Natco Pharma secures USFDA tentative nod for generic Erdafitinib tablets

Natco Pharma Limited has received tentative approval from the U.S. Food and Drug Administration (FDA) for its generic Erdafitinib tablets, the equivalent of Balversa®, used in treating advanced urothelial carcinoma. The approval opens up a projected U.S. market opportunity of about $60 million and strengthens Natco’s presence in the oncology generics segment.

Regulatory Milestone

Natco Pharma has achieved tentative FDA approval for its generic version of Erdafitinib tablets, marking a key development in the company’s oncology portfolio. The product references Balversa®, a targeted therapy indicated for patients with advanced urothelial carcinoma.

Tentative approval indicates that the product meets all regulatory requirements for quality, safety, and efficacy but may be subject to patent or exclusivity considerations before final marketing authorization in the U.S.

Parameter Details

Product Erdafitinib Tablets (Generic)

Reference Drug Balversa®

Indication Advanced Urothelial Carcinoma

Expected U.S. Sales ~$60 Million

Approval Status Tentative FDA Approval

Market Opportunity

Natco estimates annual U.S. sales potential of around $60 million for the product. The oncology segment, particularly targeted therapies for bladder cancer, represents a specialized and high-value therapeutic market. Entry into this segment through a complex generic further diversifies the company’s revenue base.

Therapeutic Relevance

Erdafitinib is used in the treatment of advanced urothelial carcinoma, a type of bladder cancer often requiring precision-targeted therapies. The introduction of a generic alternative may improve treatment affordability and access once commercial launch is permitted.

Strategic Significance

This development reinforces Natco Pharma’s capabilities in developing and filing complex oncology generics. Securing tentative FDA approval in a specialized cancer therapy category highlights the company’s regulatory strength and positions it competitively in the global oncology market.

The approval adds momentum to Natco’s strategy of expanding its footprint in niche, high-barrier therapeutic areas while building long-term growth through regulated market opportunities.