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- 美国专利到期不等于中国专利到期。本页日期来自美国橙皮书，中国专利状态需另行核查。
- 橙皮书只列持有人申报的专利，未涵盖全部相关专利。
- 中国一侧“未匹配”表示本站已载入的中国官方名称来源中没有该成分的英文名对应，不表示中国没有批准或没有企业申报；“计数为零”表示有中文名但本站来源中未见记录。各源截止时间列于下方。
- 本页不含销售额和市场规模，不能据此判断开发价值。
- 未对接行的药名为 FDA 橙皮书原文，未做中文翻译；同一成分在中国的通用名可能不同。
美国批准产品
保留申请号、产品号及原文字段。已停止销售与原文件上市状态按行展示。
最早批准2015/03/30
仿制药申请数15
参比制剂申请人NOVARTIS PHARMACEUTICALS CORP
当前在售产品数: 36 · 按 FDA 上市状态原文统计处方药及 OTC 产品；停销和未知状态不计入。
| 申请号 / 产品号 | 商品名原文 | 申请人原文 | 剂型原文 | 给药途径原文 | 规格原文 | 最早批准 | RLD / RS | 上市状态原文 | 查看官方来源 |
|---|---|---|---|---|---|---|---|---|---|
| A208697-001 | DEFERASIROX | ACTAVIS ELIZABETH LLC | TABLET | ORAL | DEFERASIROX: 90MG | 2019/12/13 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A208697-002 | DEFERASIROX | ACTAVIS ELIZABETH LLC | TABLET | ORAL | DEFERASIROX: 180MG | 2019/12/13 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A208697-003 | DEFERASIROX | ACTAVIS ELIZABETH LLC | TABLET | ORAL | DEFERASIROX: 360MG | 2019/12/13 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A209223-001 | DEFERASIROX | TEVA PHARMACEUTICALS USA INC | TABLET | ORAL | DEFERASIROX: 90MG | 2019/11/25 | N / N | DISCONTINUED | openFDA ↗ |
| A209223-002 | DEFERASIROX | TEVA PHARMACEUTICALS USA INC | TABLET | ORAL | DEFERASIROX: 360MG | 2019/11/25 | N / N | DISCONTINUED | openFDA ↗ |
| A209223-003 | DEFERASIROX | TEVA PHARMACEUTICALS USA INC | TABLET | ORAL | DEFERASIROX: 180MG | 2020/04/24 | N / N | DISCONTINUED | openFDA ↗ |
| A210555-001 | DEFERASIROX | ALKEM LABORATORIES LTD | TABLET | ORAL | DEFERASIROX: 90MG | 2020/03/30 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A210555-002 | DEFERASIROX | ALKEM LABORATORIES LTD | TABLET | ORAL | DEFERASIROX: 360MG | 2020/03/30 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A210555-003 | DEFERASIROX | ALKEM LABORATORIES LTD | TABLET | ORAL | DEFERASIROX: 180MG | 2020/07/02 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A210727-001 | DEFERASIROX | JEROME STEVENS PHARMACEUTICALS INC | TABLET | ORAL | DEFERASIROX: 90MG | 2019/12/27 | N / N | DISCONTINUED | openFDA ↗ |
| A210727-002 | DEFERASIROX | JEROME STEVENS PHARMACEUTICALS INC | TABLET | ORAL | DEFERASIROX: 360MG | 2019/12/27 | N / N | DISCONTINUED | openFDA ↗ |
| A210727-003 | DEFERASIROX | JEROME STEVENS PHARMACEUTICALS INC | TABLET | ORAL | DEFERASIROX: 180MG | 2020/06/15 | N / N | DISCONTINUED | openFDA ↗ |
| A210945-001 | DEFERASIROX | MSN LABORATORIES PRIVATE LTD | TABLET | ORAL | DEFERASIROX: 90MG | 2019/11/20 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A210945-002 | DEFERASIROX | MSN LABORATORIES PRIVATE LTD | TABLET | ORAL | DEFERASIROX: 360MG | 2019/11/20 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A210945-003 | DEFERASIROX | MSN LABORATORIES PRIVATE LTD | TABLET | ORAL | DEFERASIROX: 180MG | 2020/06/16 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A211383-001 | DEFERASIROX | ZYDUS PHARMACEUTICALS USA INC | TABLET | ORAL | DEFERASIROX: 90MG | 2019/11/20 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A211383-002 | DEFERASIROX | ZYDUS PHARMACEUTICALS USA INC | TABLET | ORAL | DEFERASIROX: 360MG | 2019/11/20 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A211383-003 | DEFERASIROX | ZYDUS PHARMACEUTICALS USA INC | TABLET | ORAL | DEFERASIROX: 180MG | 2020/06/15 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A211395-001 | DEFERASIROX | PHARMOBEDIENT CONSULTING LLC | TABLET | ORAL | DEFERASIROX: 90MG | 2024/03/22 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A211395-002 | DEFERASIROX | PHARMOBEDIENT CONSULTING LLC | TABLET | ORAL | DEFERASIROX: 180MG | 2024/03/22 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A211395-003 | DEFERASIROX | PHARMOBEDIENT CONSULTING LLC | TABLET | ORAL | DEFERASIROX: 360MG | 2024/03/22 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A211641-001 | DEFERASIROX | SUN PHARMACEUTICAL INDUSTRIES LTD | TABLET | ORAL | DEFERASIROX: 90MG | 2020/01/02 | N / N | DISCONTINUED | openFDA ↗ |
| A211641-002 | DEFERASIROX | SUN PHARMACEUTICAL INDUSTRIES LTD | TABLET | ORAL | DEFERASIROX: 360MG | 2020/01/02 | N / N | DISCONTINUED | openFDA ↗ |
| A211641-003 | DEFERASIROX | SUN PHARMACEUTICAL INDUSTRIES LTD | TABLET | ORAL | DEFERASIROX: 180MG | 2020/06/15 | N / N | DISCONTINUED | openFDA ↗ |
| A211660-001 | DEFERASIROX | JUBILANT GENERICS LTD | TABLET | ORAL | DEFERASIROX: 90MG | 2025/04/11 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A211660-002 | DEFERASIROX | JUBILANT GENERICS LTD | TABLET | ORAL | DEFERASIROX: 180MG | 2025/04/11 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A211660-003 | DEFERASIROX | JUBILANT GENERICS LTD | TABLET | ORAL | DEFERASIROX: 360MG | 2025/04/11 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A211824-001 | DEFERASIROX | ALEMBIC PHARMACEUTICALS LTD | TABLET | ORAL | DEFERASIROX: 90MG | 2019/11/20 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A211824-002 | DEFERASIROX | ALEMBIC PHARMACEUTICALS LTD | TABLET | ORAL | DEFERASIROX: 360MG | 2019/11/20 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A211824-003 | DEFERASIROX | ALEMBIC PHARMACEUTICALS LTD | TABLET | ORAL | DEFERASIROX: 180MG | 2020/06/15 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A211852-001 | DEFERASIROX | CIPLA LTD | TABLET | ORAL | DEFERASIROX: 90MG | 2020/02/11 | N / N | DISCONTINUED | openFDA ↗ |
