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Sign in to subscribeVortioxetine Hydrobromide Tablets
Matched- Active ingredients (original)
- VORTIOXETINE HYDROBROMIDE
- Dosage form (original)
- TABLET
- Route (original)
- ORAL
Read these limits
- US patent expiration does not establish Chinese patent expiration. Dates here come from the US Orange Book; Chinese patent status needs separate checking.
- The Orange Book lists holder-submitted patents and does not cover all related patents.
- “Unmatched” means no English ingredient-name counterpart in the Chinese official-name sources loaded here; it does not mean no Chinese approval or filing. A zero count means a Chinese name is matched but no records were found in the loaded source. Source dates appear below.
- This page contains no sales or market-size data and cannot establish development value.
- Names on unmatched rows are the original FDA Orange Book names, without Chinese translation. The same ingredient may have a different generic name in China.
US-approved products
Application numbers, product numbers and original fields are retained. Marketing status is shown as listed in the source.
Earliest approval2013/09/30
ANDA applications0
RLD applicantTAKEDA PHARMACEUTICALS USA INC
Currently marketed products: 3 · Counts FDA prescription and OTC marketing categories as listed; discontinued or unknown categories are excluded.
| Application / product number | Brand name (original) | Applicant (original) | Dosage form (original) | Route (original) | Strength (original) | Earliest approval | RLD / RS | Marketing status (original) | Official source |
|---|---|---|---|---|---|---|---|---|---|
| N204447-001 | TRINTELLIX | TAKEDA PHARMACEUTICALS USA INC | TABLET | ORAL | VORTIOXETINE HYDROBROMIDE: EQ 5MG BASE | 2013/09/30 | Y / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N204447-002 | TRINTELLIX | TAKEDA PHARMACEUTICALS USA INC | TABLET | ORAL | VORTIOXETINE HYDROBROMIDE: EQ 10MG BASE | 2013/09/30 | Y / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N204447-003 | TRINTELLIX | TAKEDA PHARMACEUTICALS USA INC | TABLET | ORAL | VORTIOXETINE HYDROBROMIDE: EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 2013/09/30 | Y / N | DISCONTINUED | openFDA ↗ |
| N204447-004 | TRINTELLIX | TAKEDA PHARMACEUTICALS USA INC | TABLET | ORAL | VORTIOXETINE HYDROBROMIDE: EQ 20MG BASE | 2013/09/30 | Y / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
Listed US patents
*PED rows, substance/product flags, use codes and delisting-request flags are retained without determining legal effect.
Latest listed patent expiration2032/09/21This latest date comes from a *PED row in the source and is displayed as listed.
Substance patent expiration (DS flag)2031/06/30
This column includes only source rows explicitly flagged DS. A PED row without that flag is not assigned one by this site.
| Application / product number | Patent number | Listed expiration | Substance / product flags | Use code | Delisting request | Official source |
|---|---|---|---|---|---|---|
| N204447-001 | 11458134 | 2027/06/15 | — / Y | U-3463 | — | openFDA ↗ |
| N204447-001 | 11458134*PED | 2027/12/15 | — / — | — | — | openFDA ↗ |
| N204447-001 | 7144884 | 2026/06/17 | Y / Y | U-1439 | — | openFDA ↗ |
| N204447-001 | 7144884*PED | 2026/12/17 | — / — | — | — | openFDA ↗ |
