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Sign in to subscribeMycophenolate Mofetil Capsules
Matched- Active ingredients (original)
- MYCOPHENOLATE MOFETIL
- Dosage form (original)
- CAPSULE
- 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 approval1995/05/03
ANDA applications17
RLD applicantROCHE PALO ALTO LLC
Currently marketed products: 11 · 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 |
|---|---|---|---|---|---|---|---|---|---|
| A065379-001 | MYCOPHENOLATE MOFETIL | SANDOZ INC | CAPSULE | ORAL | MYCOPHENOLATE MOFETIL: 250MG | 2008/10/15 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A065410-001 | MYCOPHENOLATE MOFETIL | HIKMA PHARMACEUTICALS USA INC | CAPSULE | ORAL | MYCOPHENOLATE MOFETIL: 250MG | 2008/07/29 | N / N | DISCONTINUED | openFDA ↗ |
| A065433-001 | MYCOPHENOLATE MOFETIL | ZYDUS PHARMACEUTICALS USA INC | CAPSULE | ORAL | MYCOPHENOLATE MOFETIL: 250MG | 2009/05/04 | N / N | DISCONTINUED | openFDA ↗ |
| A065491-001 | MYCOPHENOLATE MOFETIL | TEVA PHARMACEUTICALS USA | CAPSULE | ORAL | MYCOPHENOLATE MOFETIL: 250MG | 2009/05/06 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A065520-001 | MYCOPHENOLATE MOFETIL | MYLAN PHARMACEUTICALS INC | CAPSULE | ORAL | MYCOPHENOLATE MOFETIL: 250MG | 2009/05/04 | N / N | DISCONTINUED | openFDA ↗ |
| A090055-001 | MYCOPHENOLATE MOFETIL | STRIDES PHARMA GLOBAL PTE LTD | CAPSULE | ORAL | MYCOPHENOLATE MOFETIL: 250MG | 2010/06/10 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A090111-001 | MYCOPHENOLATE MOFETIL | STRIDES PHARMA INTERNATIONAL AG | CAPSULE | ORAL | MYCOPHENOLATE MOFETIL: 250MG | 2009/12/22 | N / N | DISCONTINUED | openFDA ↗ |
| A090253-001 | MYCOPHENOLATE MOFETIL | ACCORD HEALTHCARE INC | CAPSULE | ORAL | MYCOPHENOLATE MOFETIL: 250MG | 2009/05/04 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A090419-001 | MYCOPHENOLATE MOFETIL | APOTEX CORP | CAPSULE | ORAL | MYCOPHENOLATE MOFETIL: 250MG | 2009/04/22 | N / N | DISCONTINUED | openFDA ↗ |
| A090762-001 | MYCOPHENOLATE MOFETIL | JUBILANT CADISTA PHARMACEUTICALS INC | CAPSULE | ORAL | MYCOPHENOLATE MOFETIL: 250MG | 2014/12/15 | N / N | DISCONTINUED | openFDA ↗ |
| A091315-001 | MYCOPHENOLATE MOFETIL | DR REDDYS LABORATORIES LTD | CAPSULE | ORAL | MYCOPHENOLATE MOFETIL: 250MG | 2011/10/27 | N / N | DISCONTINUED | openFDA ↗ |
| A200197-001 | MYCOPHENOLATE MOFETIL | ALKEM LABORATORIES LTD | CAPSULE | ORAL | MYCOPHENOLATE MOFETIL: 250MG | 2013/06/13 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A204077-001 | MYCOPHENOLATE MOFETIL | ZHEJIANG HISUN PHARMACEUTICAL CO LTD | CAPSULE | ORAL | MYCOPHENOLATE MOFETIL: 250MG | 2017/11/13 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A207022-001 | MYCOPHENOLATE MOFETIL | HETERO LABS LTD UNIT V | CAPSULE | ORAL | MYCOPHENOLATE MOFETIL: 250MG | 2024/10/22 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A210181-001 | MYCOPHENOLATE MOFETIL | CONCORD BIOTECH LTD | CAPSULE | ORAL | MYCOPHENOLATE MOFETIL: 250MG | 2019/01/08 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A214079-001 | MYCOPHENOLATE MOFETIL | WUXI FORTUNE PHARMACEUTICAL CO LTD | CAPSULE | ORAL | MYCOPHENOLATE MOFETIL: 250MG | 2024/11/07 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A217828-001 | MYCOPHENOLATE MOFETIL | AUROBINDO PHARMA LTD | CAPSULE | ORAL | MYCOPHENOLATE MOFETIL: 250MG | 2024/01/05 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N050722-001 | CELLCEPT | ROCHE PALO ALTO LLC | CAPSULE | ORAL | MYCOPHENOLATE MOFETIL: 250MG | 1995/05/03 | 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 12
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Mylan Laboratories Limited | 国药准字HJ202500980.25g | 2025/08/19 | Official source ↗ |
| Wuxi Fu Qi Pharmaceutical Co., Ltd. romanized | 国药准字H200806420.25g | 2024/05/10 | Official source ↗ |
| Zhejiang Jian Feng Pharma Co., Ltd. romanized | 国药准字H200702670.25g | 2023/09/12 | Official source ↗ |
