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Matched- Active ingredients (original)
- ADAPALENE
- Dosage form (original)
- GEL
- 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 approval2007/06/19
ANDA applications8
RLD applicantGALDERMA LABORATORIES LP
Currently marketed products: 10 · 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 |
|---|---|---|---|---|---|---|---|---|---|
| A090962-001 | ADAPALENE | P AND L DEVELOPMENT LLC | GEL | TOPICAL | ADAPALENE: 0.1% | 2010/06/02 | N / N | HUMAN OTC DRUG | openFDA ↗ |
| A091314-001 | ADAPALENE | GLENMARK PHARMACEUTICALS INC USA | GEL | TOPICAL | ADAPALENE: 0.1% | 2010/07/01 | N / N | HUMAN OTC DRUG | openFDA ↗ |
| A200298-001 | ADAPALENE | ENCUBE ETHICALS PVT LTD | GEL | TOPICAL | ADAPALENE: 0.3% | 2012/06/14 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A201000-001 | ADAPALENE | ACTAVIS MID ATLANTIC LLC | GEL | TOPICAL | ADAPALENE: 0.3% | 2014/10/27 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A208322-001 | ADAPALENE | SUN PHARMA CANADA INC | GEL | TOPICAL | ADAPALENE: 0.3% | 2016/06/23 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A213508-001 | ADAPALENE | ALEMBIC PHARMACEUTICALS LTD | GEL | TOPICAL | ADAPALENE: 0.3% | 2020/06/18 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A215940-001 | ADAPALENE | SUN PHARMA CANADA INC | GEL | TOPICAL | ADAPALENE: 0.1% | 2022/01/14 | N / N | HUMAN OTC DRUG | openFDA ↗ |
| A219565-001 | ADAPALENE | RISING PHARMA HOLDINGS INC | GEL | TOPICAL | ADAPALENE: 0.1% | 2026/06/30 | N / N | HUMAN OTC DRUG | openFDA ↗ |
| N020380-002 | DIFFERIN | GALDERMA LABORATORIES LP | GEL | TOPICAL | ADAPALENE: 0.1% | 2016/07/08 | Y / Y | HUMAN OTC DRUG | openFDA ↗ |
| N021753-001 | DIFFERIN | GALDERMA LABORATORIES LP | GEL | TOPICAL | ADAPALENE: 0.3% | 2007/06/19 | 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 0
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| No matching records in this loaded source. | |||
NHSA approval numbers 19
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized | 国药准字H200836550.1% | — | Official source ↗ |
| Jiangsu Fu Bang Pharma Co., Ltd. romanized | 国药准字H201133730.1%(30g:30mg) | — | Official source ↗ |
| Suzhou Tian Ma Pharmaceuticals Group Tian Ji Biopharmaceutical Co., Ltd. romanized | 国药准字H202639060.1%(30g:30mg) | — | Official source ↗ |
| Hubei Ke Tian Pharma Co., Ltd. romanized | 国药准字H202647330.1% (30g:30mg) | — | Official source ↗ |
| Wuhan Nuo An Pharma Co., Ltd. romanized | 国药准字H201734060.1%(30g:30mg) | — | Official source ↗ |
| Sichuan Ming Xin Pharma Co., Ltd. romanized | 国药准字H2006554415g:15mg | — | Official source ↗ |
| Hua Dong Pharmaceuticals (Xian) Bo Hua Pharmaceutical Co., Ltd. romanized | 国药准字H202646830.1%(30g:30mg) | — | Official source ↗ |
| Heilongjiang Fu He Pharmaceutical Group Co., Ltd. romanized | 国药准字H200568710.1% | — | Official source ↗ |
| Wan Quan Wan Te Pharmaceutical Jiangsu Co., Ltd. romanized | 国药准字H200666210.1% | — | Official source ↗ |
| Laboratoires GALDERMA | H201600220.1% | — | Official source ↗ |
| Guangdong Dong Yang Guang Pharma Co., Ltd. romanized | 国药准字H201830780.1%(10g:10mg) | — | Official source ↗ |
| Fu Yuan Pharma Co., Ltd. romanized | 国药准字H201834000.1%(15g:15mg) | — | Official source ↗ |
| Zhejiang Pu Li Pharma Co., Ltd. romanized | 国药准字H202648970.1%(30g:30mg) | — | Official source ↗ |
| Hainan Cheng Rui Bio Technology Co., Ltd. romanized | 国药准字H20263559See source | — | Official source ↗ |
| Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202640350.1%(30g:30mg) | — | Official source ↗ |
| Suzhou Gao Mai Pharma Co., Ltd. romanized | 国药准字H202490380.1%(30g:30mg) | — | Official source ↗ |
| Hangzhou Ling Ye Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202552170.1%(30g:30mg) | — | Official source ↗ |
| Suzhou Tian Ma Pharmaceuticals Group Tian Ji Biopharmaceutical Co., Ltd. romanized | 国药准字H202639060.1%(30g:30mg) | — | Official source ↗ |
| Wuhan Nuo An Pharma Co., Ltd. romanized | 国药准字H201734060.1%(30g:30mg) | — | Official source ↗ |
| Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized | 国药准字H200836550.1% | — | Official source ↗ |
| Jiangsu Fu Bang Pharma Co., Ltd. romanized | 国药准字H201133730.1%(30g:30mg) | — | Official source ↗ |
| Hubei Ke Tian Pharma Co., Ltd. romanized | 国药准字H202647330.1% (30g:30mg) | — | Official source ↗ |
| Wuhan Nuo An Pharma Co., Ltd. romanized | 国药准字H201734060.1%(30g:30mg) | — | Official source ↗ |
| Sichuan Ming Xin Pharma Co., Ltd. romanized | 国药准字H2006554415g:15mg | — | Official source ↗ |
| Heilongjiang Fu He Pharmaceutical Group Co., Ltd. romanized | 国药准字H200568710.1% | — | Official source ↗ |
| Wan Quan Wan Te Pharmaceutical Jiangsu Co., Ltd. romanized | 国药准字H200666210.1% | — | Official source ↗ |
| Galderma International | 国药准字HJ201600220.1% | — | Official source ↗ |
| Guangdong Dong Yang Guang Pharma Co., Ltd. romanized | 国药准字H201830780.1%(10g:10mg) | — | Official source ↗ |
| Fu Yuan Pharma Co., Ltd. romanized | 国药准字H201834000.1%(15g:15mg) | — | Official source ↗ |
| Jiangsu Fu Bang Pharma Co., Ltd. romanized | 国药准字H201133730.1%(30g:30mg) | — | Official source ↗ |
| Jiangsu Xiao Lin Pharmaceutical Co., Ltd. romanized | 国药准字H20064230See source | — | Official source ↗ |
| Wuhan Nuo An Pharma Co., Ltd. romanized | 国药准字H201734060.1%(30g:30mg) | — | Official source ↗ |
| Sichuan Ming Xin Pharma Co., Ltd. romanized | 国药准字H2006554415g:15mg | — | Official source ↗ |
| Wan Quan Wan Te Pharmaceutical Jiangsu Co., Ltd. romanized | 国药准字H200666210.1% | — | Official source ↗ |
| Guangdong Dong Yang Guang Pharma Co., Ltd. romanized | 国药准字H201830780.1%(10g:10mg) | — | Official source ↗ |
| Fu Yuan Pharma Co., Ltd. romanized | 国药准字H201834000.1%(15g:15mg) | — | Official source ↗ |
| Jiangsu Fu Bang Pharma Co., Ltd. romanized | 国药准字H201133730.1%(30g:30mg) | — | Official source ↗ |
| Wuhan Nuo An Pharma Co., Ltd. romanized | 国药准字H201734060.1%(30g:30mg) | — | Official source ↗ |
| Wan Quan Wan Te Pharmaceutical Jiangsu Co., Ltd. romanized | 国药准字H200666210.1% | — | Official source ↗ |
| Fu Yuan Pharma Co., Ltd. romanized | 国药准字H201834000.1%(15g:15mg) | — | Official source ↗ |
| Jiangsu Fu Bang Pharma Co., Ltd. romanized | 国药准字H201133730.1%(30g:30mg) | — | Official source ↗ |
| Wuhan Nuo An Pharma Co., Ltd. romanized | 国药准字H201734060.1%(30g:30mg) | — | Official source ↗ |
| Wan Quan Wan Te Pharmaceutical Jiangsu Co., Ltd. romanized | 国药准字H200666210.1% | — | Official source ↗ |
| Jiangsu Fu Bang Pharma Co., Ltd. romanized | 国药准字H201133730.1%(30g:30mg) | — | Official source ↗ |
| Wuhan Nuo An Pharma Co., Ltd. romanized | 国药准字H201734060.1%(30g:30mg) | — | Official source ↗ |
| Wan Quan Wan Te Pharmaceutical Jiangsu Co., Ltd. romanized | 国药准字H200666210.1% | — | Official source ↗ |
| Wuhan Nuo An Pharma Co., Ltd. romanized | 国药准字H201734060.1%(30g:30mg) | — | Official source ↗ |
| Wuhan Nuo An Pharma Co., Ltd. romanized | 国药准字H201734060.1%(30g:30mg) | — | Official source ↗ |
