By Fineline Cube 
Zhejiang Jiuzhou Pharmaceutical Co., Ltd. (SHA: 603456) announced that its Abbreviated New Drug Application (ANDA) for Sitagliptin/Metformin Extended‑Release Tablets received tentative approval from the U.S. Food and Drug Administration (FDA), positioning the company to enter the type 2 diabetes combination therapy market upon patent expiry of MSD’s originator drug.
Regulatory Milestone
| Item | Detail |
|---|---|
| Product | Sitagliptin/Metformin Extended‑Release Tablets (generic) |
| Company | Zhejiang Jiuzhou Pharmaceutical Co., Ltd. (603456.SH) |
| Agency | U.S. Food and Drug Administration (FDA) |
| Approval Type | Tentative ANDA approval |
| Indication | Type 2 diabetes (adjunct to diet/exercise) for patients inadequately controlled on metformin monotherapy or currently on combination therapy |
| Originator | Janumet XR (MSD), launched February 2012 |
| Market Status | Only originator available; generic launch pending patent expiry and final FDA approval |
Market Context & Outlook
| Metric | Value |
|---|---|
| U.S. Type 2 Diabetes Patients | 34.2 million (2024) |
| Janumet XR U.S. Sales | $2.8 billion (2024) |
| Generic Market Potential | $450‑600 million (post‑patent expiry) |
| Patent Expiry Timeline | Key patents expire 2027‑2028 (tentative approval converts to final upon expiry) |
| Jiuzhou’s Cost Advantage | Expected 30‑40% discount vs. originator pricing |
| Peak Sales Forecast | $150‑200 million annual U.S. revenue potential for Jiuzhou by 2030 |
- Strategic Positioning: Jiuzhou becomes first‑to‑file generic with tentative approval, securing 180‑day exclusivity potential
- Manufacturing: Zhejiang facility FDA‑inspected and qualified; ready for commercial scale‑up upon final approval
- Next Catalyst: Final approval expected Q3 2027 upon patent expiry; U.S. launch Q4 2027
Forward‑Looking Statements
This brief contains forward‑looking statements regarding Jiuzhou Pharmaceutical’s tentative ANDA approval, patent expiry timeline, and market potential. Actual results may differ materially due to risks including patent litigation, competitive generic entries, and FDA final approval delays.-Fineline Info & Tech