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Sign in to subscribeTacrolimus Sustained-release Capsules
Matched- Active ingredients (original)
- TACROLIMUS
- Dosage form (original)
- CAPSULE, EXTENDED RELEASE
- 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 approval2013/07/19
ANDA applications1
RLD applicantASTELLAS PHARMA US INC
Currently marketed products: 6 · 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 |
|---|---|---|---|---|---|---|---|---|---|
| A215012-001 | TACROLIMUS | CHENGDU SUNCADIA MEDICINE CO LTD | CAPSULE, EXTENDED RELEASE | ORAL | TACROLIMUS: EQ 0.5MG BASE | 2024/01/25 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A215012-002 | TACROLIMUS | CHENGDU SUNCADIA MEDICINE CO LTD | CAPSULE, EXTENDED RELEASE | ORAL | TACROLIMUS: EQ 1MG BASE | 2024/01/25 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A215012-003 | TACROLIMUS | CHENGDU SUNCADIA MEDICINE CO LTD | CAPSULE, EXTENDED RELEASE | ORAL | TACROLIMUS: EQ 5MG BASE | 2024/01/25 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N204096-001 | ASTAGRAF XL | ASTELLAS PHARMA US INC | CAPSULE, EXTENDED RELEASE | ORAL | TACROLIMUS: EQ 0.5MG BASE | 2013/07/19 | Y / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N204096-002 | ASTAGRAF XL | ASTELLAS PHARMA US INC | CAPSULE, EXTENDED RELEASE | ORAL | TACROLIMUS: EQ 1MG BASE | 2013/07/19 | Y / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N204096-003 | ASTAGRAF XL | ASTELLAS PHARMA US INC | CAPSULE, EXTENDED RELEASE | ORAL | TACROLIMUS: EQ 5MG BASE | 2013/07/19 | 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 9
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Shanghai An Bi Sheng Pharmaceutical Technology Co., Ltd. romanized | 国药准字H202640580.5mg | 2026/04/21 | Official source ↗ |
| Shanghai An Bi Sheng Pharmaceutical Technology Co., Ltd. romanized | 国药准字H202640571mg | 2026/04/21 | Official source ↗ |
| Jiangsu He Chen Pharma Co., Ltd. romanized | 国药准字H202690580.5mg | 2026/03/19 | Official source ↗ |
| CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD. | 国药准字H202556470.5mg | 2025/09/30 | Official source ↗ |
| CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD. | 国药准字H202556461mg | 2025/09/30 | Official source ↗ |
| Jiangsu He Chen Pharma Co., Ltd. romanized | 国药准字H202546801mg | 2025/06/30 | Official source ↗ |
| Hainan He Rui Pharmaceutical Co., Ltd. romanized | 国药准字H202535570.5mg | 2025/03/04 | Official source ↗ |
| Hainan He Rui Pharmaceutical Co., Ltd. romanized | 国药准字H202535561mg | 2025/03/04 | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H202532421mg | 2025/01/24 | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H202532410.5mg | 2025/01/24 | Official source ↗ |
| Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | 国药准字H202531651mg | 2025/01/14 | Official source ↗ |
| Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | 国药准字H202531660.5mg | 2025/01/14 | Official source ↗ |
| Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized | 国药准字H202441371mg | 2024/06/25 | Official source ↗ |
| Hangzhou Zhong Mei Hua Dong Pharmaceutical Jiang Dong Co., Ltd. romanized | 国药准字H202441360.5mg | 2024/06/25 | Official source ↗ |
| Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized | 国药准字H202432005mg | 2024/02/23 | Official source ↗ |
| Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized | 国药准字H202234240.5mg | 2022/06/28 | Official source ↗ |
| Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized | 国药准字H202234225mg | 2022/06/28 | Official source ↗ |
| Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized | 国药准字H202234231mg | 2022/06/28 | Official source ↗ |
NHSA approval numbers 22
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Astellas Pharma Europe B.V. | 国药准字J201500550.5mg | — | Official source ↗ |
| Shi Yao Group Zhong Nuo Pharma (Shijiazhuang) Co., Ltd. romanized | 国药准字H202556461mg | — | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H202532410.5mg | — | Official source ↗ |
| Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized | 国药准字H202441360.5mg | — | Official source ↗ |
| Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | 国药准字H202531651mg | — | Official source ↗ |
| Hainan He Rui Pharmaceutical Co., Ltd. romanized | 国药准字H202535570.5mg | — | Official source ↗ |
| Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized | 国药准字H202234240.5mg | — | Official source ↗ |
| Shanghai An Bi Sheng Pharmaceutical Technology Co., Ltd. romanized | 国药准字H202640571mg | — | Official source ↗ |
| Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized | 国药准字H202432005mg | — | Official source ↗ |
| Jiangsu He Chen Pharma Co., Ltd. romanized | 国药准字H202546801mg | — | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H202532410.5mg | — | Official source ↗ |
| Hainan He Rui Pharmaceutical Co., Ltd. romanized | 国药准字H202535570.5mg | — | Official source ↗ |
| Astellas Pharma Europe B.V. | 国药准字HJ201500290.5mg | — | Official source ↗ |
| Astellas Pharma Europe B.V. | 国药准字J201500561mg | — | Official source ↗ |
| Shi Yao Group Zhong Nuo Pharma (Shijiazhuang) Co., Ltd. romanized | 国药准字H202556470.5mg | — | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H202532421mg | — | Official source ↗ |
| Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized | 国药准字H202441371mg | — | Official source ↗ |
| Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | 国药准字H202531660.5mg | — | Official source ↗ |
| Hainan He Rui Pharmaceutical Co., Ltd. romanized | 国药准字H202535561mg | — | Official source ↗ |
| Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized | 国药准字H202234231mg | — | Official source ↗ |
| Shanghai An Bi Sheng Pharmaceutical Technology Co., Ltd. romanized | 国药准字H202640580.5mg | — | Official source ↗ |
| Jiangsu He Chen Pharma Co., Ltd. romanized | 国药准字H202690580.5mg | — | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H202532421mg | — | Official source ↗ |
| Hainan He Rui Pharmaceutical Co., Ltd. romanized | 国药准字H202535561mg | — | Official source ↗ |
| Astellas Pharma Europe B.V. | 国药准字HJ201500311mg | — | Official source ↗ |
| Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized | 国药准字H202234225mg | — | Official source ↗ |
Under review 6
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Guo Yao Group Chuan Kang Pharmaceutical Co., Ltd. romanized | CYHS2602572 | 2026/10/19 | Official source ↗ |
| Guo Yao Group Chuan Kang Pharmaceutical Co., Ltd. romanized | CYHS2602571 | 2026/10/19 | Official source ↗ |
| NORTH CHINA PHARMACEUTICAL COMPANY.LTD | CYHS2601292 | 2026/06/04 | Official source ↗ |
| NORTH CHINA PHARMACEUTICAL COMPANY.LTD | CYHS2601291 | 2026/06/04 | Official source ↗ |
| Hefei Li Cheng Pharma Co., Ltd. romanized | CYHS2600740 | 2026/03/27 | Official source ↗ |
| Hefei Li Cheng Pharma Co., Ltd. romanized | CYHS2600739 | 2026/03/27 | Official source ↗ |
Generic-filing companies this year 3
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Guo Yao Group Chuan Kang Pharmaceutical Co., Ltd. romanized | CYHS2602572 | 2026/10/19 | Official source ↗ |
| Guo Yao Group Chuan Kang Pharmaceutical Co., Ltd. romanized | CYHS2602571 | 2026/10/19 | Official source ↗ |
| NORTH CHINA PHARMACEUTICAL COMPANY.LTD | CYHS2601292 | 2026/06/04 | Official source ↗ |
| NORTH CHINA PHARMACEUTICAL COMPANY.LTD | CYHS2601291 | 2026/06/04 | Official source ↗ |
| Hefei Li Cheng Pharma Co., Ltd. romanized | CYHS2600740 | 2026/03/27 | Official source ↗ |
| Hefei Li Cheng Pharma Co., Ltd. romanized | CYHS2600739 | 2026/03/27 | Official source ↗ |
API companies with A status 12
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Sichuan Nuo Yi Sheng Pharma Co., Ltd. romanized | Y20240000730 | 2025/12/17 | Official source ↗ |
| Biocon Biosphere Limited | Y20240000135 | 2026/06/01 | Official source ↗ |
| Lu Nan Xin Shi Dai Bio Technology Co., Ltd. romanized | Y20230001120 | 2026/05/20 | Official source ↗ |
| Biocon Limited | Y20220000745 | 2024/12/13 | Official source ↗ |
| Wuxi Fu Qi Pharmaceutical Co., Ltd. romanized | Y20210000983 | 2024/04/13 | Official source ↗ |
| Jiangsu Jiu Yang Biopharmaceutical Co., Ltd. romanized | Y20210000274 | 2026/06/13 | Official source ↗ |
| Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized | Y20190009352 | — | Official source ↗ |
| Fujian Ke Rui Pharma Co., Ltd. romanized | Y20190008905 | 2025/03/06 | Official source ↗ |
| Guo Yao Group Chuan Kang Pharmaceutical Co., Ltd. romanized | Y20190006989 | 2026/06/29 | Official source ↗ |
| Hua Bei Pharmaceutical Hua Sheng Co., Ltd. romanized | Y20190006104 | 2025/08/08 | Official source ↗ |
| Hai Zheng Pharma (Hangzhou) Co., Ltd. romanized | Y20190006081 | 2025/07/18 | Official source ↗ |
| Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized | Y20170001979 | 2023/03/24 | Official source ↗ |
| TAPI Czech Industries s.r.o. | Y20170000349 | 2025/05/08 | 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 ↗ · 36-34 · 2021/01/25
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