Hybio challenges Eli Lilly with FDA bid for tirzepatide generic

The global GLP-1 arena is bracing for a new wave of competition as Hybio Pharmaceutical announced Tuesday that the US FDA had accepted its abbreviated new drug application (ANDA) for tirzepatide injection, the world's top-selling drug with $36.5 billion in 2025 sales.

The Shenzhen-based drugmaker filed the ANDA on May 13 and simultaneously launched a Paragraph IV patent challenge against Eli Lilly & Company, the brand-name manufacturer. The application covers six specifications targeting type 2 diabetes, chronic weight management, and obstructive sleep apnea, Cailian Press reported on Tuesday.

With the US market accounting for 88 percent of tirzepatide's global revenue — approximately $32 billion — the race for first-generic status carries enormous commercial stakes. A successful Paragraph IV challenge could grant Hybio a 180-day market exclusivity period.

Hybio's tirzepatide API Drug Master File was the first globally to pass the FDA completeness review, and the company previously secured FDA first-generic approval for liraglutide. Phase III trials of the company's semaglutide generics are advancing in China.

However, Hybio cautioned that final approval remains contingent on regulatory review and potential patent litigation, which could trigger a 30-month stay if Lilly files suit within 45 days. The outcome will likely reshape the competitive dynamics of the rapidly expanding GLP-1 market.