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Sign in to subscribeCrisaborole Ointment
Matched- Active ingredients (original)
- CRISABOROLE
- Dosage form (original)
- OINTMENT
- Route (original)
- TOPICAL
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 approval2016/12/14
ANDA applications1
RLD applicantANACOR PHARMACEUTICALS INC
Currently marketed products: 2 · 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 |
|---|---|---|---|---|---|---|---|---|---|
| A216242-001 | CRISABOROLE | MACLEODS PHARMACEUTICALS LTD | OINTMENT | TOPICAL | CRISABOROLE: 2% | 2026/09/24 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N207695-001 | EUCRISA | ANACOR PHARMACEUTICALS INC | OINTMENT | TOPICAL | CRISABOROLE: 2% | 2016/12/14 | 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 expiration2030/07/20This latest date comes from a *PED row in the source and is displayed as listed.
Substance patent expiration (DS flag)2029/06/29
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 |
|---|---|---|---|---|---|---|
| N207695-001 | 8039451 | 2029/06/29 | Y / Y | — | — | openFDA ↗ |
| N207695-001 | 8039451*PED | 2029/12/29 | — / — | — | — | openFDA ↗ |
| N207695-001 | 8168614 | 2030/01/20 | — / — | U-1932 | — | openFDA ↗ |
| N207695-001 | 8168614*PED | 2030/07/20 | — / — | — | — | openFDA ↗ |
| N207695-001 | 8501712 | 2027/02/16 | — / — | U-1932 | — | openFDA ↗ |
| N207695-001 | 8501712*PED | 2027/08/16 | — / — | — | — | openFDA ↗ |
| N207695-001 | 9682092 | 2027/02/16 | — / — | U-1932 | — | openFDA ↗ |
| N207695-001 | 9682092*PED | 2027/08/16 | — / — | — | — | openFDA ↗ |
Exclusivity source records
FDA exclusivity code list ↗Latest exclusivity expiration: 2026/04/03
| Application / product number | Exclusivity code | Listed expiration | Official source |
|---|---|---|---|
| N207695-001 | D-191 | 2026/04/03 | 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 1
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Anacor Pharmaceuticals, Inc. | 国药准字HJ202000222% | 2020/07/29 | Official source ↗ |
NHSA approval numbers 23
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Fu Yuan Pharma Co., Ltd. romanized | 国药准字H202646502%(30g:0.6g) | — | Official source ↗ |
| Guangdong Hua Run Shun Feng Pharma Co., Ltd. romanized | 国药准字H202558672%(30g:0.6g) | — | Official source ↗ |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H202548962%(30g:0.6g) | — | Official source ↗ |
| Hubei Heng An Fu Lin Pharma Co., Ltd. romanized | 国药准字H202560132%(30g:0.6g) | — | Official source ↗ |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H202652042%(30g∶0.6g) | — | Official source ↗ |
| Ya Bao Pharma Group Co., Ltd. romanized | 国药准字H202649932%(30g∶0.6g) | — | Official source ↗ |
| Hangzhou Zhu Yang Xin Pharma Co., Ltd. romanized | 国药准字H202557402%(30g:0.6g) | — | Official source ↗ |
| Zhejiang AngLiKang Pharmaceutical CO.,LTD. | 国药准字H202639042%(30g:0.6g) | — | Official source ↗ |
| Hunan Jiudian Pharmaceutical Co., Ltd | 国药准字H202641732%(30g:0.6g) | — | Official source ↗ |
| Hunan Ming Rui Pharmaceutical Co., Ltd. romanized | 国药准字H202560482%(30g:0.6g) | — | Official source ↗ |
| Nanjing Hai Na Pharmaceutical Co., Ltd. romanized | 国药准字H202641702%(30g:0.6g) | — | Official source ↗ |
| Anacor Pharmaceuticals, LLC | 国药准字HJ202000222% | — | Official source ↗ |
| Shandong Chen Xin Fu Dou Pharma Co., Ltd. romanized | 国药准字H202560152%(30g:0.6g) | — | Official source ↗ |
| Hebei He Du Pharma Co., Ltd. romanized | 国药准字H202659982%(30g:0.6g) | — | Official source ↗ |
| Fujian Sheng Bao Nuo Pharmaceuticals Research and Development Co., Ltd. romanized | 国药准字H202643142%(30g:0.6g) | — | Official source ↗ |
| Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | 国药准字H202553802%(30g:0.6g) | — | Official source ↗ |
| Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202554872%(30g:0.6g) | — | Official source ↗ |
| Zhejiang Huan Ling Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202644212%(30g:0.6g) | — | Official source ↗ |
| Nanjing Wan Rong Jian Cheng Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202449792%(30g:0.6g) | — | Official source ↗ |
