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Sign in to subscribeColchicine Tablets
Matched- Active ingredients (original)
- COLCHICINE
- 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 approval2009/07/29
ANDA applications12
RLD applicantAGEPHA PHARMA FZ LLC / TAKEDA PHARMACEUTICALS USA INC
Currently marketed products: 14 · 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 |
|---|---|---|---|---|---|---|---|---|---|
| A203976-001 | COLCHICINE | PH HEALTH LTD | TABLET | ORAL | COLCHICINE: 0.6MG | 2021/08/12 | N / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A204461-001 | COLCHICINE | WATSON LABORATORIES INC | TABLET | ORAL | COLCHICINE: 0.6MG | 2019/07/31 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A204711-001 | COLCHICINE | AMNEAL PHARMACEUTICALS | TABLET | ORAL | COLCHICINE: 0.6MG | 2016/09/28 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A208993-001 | COLCHICINE | HETERO LABS LTD UNIT V | TABLET | ORAL | COLCHICINE: 0.6MG | 2021/08/13 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A209173-001 | COLCHICINE | STRIDES PHARMA GLOBAL PTE LTD | TABLET | ORAL | COLCHICINE: 0.6MG | 2022/03/10 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A209470-001 | COLCHICINE | MYLAN PHARMACEUTICALS INC | TABLET | ORAL | COLCHICINE: 0.6MG | 2019/09/16 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A209876-001 | COLCHICINE | DR REDDYS LABORATORIES LTD | TABLET | ORAL | COLCHICINE: 0.6MG | 2019/09/06 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A210425-001 | COLCHICINE | GRANULES PHARMACEUTICALS INC | TABLET | ORAL | COLCHICINE: 0.6MG | 2020/02/05 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A210633-001 | COLCHICINE | MACLEODS PHARMACEUTICALS LTD | TABLET | ORAL | COLCHICINE: 0.6MG | 2026/02/13 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A211250-001 | COLCHICINE | ALKEM LABORATORIES LTD | TABLET | ORAL | COLCHICINE: 0.6MG | 2019/02/08 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A211519-001 | COLCHICINE | ZYDUS PHARMACEUTICALS USA INC | TABLET | ORAL | COLCHICINE: 0.6MG | 2019/02/19 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A211519-002 | COLCHICINE | ZYDUS PHARMACEUTICALS USA INC | TABLET | ORAL | COLCHICINE: 0.3MG | 2019/11/14 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A215444-001 | COLCHICINE | AUROBINDO PHARMA LTD | TABLET | ORAL | COLCHICINE: 0.6MG | 2022/01/06 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N022352-001 | COLCRYS | TAKEDA PHARMACEUTICALS USA INC | TABLET | ORAL | COLCHICINE: 0.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 2009/07/29 | Y / N | DISCONTINUED | openFDA ↗ |
| N215727-001 | LODOCO | AGEPHA PHARMA FZ LLC | TABLET | ORAL | COLCHICINE: 0.5MG | 2023/06/16 | 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 expiration2034/05/09
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 |
|---|---|---|---|---|---|---|
| N022352-001 | 7601758 | 2029/02/10 | — / — | U-1007 | — | openFDA ↗ |
| N022352-001 | 7619004 | 2028/12/03 | — / — | U-1020 | — | openFDA ↗ |
| N022352-001 | 7820681 | 2029/02/17 | — / — | U-1020 | — | openFDA ↗ |
| N022352-001 | 7906519 | 2029/02/17 | — / — | U-1116 | — | openFDA ↗ |
| N022352-001 | 7915269 | 2029/02/17 | — / — | U-1007 | — | openFDA ↗ |
| N022352-001 | 7935731 | 2028/12/03 | — / — | U-1116 | — | openFDA ↗ |
| N022352-001 | 7964647 | 2028/10/06 | — / — | U-1007 | — | openFDA ↗ |
| N022352-001 | 7964648 | 2028/10/06 | — / — | U-1161 | — | openFDA ↗ |
| N022352-001 | 7981938 | 2028/10/06 | — / — | U-1166 | — | openFDA ↗ |
| N022352-001 | 8093296 | 2028/10/06 | — / — | U-1007 | — | openFDA ↗ |
| N022352-001 | 8093297 | 2028/10/06 | — / — | U-1161 | — | openFDA ↗ |
| N022352-001 | 8093298 | 2028/10/06 | — / — | U-1116 | — | openFDA ↗ |