| N204447-001 | 8722684 | 2031/06/30 | Y / Y | — | — | openFDA ↗ |
| N204447-001 | 8722684*PED | 2031/12/30 | — / — | — | — | openFDA ↗ |
| N204447-001 | 8969355 | 2027/06/15 | — / — | U-1668 | — | openFDA ↗ |
| N204447-001 | 8969355*PED | 2027/12/15 | — / — | — | — | openFDA ↗ |
| N204447-001 | 9125908 | 2027/06/15 | — / — | U-2309 | — | openFDA ↗ |
| N204447-001 | 9125908*PED | 2027/12/15 | — / — | — | — | openFDA ↗ |
| N204447-001 | 9125909 | 2027/06/15 | — / — | U-2309 | — | openFDA ↗ |
| N204447-001 | 9125909*PED | 2027/12/15 | — / — | — | — | openFDA ↗ |
| N204447-001 | 9125910 | 2027/06/15 | — / — | U-2309 | — | openFDA ↗ |
| N204447-001 | 9125910*PED | 2027/12/15 | — / — | — | — | openFDA ↗ |
| N204447-001 | 9227946 | 2027/06/15 | — / — | U-1668 | — | openFDA ↗ |
| N204447-001 | 9227946*PED | 2027/12/15 | — / — | — | — | openFDA ↗ |
| N204447-001 | 9278096 | 2032/03/21 | — / — | U-2436 | — | openFDA ↗ |
| N204447-001 | 9278096*PED | 2032/09/21 | — / — | — | — | openFDA ↗ |
| N204447-001 | 9861630 | 2027/06/15 | — / — | U-1668 | — | openFDA ↗ |
| N204447-001 | 9861630*PED | 2027/12/15 | — / — | — | — | openFDA ↗ |
| N204447-002 | 11458134 | 2027/06/15 | — / Y | U-3463 | — | openFDA ↗ |
| N204447-002 | 11458134*PED | 2027/12/15 | — / — | — | — | openFDA ↗ |
| N204447-002 | 7144884 | 2026/06/17 | Y / Y | U-1439 | — | openFDA ↗ |
| N204447-002 | 7144884*PED | 2026/12/17 | — / — | — | — | openFDA ↗ |
| N204447-002 | 8722684 | 2031/06/30 | Y / Y | — | — | openFDA ↗ |
| N204447-002 | 8722684*PED | 2031/12/30 | — / — | — | — | openFDA ↗ |
| N204447-002 | 8969355 | 2027/06/15 | — / — | U-1668 | — | openFDA ↗ |
| N204447-002 | 8969355*PED | 2027/12/15 | — / — | — | — | openFDA ↗ |
| N204447-002 | 9125908 | 2027/06/15 | — / — | U-2309 | — | openFDA ↗ |
| N204447-002 | 9125908*PED | 2027/12/15 | — / — | — | — | openFDA ↗ |
| N204447-002 | 9125909 | 2027/06/15 | — / — | U-2309 | — | openFDA ↗ |
| N204447-002 | 9125909*PED | 2027/12/15 | — / — | — | — | openFDA ↗ |
| N204447-002 | 9125910 | 2027/06/15 | — / — | U-2309 | — | openFDA ↗ |
| N204447-002 | 9125910*PED | 2027/12/15 | — / — | — | — | openFDA ↗ |
| N204447-002 | 9227946 | 2027/06/15 | — / — | U-1668 | — | openFDA ↗ |
| N204447-002 | 9227946*PED | 2027/12/15 | — / — | — | — | openFDA ↗ |
| N204447-002 | 9278096 | 2032/03/21 | — / — | U-2436 | — | openFDA ↗ |
| N204447-002 | 9278096*PED | 2032/09/21 | — / — | — | — | openFDA ↗ |
| N204447-002 | 9861630 | 2027/06/15 | — / — | U-1668 | — | openFDA ↗ |
| N204447-002 | 9861630*PED | 2027/12/15 | — / — | — | — | openFDA ↗ |
| N204447-003 | 11458134 | 2027/06/15 | — / Y | U-3463 | — | openFDA ↗ |
| N204447-003 | 11458134*PED | 2027/12/15 | — / — | — | — | openFDA ↗ |
| N204447-003 | 7144884 | 2026/06/17 | Y / Y | U-1439 | — | openFDA ↗ |
| N204447-003 | 7144884*PED | 2026/12/17 | — / — | — | — | openFDA ↗ |
| N204447-003 | 8722684 | 2031/06/30 | Y / Y | — | — | openFDA ↗ |
| N204447-003 | 8722684*PED | 2031/12/30 | — / — | — | — | openFDA ↗ |
| N204447-003 | 8969355 | 2027/06/15 | — / — | U-1668 | — | openFDA ↗ |
| N204447-003 | 8969355*PED | 2027/12/15 | — / — | — | — | openFDA ↗ |
| N204447-003 | 9125908 | 2027/06/15 | — / — | U-2309 | — | openFDA ↗ |
| N204447-003 | 9125908*PED | 2027/12/15 | — / — | — | — | openFDA ↗ |
