{"id":49368,"date":"2025-11-28T23:41:05","date_gmt":"2025-11-28T15:41:05","guid":{"rendered":"https:\/\/flcube.com\/?p=49368"},"modified":"2025-11-28T23:41:06","modified_gmt":"2025-11-28T15:41:06","slug":"jiuzhou-pharmaceutical-wins-tentative-fda-approval-for-generic-janumet-xr","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=49368","title":{"rendered":"Jiuzhou Pharmaceutical Wins Tentative FDA Approval for Generic Janumet XR"},"content":{"rendered":"\n

Zhejiang Jiuzhou Pharmaceutical Co., Ltd.<\/strong> (SHA: 603456<\/a>) announced that its Abbreviated New Drug Application (ANDA)<\/strong> for Sitagliptin\/Metformin Extended\u2011Release Tablets<\/strong> received tentative approval<\/strong> from the U.S. Food and Drug Administration (FDA)<\/strong>, positioning the company to enter the type 2 diabetes combination therapy market<\/strong> upon patent expiry of MSD\u2019s originator drug.<\/p>\n\n\n\n

Regulatory Milestone<\/h2>\n\n\n\n
Item<\/th>Detail<\/th><\/tr><\/thead>
Product<\/strong><\/td>Sitagliptin\/Metformin Extended\u2011Release Tablets (generic)<\/td><\/tr>
Company<\/strong><\/td>Zhejiang Jiuzhou Pharmaceutical Co., Ltd. (603456.SH)<\/td><\/tr>
Agency<\/strong><\/td>U.S. Food and Drug Administration (FDA)<\/td><\/tr>
Approval Type<\/strong><\/td>Tentative ANDA approval<\/td><\/tr>
Indication<\/strong><\/td>Type 2 diabetes (adjunct to diet\/exercise) for patients inadequately controlled on metformin monotherapy or currently on combination therapy<\/td><\/tr>
Originator<\/strong><\/td>Janumet XR (MSD), launched February\u202f2012<\/td><\/tr>
Market Status<\/strong><\/td>Only originator available; generic launch pending patent expiry and final FDA approval<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Market Context & Outlook<\/h2>\n\n\n\n
Metric<\/th>Value<\/th><\/tr><\/thead>
U.S. Type 2 Diabetes Patients<\/strong><\/td>34.2\u202fmillion<\/strong> (2024)<\/td><\/tr>
Janumet XR U.S. Sales<\/strong><\/td>$2.8\u202fbillion<\/strong> (2024)<\/td><\/tr>
Generic Market Potential<\/strong><\/td>$450\u2011600\u202fmillion<\/strong> (post\u2011patent expiry)<\/td><\/tr>
Patent Expiry Timeline<\/strong><\/td>Key patents expire 2027\u20112028<\/strong> (tentative approval converts to final upon expiry)<\/td><\/tr>
Jiuzhou\u2019s Cost Advantage<\/strong><\/td>Expected 30\u201140% discount<\/strong> vs. originator pricing<\/td><\/tr>
Peak Sales Forecast<\/strong><\/td>$150\u2011200\u202fmillion<\/strong> annual U.S. revenue potential for Jiuzhou by 2030<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n