| N022352-001 | 8097655 | 2028/10/06 | — / — | U-1020 | — | openFDA ↗ |
| N022352-001 | 8415395 | 2028/10/06 | — / — | U-1007 | — | openFDA ↗ |
| N022352-001 | 8415396 | 2028/10/06 | — / — | U-1007 | — | openFDA ↗ |
| N022352-001 | 8440721 | 2029/02/17 | — / — | U-1007 | — | openFDA ↗ |
| N022352-001 | 8440722 | 2029/02/17 | — / — | U-1020 | — | openFDA ↗ |
| N215727-001 | 10130585 | 2034/05/09 | — / — | U-3642 | — | openFDA ↗ |
| N215727-001 | 10206891 | 2033/11/01 | — / — | U-3641 | — | openFDA ↗ |
| N215727-001 | 10265281 | 2033/11/01 | — / — | U-3639 | — | openFDA ↗ |
| N215727-001 | 10842762 | 2033/11/01 | — / — | U-3640 | — | openFDA ↗ |
| N215727-001 | 11026899 | 2033/11/01 | — / — | U-3639 | — | openFDA ↗ |
| N215727-001 | 11026900 | 2033/11/01 | — / — | U-3639 | — | openFDA ↗ |
| N215727-001 | 11026901 | 2033/11/01 | — / — | U-3638 | — | openFDA ↗ |
| N215727-001 | 11944594 | 2033/11/01 | — / — | U-3864 | — | openFDA ↗ |
| N215727-001 | 11944595 | 2033/11/01 | — / — | U-3868 | — | openFDA ↗ |
| N215727-001 | 12233035 | 2033/11/01 | — / — | U-4132 | — | openFDA ↗ |
| N215727-001 | 12280025 | 2033/11/01 | — / — | U-4168 | — | openFDA ↗ |
| N215727-001 | 12364675 | 2033/11/01 | — / — | U-3639 | — | openFDA ↗ |
| N215727-001 | 9744144 | 2033/11/01 | — / — | U-3643 | — | openFDA ↗ |
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 2
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Beijing Jia Lin Pharma Co., Ltd. romanized | 国药准字H200038420.5mg | 2024/10/30 | Official source ↗ |
| Xi Shuang Ban Na Ban Na Pharma Co., Ltd. romanized | 国药准字H53021369See source | 2024/08/27 | Official source ↗ |
NHSA approval numbers 12
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Beijing Jia Lin Pharma Co., Ltd. romanized | 国药准字H200038420.5mg | — | Official source ↗ |
| Guangdong Bi Di Pharma Co., Ltd. romanized | 国药准字H201132080.5mg | — | Official source ↗ |
| Guangzhou Bai Sai Luo Pharma Co., Ltd. romanized | 国药准字H199990640.5mg | — | Official source ↗ |
| Jilin Long Xin Pharma Co., Ltd. romanized | 国药准字H220204910.5mg | — | Official source ↗ |
| Jilin Jia Tai Pharmaceutical Co., Ltd. romanized | 国药准字H220208640.5mg | — | Official source ↗ |
| Kun Yao Group Co., Ltd. romanized | 国药准字H530213890.5mg | — | Official source ↗ |
| Xi Shuang Ban Na Ban Na Pharma Co., Ltd. romanized | 国药准字H530213690.5mg | — | Official source ↗ |
| Yunnan Hao Bang Pharmaceutical Co., Ltd. romanized | 国药准字H530217980.5mg | — | Official source ↗ |
| Hong Yun Pharmaceutical (Yu Xi) Co., Ltd. romanized | 国药准字H530219040.5mg | — | Official source ↗ |
| Yunnan Zhi Wu Pharma Co., Ltd. romanized | 国药准字H530201660.5mg | — | Official source ↗ |
| Beijing Jia Lin Pharma Co., Ltd. romanized | 国药准字H200038420.5mg | — | Official source ↗ |
| Guangdong Bi Di Pharma Co., Ltd. romanized | 国药准字H201132080.5mg | — | Official source ↗ |
| Tong Hua Bai Xin Pharma Co., Ltd. romanized | 国药准字H220223130.5mg | — | Official source ↗ |
| Kun Yao Group Co., Ltd. romanized | 国药准字H530213890.5mg | — | Official source ↗ |
| Xi Shuang Ban Na Ban Na Pharma Co., Ltd. romanized | 国药准字H530213690.5mg | — | Official source ↗ |
| Yunnan Hao Bang Pharmaceutical Co., Ltd. romanized | 国药准字H530217980.5mg | — | Official source ↗ |
| Hong Yun Pharmaceutical (Yu Xi) Co., Ltd. romanized | 国药准字H530219040.5mg | — | Official source ↗ |
| Yunnan Zhi Wu Pharma Co., Ltd. romanized | 国药准字H530201660.5mg | — | Official source ↗ |
| Yunnan Hao Bang Pharmaceutical Co., Ltd. romanized | 国药准字H530217980.5mg | — | Official source ↗ |
| Hong Yun Pharmaceutical (Yu Xi) Co., Ltd. romanized | 国药准字H530219040.5mg | — | Official source ↗ |
| Yunnan Zhi Wu Pharma Co., Ltd. romanized | 国药准字H530201660.5mg | — | Official source ↗ |