| Suzhou Gao Mai Pharma Co., Ltd. romanized | 国药准字H202643852%(30g:0.6g) | — | Official source ↗ |
| Hubei Min Kang Pharma Group Co., Ltd. romanized | 国药准字H202659472%(30g:0.6g) | — | Official source ↗ |
| Hangzhou Ling Ye Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202548922%(60g:1.2g) | — | Official source ↗ |
| Anacor Pharmaceuticals, LLC | 国药准字HJ202000222% | — | Official source ↗ |
| Hubei Min Kang Pharma Group Co., Ltd. romanized | 国药准字H202659482%(60g:1.2g) | — | Official source ↗ |
| Anacor Pharmaceuticals, LLC | 国药准字HJ202000222% | — | Official source ↗ |
Under review 26
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Haerbin Kui Hua Pharma Co., Ltd. romanized; Jiangsu Ziyond Pharmaceutical Co., Ltd. | CYHS2503831 | 2025/10/30 | Official source ↗ |
| Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized | CYHS2601187 | 2026/05/20 | Official source ↗ |
| Jiangsu Zheng Da Qing Jiang Pharmaceutical Co., Ltd. romanized | CYHS2502537 | 2025/07/16 | Official source ↗ |
| Suzhou Dong Rui Pharmaceutical Co., Ltd. romanized | CYHS2503518 | 2025/09/25 | Official source ↗ |
| Jiangsu Dong Ke Kang De Pharma Co., Ltd. romanized; Hua Yi Tai Kang Pharma Co., Ltd. romanized | CYHS2504411 | 2025/12/26 | Official source ↗ |
| Suzhou Di Si Pharmaceutical Factory Co., Ltd. romanized | CYHS2600855 | 2026/04/14 | Official source ↗ |
| Ha Yao Group Bio Gong Cheng Co., Ltd. romanized | CYHS2601367 | 2026/06/10 | Official source ↗ |
| Hubei Cheng Tian Pharma Co., Ltd. romanized | CYHS2601104 | 2026/05/13 | Official source ↗ |
| Shandong Fang Ming Pharma Group Co., Ltd. romanized | CYHS2600938 | 2026/04/23 | Official source ↗ |
| Ma Ying Long Pharma Group Co., Ltd. romanized | CYHS2600823 | 2026/04/09 | Official source ↗ |
| Hunan Si Qi Biopharmaceutical Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized | CYHS2600433 | 2026/02/10 | Official source ↗ |
| Hunan Si Qi Biopharmaceutical Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized | CYHS2600432 | 2026/02/10 | Official source ↗ |
| Haerbin Da Zhong Pharmaceutical Co., Ltd. romanized | CYHS2600431 | 2026/02/10 | Official source ↗ |
| Hubei Ke Yi Pharma Co., Ltd. romanized | CYHS2600243 | 2026/01/21 | Official source ↗ |
| Hainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanized | CYHS2600180 | 2026/01/14 | Official source ↗ |
| Hunan Di Nuo Pharmaceutical Co., Ltd. romanized | CYHS2600094 | 2026/01/08 | Official source ↗ |
| Guo Yao Group San Yi Pharma (Wu Hu) Co., Ltd. romanized | CYHS2504438 | 2025/12/27 | Official source ↗ |
| Chongqing Xi Er An Pharma Co., Ltd. romanized | CYHS2504330 | 2025/12/19 | Official source ↗ |
| Jin Hua Pharmaceuticals Technology (Hu Zhou) Co., Ltd. romanized; Chongqing Bo Teng Pharma Co., Ltd. romanized | CYHS2504256 | 2025/12/11 | Official source ↗ |
| Beijing Jing Feng Pharmaceutical (Hebei) Co., Ltd. romanized | CYHS2504114 | 2025/11/29 | Official source ↗ |
| Yao Da Pharmaceutical Co., Ltd. romanized | CYHS2504104 | 2025/11/28 | Official source ↗ |
| Lu Nan Bei Te Pharmaceutical Co., Ltd. romanized | CYHS2503828 | 2025/10/29 | Official source ↗ |
| You Hua Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized | CYHS2503633 | 2025/10/11 | Official source ↗ |
| Wuhan Yi Bo Yuan Pharmaceuticals Technology Co., Ltd. romanized; Hangzhou Ling Ye Pharmaceuticals Technology Co., Ltd. romanized | CYHS2502633 | 2025/07/22 | Official source ↗ |
| Qilu Pharmaceutical Co., Ltd. | CYHB2601976 | 2026/10/29 | Official source ↗ |
| Qilu Pharmaceutical Co., Ltd. | CYHB2601975 | 2026/10/29 | Official source ↗ |
Generic-filing companies this year 11
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized | CYHS2601187 | 2026/05/20 | Official source ↗ |
| Suzhou Di Si Pharmaceutical Factory Co., Ltd. romanized | CYHS2600855 | 2026/04/14 | Official source ↗ |
| Ha Yao Group Bio Gong Cheng Co., Ltd. romanized | CYHS2601367 | 2026/06/10 | Official source ↗ |
| Hubei Cheng Tian Pharma Co., Ltd. romanized | CYHS2601104 | 2026/05/13 | Official source ↗ |
| Shandong Fang Ming Pharma Group Co., Ltd. romanized | CYHS2600938 | 2026/04/23 | Official source ↗ |
