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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2000/08/24
仿制药申请数5
参比制剂申请人GLAXO GROUP LTD ENGLAND DBA GLAXOSMITHKLINE / TEVA PHARMACEUTICAL INDUSTRIES LTD
当前在售产品数: 20 · 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 |
|---|---|---|---|---|---|---|---|---|---|
| A203433-001 | FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE | HIKMA PHARMACEUTICALS USA INC | POWDER | INHALATION | FLUTICASONE PROPIONATE: 0.1MG/INH SALMETEROL XINAFOATE: EQ 0.05MG BASE/INH | 2020/12/17 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A203433-002 | FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE | HIKMA PHARMACEUTICALS USA INC | POWDER | INHALATION | FLUTICASONE PROPIONATE: 0.25MG/INH SALMETEROL XINAFOATE: EQ 0.05MG BASE/INH | 2020/12/17 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A203433-003 | FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE | HIKMA PHARMACEUTICALS USA INC | POWDER | INHALATION | FLUTICASONE PROPIONATE: 0.5MG/INH SALMETEROL XINAFOATE: EQ 0.05MG BASE/INH | 2023/12/19 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A208891-001 | WIXELA INHUB | MYLAN PHARMACEUTICALS INC | POWDER | INHALATION | FLUTICASONE PROPIONATE: 0.1MG/INH SALMETEROL XINAFOATE: EQ 0.05MG BASE/INH | 2019/01/30 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A208891-002 | WIXELA INHUB | MYLAN PHARMACEUTICALS INC | POWDER | INHALATION | FLUTICASONE PROPIONATE: 0.25MG/INH SALMETEROL XINAFOATE: EQ 0.05MG BASE/INH | 2019/01/30 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A208891-003 | WIXELA INHUB | MYLAN PHARMACEUTICALS INC | POWDER | INHALATION | FLUTICASONE PROPIONATE: 0.5MG/INH SALMETEROL XINAFOATE: EQ 0.05MG BASE/INH | 2019/01/30 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A213087-001 | FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE | CIPLA LTD | POWDER | INHALATION | FLUTICASONE PROPIONATE: 0.1MG/INH SALMETEROL XINAFOATE: EQ 0.05MG BASE/INH | 2026/07/27 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A213087-002 | FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE | CIPLA LTD | POWDER | INHALATION | FLUTICASONE PROPIONATE: 0.25MG/INH SALMETEROL XINAFOATE: EQ 0.05MG BASE/INH | 2026/07/27 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A213087-003 | FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE | CIPLA LTD | POWDER | INHALATION | FLUTICASONE PROPIONATE: 0.5MG/INH SALMETEROL XINAFOATE: EQ 0.05MG BASE/INH | 2026/07/27 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A213948-001 | FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE | TEVA PHARMACEUTICALS USA INC | POWDER | INHALATION | FLUTICASONE PROPIONATE: 0.1MG/INH SALMETEROL XINAFOATE: EQ 0.05MG BASE/INH | 2021/12/13 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A213948-002 | FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE | TEVA PHARMACEUTICALS USA INC | POWDER | INHALATION | FLUTICASONE PROPIONATE: 0.25MG/INH SALMETEROL XINAFOATE: EQ 0.05MG BASE/INH | 2021/12/13 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A213948-003 | FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE | TEVA PHARMACEUTICALS USA INC | POWDER | INHALATION | FLUTICASONE PROPIONATE: 0.5MG/INH SALMETEROL XINAFOATE: EQ 0.05MG BASE/INH | 2021/12/13 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A214464-001 | FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE | RESPIRENT PHARMACEUTICALS CO LTD | POWDER | INHALATION | FLUTICASONE PROPIONATE: 0.1MG/INH SALMETEROL XINAFOATE: EQ 0.05MG BASE/INH | 2026/01/12 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A214464-002 | FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE | RESPIRENT PHARMACEUTICALS CO LTD | POWDER | INHALATION | FLUTICASONE PROPIONATE: 0.25MG/INH SALMETEROL XINAFOATE: EQ 0.05MG BASE/INH | 2026/01/12 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N021077-001 | ADVAIR DISKUS 100/50 | GLAXO GROUP LTD ENGLAND DBA GLAXOSMITHKLINE | POWDER | INHALATION | FLUTICASONE PROPIONATE: 0.1MG/INH SALMETEROL XINAFOATE: EQ 0.05MG BASE/INH | 2000/08/24 | Y / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N021077-002 | ADVAIR DISKUS 250/50 | GLAXO GROUP LTD ENGLAND DBA GLAXOSMITHKLINE | POWDER | INHALATION | FLUTICASONE PROPIONATE: 0.25MG/INH SALMETEROL XINAFOATE: EQ 0.05MG BASE/INH | 2000/08/24 | Y / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N021077-003 | ADVAIR DISKUS 500/50 | GLAXO GROUP LTD ENGLAND DBA GLAXOSMITHKLINE | POWDER | INHALATION | FLUTICASONE PROPIONATE: 0.5MG/INH SALMETEROL XINAFOATE: EQ 0.05MG BASE/INH | 2000/08/24 | Y / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N208799-001 | AIRDUO RESPICLICK | TEVA PHARMACEUTICAL INDUSTRIES LTD | POWDER | INHALATION | FLUTICASONE PROPIONATE: 0.055MG/INH SALMETEROL XINAFOATE: EQ 0.014MG BASE/INH | 2017/01/27 | Y / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N208799-002 | AIRDUO RESPICLICK | TEVA PHARMACEUTICAL INDUSTRIES LTD | POWDER | INHALATION | FLUTICASONE PROPIONATE: 0.113MG/INH SALMETEROL XINAFOATE: EQ 0.014MG BASE/INH | 2017/01/27 | Y / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N208799-003 | AIRDUO RESPICLICK | TEVA PHARMACEUTICAL INDUSTRIES LTD | POWDER | INHALATION | FLUTICASONE PROPIONATE: 0.232MG/INH SALMETEROL XINAFOATE: EQ 0.014MG BASE/INH | 2017/01/27 | Y / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N208799-004 | AIRDUO DIGIHALER | TEVA PHARMACEUTICAL INDUSTRIES LTD | POWDER | INHALATION | FLUTICASONE PROPIONATE: 0.055MG/INH SALMETEROL XINAFOATE: EQ 0.014MG BASE/INH | 2019/07/12 | Y / N | DISCONTINUED | openFDA ↗ |
