Zydus Lifesciences Limited has secured final approval from the United States Food and Drug Administration (USFDA) for Ammonium Lactate Cream, 12%, marking another milestone in the company's US pharmaceutical portfolio expansion.

Product Details and Therapeutic Applications

Ammonium lactate cream, 12% is a topical prescription medication specifically indicated for treating dry, scaly skin conditions. The cream addresses two primary conditions:

• Xerosis: General dry, scaly skin condition
• Ichthyosis vulgaris: An inherited dry skin condition

As an alpha-hydroxy acid formulation, the medication works by increasing skin hydration and providing multiple therapeutic benefits including relieving itching, softening skin, and decreasing skin scaling.

Manufacturing and Distribution Strategy

The product will be manufactured at Zydus's established topical manufacturing facility in Changodar, Ahmedabad, leveraging the company's existing infrastructure and quality systems.

Market Opportunity

The approval represents entry into a significant market segment, with Ammonium lactate cream recording annual sales of USD 15 mn in the United States according to IQVIA MAT December 2025 data. This market size indicates substantial commercial potential for the newly approved generic version.

Regulatory Portfolio Expansion

*As on 31-Dec-2025

This latest approval brings Zydus Lifesciences' total USFDA approvals to 430, while the company has filed 505 Abbreviated New Drug Applications (ANDAs) since commencing its US filing process in FY 2003-04. The consistent approval rate demonstrates the company's regulatory expertise and manufacturing quality standards.

Strategic Significance

The Ammonium Lactate Cream approval strengthens Zydus Lifesciences' dermatology portfolio in the US market. The topical medication addresses common skin conditions, potentially providing steady revenue streams from both prescription and healthcare provider channels. The company's established manufacturing capabilities and distribution partnership position it well for market entry and commercialisation of this therapeutic product.

Zydus Lifesciences Limited has announced a settlement agreement with Astellas Pharma Inc. regarding the patent litigation over Myrbetriq (generic name: Mirabegron), concluding a legal dispute that began with the company's earlier intimation dated April 17, 2025. The pharmaceutical company disclosed this development through a regulatory filing under Regulation 30 of the Securities and Exchange Board of India (Listing Obligations and Disclosure Requirements) Regulations, 2015.

Settlement Agreement Terms

The settlement involves both Zydus Lifesciences Limited and its wholly owned subsidiary, Zydus Pharmaceuticals USA, Inc. The financial terms of the agreement include significant payment obligations for the Indian pharmaceutical company.

Impact on Business Operations

The settlement agreement provides clarity for Zydus' operations in the US generic drug market. Under the terms, Zydus will pay Astellas an aggregate amount of USD 120 million as part of the resolution. Additionally, the company has agreed to pay prepaid per unit licensing fees on units of its generic Mirabegron sold in the US market from the date of the settlement agreement until September 2027.

Legal Resolution

This settlement concludes all litigation between Astellas and Zydus relating to Myrbetriq and Mirabegron. The agreement enables Zydus to continue marketing its generic version of Mirabegron in the United States without further legal challenges from Astellas regarding this particular product.

Confidential Terms

While the company has disclosed the key financial aspects of the settlement, other terms and conditions of the agreement remain confidential. The settlement represents a strategic resolution that allows both parties to move forward without prolonged litigation costs and uncertainties.

The announcement was signed by Dhaval N. Soni, Company Secretary and Compliance Officer, and filed with both BSE Limited and the National Stock Exchange of India Limited on February 12, 2026.