Zydus Receives Tentative USFDA Approval for Ibrutinib Tablets in Multiple Strengths, Targeting $2.1 Billion Market

Zydus Lifesciences Ltd., one of India’s leading pharmaceutical companies, announced today that it has received tentative approval from the United States Food and Drug Administration (USFDA) for its generic version of Zydus Ibrutinib tablets in 140 mg, 280 mg, and 420 mg strengths. The tablets are the generic equivalent of Imbruvica®, a blockbuster oncology drug developed by Pharmacyclics and AbbVie, used in the treatment of Chronic Lymphocytic Leukemia (CLL) with 17p deletion, Small Lymphocytic Lymphoma (SLL), and Waldenström’s Macroglobulinemia (WM).

The USFDA approval paves the way for Zydus to enter the high-value U.S. oncology market with a product that recorded annual sales of USD 2.15 billion as of May 2025, according to IQVIA data.

The drug will be manufactured at Zydus’ SEZ facility in Ahmedabad, which is known for its high-quality production and regulatory compliance. Although the current approval is tentative, it positions Zydus to launch the product upon the expiration of existing patents or exclusivity periods for Imbruvica®, pending final USFDA approval.

Ibrutinib tablets are a kinase inhibitor that works by blocking proteins that signal cancer cells to grow. It has been a cornerstone treatment for blood cancers, especially in patients with high-risk genetic mutations such as the 17p deletion in CLL.

Zydus Receives Tentative USFDA Approval for Ibrutinib Tablets

This marks another significant milestone in Zydus’ U.S. generics journey. The company has now secured 420 total ANDA (Abbreviated New Drug Application) approvals from the USFDA since it began filing in FY 2003-04. As of June 30, 2025, Zydus has filed 484 ANDAs, solidifying its position as a top Indian generic manufacturer serving the U.S. market.

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In a statement, Zydus reaffirmed its commitment to making cancer care more accessible and affordable. “This approval represents another step forward in our mission to democratize access to high-quality generics for critical therapeutic areas like oncology,” the company said.

As the pharmaceutical world awaits the final go-ahead for Zydus’ Ibrutinib tablets launch, the tentative approval signals confidence from the USFDA in the company’s manufacturing capabilities and regulatory compliance.

With the U.S. healthcare system continually seeking cost-effective alternatives to expensive cancer treatments, Zydus’ Ibrutinib tablets could play a pivotal role in increasing accessibility and reducing patient burden in the years to come.