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Sign in to subscribeTranexamic Acid Tablets
Matched- Active ingredients (original)
- TRANEXAMIC ACID
- 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 approval1986/12/30
ANDA applications8
RLD applicantJ MOLNER HOLDINGS INC
Currently marketed products: 7 · 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 |
|---|---|---|---|---|---|---|---|---|---|
| A202093-001 | TRANEXAMIC ACID | ACTAVIS LABORATORIES FL INC | TABLET | ORAL | TRANEXAMIC ACID: 650MG | 2012/12/27 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A202286-001 | TRANEXAMIC ACID | APOTEX INC | TABLET | ORAL | TRANEXAMIC ACID: 650MG | 2014/01/27 | N / N | DISCONTINUED | openFDA ↗ |
| A203256-001 | TRANEXAMIC ACID | ANI PHARMACEUTICALS INC | TABLET | ORAL | TRANEXAMIC ACID: 650MG | 2016/07/25 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A205133-001 | TRANEXAMIC ACID | AUROBINDO PHARMA USA INC | TABLET | ORAL | TRANEXAMIC ACID: 650MG | 2015/09/21 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A218320-001 | TRANEXAMIC ACID | RUBICON RESEARCH LTD | TABLET | ORAL | TRANEXAMIC ACID: 650MG | 2024/06/11 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A218729-001 | TRANEXAMIC ACID | APPCO PHARMA LLC | TABLET | ORAL | TRANEXAMIC ACID: 650MG | 2025/06/11 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A219123-001 | TRANEXAMIC ACID | BIONPHARMA INC | TABLET | ORAL | TRANEXAMIC ACID: 650MG | 2025/08/19 | N / N | DISCONTINUED | openFDA ↗ |
| A219702-001 | TRANEXAMIC ACID | PHARMAZONE | TABLET | ORAL | TRANEXAMIC ACID: 650MG | 2026/01/26 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N019280-001 | CYKLOKAPRON | PHARMACIA AND UPJOHN CO | TABLET | ORAL | TRANEXAMIC ACID: 500MG | 1986/12/30 | N / N | DISCONTINUED | openFDA ↗ |
| N022430-001 | LYSTEDA | J MOLNER HOLDINGS INC | TABLET | ORAL | TRANEXAMIC ACID: 650MG | 2009/11/13 | 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 expiration—
Substance patent expiration (DS flag)—
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 |
|---|---|---|---|---|---|---|
| Not listed | ||||||
Exclusivity source records
FDA exclusivity code list ↗Latest exclusivity expiration: —
| Application / product number | Exclusivity code | Listed expiration | Official source |
|---|---|---|---|
| Not listed | |||
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 10
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Chengdu Brilliant Pharmaceutical Co., Ltd. | 国药准字H202642990.25g | 2026/05/12 | Official source ↗ |
| Zhejiang Xiong Di Pharma Co., Ltd. romanized | 国药准字H202640550.5g | 2026/04/21 | Official source ↗ |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H202638160.25g | 2026/03/31 | Official source ↗ |
| Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | 国药准字H202634660.5g | 2026/02/25 | Official source ↗ |
| Jiangsu Ziyond Pharmaceutical Co., Ltd. | 国药准字H202631080.25g | 2026/01/14 | Official source ↗ |
| Hainan Yao Gu Yun Bio Technology Co., Ltd. romanized | 国药准字H202561560.5g | 2025/12/03 | Official source ↗ |
| Hangzhou Kang En Bei Pharmaceutical Co., Ltd. romanized | 国药准字H202550250.25g | 2025/07/29 | Official source ↗ |
| Yan Tai Wan Run Pharma Co., Ltd. romanized | 国药准字H202346460.25g | 2023/12/13 | Official source ↗ |
| Hunan Dong Ting Pharma Co., Ltd. romanized | 国药准字H430205640.25g | 2023/10/30 | Official source ↗ |
| Di Yi San Gong Zhu Shi Hui She romanized | H201602820.5g | 2000/10/07 | Official source ↗ |
NHSA approval numbers 13
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Hainan Yao Gu Yun Bio Technology Co., Ltd. romanized | 国药准字H202561560.5g | — | Official source ↗ |
| Shanghai Xin Yi Wan Xiang Pharma Co., Ltd. romanized | 国药准字H310200400.25g | — | Official source ↗ |
| Chengdu Brilliant Pharmaceutical Co., Ltd. | 国药准字H202642990.25g | — | Official source ↗ |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H202534130.5g | — | Official source ↗ |
| Shanghai Kai Bao Xin Yi (Xin Xiang) Pharma Co., Ltd. romanized | 国药准字H410214810.125g | — | Official source ↗ |
| Jilin Wan Tong Pharma Group Zhengzhou Wan Tong Fu Sheng Pharma Co., Ltd. romanized | 国药准字H410256280.125g | — | Official source ↗ |
| Yan Tai Wan Run Pharma Co., Ltd. romanized | 国药准字H202346460.25g | — | Official source ↗ |
| Hangzhou Kang En Bei Pharmaceutical Co., Ltd. romanized | 国药准字H202550250.25g | — | Official source ↗ |
| Hunan Dong Ting Pharma Co., Ltd. romanized | 国药准字H430205640.25g | — | Official source ↗ |
| Guo Yao Group Tong Ji Tang (Guizhou) Pharmaceutical Co., Ltd. romanized | 国药准字H520208980.25g | — | Official source ↗ |
| DAIICHI SANKYO CO., LTD. | 国药准字HJ201602820.5g | — | Official source ↗ |
| Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | 国药准字H202634660.5g | — | Official source ↗ |
| Hainan Yao Gu Yun Bio Technology Co., Ltd. romanized | 国药准字H202561560.5g | — | Official source ↗ |
| Shanghai Xin Yi Wan Xiang Pharma Co., Ltd. romanized | 国药准字H310200400.25g | — | Official source ↗ |
| Shanghai Kai Bao Xin Yi (Xin Xiang) Pharma Co., Ltd. romanized | 国药准字H410214810.125g | — | Official source ↗ |
| Yan Tai Wan Run Pharma Co., Ltd. romanized | 国药准字H202346460.25g | — | Official source ↗ |
| Hangzhou Kang En Bei Pharmaceutical Co., Ltd. romanized | 国药准字H202550250.25g | — | Official source ↗ |
| Hunan Dong Ting Pharma Co., Ltd. romanized | 国药准字H430205640.25g | — | Official source ↗ |
| Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | 国药准字H202634660.5g | — | Official source ↗ |
| Hainan Yao Gu Yun Bio Technology Co., Ltd. romanized | 国药准字H202561560.5g | — | Official source ↗ |
| Shanghai Xin Yi Wan Xiang Pharma Co., Ltd. romanized | 国药准字H310200400.25g | — | Official source ↗ |
| Yan Tai Wan Run Pharma Co., Ltd. romanized | 国药准字H202346460.25g | — | Official source ↗ |
| Hunan Dong Ting Pharma Co., Ltd. romanized | 国药准字H430205640.25g | — | Official source ↗ |
| Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | 国药准字H202634660.5g | — | Official source ↗ |
| Hainan Yao Gu Yun Bio Technology Co., Ltd. romanized | 国药准字H202561560.5g | — | Official source ↗ |
| Shanghai Xin Yi Wan Xiang Pharma Co., Ltd. romanized | 国药准字H310200400.25g | — | Official source ↗ |
| Yan Tai Wan Run Pharma Co., Ltd. romanized | 国药准字H202346460.25g | — | Official source ↗ |
| Hunan Dong Ting Pharma Co., Ltd. romanized | 国药准字H430205640.25g | — | Official source ↗ |
| Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | 国药准字H202634660.5g | — | Official source ↗ |
| Shanghai Xin Yi Wan Xiang Pharma Co., Ltd. romanized | 国药准字H310200400.25g | — | Official source ↗ |
| Yan Tai Wan Run Pharma Co., Ltd. romanized | 国药准字H202346460.25g | — | Official source ↗ |
| Yan Tai Wan Run Pharma Co., Ltd. romanized | 国药准字H202346460.25g | — | Official source ↗ |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H202638160.25g | — | Official source ↗ |
Under review 9
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Jiangsu Fu Bang Pharma Co., Ltd. romanized | CYHS2600960 | 2026/04/24 | Official source ↗ |
| Changzhou Yin Sheng Pharma Co., Ltd. romanized | CYHS2602371 | 2026/09/21 | Official source ↗ |
| Changzhou Yin Sheng Pharma Co., Ltd. romanized | CYHS2602370 | 2026/09/21 | Official source ↗ |
| Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized | CYHS2602439 | 2026/09/30 | Official source ↗ |
| Sichuan Bei Ling He Yi Pharmaceutical Co., Ltd. romanized | CYHS2601889 | 2026/08/04 | Official source ↗ |
| Chongqing Ke Rui Pharmaceutical (Group) Co., Ltd. romanized | CYHS2601512 | 2026/06/26 | Official source ↗ |
| Da Tong Pharmaceutical (Zhongguo) Co., Ltd. romanized | CYHS2504106 | 2025/11/28 | Official source ↗ |
| Guangzhou Hua Sheng Pharmaceutical Co., Ltd. romanized | CYHS2503947 | 2025/11/13 | Official source ↗ |
| Guangzhou Hua Sheng Pharmaceutical Co., Ltd. romanized | CYHS2503946 | 2025/11/13 | Official source ↗ |
Generic-filing companies this year 5
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Jiangsu Fu Bang Pharma Co., Ltd. romanized | CYHS2600960 | 2026/04/24 | Official source ↗ |
| Changzhou Yin Sheng Pharma Co., Ltd. romanized | CYHS2602371 | 2026/09/21 | Official source ↗ |
| Changzhou Yin Sheng Pharma Co., Ltd. romanized | CYHS2602370 | 2026/09/21 | Official source ↗ |
| Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized | CYHS2602439 | 2026/09/30 | Official source ↗ |
| Sichuan Bei Ling He Yi Pharmaceutical Co., Ltd. romanized | CYHS2601889 | 2026/08/04 | Official source ↗ |
| Chongqing Ke Rui Pharmaceutical (Group) Co., Ltd. romanized | CYHS2601512 | 2026/06/26 | Official source ↗ |
API companies with A status 15
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Sichuan Ren An Pharma Co., Ltd. romanized | Y20240001282 | 2026/02/09 | Official source ↗ |
| Ami lifesciences Pvt. Ltd. | Y20210000315 | 2026/09/06 | Official source ↗ |
| Hunan Sai Long Pharma Co., Ltd. romanized | Y20210000177 | 2026/05/08 | Official source ↗ |
| DAIICHI SANKYO CO.,LTD. | Y20190009106 | — | Official source ↗ |
| Xian Li Bang Pharmaceutical Co., Ltd. romanized | Y20190008931 | 2024/01/31 | Official source ↗ |
| Jiangsu Lianhuan Pharmaceutical Co.,Ltd. | Y20190006868 | 2023/03/24 | Official source ↗ |
| Hubei Zhong Jia He Cheng Pharmaceutical Co., Ltd. romanized | Y20190006325 | 2026/04/15 | Official source ↗ |
| Changzhou Yin Sheng Pharma Co., Ltd. romanized | Y20190006181 | 2025/12/23 | Official source ↗ |
| Kai Feng Pharmaceutical (Group) Co., Ltd. romanized | Y20190004445 | 2024/09/11 | Official source ↗ |
| Hua Run Shuang He Pharma Co., Ltd. romanized | Y20190003756 | — | Official source ↗ |
| Hunan Dong Ting Pharma Co., Ltd. romanized | Y20190002895 | 2025/03/04 | Official source ↗ |
| Yang Zi Jiang Pharma Group Jiangsu Hai Ci Bio Pharma Co., Ltd. romanized | Y20190002704 | — | Official source ↗ |
| Hainan Huluwa Pharmaceutical Group Co., Ltd. | Y20190002448 | 2024/07/16 | Official source ↗ |
| Shanghai Xian Dai Ha Sen (Shang Qiu) Pharma Co., Ltd. romanized | Y20190001677 | 2025/03/12 | Official source ↗ |
| Yan Tai Wan Run Pharma Co., Ltd. romanized | Y20170000447 | 2024/01/12 | 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 ↗ · 20-1 · 2019/02/27
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