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Zydus Lifesciences received USFDA approval to produce generic Enzalutamide tablets for prostate cancer. The drug generated $1.4 billion in US sales annually and will be manufactured in Ahmedabad.
Zydus Lifesciences, one of India’s leading pharmaceutical companies, has secured tentative approval from the US Food and Drug Administration (USFDA) to manufacture generic Enzalutamide tablets. These tablets, in doses of 40 mg and 80 mg, are used to treat patients suffering from castration-resistant prostate cancer and metastatic castration-sensitive prostate cancer.
The company has announced that the production of Enzalutamide tablets will take place at its state-of-the-art manufacturing facility located in the Special Economic Zone (SEZ) in Ahmedabad. This approval marks an important milestone for Zydus Lifesciences as it further strengthens its foothold in the global pharmaceutical market, particularly in oncology treatments.
Enzalutamide is an androgen receptor inhibitor, which is a crucial treatment for advanced stages of prostate cancer. According to IQVIA data from July 2024, the US market for Enzalutamide tablets (40 mg and 80 mg) is significant, with annual sales of $1,417.2 million. The US FDA's approval provides Zydus with an opportunity to tap into this lucrative market with its generic version, creating potential competition in a field currently dominated by branded drugs.
Zydus Lifesciences has steadily built an impressive portfolio of generic drugs, with the company now securing 400 approvals from the US FDA. Since it began filing Abbreviated New Drug Applications (ANDAs) in FY 2003-04, Zydus has submitted over 465 ANDAs, positioning itself as a major player in the generic drug industry.
Prostate cancer is one of the most common cancers affecting men worldwide, with increasing demand for effective treatments. Introducing a more affordable generic version of Enzalutamide in the US market is expected to benefit patients by improving access to life-saving medication. Zydus Lifesciences’ foray into the prostate cancer treatment market with the approval of this drug aligns with global healthcare efforts to meet the rising demand for cancer treatments.
Zydus Lifesciences’ latest US FDA approval signifies the company’s growing expertise in oncology treatments. With the launch of its generic Enzalutamide tablets, the firm is poised to expand its market reach further.
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