| NORTH CHINA PHARMACEUTICAL COMPANY.LTD | 国药准字H200802970.25g | 2022/12/07 | Official source ↗ |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H202234410.25g | 2022/06/28 | Official source ↗ |
| HUNAN WARRANT PHARMACEUTICAL CO.,LTD | 国药准字H200800160.25g | 2022/03/08 | Official source ↗ |
| Hainan Xian Sheng Pharma Co., Ltd. romanized | 国药准字H202131500.25g | — | Official source ↗ |
| Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized | 国药准字H200800030.25g | 2020/12/23 | Official source ↗ |
| Qiong Lai Tian Yin Pharmaceutical Co., Ltd. romanized | 国药准字H200808190.25g | 2020/12/03 | Official source ↗ |
| Han Hui Pharmaceutical Co., Ltd. romanized | 国药准字H200700810.25g | 2020/04/28 | Official source ↗ |
| Shanghai Luo Shi Pharmaceutical Co., Ltd. romanized | 国药准字H200312400.25g | 2003/12/12 | Official source ↗ |
| Roche Registration Ltd. | H201303630.25g | 1997/07/24 | Official source ↗ |
NHSA approval numbers 13
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Shanghai Luo Shi Pharmaceutical Co., Ltd. romanized | 国药准字H200312400.25g | — | Official source ↗ |
| Wuxi Fu Qi Pharmaceutical Co., Ltd. romanized | 国药准字H200806420.25g | — | Official source ↗ |
| Qiong Lai Tian Yin Pharmaceutical Co., Ltd. romanized | 国药准字H200808190.25g | — | Official source ↗ |
| NORTH CHINA PHARMACEUTICAL COMPANY.LTD | 国药准字H200802970.25g | — | Official source ↗ |
| Shandong Hua Lu Pharmaceutical Co., Ltd. romanized | 国药准字H201001180.25g | — | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H200807640.25g | — | Official source ↗ |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H202234410.25g | — | Official source ↗ |
| Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized | 国药准字H200800030.25g | — | Official source ↗ |
| Zhejiang Zhang Dian Drug Technology Kai Fa Co., Ltd. romanized | 国药准字H200700810.25g | — | Official source ↗ |
| Zhejiang Jian Feng Pharma Co., Ltd. romanized | 国药准字H200702670.25g | — | Official source ↗ |
| HUNAN WARRANT PHARMACEUTICAL CO.,LTD | 国药准字H200800160.25g | — | Official source ↗ |
| Hainan Xian Sheng Pharma Co., Ltd. romanized | 国药准字H202131500.25g | — | Official source ↗ |
| Bei Da Pharmaceuticals Co., Ltd. romanized | 国药准字H20133045250mg | — | Official source ↗ |
| Shanghai Luo Shi Pharmaceutical Co., Ltd. romanized | 国药准字H200312400.25g | — | Official source ↗ |
| Wuxi Fu Qi Pharmaceutical Co., Ltd. romanized | 国药准字H200806420.25g | — | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H200807640.25g | — | Official source ↗ |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H202234410.25g | — | Official source ↗ |
| Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized | 国药准字H200800030.25g | — | Official source ↗ |
| Zhejiang Zhang Dian Drug Technology Kai Fa Co., Ltd. romanized | 国药准字H200700810.25g | — | Official source ↗ |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H202234410.25g | — | Official source ↗ |
| Zhejiang Zhang Dian Drug Technology Kai Fa Co., Ltd. romanized | 国药准字H200700810.25g | — | Official source ↗ |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H202234410.25g | — | Official source ↗ |
| Zhejiang Zhang Dian Drug Technology Kai Fa Co., Ltd. romanized | 国药准字H200700810.25g | — | Official source ↗ |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H202234410.25g | — | Official source ↗ |
| Zhejiang Zhang Dian Drug Technology Kai Fa Co., Ltd. romanized | 国药准字H200700810.25g | — | Official source ↗ |
| HUNAN WARRANT PHARMACEUTICAL CO.,LTD | 国药准字H200800160.25g | — | Official source ↗ |
| HUNAN WARRANT PHARMACEUTICAL CO.,LTD | 国药准字H200800160.25g | — | Official source ↗ |
Under review 4
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Zhejiang Nord Pharmaceutical Co., Ltd | CYHS2600006 | 2026/01/05 | Official source ↗ |
| Shanghai Luo Shi Pharmaceutical Co., Ltd. romanized | CYHB2601769 | 2026/09/20 | Official source ↗ |
