Zydus Lifesciences Gets USFDA Approval for Ascorbic Acid Injection with 180-Day CGT Exclusivity

Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Ascorbic Acid Injection USP in two strengths: 25,000 mg/50 mL and 5,000 mg/10 mL, both at a concentration of 500 mg/mL.

The injectable is primarily used for the short-term treatment of scurvy in adult and paediatric patients aged five months and older when oral administration is not possible, insufficient or contraindicated. Zydus’ product is the generic equivalent of Ascor® Injection, the reference listed drug in the US market.

Importantly, the USFDA has designated Zydus’ ANDA as a Competitive Generic Therapy (CGT). The product is eligible for 180-day exclusivity, with the applicable exclusivity period determined by the USFDA and, where applicable, beginning from the first day of commercial marketing.

The product will be manufactured at Zydus’ USFDA-approved injectable manufacturing facility at Jarod near Vadodara, Gujarat, and will be marketed in the United States through Zydus Pharmaceuticals (USA) Inc.

The reference brand recorded annual sales of approximately US$11.6 million in the US, based on IQVIA MAT data for June 2026. The approval further expands Zydus Lifesciences’ portfolio of approved generic products in the US market.

With this approval, the Zydus Group now has 448 approvals and has filed 513 ANDAs with the USFDA as of June 30, 2026. The latest approval strengthens the company’s US generics portfolio and adds another product with CGT exclusivity potential.