--- title: "China's Hybio Challenges Eli Lilly Patents With First Generic Filing for Blockbuster Weight-Loss Drug Tirzepatide" type: "News" locale: "en" url: "https://longbridge.com/en/news/291408493.md" description: "China's Hybio Pharmaceutical announced that the FDA accepted its ANDA for generic tirzepatide, making it the first to file. The submission includes Paragraph IV certifications challenging Eli Lilly's patents, likely triggering litigation. If successful, Hybio could gain 180 days of exclusivity before the core patent expires in 2036. Following the news, Hybio's shares rose 8.4%." datetime: "2026-07-01T11:31:58.000Z" locales: - [zh-CN](https://longbridge.com/zh-CN/news/291408493.md) - [en](https://longbridge.com/en/news/291408493.md) - [zh-HK](https://longbridge.com/zh-HK/news/291408493.md) generator: "portal-rs" --- # China's Hybio Challenges Eli Lilly Patents With First Generic Filing for Blockbuster Weight-Loss Drug Tirzepatide (Yicai) July 1 -- China's Hybio Pharmaceutical said the US Food and Drug Administration has accepted its abbreviated new drug applications (ANDAs) for generic versions of Eli Lilly's blockbuster weight-loss drug tirzepatide injection, making it the first company to publicly announce such a filing despite the originator drug's core US patent remaining in force until 2036. Hybio's shares jumped after the news. Shares of Hybio \[SHE: 300199\] closed at CNY23.93 (USD3.30) today, up 8.4 percent after rising as much as 9.1 percent intraday, while Shenzhen's ChiNext Index fell 1.9 percent. The applications include Paragraph IV patent certifications challenging Eli Lilly's patents, a move that is likely to trigger patent litigation. If Hybio ultimately prevails in court, it could launch its generic version before the patents expire and receive 180 days of generic market exclusivity in the US. Hybio announced yesterday that it had submitted two ANDAs for tirzepatide injection and had received official acceptance notices from the FDA. The company said it has developed proprietary synthesis technology and large-scale manufacturing capabilities for the drug's active pharmaceutical ingredient, adding that it was the first supplier whose tirzepatide API Drug Master File (DMF) passed the FDA's completeness assessment. Tirzepatide is a once-weekly injectable dual glucagon-like peptide-1 receptor (GLP-1R) and glucose-dependent insulinotropic polypeptide receptor (GIPR) agonist developed by Eli Lilly. The drug is marketed as Mounjaro for adults with Type 2 diabetes and as Zepbound for chronic weight management in adults who are overweight or obese. No generic version has yet been launched anywhere in the world. The drug's core US compound patent is scheduled to expire on Jan. 5, 2036, while various secondary patents expire at different times, with the latest extending to 2041, according to publicly available patent information. The global boom in weight-loss therapies has made tirzepatide one of Eli Lilly's biggest revenue drivers. According to the company's 2025 annual report, global sales of tirzepatide reached USD36.51 billion last year, including almost USD23 billion from Mounjaro and USD13.54 billion from Zepbound. US sales totaled about USD32 billion, accounting for roughly 88 percent of global revenue. Industry analysts said Hybio's Paragraph IV filing is highly likely to prompt a patent infringement lawsuit from Eli Lilly. Under US law, a successful Paragraph IV challenger may obtain 180 days of marketing exclusivity as the first generic applicant, during which the FDA generally cannot approve competing generic versions other than any authorized generic marketed by the originator. Editor: Emmi Laine ### Related Stocks - [300199.CN](https://longbridge.com/en/quote/300199.CN.md) - [LLY.US](https://longbridge.com/en/quote/LLY.US.md) - [LLYX.US](https://longbridge.com/en/quote/LLYX.US.md) - [ELIS.US](https://longbridge.com/en/quote/ELIS.US.md) - [ELIL.US](https://longbridge.com/en/quote/ELIL.US.md) - [LLYZ.US](https://longbridge.com/en/quote/LLYZ.US.md) - [399006.CN](https://longbridge.com/en/quote/399006.CN.md) ## Related News & Research - [How Eli Lilly’s Global Vault CRM Rollout At Veeva Systems (VEEV) Has Changed Its Investment Story](https://longbridge.com/en/news/296430987.md) - [Laekna Advances Obesity Drug LAE102 With Positive Phase I Data](https://longbridge.com/en/news/296933979.md) - [Eli Lilly Is Building a Weight Loss Drug for Every Kind of Patient](https://longbridge.com/en/news/296005917.md) - [Eli Lilly EVP, international president Patrik Jonsson disposes of 6,500 shares worth $7.64 million](https://longbridge.com/en/news/296266483.md) - [Why Is Omniab Stock Rallying After Eli Lilly Deal?](https://longbridge.com/en/news/296113651.md) --- > **Disclaimer: This article is for reference only and does not constitute any investment advice.**