| Yunnan Hao Bang Pharmaceutical Co., Ltd. romanized | 国药准字H530217980.5mg | — | Official source ↗ |
| Hong Yun Pharmaceutical (Yu Xi) Co., Ltd. romanized | 国药准字H530219040.5mg | — | Official source ↗ |
| Yunnan Zhi Wu Pharma Co., Ltd. romanized | 国药准字H530201660.5mg | — | Official source ↗ |
| Yunnan Hao Bang Pharmaceutical Co., Ltd. romanized | 国药准字H530217980.5mg | — | Official source ↗ |
| Hong Yun Pharmaceutical (Yu Xi) Co., Ltd. romanized | 国药准字H530219040.5mg | — | Official source ↗ |
| Yunnan Zhi Wu Pharma Co., Ltd. romanized | 国药准字H530201660.5mg | — | Official source ↗ |
| Yunnan Hao Bang Pharmaceutical Co., Ltd. romanized | 国药准字H530217980.5mg | — | Official source ↗ |
| Hong Yun Pharmaceutical (Yu Xi) Co., Ltd. romanized | 国药准字H530219040.5mg | — | Official source ↗ |
| Yunnan Hao Bang Pharmaceutical Co., Ltd. romanized | 国药准字H530217980.5mg | — | Official source ↗ |
| Hong Yun Pharmaceutical (Yu Xi) Co., Ltd. romanized | 国药准字H530219040.5mg | — | Official source ↗ |
| Yunnan Hao Bang Pharmaceutical Co., Ltd. romanized | 国药准字H530217980.5mg | — | Official source ↗ |
| Hong Yun Pharmaceutical (Yu Xi) Co., Ltd. romanized | 国药准字H530219040.5mg | — | Official source ↗ |
| Yunnan Hao Bang Pharmaceutical Co., Ltd. romanized | 国药准字H530217980.5mg | — | Official source ↗ |
| Hong Yun Pharmaceutical (Yu Xi) Co., Ltd. romanized | 国药准字H530219040.5mg | — | Official source ↗ |
| Yunnan Hao Bang Pharmaceutical Co., Ltd. romanized | 国药准字H530217980.5mg | — | Official source ↗ |
| Hong Yun Pharmaceutical (Yu Xi) Co., Ltd. romanized | 国药准字H530219040.5mg | — | Official source ↗ |
| Hong Yun Pharmaceutical (Yu Xi) Co., Ltd. romanized | 国药准字H530219040.5mg | — | Official source ↗ |
| Hong Yun Pharmaceutical (Yu Xi) Co., Ltd. romanized | 国药准字H530219040.5mg | — | Official source ↗ |
| Hong Yun Pharmaceutical (Yu Xi) Co., Ltd. romanized | 国药准字H530219040.5mg | — | Official source ↗ |
| Hong Yun Pharmaceutical (Yu Xi) Co., Ltd. romanized | 国药准字H530219040.5mg | — | Official source ↗ |
| Hong Yun Pharmaceutical (Yu Xi) Co., Ltd. romanized | 国药准字H530219040.5mg | — | Official source ↗ |
| Kun Yao Group Co., Ltd. romanized | 国药准字H530215341mg | — | Official source ↗ |
Under review 6
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | CYHS2404014 | 2024/11/22 | Official source ↗ |
| Xiamen Zi Xu Pharmaceuticals Technology Co., Ltd. romanized; Guangdong An Nuo Pharma Co., Ltd. romanized | CYHS2600467 | 2026/02/13 | Official source ↗ |
| Shanghai Li Xiang Pharmaceutical Co., Ltd. romanized; Zhejiang Zhe Bei Pharma Co., Ltd. romanized | CYHS2600303 | 2026/01/29 | Official source ↗ |
| Heilongjiang Yi Da Hong Pharma Co., Ltd. romanized | CYHS2504054 | 2025/11/25 | Official source ↗ |
| Yi Jia Pharma (Hubei) Co., Ltd. romanized; Zhejiang Zhe Bei Pharma Co., Ltd. romanized | CYHS2501148 | 2025/03/22 | Official source ↗ |
| Zhejiang Zhe Bei Pharma Co., Ltd. romanized | CYHS2500508 | 2025/01/27 | Official source ↗ |
Generic-filing companies this year 2
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Xiamen Zi Xu Pharmaceuticals Technology Co., Ltd. romanized; Guangdong An Nuo Pharma Co., Ltd. romanized | CYHS2600467 | 2026/02/13 | Official source ↗ |
| Shanghai Li Xiang Pharmaceutical Co., Ltd. romanized; Zhejiang Zhe Bei Pharma Co., Ltd. romanized | CYHS2600303 | 2026/01/29 | Official source ↗ |
API companies with A status 3
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| SARV BIO LABS PVT LTD | Y20230000810 | 2025/10/19 | Official source ↗ |
| Xi Shuang Ban Na Ban Na Pharma Co., Ltd. romanized | Y20190003853 | — | Official source ↗ |
| Kun Yao Group Co., Ltd. romanized | Y20190003490 | 2026/01/15 | 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 ↗ · 7-52 · 2017/07/27
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