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Sign in to subscribePimecrolimus Cream
Matched- Active ingredients (original)
- PIMECROLIMUS
- Dosage form (original)
- CREAM
- 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 approval2001/12/13
ANDA applications2
RLD applicantBAUSCH HEALTH US LLC
Currently marketed products: 3 · 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 |
|---|---|---|---|---|---|---|---|---|---|
| A209345-001 | PIMECROLIMUS | ACTAVIS LABORATORIES UT INC INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC | CREAM | TOPICAL | PIMECROLIMUS: 1% | 2018/12/27 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A211769-001 | PIMECROLIMUS | GLENMARK PHARMACEUTICALS LTD | CREAM | TOPICAL | PIMECROLIMUS: 1% | 2019/08/29 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N021302-001 | ELIDEL | BAUSCH HEALTH US LLC | CREAM | TOPICAL | PIMECROLIMUS: 1% | 2001/12/13 | 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 0
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| No matching records in this loaded source. | |||
NHSA approval numbers 10
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Jiangsu Wu Zhong Pharmaceuticals Group Co., Ltd. Suzhou Pharmaceutical Factory romanized | 国药准字H202638711%(15g:0.15g) | — | Official source ↗ |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H202641351%(15g:0.15g) | — | Official source ↗ |
| HAINAN HUALON PHARMACEUTICAL CO.,LTD | 国药准字H202546131%(10g:0.1g) | — | Official source ↗ |
| Hubei Cheng Tian Pharma Co., Ltd. romanized | 国药准字H202642141%(15g:0.15g) | — | Official source ↗ |
| Jiangsu Ying Ke Biopharmaceutical Co., Ltd. romanized | 国药准字H202661321% (15g:0.15g) | — | Official source ↗ |
| MEDA Pharma GmbH & Co. KG | H201700031% | — | Official source ↗ |
| Fu Yuan Pharma Co., Ltd. romanized | 国药准字H202647751%(15g:0.15g) | — | Official source ↗ |
| Jiangsu Ziyond Pharmaceutical Co., Ltd. | 国药准字H202238201%(10g:0.1g) | — | Official source ↗ |
| Hainan Zhen Dong Bio Technology Co., Ltd. romanized | 国药准字H202442301%(15g:0.15g) | — | Official source ↗ |
| Viatris Healthcare GmbH | 国药准字HJ201700041% | — | Official source ↗ |
| Jiangsu Ziyond Pharmaceutical Co., Ltd. | 国药准字H202238201%(10g:0.1g) | — | Official source ↗ |
| Viatris Healthcare GmbH | 国药准字HJ201700041% | — | Official source ↗ |
| Jiangsu Ziyond Pharmaceutical Co., Ltd. | 国药准字H202238201%(10g:0.1g) | — | Official source ↗ |
Under review 5
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Shanxi Ze Chen Pharmaceuticals Technology Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd | CYHS2600929 | 2026/04/23 | Official source ↗ |
| Chongqing Wan Lin Biopharmaceuticals Technology Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd | CYHS2600460 | 2026/02/13 | Official source ↗ |
| Zhejiang Bai Dai Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | CYHS2504504 | 2025/12/31 | Official source ↗ |
| Shanghai Xin Ya Pharma Min Xing Co., Ltd. romanized; Hainan Hai Shen Tong Zhou Pharmaceutical Co., Ltd. romanized | CYHS2503311 | 2025/09/06 | Official source ↗ |
| Shanghai Zhao Hui Pharma Co., Ltd. romanized | CYHS2501744 | 2025/05/14 | Official source ↗ |
Generic-filing companies this year 2
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Shanxi Ze Chen Pharmaceuticals Technology Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd | CYHS2600929 | 2026/04/23 | Official source ↗ |
| Chongqing Wan Lin Biopharmaceuticals Technology Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd | CYHS2600460 | 2026/02/13 | Official source ↗ |
API companies with A status 1
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Bo Rui Pharmaceutical (Suzhou) Co., Ltd. romanized | Y20210000257 | 2024/04/19 | 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.
Formulation crosswalk to CREAM / TOPICAL, based on the Chinese Pharmacopoeia general formulation provisions, rule CHP-FORM-057. Chinese Pharmacopoeia general chapter 0109
Comparison generated: 2026/11/13 18:41 · openFDA Orange Book ↗
Name and dosage-form matching sources
- NMPA reference-product directory, Shaanxi MPA republication ↗ · 29-3 · 2020/08/06
- Chinese Pharmacopoeia 2025, formulation chapter; site crosswalk ↗ · See source
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