| Yi Chang Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanized | CYHS2601858 | 2026/08/03 | Official source ↗ |
| Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized | CYHB2602033 | 2026/11/09 | Official source ↗ |
Generic-filing companies this year 2
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Zhejiang Nord Pharmaceutical Co., Ltd | CYHS2600006 | 2026/01/05 | Official source ↗ |
| Yi Chang Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanized | CYHS2601858 | 2026/08/03 | Official source ↗ |
API companies with A status 28
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Concord Biotech Limited | Y20210000932 | 2024/11/09 | Official source ↗ |
| Roche Pharma (Schweiz) AG | Y20190000656 | 2026/06/16 | Official source ↗ |
| Roche Pharma (Schweiz) Ltd. | Y20190009938 | — | Official source ↗ |
| Roche Pharma (Schweiz) Ltd. | Y20190009937 | — | Official source ↗ |
| Hai Zheng Pharma (Hangzhou) Co., Ltd. romanized | Y20190009807 | — | Official source ↗ |
| Guo Yao Group Chuan Kang Pharmaceutical Co., Ltd. romanized | Y20190009643 | 2025/09/27 | Official source ↗ |
| Wuxi Fu Qi Pharmaceutical Co., Ltd. romanized | Y20190008682 | 2026/07/10 | Official source ↗ |
| Fujian Ke Rui Pharma Co., Ltd. romanized | Y20190008499 | 2024/09/04 | Official source ↗ |
| Yi Chang Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanized | Y20190007112 | 2023/03/24 | Official source ↗ |
| Li Zhu Group Xin Bei Jiang Pharmaceutical Co., Ltd. romanized | Y20190006954 | 2023/03/24 | Official source ↗ |
| Nanjing Jing Lun Pharmaceutical Co., Ltd. romanized | Y20190006521 | — | Official source ↗ |
| Hainan Zhuo Ke Pharmaceutical Co., Ltd. romanized | Y20190006157 | 2026/02/25 | Official source ↗ |
| Hubei Wu Shi Pharma Co., Ltd. romanized | Y20190006087 | 2025/12/24 | Official source ↗ |
| Ji Chuan Pharma Group Co., Ltd. romanized | Y20190006082 | — | Official source ↗ |
| Shandong Chen Long Pharma Co., Ltd. romanized | Y20190005848 | 2024/02/08 | Official source ↗ |
| Chongqing Lai Mei Long Yu Pharma Co., Ltd. romanized | Y20190005179 | 2025/06/05 | Official source ↗ |
| Fuzhou Hai Wang Fu Yao Pharmaceutical Co., Ltd. romanized | Y20190005113 | — | Official source ↗ |
| Hebei Bai Qi Pharma Co., Ltd. romanized | Y20190004938 | — | Official source ↗ |
| Jiangsu Wu Zhong Pharmaceuticals Group Co., Ltd. Suzhou Pharmaceutical Factory romanized | Y20190004770 | 2025/06/28 | Official source ↗ |
| Hua Bei Pharmaceutical Hua Sheng Co., Ltd. romanized | Y20190004299 | 2024/12/31 | Official source ↗ |
| Yang Zhou Shi San Yao Pharmaceutical Co., Ltd. romanized | Y20190004067 | — | Official source ↗ |
| Hubei Tian Yi Pharma Co., Ltd. romanized | Y20190004056 | 2026/05/20 | Official source ↗ |
| Hunan Hua Na Da Pharmaceutical Factory Shou Xing Drug Co., Ltd. romanized | Y20190004030 | 2025/12/19 | Official source ↗ |
| Jiangsu Shen Long Pharma Co., Ltd. romanized | Y20190003083 | — | Official source ↗ |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | Y20190002063 | 2025/01/11 | Official source ↗ |
| Jiangsu Jiu Yang Biopharmaceutical Co., Ltd. romanized | Y20190001419 | 2026/10/29 | Official source ↗ |
| Chongqing Xin Da Xin Pharma Co., Ltd. romanized | Y20190001329 | 2026/05/20 | Official source ↗ |
| Hua Run San Jiu (Tang Shan) Pharma Co., Ltd. romanized | Y20190001226 | 2024/04/11 | Official source ↗ |
| Hai Zheng Pharma (Hangzhou) Co., Ltd. romanized | Y20180000985 | 2024/12/07 | Official source ↗ |
| Roche Pharma (Schweiz) Ltd. | Y20170002082 | — | Official source ↗ |
| Shanghai Luo Shi Pharmaceutical Co., Ltd. romanized | Y20170001961 | 2019/01/14 | Official source ↗ |
| Guo Yao Group Chuan Kang Pharmaceutical Co., Ltd. romanized | Y20170001960 | 2022/11/08 | 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 ↗ · 16-11 · 2019/02/27
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