| A211852-002 | DEFERASIROX | CIPLA LTD | TABLET | ORAL | DEFERASIROX: 360MG | 2020/02/11 | N / N | DISCONTINUED | openFDA ↗ |
| A211852-003 | DEFERASIROX | CIPLA LTD | TABLET | ORAL | DEFERASIROX: 180MG | 2020/06/15 | N / N | DISCONTINUED | openFDA ↗ |
| A212669-001 | DEFERASIROX | CHARTWELL RX SCIENCES LLC | TABLET | ORAL | DEFERASIROX: 90MG | 2021/05/27 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A212669-002 | DEFERASIROX | CHARTWELL RX SCIENCES LLC | TABLET | ORAL | DEFERASIROX: 180MG | 2021/05/27 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A212669-003 | DEFERASIROX | CHARTWELL RX SCIENCES LLC | TABLET | ORAL | DEFERASIROX: 360MG | 2021/05/27 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A212995-001 | DEFERASIROX | PIRAMAL HEALTHCARE UK LTD | TABLET | ORAL | DEFERASIROX: 90MG | 2019/12/30 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A212995-002 | DEFERASIROX | PIRAMAL HEALTHCARE UK LTD | TABLET | ORAL | DEFERASIROX: 360MG | 2019/12/30 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A212995-003 | DEFERASIROX | PIRAMAL HEALTHCARE UK LTD | TABLET | ORAL | DEFERASIROX: 180MG | 2020/06/15 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A214341-001 | DEFERASIROX | ANNORA PHARMA PRIVATE LTD | TABLET | ORAL | DEFERASIROX: 90MG | 2021/05/14 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A214341-002 | DEFERASIROX | ANNORA PHARMA PRIVATE LTD | TABLET | ORAL | DEFERASIROX: 180MG | 2021/05/14 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A214341-003 | DEFERASIROX | ANNORA PHARMA PRIVATE LTD | TABLET | ORAL | DEFERASIROX: 360MG | 2021/05/14 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A214474-001 | DEFERASIROX | AUROBINDO PHARMA LTD | TABLET | ORAL | DEFERASIROX: 90MG | 2023/10/16 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A214474-002 | DEFERASIROX | AUROBINDO PHARMA LTD | TABLET | ORAL | DEFERASIROX: 180MG | 2023/10/16 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A214474-003 | DEFERASIROX | AUROBINDO PHARMA LTD | TABLET | ORAL | DEFERASIROX: 360MG | 2023/10/16 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N206910-001 | JADENU | NOVARTIS PHARMACEUTICALS CORP | TABLET | ORAL | DEFERASIROX: 90MG | 2015/03/30 | Y / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N206910-002 | JADENU | NOVARTIS PHARMACEUTICALS CORP | TABLET | ORAL | DEFERASIROX: 180MG | 2015/03/30 | Y / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N206910-003 | JADENU | NOVARTIS PHARMACEUTICALS CORP | TABLET | ORAL | DEFERASIROX: 360MG | 2015/03/30 | Y / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
所列美国专利
逐条保留 *PED、物质/制剂标记、用途码及移除请求标记，不据此解释权利效力。
最晚所列专利到期2034/11/21
物质专利到期（DS 标记）2034/11/21
此列只汇总来源明确标为物质专利（DS）的行。PED 行若未带 DS 标记，不为其补标或推断。