| N204447-003 | 9125909 | 2027/06/15 | — / — | U-2309 | — | openFDA ↗ |
| N204447-003 | 9125909*PED | 2027/12/15 | — / — | — | — | openFDA ↗ |
| N204447-003 | 9125910 | 2027/06/15 | — / — | U-2309 | — | openFDA ↗ |
| N204447-003 | 9125910*PED | 2027/12/15 | — / — | — | — | openFDA ↗ |
| N204447-003 | 9227946 | 2027/06/15 | — / — | U-1668 | — | openFDA ↗ |
| N204447-003 | 9227946*PED | 2027/12/15 | — / — | — | — | openFDA ↗ |
| N204447-003 | 9278096 | 2032/03/21 | — / — | U-2436 | — | openFDA ↗ |
| N204447-003 | 9278096*PED | 2032/09/21 | — / — | — | — | openFDA ↗ |
| N204447-003 | 9861630 | 2027/06/15 | — / — | U-1668 | — | openFDA ↗ |
| N204447-003 | 9861630*PED | 2027/12/15 | — / — | — | — | openFDA ↗ |
| N204447-004 | 11458134 | 2027/06/15 | — / Y | U-3463 | — | openFDA ↗ |
| N204447-004 | 11458134*PED | 2027/12/15 | — / — | — | — | openFDA ↗ |
| N204447-004 | 7144884 | 2026/06/17 | Y / Y | U-1439 | — | openFDA ↗ |
| N204447-004 | 7144884*PED | 2026/12/17 | — / — | — | — | openFDA ↗ |
| N204447-004 | 8722684 | 2031/06/30 | Y / Y | — | — | openFDA ↗ |
| N204447-004 | 8722684*PED | 2031/12/30 | — / — | — | — | openFDA ↗ |
| N204447-004 | 8969355 | 2027/06/15 | — / — | U-1668 | — | openFDA ↗ |
| N204447-004 | 8969355*PED | 2027/12/15 | — / — | — | — | openFDA ↗ |
| N204447-004 | 9125908 | 2027/06/15 | — / — | U-2309 | — | openFDA ↗ |
| N204447-004 | 9125908*PED | 2027/12/15 | — / — | — | — | openFDA ↗ |
| N204447-004 | 9125909 | 2027/06/15 | — / — | U-2309 | — | openFDA ↗ |
| N204447-004 | 9125909*PED | 2027/12/15 | — / — | — | — | openFDA ↗ |
| N204447-004 | 9125910 | 2027/06/15 | — / — | U-2309 | — | openFDA ↗ |
| N204447-004 | 9125910*PED | 2027/12/15 | — / — | — | — | openFDA ↗ |
| N204447-004 | 9227946 | 2027/06/15 | — / — | U-1668 | — | openFDA ↗ |
| N204447-004 | 9227946*PED | 2027/12/15 | — / — | — | — | openFDA ↗ |
| N204447-004 | 9278096 | 2032/03/21 | — / — | U-2436 | — | openFDA ↗ |
| N204447-004 | 9278096*PED | 2032/09/21 | — / — | — | — | openFDA ↗ |
| N204447-004 | 9861630 | 2027/06/15 | — / — | U-1668 | — | openFDA ↗ |
| N204447-004 | 9861630*PED | 2027/12/15 | — / — | — | — | openFDA ↗ |
Exclusivity source records
FDA exclusivity code list ↗Latest exclusivity expiration: 2027/02/23
| Application / product number | Exclusivity code | Listed expiration | Official source |
|---|---|---|---|
| N204447-001 | M-232 | 2026/08/23 | openFDA ↗ |
| N204447-001 | PED | 2027/02/23 | openFDA ↗ |
| N204447-002 | M-232 | 2026/08/23 | openFDA ↗ |
| N204447-002 | PED | 2027/02/23 | openFDA ↗ |
| N204447-003 | M-232 | 2026/08/23 | openFDA ↗ |
| N204447-003 | PED | 2027/02/23 | openFDA ↗ |
| N204447-004 | M-232 | 2026/08/23 | openFDA ↗ |
| N204447-004 | PED | 2027/02/23 | openFDA ↗ |
Chinese record details
Chinese product landscape ↗The four-zero filter applies only to matched rows: catalog holders, NHSA approval numbers, applications under review, and companies filing generics this year. Unmatched rows have no Chinese counts. Filings are counted by acceptance number and filing companies by first applicant. Strengths may have separate applications. Drug names are normalized only for width and whitespace; distinct generic names, dosage forms and combinations remain separate. Unstated strengths are marked. Company counts from different sources must not be added together.
Catalog holders 27
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Hua Run Shuang He Xiang Zhong Pharma (Hunan) Co., Ltd. romanized | 国药准字H20264747See source | 2026/06/10 | Official source ↗ |
| Jilin Si Huan Pharmaceutical Co., Ltd. romanized | 国药准字H20264624See source | 2026/06/03 | Official source ↗ |
| Jiu Zhou Biopharmaceuticals (Tai Zhou) Co., Ltd. romanized | 国药准字H20263532See source | 2026/03/10 | Official source ↗ |
| Jiu Zhou Biopharmaceuticals (Tai Zhou) Co., Ltd. romanized | 国药准字H20263533See source | 2026/03/10 | Official source ↗ |
| Shanxi Yuan Yang Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20256346See source | 2025/12/22 | Official source ↗ |
| Hainan Bei Kang Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20256261See source | 2025/12/16 | Official source ↗ |
| Hefei Innovation Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20255943See source | 2025/11/12 | Official source ↗ |
| Hefei Innovation Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H2025594210mg | 2025/11/12 | Official source ↗ |
| YaoPharma Co., Ltd. | 国药准字H20255601See source | 2025/09/30 | Official source ↗ |
| Pu Ji Bio Technology (Tai Zhou) Co., Ltd. romanized | 国药准字H20255195See source | 2025/08/26 | Official source ↗ |
| Pu Ji Bio Technology (Tai Zhou) Co., Ltd. romanized | 国药准字H20255194See source | 2025/08/26 | Official source ↗ |
| Hunan Sheng Xiang Zhong Pharmaceutical Co., Ltd. romanized | 国药准字H20254349See source | 2025/05/27 | Official source ↗ |
| Shijiazhuang Long Ze Pharmaceutical Co., Ltd. romanized | 国药准字H20253149See source | 2025/01/14 | Official source ↗ |
| Zhongshan Wanhan Pharmaceuticals Co., Ltd. | 国药准字H20253190See source | 2025/01/14 | Official source ↗ |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20253161See source | 2025/01/14 | Official source ↗ |
| Jiangsu En Hua Pharma Co., Ltd. romanized | 国药准字H20253153See source | 2025/01/14 | Official source ↗ |
| Zhongshan Wanhan Pharmaceuticals Co., Ltd. | 国药准字H20253191See source | 2025/01/14 | Official source ↗ |
| Hangzhou He Kang Pharma Co., Ltd. romanized | 国药准字H20249594See source | 2024/12/01 | Official source ↗ |
| Bei Da Pharmaceuticals Co., Ltd. romanized | 国药准字H20249356See source | 2024/11/15 | Official source ↗ |
| Bei Da Pharmaceuticals Co., Ltd. romanized | 国药准字H20249358See source | 2024/11/15 | Official source ↗ |
| Bei Da Pharmaceuticals Co., Ltd. romanized | 国药准字H20249357See source | 2024/11/15 | Official source ↗ |
| Fujian Sheng Min Dong Li Jie Xun Pharma Co., Ltd. romanized | 国药准字H20244342See source | 2024/06/28 | Official source ↗ |
| Jewim Pharmaceutical (Shandong) Co., Ltd. | 国药准字H20243891See source | 2024/06/04 | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20243147See source | 2024/02/06 | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20243148See source | 2024/02/06 | Official source ↗ |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20243027See source | 2024/01/09 | Official source ↗ |
| Hebei Long Hai Pharma Co., Ltd. romanized | 国药准字H20233417See source | 2023/04/04 | Official source ↗ |
| Yangtze River Pharmaceutical Group Co., Ltd | 国药准字H20233155See source | 2023/02/14 | Official source ↗ |
| Nanjing Fang Sheng He Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20223341See source | 2022/05/25 | Official source ↗ |
| Jiangsu Hao Sen Pharma Group Co., Ltd. romanized | 国药准字H20223282See source | 2022/05/10 | Official source ↗ |
| Jiangsu Hao Sen Pharma Group Co., Ltd. romanized | 国药准字H20223303See source | 2022/05/10 | Official source ↗ |
| CSPC OUYI PHARMACEUTICAL CO., LTD. | 国药准字H20223237See source | 2022/04/19 | Official source ↗ |
| Chengdu Kang Hong Pharma Group Co., Ltd. romanized | 国药准字H20213844See source | 2021/11/03 | Official source ↗ |
| Chengdu Brilliant Pharmaceutical Co., Ltd. | 国药准字H20213823See source | 2021/10/26 | Official source ↗ |
| CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | 国药准字H20213597See source | 2021/07/20 | Official source ↗ |
| CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | 国药准字H20213598See source | 2021/07/20 | Official source ↗ |
| H.Lundbeck A/S | H20170381;H20170382See source | 2017/11/21 | Official source ↗ |
| H.Lundbeck A/S | H20170383;H20170384See source | 2017/11/21 | Official source ↗ |
| CSPC OUYI PHARMACEUTICAL CO., LTD. | 国药准字H20223436See source | 2022/06/28 | Official source ↗ |
NHSA approval numbers 35
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Jiangsu En Hua Pharma Co., Ltd. romanized | 国药准字H20253153See source | — | Official source ↗ |
| Jiangsu Hao Sen Pharma Group Co., Ltd. romanized | 国药准字H20223303See source | — | Official source ↗ |
| CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | 国药准字H20213597See source | — | Official source ↗ |
| Yangtze River Pharmaceutical Group Co., Ltd | 国药准字H20233155See source | — | Official source ↗ |
| Chengdu Brilliant Pharmaceutical Co., Ltd. | 国药准字H20213823See source | — | Official source ↗ |
| Chengdu Kang Hong Pharma Group Co., Ltd. romanized | 国药准字H20213844See source | — | Official source ↗ |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20243027See source | — | Official source ↗ |
| Hebei Long Hai Pharma Co., Ltd. romanized | 国药准字H20233417See source | — | Official source ↗ |
| CSPC OUYI PHARMACEUTICAL CO., LTD. | 国药准字H20223436See source | — | Official source ↗ |
| Jilin Si Huan Pharmaceutical Co., Ltd. romanized | 国药准字H20264624See source | — | Official source ↗ |
| Jewim Pharmaceutical (Shandong) Co., Ltd. | 国药准字H20243891See source | — | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20243147See source | — | Official source ↗ |
| Fujian Sheng Min Dong Li Jie Xun Pharma Co., Ltd. romanized | 国药准字H20244342See source | — | Official source ↗ |
| Hua Run Shuang He Xiang Zhong Pharma (Hunan) Co., Ltd. romanized | 国药准字H20254349See source | — | Official source ↗ |
| Bei Da Pharmaceuticals Co., Ltd. romanized | 国药准字H20249356See source | — | Official source ↗ |
| Zhongshan Wanhan Pharmaceuticals Co., Ltd. | 国药准字H20253190See source | — | Official source ↗ |
| H. Lundbeck A/S | 国药准字HJ20170383See source | — | Official source ↗ |
| Shijiazhuang Long Ze Pharmaceutical Co., Ltd. romanized | 国药准字H20253149See source | — | Official source ↗ |
| Nanjing Fang Sheng He Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20223341See source | — | Official source ↗ |
| Hangzhou He Kang Pharma Co., Ltd. romanized | 国药准字H20249594See source | — | Official source ↗ |
| Shanxi Yuan Yang Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20256346See source | — | Official source ↗ |
| Pu Ji Bio Technology (Tai Zhou) Co., Ltd. romanized | 国药准字H20255194See source | — | Official source ↗ |
| Hainan Bei Kang Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20256261See source | — | Official source ↗ |
| Jiangsu Hao Sen Pharma Group Co., Ltd. romanized | 国药准字H20223303See source | — | Official source ↗ |
| CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | 国药准字H20213597See source | — | Official source ↗ |
| Hebei Long Hai Pharma Co., Ltd. romanized | 国药准字H20233417See source | — | Official source ↗ |
| Jilin Si Huan Pharmaceutical Co., Ltd. romanized | 国药准字H20264624See source | — | Official source ↗ |
| Jewim Pharmaceutical (Shandong) Co., Ltd. | 国药准字H20243891See source | — | Official source ↗ |
| H. Lundbeck A/S | 国药准字HJ20170383See source | — | Official source ↗ |
| Hangzhou He Kang Pharma Co., Ltd. romanized | 国药准字H20249594See source | — | Official source ↗ |
| Shanxi Yuan Yang Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20256346See source | — | Official source ↗ |
| Pu Ji Bio Technology (Tai Zhou) Co., Ltd. romanized | 国药准字H20255194See source | — | Official source ↗ |
| Hainan Bei Kang Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20256261See source | — | Official source ↗ |
| Jiangsu Hao Sen Pharma Group Co., Ltd. romanized | 国药准字H20223303See source | — | Official source ↗ |
| CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | 国药准字H20213597See source | — | Official source ↗ |
| Hebei Long Hai Pharma Co., Ltd. romanized | 国药准字H20233417See source | — | Official source ↗ |
| Jilin Si Huan Pharmaceutical Co., Ltd. romanized | 国药准字H20264624See source | — | Official source ↗ |
| Jewim Pharmaceutical (Shandong) Co., Ltd. | 国药准字H20243891See source | — | Official source ↗ |
| H.Lundbeck A/S | H20170384See source | — | Official source ↗ |
| Hangzhou He Kang Pharma Co., Ltd. romanized | 国药准字H20249594See source | — | Official source ↗ |
| Jiangsu Hao Sen Pharma Group Co., Ltd. romanized | 国药准字H20223303See source | — | Official source ↗ |
| CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | 国药准字H20213597See source | — | Official source ↗ |
| Hebei Long Hai Pharma Co., Ltd. romanized | 国药准字H20233417See source | — | Official source ↗ |
| H.Lundbeck A/S | H20170384See source | — | Official source ↗ |
| Jiangsu Hao Sen Pharma Group Co., Ltd. romanized | 国药准字H20223282See source | — | Official source ↗ |
| CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | 国药准字H20213598See source | — | Official source ↗ |
| Chengdu Kang Hong Pharma Group Co., Ltd. romanized | 国药准字H20213844See source | — | Official source ↗ |
| CSPC OUYI PHARMACEUTICAL CO., LTD. | 国药准字H20223237See source | — | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20243148See source | — | Official source ↗ |
| Bei Da Pharmaceuticals Co., Ltd. romanized | 国药准字H20249357See source | — | Official source ↗ |
| Zhongshan Wanhan Pharmaceuticals Co., Ltd. | 国药准字H20253191See source | — | Official source ↗ |
| H.Lundbeck A/S | H20170381See source | — | Official source ↗ |
| Pu Ji Bio Technology (Tai Zhou) Co., Ltd. romanized | 国药准字H20255195See source | — | Official source ↗ |
| Jiangsu Hao Sen Pharma Group Co., Ltd. romanized | 国药准字H20223282See source | — | Official source ↗ |
| CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | 国药准字H20213598See source | — | Official source ↗ |
| Chengdu Kang Hong Pharma Group Co., Ltd. romanized | 国药准字H20213844See source | — | Official source ↗ |
| Zhongshan Wanhan Pharmaceuticals Co., Ltd. | 国药准字H20253191See source | — | Official source ↗ |
| H.Lundbeck A/S | H20170381See source | — | Official source ↗ |
| Pu Ji Bio Technology (Tai Zhou) Co., Ltd. romanized | 国药准字H20255195See source | — | Official source ↗ |
| CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | 国药准字H20213598See source | — | Official source ↗ |
| H.Lundbeck A/S | H20170382See source | — | Official source ↗ |
| CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | 国药准字H20213598See source | — | Official source ↗ |
| H.Lundbeck A/S | H20170382See source | — | Official source ↗ |
| Jiangsu Hao Sen Pharma Group Co., Ltd. romanized | 国药准字H20237133See source | — | Official source ↗ |
| Bei Da Pharmaceuticals Co., Ltd. romanized | 国药准字H20249358See source | — | Official source ↗ |
| Jiangsu Hao Sen Pharma Group Co., Ltd. romanized | 国药准字H20237133See source | — | Official source ↗ |
| Jiangsu Hao Sen Pharma Group Co., Ltd. romanized | 国药准字H20237133See source | — | Official source ↗ |
| Jiangsu Hao Sen Pharma Group Co., Ltd. romanized | 国药准字H20237133See source | — | Official source ↗ |
Under review 10
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | CYHS2601752 | 2026/07/21 | Official source ↗ |
| Yun Peng Pharmaceuticals Group Co., Ltd. romanized | CYHS2504393 | 2025/12/25 | Official source ↗ |
| Ma Ying Long Pharma Group Co., Ltd. romanized | CYHS2504370 | 2025/12/24 | Official source ↗ |
| Ma Ying Long Pharma Group Co., Ltd. romanized | CYHS2504369 | 2025/12/24 | Official source ↗ |
| Shanghai Gu Fang Meng Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Hai Xiang Pharma Co., Ltd. romanized | CYHS2503642 | 2025/10/14 | Official source ↗ |
| Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized | CYHS2602652 | 2026/10/29 | Official source ↗ |
| Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized | CYHS2602651 | 2026/10/29 | Official source ↗ |
| Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized | CYHS2602650 | 2026/10/29 | Official source ↗ |
| Suzhou Di San Pharmaceutical Factory Co., Ltd. romanized | CYHS2602765 | 2026/11/10 | Official source ↗ |
| Suzhou Di San Pharmaceutical Factory Co., Ltd. romanized | CYHS2602764 | 2026/11/10 | Official source ↗ |
Generic-filing companies this year 3
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | CYHS2601752 | 2026/07/21 | Official source ↗ |
| Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized | CYHS2602652 | 2026/10/29 | Official source ↗ |
| Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized | CYHS2602651 | 2026/10/29 | Official source ↗ |
| Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized | CYHS2602650 | 2026/10/29 | Official source ↗ |
| Suzhou Di San Pharmaceutical Factory Co., Ltd. romanized | CYHS2602765 | 2026/11/10 | Official source ↗ |
| Suzhou Di San Pharmaceutical Factory Co., Ltd. romanized | CYHS2602764 | 2026/11/10 | Official source ↗ |
API companies with A status 26
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Zhejiang Le Pu Pharma Co., Ltd. romanized | Y20250000384 | 2026/09/11 | Official source ↗ |
| Hua Run Shuang He Xiang Zhong Pharma (Hunan) Co., Ltd. romanized | Y20250000126 | 2026/09/29 | Official source ↗ |
| Zhejiang Hua Hai Jian Cheng Pharma Co., Ltd. romanized | Y20240001365 | 2026/08/06 | Official source ↗ |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | Y20240001098 | 2026/06/24 | Official source ↗ |
| Sichuan Ren An Pharma Co., Ltd. romanized | Y20240000098 | 2026/09/16 | Official source ↗ |
| Anhui Jin Tai Yang Sheng Hua Pharma Co., Ltd. romanized | Y20240000117 | 2025/11/19 | Official source ↗ |
| Zhejiang Le Pu Pharma Co., Ltd. romanized | Y20230001182 | 2025/09/04 | Official source ↗ |
| Zhejiang Jiu Zhou Pharma Co., Ltd. romanized | Y20230001011 | 2025/11/02 | Official source ↗ |
| Jiangsu En Hua Pharma Co., Ltd. romanized | Y20230000789 | 2025/01/23 | Official source ↗ |
| Shijiazhuang Long Ze Pharmaceutical Co., Ltd. romanized | Y20230000555 | 2026/01/07 | Official source ↗ |
| Hunan Dong Ting Pharma Co., Ltd. romanized | Y20230000195 | 2024/11/07 | Official source ↗ |
| Zhejiang Jing Jin Pharma Co., Ltd. romanized | Y20230000034 | 2026/01/05 | Official source ↗ |
| Bei Da Pharmaceuticals Co., Ltd. romanized | Y20230000027 | 2024/07/17 | Official source ↗ |
| Fujian Sheng Fu Kang Pharma Co., Ltd. romanized | Y20220000989 | 2025/10/10 | Official source ↗ |
| Qian Hui Pharma (Anhui) Co., Ltd. romanized | Y20220000103 | 2024/01/25 | Official source ↗ |
| Hebei Guang Xiang Pharmaceutical Co., Ltd. romanized | Y20220000116 | 2025/02/18 | Official source ↗ |
| Shandong Chen Long Pharma Co., Ltd. romanized | Y20220000238 | 2025/07/09 | Official source ↗ |
| Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized | Y20220000220 | 2024/10/29 | Official source ↗ |
| Zhongshan Wanhan Pharmaceuticals Co., Ltd. | Y20210001265 | 2026/02/07 | Official source ↗ |
| Shandong Rui Shun Pharma Co., Ltd. romanized | Y20210001276 | 2024/05/09 | Official source ↗ |
| Hetero Labs Limited | Y20200001223 | 2026/03/01 | Official source ↗ |
| Jilin Hui Kang Pharmaceutical Co., Ltd. romanized | Y20200000737 | 2022/10/28 | Official source ↗ |
| Sichuan Ren An Pharma Co., Ltd. romanized | Y20200000572 | 2026/05/06 | Official source ↗ |
| Chongqing Bo Teng Pharmaceutical Technology Co., Ltd. romanized | Y20200000505 | 2026/04/30 | Official source ↗ |
| Sichuan Hong Yuan Pharma Co., Ltd. romanized | Y20200000548 | 2026/03/17 | Official source ↗ |
| Jiangsu Hao Sen Pharma Group Co., Ltd. romanized | Y20190021303 | 2026/09/15 | Official source ↗ |
| Lian Yun Gang Run Zhong Pharmaceutical Co., Ltd. romanized | Y20190000584 | 2026/02/13 | Official source ↗ |
| Yang Zi Jiang Pharma Group Jiangsu Hai Ci Bio Pharma Co., Ltd. romanized | Y20180001103 | 2024/08/26 | Official source ↗ |
Trial registrations 2025/2026 —
Not loaded
Sources and dates
- FDA Orange Book
- 2026/11/06
- CDE acceptance and review
- 2026/11/13 06:42
- Chemical Drug Catalog
- 2026/11/13 06:39
- API registration records
- 2026/11/13 06:41
- NHSA drug code database
- 2026/10/23
- Trial registry
- 2026/11/13 08:09 · Incomplete coverage
Chinese counts use complete ingredient, dosage-form and route matches. Unmatched and partial rows show name-source matching only and make no finding about Chinese approvals or filings. Trials cover registration-number years 2025/2026 only.
Comparison generated: 2026/11/13 18:41 · openFDA Orange Book ↗
Name and dosage-form matching sources
- NMPA reference-product directory, Shaanxi MPA republication ↗ · 46-45 · 2021/10/21
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