New Delhi: Drugmaker Wockhardt said its novel antibiotic Zaynich has an addressable market opportunity of $7 billion in the US and Europe.

The company said it has completed a pre-NDA (non-disclosure agreement) meeting with the US Food and Drug Administration (USFDA) in May 2025. Filing to the USFDA is slated in the second quarter of the current fiscal with potential launch in FY2026-27, Wockhardt Ltd said in a regulatory filing. The company plans for regulatory approval for the product in Europe and emerging markets in the second half of the current financial year, it added.

Wockhardt said it has also filed for approval of Zaynich with the Drug Controller General of India (DCGI) and expects to launch the product in the domestic market in the second half of the current fiscal. The antibiotic, to be used against gram-negative infections, is expected to help 11 lakh cases in India alone, the Mumbai-based drug maker said.