| 申请号 / 产品号 | 专利号 | 所列到期日 | 物质 / 制剂标记 | 用途码 | 移除请求标记 | 查看官方来源 |
|---|---|---|---|---|---|---|
| N206910-001 | 9283209 | 2034/11/21 | Y / Y | — | — | openFDA ↗ |
| N206910-002 | 9283209 | 2034/11/21 | Y / Y | — | — | openFDA ↗ |
| N206910-003 | 9283209 | 2034/11/21 | Y / Y | — | — | openFDA ↗ |
中国记录明细
查看中国品种页 ↗四项全零只适用于已对接行：目录集持有人、医保批准文号、当前在审、今年新报仿制企业。未对接行不显示中国计数。 件按受理号计，企业按第一申请人计；不同规格可有多个受理号。药名只做全半角与空白归一化，不同通用名、剂型及复方分开；来源未列规格时标注未列。三类企业数不得相加。
目录集持有人 3
| 企业原文 | 编号原文 | 来源日期 | 查看官方来源 |
|---|---|---|---|
| Annora Pharma Private Limited | 国药准字HJ20250123180mg | 2025/10/14 | 查看官方来源 ↗ |
| Annora Pharma Private Limited | 国药准字HJ20250124360mg | 2025/10/14 | 查看官方来源 ↗ |
| Annora Pharma Private Limited | 国药准字HJ2025012290mg | 2025/10/14 | 查看官方来源 ↗ |
| MSN Laboratories Private Limited | 国药准字HJ20240001360mg | 2024/01/09 | 查看官方来源 ↗ |
| 江苏豪森药业集团有限公司 | 国药准字H2022330190mg | 2022/05/10 | 查看官方来源 ↗ |
| 江苏豪森药业集团有限公司 | 国药准字H20223302360mg | 2022/05/10 | 查看官方来源 ↗ |
医保批准文号 8
| 企业原文 | 编号原文 | 来源日期 | 查看官方来源 |
|---|---|---|---|
| 江苏豪森药业集团有限公司 | 国药准字H2022330190mg | — | 查看官方来源 ↗ |
| 上海复星医药产业发展有限公司 | 国药准字H2025569990mg | — | 查看官方来源 ↗ |
| MSN Laboratories Private Limited | 国药准字HJ20240001360mg | — | 查看官方来源 ↗ |
| Annora Pharma Private Limited | 国药准字HJ2025012290mg | — | 查看官方来源 ↗ |
| 上海复星医药产业发展有限公司 | 国药准字H2025569990mg | — | 查看官方来源 ↗ |
| 江苏豪森药业集团有限公司 | 国药准字H20223302360mg | — | 查看官方来源 ↗ |
| 上海复星医药产业发展有限公司 | 国药准字H20255700360mg | — | 查看官方来源 ↗ |
| Annora Pharma Private Limited | 国药准字HJ20250124360mg | — | 查看官方来源 ↗ |
| 上海复星医药产业发展有限公司 | 国药准字H20255700360mg | — | 查看官方来源 ↗ |
| Annora Pharma Private Limited | 国药准字HJ20250123180mg | — | 查看官方来源 ↗ |
当前在审 3
今年新报仿制企业 2
A 状态原料药企业 8
| 企业原文 | 编号原文 | 来源日期 | 查看官方来源 |
|---|---|---|---|
| 徐州万邦金桥制药有限公司 | Y20240001468 | 2026/07/13 | 查看官方来源 ↗ |
| SYMED LABS LIMITED | Y20240000203 | 2025/09/28 | 查看官方来源 ↗ |
| 河北国龙制药有限公司 | Y20220001252 | 2025/11/22 | 查看官方来源 ↗ |
| Alembic Pharmaceuticals Limited | Y20200000936 | 2025/04/11 | 查看官方来源 ↗ |
| 江苏豪森药业集团有限公司 | Y20200001185 | 2026/09/29 | 查看官方来源 ↗ |
| 湖北华世通生物医药科技有限公司 | Y20200000681 | 2024/08/13 | 查看官方来源 ↗ |
| MSN Laboratories Private Limited | Y20200000199 | 2025/12/06 | 查看官方来源 ↗ |
| 南京海润医药有限公司 | Y20200000037 | 2026/03/18 | 查看官方来源 ↗ |
试验登记 2025/2026 —
未载入
来源与截止时间
- FDA 橙皮书
- 2026/11/06
- CDE 受理与在审
- 2026/11/13 06:42
- 化学药品目录集
- 2026/11/13 06:39
- 原辅包登记
- 2026/11/13 06:41
- 医保药品代码库
- 2026/10/23
- 试验登记
- 2026/11/13 08:09 · 覆盖不完整
已对接行按完整成分、剂型与途径计算中国计数；未匹配和部分成分行只列来源对接状态，不推断中国批准或申报情况。试验登记仅覆盖登记号 2025/2026。
本次对照生成于: 2026/11/13 18:41 · openFDA Orange Book ↗
名称和剂型对接依据
- NMPA reference-product directory, Shaanxi MPA republication ↗ · 30-28 · 2020/09/08
订阅
次日事实提醒与时间线交付
- 关注品种采集到新事实时，次日一封邮件。
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