Lupin Gets Tentative FDA Nod for Enzalutamide, Adds Dosing Edge

Mumbai-based drugmaker Lupin Ltd said Friday it received tentative approval from the US Food and Drug Administration for its abbreviated new drug application covering Enzalutamide Tablets in 40 mg, 80 mg, 120 mg and 160 mg strengths.

The FDA tentatively approved the 40 mg and 80 mg versions as bioequivalent to Astellas' Xtandi Tablets, the reference listed drug, for the indication in the approved labeling. Xtandi is traditionally available only in those two strengths.

Lupin's tentatively approved 120 mg and 160 mg tablet strengths are not standard for the reference product. The company said those options will give healthcare providers and patients alternative dosing choices, a potential differentiator if the final approval clears.

Enzalutamide is an androgen receptor inhibitor used to treat prostate cancer. The market for generic versions of the drug is competitive, with several ANDAs filed or approved. Lupin's ability to offer higher-strength tablets could help it capture a share of the prescription volume that typically requires patients to take multiple 40 mg or 80 mg capsules per dose.

Lupin distributes products in more than 100 markets and runs a portfolio spanning branded and generic formulations, complex generics, biotechnology products and active pharmaceutical ingredients. The company operates 15 manufacturing sites and seven research centers globally, with subsidiaries including Lupin Diagnostics, Lupin Digital Health and Lupin Manufacturing Solutions.

Tentative approval means the drug meets FDA standards for safety and efficacy but cannot be marketed until certain patent or exclusivity barriers expire. The final launch timing will depend on the resolution of those protections and any litigation tied to Xtandi's patent estate.

Lupin shares closed flat on the National Stock Exchange Friday, in line with a broader market that edged higher on lower crude oil prices during a holiday-shortened session for Muharram.