Global pharmaceutical leader Lupin announced on June 26, 2026, that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Enzalutamide Tablets. The approval covers four strengths: 40 mg, 80 mg, 120 mg, and 160 mg. This regulatory milestone allows the company to offer alternative dosing options to healthcare providers and patients, potentially expanding access to treatment.

Approval Details and Reference Drug

The U.S. FDA has tentatively approved the 40 mg and 80 mg strengths as bioequivalent to the reference listed drug (RLD) Xtandi® Tablets, marketed by Astellas Pharma Inc., for the indications specified in the approved labeling. Lupin's inclusion of 120 mg and 160 mg strengths provides additional flexibility in dosing regimens beyond what is traditionally available with the reference drug.

The following table outlines the approved strengths and their respective reference drug details:

About Lupin Limited

Lupin Limited is headquartered in Mumbai, India, and distributes its products in over 100 markets globally. The company's portfolio includes branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. It maintains a strong presence in India and the U.S. across various therapy areas such as respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women's health. The company operates 15 manufacturing sites and 7 research centers worldwide, supported by a workforce of over 24,000 professionals. Through its subsidiaries—Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions—the firm focuses on improving patient health outcomes.

Lupin Limited announced the launch of Azilsartan Medoxomil Tablets, 40mg and 80mg, in the United States on June 17, 2026. The product is indicated for the treatment of hypertension in adults to lower blood pressure and is bioequivalent to Edarbi® of Azurity Pharmaceuticals, Inc. Lupin is the exclusive first-to-file for this product, making it eligible for 180-day generic drug exclusivity. This exclusivity period allows the company to capitalize on the market before other generic competitors enter. Azilsartan Medoxomil Tablets had estimated annual sales of USD 53.5 million in the U.S., according to IQVIA MAT April 2026 data.

Market and Product Details

The introduction of this product strengthens Lupin's portfolio in the cardiovascular therapy area. The company holds a strong position in the U.S. market across multiple segments, including respiratory, anti-diabetic, and anti-infective therapies. Additionally, Lupin maintains a presence in gastrointestinal, central nervous system, and women's health sectors.

Company Overview

Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. The company specializes in branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Lupin operates 15 manufacturing sites and 7 research centers globally, supported by a workforce of over 24,000 professionals. The company is also committed to improving patient health outcomes through its subsidiaries — Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions.