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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1982 年前已批准
仿制药申请数15
参比制剂申请人BAXTER HEALTHCARE CORP
当前在售产品数: 27 · 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 |
|---|---|---|---|---|---|---|---|---|---|
| A040015-001 | NEOSAR | TEVA PARENTERAL MEDICINES INC | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 100MG/VIAL | 1993/04/29 | N / N | DISCONTINUED | openFDA ↗ |
| A040015-002 | NEOSAR | TEVA PARENTERAL MEDICINES INC | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 200MG/VIAL | 1993/04/29 | N / N | DISCONTINUED | openFDA ↗ |
| A040015-003 | NEOSAR | TEVA PARENTERAL MEDICINES INC | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 500MG/VIAL | 1993/04/29 | N / N | DISCONTINUED | openFDA ↗ |
| A040015-004 | NEOSAR | TEVA PARENTERAL MEDICINES INC | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 1GM/VIAL | 1993/04/29 | N / N | DISCONTINUED | openFDA ↗ |
| A040015-005 | NEOSAR | TEVA PARENTERAL MEDICINES INC | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 2GM/VIAL | 1993/04/29 | N / N | DISCONTINUED | openFDA ↗ |
| A040745-001 | CYCLOPHOSPHAMIDE | BAXTER HEALTHCARE CORP | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 500MG/VIAL | 2008/05/21 | N / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A040745-002 | CYCLOPHOSPHAMIDE | BAXTER HEALTHCARE CORP | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 1GM/VIAL | 2008/05/21 | N / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A040745-003 | CYCLOPHOSPHAMIDE | BAXTER HEALTHCARE CORP | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 2GM/VIAL | 2008/05/21 | N / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A087442-001 | NEOSAR | BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 100MG/VIAL | 1982/02/16 | N / N | DISCONTINUED | openFDA ↗ |
| A087442-002 | NEOSAR | BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 200MG/VIAL | 1982/02/16 | N / N | DISCONTINUED | openFDA ↗ |
| A087442-003 | NEOSAR | BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 500MG/VIAL | 1982/02/16 | N / N | DISCONTINUED | openFDA ↗ |
| A087442-004 | NEOSAR | BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 1GM/VIAL | 1983/07/08 | N / N | DISCONTINUED | openFDA ↗ |
| A087442-005 | NEOSAR | BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 2GM/VIAL | 1989/03/30 | N / N | DISCONTINUED | openFDA ↗ |
| A088371-001 | CYCLOPHOSPHAMIDE | BAXTER HEALTHCARE CORP | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 100MG/VIAL | 1986/07/03 | N / N | DISCONTINUED | openFDA ↗ |
| A088372-001 | CYCLOPHOSPHAMIDE | BAXTER HEALTHCARE CORP | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 200MG/VIAL | 1986/07/03 | N / N | DISCONTINUED | openFDA ↗ |
| A088373-001 | CYCLOPHOSPHAMIDE | BAXTER HEALTHCARE CORP | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 500MG/VIAL | 1986/07/03 | N / N | DISCONTINUED | openFDA ↗ |
| A088374-001 | CYCLOPHOSPHAMIDE | BAXTER HEALTHCARE CORP | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 1GM/VIAL | 1986/09/24 | N / N | DISCONTINUED | openFDA ↗ |
| A204555-001 | CYCLOPHOSPHAMIDE | JIANGSU HENGRUI PHARMACEUTICALS CO LTD | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 500MG/VIAL | 2014/10/31 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A204555-002 | CYCLOPHOSPHAMIDE | JIANGSU HENGRUI PHARMACEUTICALS CO LTD | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 1GM/VIAL | 2014/10/31 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A204555-003 | CYCLOPHOSPHAMIDE | JIANGSU HENGRUI PHARMACEUTICALS CO LTD | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 2GM/VIAL | 2014/10/31 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A210046-001 | CYCLOPHOSPHAMIDE | AMNEAL EU LTD | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 500MG/VIAL | 2018/05/25 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A210046-002 | CYCLOPHOSPHAMIDE | AMNEAL EU LTD | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 1GM/VIAL | 2018/05/25 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A210046-003 | CYCLOPHOSPHAMIDE | AMNEAL EU LTD | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 2GM/VIAL | 2018/05/25 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A211757-001 | CYCLOPHOSPHAMIDE | XGEN PHARMACEUTICALS DJB INC | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 500MG/VIAL | 2022/10/18 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A211757-002 | CYCLOPHOSPHAMIDE | XGEN PHARMACEUTICALS DJB INC | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 1GM/VIAL | 2022/10/18 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A211757-003 | CYCLOPHOSPHAMIDE | XGEN PHARMACEUTICALS DJB INC | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 2GM/VIAL | 2022/10/18 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A214529-001 | CYCLOPHOSPHAMIDE | SAGENT PHARMACEUTICALS INC | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 500MG/VIAL | 2023/07/17 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A214529-002 | CYCLOPHOSPHAMIDE | SAGENT PHARMACEUTICALS INC | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 1GM/VIAL | 2023/07/17 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A214529-003 | CYCLOPHOSPHAMIDE | SAGENT PHARMACEUTICALS INC | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 2GM/VIAL | 2023/07/17 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A215089-001 | CYCLOPHOSPHAMIDE | SUNNY PHARMTECH INC | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 500MG/VIAL | 2023/10/26 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A215089-002 | CYCLOPHOSPHAMIDE | SUNNY PHARMTECH INC | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 1GM/VIAL | 2023/10/26 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A215089-003 | CYCLOPHOSPHAMIDE | SUNNY PHARMTECH INC | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 2GM/VIAL | 2023/10/26 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A216958-001 | CYCLOPHOSPHAMIDE | HIKMA PHARMACEUTICALS USA INC | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 500MG/VIAL | 2023/12/18 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A216958-002 | CYCLOPHOSPHAMIDE | HIKMA PHARMACEUTICALS USA INC | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 1GM/VIAL | 2023/12/18 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A216958-003 | CYCLOPHOSPHAMIDE | HIKMA PHARMACEUTICALS USA INC | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 2GM/VIAL | 2023/12/18 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A218632-001 | CYCLOPHOSPHAMIDE | HAINAN POLY PHARM CO LTD | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 500MG/VIAL | 2024/12/26 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A218632-002 | CYCLOPHOSPHAMIDE | HAINAN POLY PHARM CO LTD | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 1GM/VIAL | 2024/12/26 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A218632-003 | CYCLOPHOSPHAMIDE | HAINAN POLY PHARM CO LTD | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 2GM/VIAL | 2024/12/26 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A218644-001 | CYCLOPHOSPHAMIDE | EPIC PHARMA LLC | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 500MG/VIAL | 2024/12/19 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A218644-002 | CYCLOPHOSPHAMIDE | EPIC PHARMA LLC | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 1GM/VIAL | 2024/12/19 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A218644-003 | CYCLOPHOSPHAMIDE | EPIC PHARMA LLC | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 2GM/VIAL | 2024/12/19 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N012142-001 | CYTOXAN | BAXTER HEALTHCARE CORP | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 1982 年前已批准 | Y / N | DISCONTINUED | openFDA ↗ |
| N012142-002 | CYTOXAN | BAXTER HEALTHCARE CORP | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 200MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 1982 年前已批准 | Y / N | DISCONTINUED | openFDA ↗ |
| N012142-003 | CYTOXAN (LYOPHILIZED) | BAXTER HEALTHCARE CORP | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 1982 年前已批准 | Y / N | DISCONTINUED | openFDA ↗ |
| N012142-004 | CYTOXAN (LYOPHILIZED) | BAXTER HEALTHCARE CORP | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 1982/08/30 | Y / N | DISCONTINUED | openFDA ↗ |
| N012142-005 | CYTOXAN (LYOPHILIZED) | BAXTER HEALTHCARE CORP | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 1982/08/30 | Y / N | DISCONTINUED | openFDA ↗ |
| N012142-006 | LYOPHILIZED CYTOXAN | BAXTER HEALTHCARE CORP | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 1985/12/05 | Y / N | DISCONTINUED | openFDA ↗ |
| N012142-007 | LYOPHILIZED CYTOXAN | BAXTER HEALTHCARE CORP | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 200MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 1985/12/10 | Y / N | DISCONTINUED | openFDA ↗ |
| N012142-008 | CYTOXAN (LYOPHILIZED) | BAXTER HEALTHCARE CORP | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 1984/01/04 | Y / N | DISCONTINUED | openFDA ↗ |
| N012142-009 | CYTOXAN (LYOPHILIZED) | BAXTER HEALTHCARE CORP | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 1985/12/10 | Y / N | DISCONTINUED | openFDA ↗ |
| N012142-010 | CYTOXAN (LYOPHILIZED) | BAXTER HEALTHCARE CORP | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 1985/09/24 | Y / N | DISCONTINUED | 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—
物质专利到期（DS 标记）—
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 |
|---|---|---|---|---|---|---|
| 未列出 | ||||||
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 0
| 企业原文 | 编号原文 | 来源日期 | 查看官方来源 |
|---|---|---|---|
| 本站该来源下未匹配到记录。 | |||
医保批准文号 0
| 企业原文 | 编号原文 | 来源日期 | 查看官方来源 |
|---|---|---|---|
| 本站该来源下未匹配到记录。 | |||
当前在审 6
今年新报仿制企业 2
A 状态原料药企业 10
| 企业原文 | 编号原文 | 来源日期 | 查看官方来源 |
|---|---|---|---|
| 连云港贵科药业有限公司 | Y20230001208 | 2026/07/18 | 查看官方来源 ↗ |
| MSN Laboratories Private Limited | Y20210000587 | 2025/03/14 | 查看官方来源 ↗ |
| 安徽普利药业有限公司 | Y20220000793 | 2024/05/22 | 查看官方来源 ↗ |
| 江苏恒瑞医药股份有限公司 | Y20190009631 | 2025/08/01 | 查看官方来源 ↗ |
| 山西普德药业有限公司 | Y20190007404 | 2026/10/10 | 查看官方来源 ↗ |
| 浙江海正药业股份有限公司 | Y20190007332 | 2023/05/25 | 查看官方来源 ↗ |
| 通化茂祥制药有限公司 | Y20190005033 | — | 查看官方来源 ↗ |
| 山西振东泰盛制药有限公司 | Y20190001726 | 2025/01/25 | 查看官方来源 ↗ |
| 北京斯利安药业有限公司 | Y20190001681 | 2024/08/21 | 查看官方来源 ↗ |
| 江苏恒瑞医药股份有限公司 | Y20180000542 | 2026/05/08 | 查看官方来源 ↗ |
| 广东岭南制药有限公司 | Y20170000200 | 2024/09/12 | 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。
剂型通用对应：注射液 → INJECTABLE · INJECTION；依据《中国药典》0102 注射剂，对应表行 CHP-FORM-076。
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 ↗ · 60-19 · 2022/10/11
- Chinese Pharmacopoeia 2025, formulation chapter; site crosswalk ↗ · CHP-FORM-076 · 0102 注射剂
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- 关注品种采集到新事实时，次日一封邮件。
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