales of USD 2,148.9 million, highlighting the high-value potential of this tentative approval.

Milestone

With this latest clearance, Zydus has now received 420 approvals and filed 484 Abbreviated New Drug Applications (ANDAs) since FY2003-04, continuing its strong momentum in the U.S. generics market.

Zydus Lifesciences Stock Performance

Zydus Lifesciences shares have gained 0.96% closing at ₹971.15 on July 24, 2025. Zydus Lifesciences shares have declined 17% over the last year, down 0.27% year-to-date, and gained 0.68% in the previous month.

Zydus Lifesciences Ltd opened trading at ₹962.95, with the stock fluctuating between a low of ₹960.15 and a high of ₹976.60 during the session. The company holds a strong market capitalisation of ₹97,720 crore.  It is currently trading at a P/E ratio of 21.59. The dividend yield stands at 1.13%, and shareholders receive a quarterly dividend of ₹2.74 per share. Over the past 52 weeks, the stock has traded within a range of ₹ 795.00 to ₹ 1,324.30, indicating a broad trading range influenced by market trends and business performance.

About Zydus Lifesciences

Zydus Lifesciences Ltd is a publicly listed Indian pharmaceutical company with a global footprint across generics, biosimilars, and specialty therapies. It is listed on both NSE and BSE and has been expanding its oncology portfolio aggressively in regulated markets.

REF: https://nsearchives.nseindia.com/corporate/Cadilahc_24072025121943_PR24072025.pdf

Disclaimer:  At HDFC SKY, we take utmost care and due diligence in curating and presenting news and market-related content. However, inadvertent errors or omissions may occasionally occur.

If you have any concerns, questions, or wish to point out any discrepancies in our content, please feel free to write to us at content@hdfcsec.com.

Please note that the information shared is intended solely for informational purposes and does not make any investment recommendations