MUMBAI, India & NAPLES, Fla., June 26, 2026
Lupin Limited announced that it has received tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Enzalutamide Tablets in 40 mg, 80 mg, 120 mg, and 160 mg strengths. The approval marks another milestone in the company’s expanding oncology portfolio and strengthens its presence in the U.S. generic pharmaceuticals market. The tentative approval allows Lupin to move closer to commercializing a generic version of Xtandi®, subject to the resolution of regulatory and patent-related requirements before receiving final FDA approval.
Bioequivalent Generic Developed for Reference Drug Xtandi®
The U.S. FDA determined that Lupin’s 40 mg and 80 mg Enzalutamide Tablets are bioequivalent to the reference listed drug (RLD) Xtandi® Tablets, marketed by Astellas, for the approved indications listed in the prescribing information. Bioequivalence confirms that Lupin’s generic formulation delivers comparable quality, safety, and therapeutic performance to the branded medicine. Enzalutamide is widely used in the treatment of prostate cancer, making the tentative approval an important development for expanding future patient access to more affordable generic oncology therapies in the United States.
Additional Strengths Offer Greater Dosing Flexibility
While the branded Xtandi® tablets are commercially available in 40 mg and 80 mg strengths, Lupin’s tentative approval also includes 120 mg and 160 mg tablets, providing healthcare professionals with additional dosing options that may simplify treatment regimens and improve patient convenience. The availability of higher-strength tablets could reduce pill burden for eligible patients requiring larger daily doses while maintaining dosing flexibility across different stages of therapy. These additional strengths further differentiate Lupin’s product offering within the competitive generic oncology market.
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Lupin Continues Expanding Its Global Generic Medicines Portfolio
Headquartered in Mumbai, India, Lupin Limited is one of the world’s leading pharmaceutical companies, with products marketed in more than 100 countries across branded medicines, generics, complex generics, biotechnology products, and active pharmaceutical ingredients. The company operates 15 manufacturing facilities, seven global research centers, and employs more than 24,000 professionals worldwide. The tentative FDA approval for Enzalutamide Tablets reflects Lupin’s ongoing strategy to strengthen its global oncology portfolio while expanding access to high-quality generic medicines that address critical therapeutic needs across the United States and international markets.
Source: Lupin press release