| Wuhan Nuo An Pharma Co., Ltd. romanized | 国药准字H201734060.1%(30g:30mg) | — | Official source ↗ |
| Wuhan Nuo An Pharma Co., Ltd. romanized | 国药准字H201734060.1%(30g:30mg) | — | Official source ↗ |
| Jiangsu Fu Bang Pharma Co., Ltd. romanized | 国药准字H201133730.1%(30g:30mg) | — | Official source ↗ |
| Wuhan Nuo An Pharma Co., Ltd. romanized | 国药准字H201734060.1%(30g:30mg) | — | Official source ↗ |
| Wuhan Nuo An Pharma Co., Ltd. romanized | 国药准字H201734060.1%(30g:30mg) | — | Official source ↗ |
| Wuhan Nuo An Pharma Co., Ltd. romanized | 国药准字H201734060.1%(30g:30mg) | — | Official source ↗ |
| Wuhan Nuo An Pharma Co., Ltd. romanized | 国药准字H201734060.1%(30g:30mg) | — | Official source ↗ |
| Wuhan Nuo An Pharma Co., Ltd. romanized | 国药准字H201734060.1%(30g:30mg) | — | Official source ↗ |
| Wuhan Nuo An Pharma Co., Ltd. romanized | 国药准字H201734060.1%(30g:30mg) | — | Official source ↗ |
| Wuhan Nuo An Pharma Co., Ltd. romanized | 国药准字H201734060.1%(30g:30mg) | — | Official source ↗ |
| Wuhan Nuo An Pharma Co., Ltd. romanized | 国药准字H201734060.1%(30g:30mg) | — | Official source ↗ |
| Wuhan Nuo An Pharma Co., Ltd. romanized | 国药准字H201734060.1%(30g:30mg) | — | Official source ↗ |
Under review 30
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Jiangsu Ziyond Pharmaceutical Co., Ltd. | CYHS2401107 | 2024/04/13 | Official source ↗ |
| Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized | CYHS2600245 | 2026/01/22 | Official source ↗ |
| Suzhou Gao Mai Pharma Co., Ltd. romanized; Yao Yuan Bio Technology (Qi Dong) Co., Ltd. romanized | CYHB2601521 | 2026/08/11 | Official source ↗ |
| Le Fu Si Health Industry Shareholding Company romanized; Yao Yuan Bio Technology (Qi Dong) Co., Ltd. romanized | CYHS2601221 | 2026/06/01 | Official source ↗ |
| Jiangsu Ying Ke Biopharmaceutical Co., Ltd. romanized | CYHS2501533 | 2025/04/23 | Official source ↗ |
| Hangzhou Ling Ye Pharmaceuticals Technology Co., Ltd. romanized | CYHB2601900 | 2026/10/15 | Official source ↗ |
| Galderma International; Laboratoires Galderma | JYHB2600483 | 2026/08/20 | Official source ↗ |
| Heilongjiang Tian Chen Pharma Co., Ltd. romanized | CYHS2601910 | 2026/08/06 | Official source ↗ |
| Jiangxi Shimei Pharmaceutical Co., Ltd | CYHS2601760 | 2026/07/22 | Official source ↗ |
| Shandong Ming Ren Fu Rui Da Pharmaceutical Co., Ltd. romanized | CYHS2601755 | 2026/07/22 | Official source ↗ |
| Hunan Zhuang Yuan Pharmaceutical Co., Ltd. romanized; Ma Ying Long Pharma Group Co., Ltd. romanized | CYHS2601740 | 2026/07/21 | Official source ↗ |
| Jin Yao Pharma Co., Ltd. romanized; Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized | CYHS2601093 | 2026/05/13 | Official source ↗ |
| Jin Yao Pharma Co., Ltd. romanized; Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized | CYHS2601092 | 2026/05/13 | Official source ↗ |
| Man Xiu Lei Dun (Zhongguo) Pharma Co., Ltd. romanized; Hua Dong Pharmaceuticals (Xian) Bo Hua Pharmaceutical Co., Ltd. romanized | CYHB2600614 | 2026/03/28 | Official source ↗ |
| Shandong Chen Xin Fu Dou Pharma Co., Ltd. romanized | CYHS2600452 | 2026/02/11 | Official source ↗ |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | CYHS2600150 | 2026/01/12 | Official source ↗ |
| Hubei Chang Jiang Rui Yi Pharmaceuticals Technology Co., Ltd. romanized; Yuan Da Pharmaceuticals (Xian Tao) Pharmaceutical Co., Ltd. romanized | CYHS2504340 | 2025/12/22 | Official source ↗ |