| Ma Ying Long Pharma Group Co., Ltd. romanized | CYHS2600823 | 2026/04/09 | Official source ↗ |
| Hunan Si Qi Biopharmaceutical Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized | CYHS2600433 | 2026/02/10 | Official source ↗ |
| Hunan Si Qi Biopharmaceutical Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized | CYHS2600432 | 2026/02/10 | Official source ↗ |
| Haerbin Da Zhong Pharmaceutical Co., Ltd. romanized | CYHS2600431 | 2026/02/10 | Official source ↗ |
| Hubei Ke Yi Pharma Co., Ltd. romanized | CYHS2600243 | 2026/01/21 | Official source ↗ |
| Hainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanized | CYHS2600180 | 2026/01/14 | Official source ↗ |
| Hunan Di Nuo Pharmaceutical Co., Ltd. romanized | CYHS2600094 | 2026/01/08 | Official source ↗ |
API companies with A status 30
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Chongqing Sheng Kai Pharmaceutical Co., Ltd. romanized | Y20250000473 | 2026/11/04 | Official source ↗ |
| Zhejiang Jiu Zhou Pharma Co., Ltd. romanized | Y20240001350 | 2026/06/01 | Official source ↗ |
| Jiangsu Run An Pharmaceutical Co., Ltd. romanized | Y20240001060 | 2026/05/15 | Official source ↗ |
| Chongqing Bo Teng Pharmaceutical Technology Co., Ltd. romanized | Y20240001071 | 2026/04/29 | Official source ↗ |
| Beijing Foyou Pharma CO.,LTD | Y20240000682 | 2025/10/22 | Official source ↗ |
| Ya Bao Pharma Group Co., Ltd. romanized | Y20240000468 | 2025/11/14 | Official source ↗ |
| Xu Zhou Wan Bang Jin Qiao Pharmaceutical Co., Ltd. romanized | Y20240000561 | 2026/04/10 | Official source ↗ |
| Beijing Jin Cheng Tai Er Pharmaceutical Co., Ltd. romanized | Y20240000380 | 2025/09/30 | Official source ↗ |
| Yi Chang Tian Rui Biopharmaceuticals Co., Ltd. romanized | Y20240000269 | 2025/09/15 | Official source ↗ |
| Shanxi Zhen Dong Tai Sheng Pharmaceutical Co., Ltd. romanized | Y20240000361 | 2025/12/17 | Official source ↗ |
| Anhui Pu Li Pharma Co., Ltd. romanized | Y20240000303 | 2026/09/03 | Official source ↗ |
| Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | Y20230001078 | 2025/06/26 | Official source ↗ |
| Hunan Ming Rui Pharmaceutical Co., Ltd. romanized | Y20230000744 | 2026/11/11 | Official source ↗ |
| Shandong Cheng Hui Shuang Da Pharma Co., Ltd. romanized | Y20230000985 | 2026/05/20 | Official source ↗ |
| Hubei Heng An Fu Lin Pharma Co., Ltd. romanized | Y20230000967 | 2026/08/08 | Official source ↗ |
| Zhongshan Wanhan Pharmaceuticals Co., Ltd. | Y20230000954 | 2025/08/11 | Official source ↗ |
| Shandong Chen Long Pharma Co., Ltd. romanized | Y20230000908 | 2026/05/20 | Official source ↗ |
| Yang Zi Jiang Pharma Group Jiangsu Hai Ci Bio Pharma Co., Ltd. romanized | Y20230000653 | 2024/12/13 | Official source ↗ |
| Shao Xing Min Sheng Pharmaceuticals Co., Ltd. romanized | Y20230000426 | 2025/03/25 | Official source ↗ |
| Sichuan Yi Nuo Da Bo Pharmaceuticals Technology Co., Ltd. romanized | Y20230000644 | 2025/06/03 | Official source ↗ |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | Y20230000380 | 2025/03/19 | Official source ↗ |
| Jiangxi Ke Rui Pharma Co., Ltd. romanized | Y20230000260 | 2025/08/01 | Official source ↗ |
| Qilu Pharmaceutical Co., Ltd. | Y20230000191 | 2024/10/25 | Official source ↗ |
| Nan Tong Chang You Pharma Technology Co., Ltd. romanized | Y20220001301 | 2024/08/15 | Official source ↗ |
| Shanghai Di Sai Nuo Chemical Pharmaceutical Co., Ltd. romanized | Y20220001304 | 2025/06/26 | Official source ↗ |
| Jiangxi Tong He Pharma Co., Ltd. romanized | Y20220001177 | 2026/11/10 | Official source ↗ |
| Zhang Zhi Shi Yuan Yan Pharmaceuticals Technology Co., Ltd. romanized | Y20220001261 | 2026/07/11 | Official source ↗ |
| Sichuan Xin Kai Yuan Pharmaceutical Co., Ltd. romanized | Y20220001073 | 2026/06/16 | Official source ↗ |
| Nanjing Hai Na Pharmaceutical Co., Ltd. romanized | Y20220000559 | 2024/02/08 | Official source ↗ |
| Honour Lab Limited, Unit - III romanized | Y20210000553 | 2025/07/29 | 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
- CDE chemical-drug catalogue detail ↗ · idCode=19b62e93a64b4eb6efd1fa0e6371a3b1
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