| N208799-005 | AIRDUO DIGIHALER | TEVA PHARMACEUTICAL INDUSTRIES LTD | POWDER | INHALATION | FLUTICASONE PROPIONATE: 0.113MG/INH SALMETEROL XINAFOATE: EQ 0.014MG BASE/INH | 2019/07/12 | Y / N | DISCONTINUED | openFDA ↗ |
| N208799-006 | AIRDUO DIGIHALER | TEVA PHARMACEUTICAL INDUSTRIES LTD | POWDER | INHALATION | FLUTICASONE PROPIONATE: 0.232MG/INH SALMETEROL XINAFOATE: EQ 0.014MG BASE/INH | 2019/07/12 | 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2041/01/06该最晚日期来自原文件的 *PED 行，按来源日期原样列出。
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 |
|---|---|---|---|---|---|---|
| N208799-001 | 10195375 | 2031/02/14 | — / Y | — | — | openFDA ↗ |
| N208799-001 | 10195375*PED | 2031/08/14 | — / — | — | — | openFDA ↗ |
| N208799-001 | 11969544 | 2039/08/20 | — / Y | — | — | openFDA ↗ |
| N208799-001 | 11969544*PED | 2040/02/20 | — / — | — | — | openFDA ↗ |
| N208799-001 | 9066957 | 2034/10/06 | — / Y | U-645 | — | openFDA ↗ |
| N208799-001 | 9066957*PED | 2035/04/06 | — / — | — | — | openFDA ↗ |
| N208799-001 | 9415008 | 2034/10/06 | — / Y | U-645 | — | openFDA ↗ |
| N208799-001 | 9415008*PED | 2035/04/06 | — / — | — | — | openFDA ↗ |
| N208799-002 | 10195375 | 2031/02/14 | — / Y | — | — | openFDA ↗ |
| N208799-002 | 10195375*PED | 2031/08/14 | — / — | — | — | openFDA ↗ |
| N208799-002 | 11969544 | 2039/08/20 | — / Y | — | — | openFDA ↗ |
| N208799-002 | 11969544*PED | 2040/02/20 | — / — | — | — | openFDA ↗ |
| N208799-002 | 9066957 | 2034/10/06 | — / Y | U-645 | — | openFDA ↗ |
| N208799-002 | 9066957*PED | 2035/04/06 | — / — | — | — | openFDA ↗ |
| N208799-003 | 10195375 | 2031/02/14 | — / Y | — | — | openFDA ↗ |
| N208799-003 | 10195375*PED | 2031/08/14 | — / — | — | — | openFDA ↗ |
| N208799-003 | 11969544 | 2039/08/20 | — / Y | — | — | openFDA ↗ |
| N208799-003 | 11969544*PED | 2040/02/20 | — / — | — | — | openFDA ↗ |
| N208799-003 | 9066957 | 2034/10/06 | — / Y | U-645 | — | openFDA ↗ |
| N208799-003 | 9066957*PED | 2035/04/06 | — / — | — | — | openFDA ↗ |
| N208799-004 | 10195375 | 2031/02/14 | — / Y | — | — | openFDA ↗ |
| N208799-004 | 10195375*PED | 2031/08/14 | — / — | — | — | openFDA ↗ |
| N208799-004 | 10918816 | 2035/12/14 | — / Y | — | — | openFDA ↗ |
| N208799-004 | 10918816*PED | 2036/06/14 | — / — | — | — | openFDA ↗ |
| N208799-004 | 11173259 | 2040/07/06 | — / Y | — | — | openFDA ↗ |
| N208799-004 | 11173259*PED | 2041/01/06 | — / — | — | — | openFDA ↗ |
| N208799-004 | 11344685 | 2039/09/26 | — / Y | — | — | openFDA ↗ |
| N208799-004 | 11344685*PED | 2040/03/26 | — / — | — | — | openFDA ↗ |
| N208799-004 | 11969544 | 2039/08/20 | — / Y | — | — | openFDA ↗ |
| N208799-004 | 11969544*PED | 2040/02/20 | — / — | — | — | openFDA ↗ |
| N208799-004 | 9066957 | 2034/10/06 | — / Y | U-645 | — | openFDA ↗ |
| N208799-004 | 9066957*PED | 2035/04/06 | — / — | — | — | openFDA ↗ |
| N208799-004 | 9415008 | 2034/10/06 | — / Y | U-645 | — | openFDA ↗ |
| N208799-004 | 9415008*PED | 2035/04/06 | — / — | — | — | openFDA ↗ |
| N208799-005 | 10195375 | 2031/02/14 | — / Y | — | — | openFDA ↗ |
| N208799-005 | 10195375*PED | 2031/08/14 | — / — | — | — | openFDA ↗ |
| N208799-005 | 10918816 | 2035/12/14 | — / Y | — | — | openFDA ↗ |
| N208799-005 | 10918816*PED | 2036/06/14 | — / — | — | — | openFDA ↗ |
| N208799-005 | 11173259 | 2040/07/06 | — / Y | — | — | openFDA ↗ |
| N208799-005 | 11173259*PED | 2041/01/06 | — / — | — | — | openFDA ↗ |
| N208799-005 | 11344685 | 2039/09/26 | — / Y | — | — | openFDA ↗ |
| N208799-005 | 11344685*PED | 2040/03/26 | — / — | — | — | openFDA ↗ |
| N208799-005 | 11969544 | 2039/08/20 | — / Y | — | — | openFDA ↗ |
| N208799-005 | 11969544*PED | 2040/02/20 | — / — | — | — | openFDA ↗ |
| N208799-005 | 9066957 | 2034/10/06 | — / Y | U-645 | — | openFDA ↗ |
| N208799-005 | 9066957*PED | 2035/04/06 | — / — | — | — | openFDA ↗ |
| N208799-006 | 10195375 | 2031/02/14 | — / Y | — | — | openFDA ↗ |
| N208799-006 | 10195375*PED | 2031/08/14 | — / — | — | — | openFDA ↗ |
| N208799-006 | 10918816 | 2035/12/14 | — / Y | — | — | openFDA ↗ |
| N208799-006 | 10918816*PED | 2036/06/14 | — / — | — | — | openFDA ↗ |
| N208799-006 | 11173259 | 2040/07/06 | — / Y | — | — | openFDA ↗ |
| N208799-006 | 11173259*PED | 2041/01/06 | — / — | — | — | openFDA ↗ |
| N208799-006 | 11344685 | 2039/09/26 | — / Y | — | — | openFDA ↗ |
| N208799-006 | 11344685*PED | 2040/03/26 | — / — | — | — | openFDA ↗ |
| N208799-006 | 11969544 | 2039/08/20 | — / Y | — | — | openFDA ↗ |
| N208799-006 | 11969544*PED | 2040/02/20 | — / — | — | — | openFDA ↗ |
| N208799-006 | 9066957 | 2034/10/06 | — / Y | U-645 | — | openFDA ↗ |
| N208799-006 | 9066957*PED | 2035/04/06 | — / — | — | — | 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 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 11
| 企业原文 | 编号原文 | 来源日期 | 查看官方来源 |
|---|---|---|---|
| Laboratoire GlaxoSmithKline | 国药准字HJ20150323每泡含昔萘酸沙美特罗50μg(按C₂₅H₃₇NO₄计)与丙 | — | 查看官方来源 ↗ |
| M/s. Cipla Limited | 国药准字HJ20250075每泡含昔萘酸沙美特罗50μg(按C₂₅H₃₇NO₄计)与丙 | — | 查看官方来源 ↗ |
| 四川普锐特药业有限公司 | 国药准字H20253521每泡含昔萘酸沙美特罗50μg(按C₂₅H₃₇NO₄计)与丙酸氟替卡松250μg,递送剂量为昔萘酸沙美特罗47µg(按C₂₅H₃₇NO₄计)与丙酸氟替卡松231µg | — | 查看官方来源 ↗ |
| 健康元药业集团股份有限公司 | 国药准字H20243906每泡含昔萘酸沙美特罗50μg(按C₂₅H₃₇NO₄计)与丙 | — | 查看官方来源 ↗ |
| 上海欧米尼医药科技有限公司 | 国药准字H20255235每泡含昔萘酸沙美特罗50μg(按C₂₅H₃₇NO₄计)与丙酸氟替卡松250μg ;递送剂量为昔萘酸沙美特罗47μg(按C₂₅H₃₇NO₄计)与丙酸氟替卡松231μg | — | 查看官方来源 ↗ |
| Neutec Ilac San. Tic. A.S. | 国药准字HJ20240136每泡含昔萘酸沙美特罗50μg(按C₂₅H₃₇NO₄计) 与 | — | 查看官方来源 ↗ |
| Laboratoire GlaxoSmithKline | 国药准字HJ20150324每泡含昔萘酸沙美特罗50μg(按C₂₅H₃₇NO₄计)与丙 | — | 查看官方来源 ↗ |
| Laboratoire GlaxoSmithKline | 国药准字HJ20150325每泡含昔萘酸沙美特罗50μg(按C₂₅H₃₇NO₄计)与丙 | — | 查看官方来源 ↗ |
| M/s. Cipla Limited | 国药准字HJ20250076每泡含昔萘酸沙美特罗50μg(按C₂₅H₃₇NO₄计)与丙 | — | 查看官方来源 ↗ |
| Neutec Ilac San. Tic. A.S. | 国药准字HJ20240137每泡含昔萘酸沙美特罗50μg(按C₂₅H₃₇NO₄计) 与 | — | 查看官方来源 ↗ |
| Laboratoire GlaxoSmithKline | 国药准字HJ20150323每泡含昔萘酸沙美特罗50μg(按C₂₅H₃₇NO₄计)与丙 | — | 查看官方来源 ↗ |
| Laboratoire GlaxoSmithKline | 国药准字HJ20150324每泡含昔萘酸沙美特罗50μg(按C₂₅H₃₇NO₄计)与丙 | — | 查看官方来源 ↗ |
| Laboratoire GlaxoSmithKline | 国药准字HJ20150325每泡含昔萘酸沙美特罗50μg(按C₂₅H₃₇NO₄计)与丙 | — | 查看官方来源 ↗ |
| M/s. Cipla Limited | 国药准字HJ20250077每泡含昔萘酸沙美特罗50μg(按C₂₅H₃₇NO₄计)与丙 | — | 查看官方来源 ↗ |
当前在审 12
| 企业原文 | 编号原文 | 来源日期 | 查看官方来源 |
|---|---|---|---|
| 博瑞制药（苏州）有限公司 | CYHS2600253 | 2026/01/22 | 查看官方来源 ↗ |
| 博瑞制药（苏州）有限公司 | CYHS2600252 | 2026/01/22 | 查看官方来源 ↗ |
| Celon Pharma S.A.;Jiangsu Simcere Pharmaceutical Co. Ltd. | JYHS2400054 | 2024/10/30 | 查看官方来源 ↗ |
| Celon Pharma S.A.;Jiangsu Simcere Pharmaceutical Co. Ltd. | JYHS2400053 | 2024/10/30 | 查看官方来源 ↗ |
| 润生药业有限公司 | CYHS2602496 | 2026/10/12 | 查看官方来源 ↗ |
| Laboratoire GlaxoSmithKline;Glaxo Wellcome Production | JYHB2600460 | 2026/08/12 | 查看官方来源 ↗ |
| Laboratoire GlaxoSmithKline;Glaxo Wellcome Production | JYHB2600459 | 2026/08/12 | 查看官方来源 ↗ |
| Laboratoire GlaxoSmithKline;Glaxo Wellcome Production | JYHB2600458 | 2026/08/12 | 查看官方来源 ↗ |
| 四川普锐特药业有限公司 | CYHB2600789 | 2026/04/22 | 查看官方来源 ↗ |
| Laboratoire GlaxoSmithKline;Glaxo Wellcome Production | JYHB2500545 | 2025/10/17 | 查看官方来源 ↗ |
| Laboratoire GlaxoSmithKline;Glaxo Wellcome Production | JYHB2500544 | 2025/10/17 | 查看官方来源 ↗ |
| Laboratoire GlaxoSmithKline;Glaxo Wellcome Production | JYHB2500543 | 2025/10/17 | 查看官方来源 ↗ |
今年新报仿制企业 2
A 状态原料药企业 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。 | |||
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：吸入粉雾剂 → POWDER · INHALATION；依据《中国药典》0111 吸入制剂，对应表行 CHP-FORM-047。
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 ↗ · 39-26 · 2021/03/03
- Chinese Pharmacopoeia 2025, formulation chapter; site crosswalk ↗ · CHP-FORM-047 · 0111 吸入制剂
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