| Guo Yao Holding Xin Ye (Hubei) Pharmaceuticals Co., Ltd. romanized; Hubei Guang Ji Pharma Co., Ltd. romanized | CYHS2503608 | 2025/10/10 | Official source ↗ |
| Beijing Jing Feng Pharmaceutical (Hebei) Co., Ltd. romanized | CYHS2503135 | 2025/08/27 | Official source ↗ |
| Name not romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | CYHS2503007 | 2025/08/16 | Official source ↗ |
| Hebei San He Shi Chuang Bio Technology Co., Ltd. romanized; Guangdong Hua Run Shun Feng Pharma Co., Ltd. romanized | CYHS2502934 | 2025/08/12 | Official source ↗ |
| Guangzhou Le Mi Pharmaceuticals Technology Co., Ltd. romanized; Nanchang Li Jian Pharma Co., Ltd. romanized | CYHS2502851 | 2025/08/06 | Official source ↗ |
| Le Tai Pharma (Lan Xi) Co., Ltd. romanized | CYHS2501879 | 2025/05/27 | Official source ↗ |
| Zhejiang Huan Ling Pharmaceuticals Technology Co., Ltd. romanized | CYHS2501614 | 2025/04/30 | Official source ↗ |
| Tang Shan Hong Xing Pharma Co., Ltd. romanized | CYHS2501604 | 2025/04/29 | Official source ↗ |
| Chengdu Shi Hai Tong Pharma Co., Ltd. romanized | CYHS2501372 | 2025/04/10 | Official source ↗ |
| Hangzhou He Ze Kun Yuan Pharma Co., Ltd. romanized; Huadong Medicine (Xi’an)Bodyguard Pharmaceutical Co.,Ltd. | CYHS2500469 | 2025/01/24 | Official source ↗ |
| Zhejiang Kang En Bei Pharmaceutical Co., Ltd. romanized | CYHS2403888 | 2024/11/13 | Official source ↗ |
| Hainan Quan Xing Pharmaceutical Co., Ltd. romanized | CYHS2402972 | 2024/09/10 | Official source ↗ |
| Shandong Liang Fu Pharmaceutical Co., Ltd. romanized | CYHS2401880 | 2024/06/25 | Official source ↗ |
Generic-filing companies this year 9
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized | CYHS2600245 | 2026/01/22 | Official source ↗ |
| Le Fu Si Health Industry Shareholding Company romanized; Yao Yuan Bio Technology (Qi Dong) Co., Ltd. romanized | CYHS2601221 | 2026/06/01 | Official source ↗ |
| Heilongjiang Tian Chen Pharma Co., Ltd. romanized | CYHS2601910 | 2026/08/06 | Official source ↗ |
| Jiangxi Shimei Pharmaceutical Co., Ltd | CYHS2601760 | 2026/07/22 | Official source ↗ |
| Shandong Ming Ren Fu Rui Da Pharmaceutical Co., Ltd. romanized | CYHS2601755 | 2026/07/22 | Official source ↗ |
| Hunan Zhuang Yuan Pharmaceutical Co., Ltd. romanized; Ma Ying Long Pharma Group Co., Ltd. romanized | CYHS2601740 | 2026/07/21 | Official source ↗ |
| Jin Yao Pharma Co., Ltd. romanized; Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized | CYHS2601093 | 2026/05/13 | Official source ↗ |
| Jin Yao Pharma Co., Ltd. romanized; Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized | CYHS2601092 | 2026/05/13 | Official source ↗ |
| Shandong Chen Xin Fu Dou Pharma Co., Ltd. romanized | CYHS2600452 | 2026/02/11 | Official source ↗ |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | CYHS2600150 | 2026/01/12 | Official source ↗ |
API companies with A status 10
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Yang Zhou Shi San Yao Pharmaceutical Co., Ltd. romanized | Y20250000095 | 2026/08/28 | Official source ↗ |
| Ru Yuan Dong Yang Guang Pharma Co., Ltd. romanized | Y20230000833 | 2026/06/02 | Official source ↗ |
| Yi Chang Nuo An Pharmaceutical Co., Ltd. romanized | Y20220000364 | 2026/03/11 | Official source ↗ |
| Aarti Pharmalabs Limited | Y20200001052 | 2026/06/27 | Official source ↗ |
| Jiangsu Lianhuan Pharmaceutical Co.,Ltd. | Y20190009578 | 2023/03/24 | Official source ↗ |
| Heilongjiang Fu He Pharmaceutical Group Co., Ltd. romanized | Y20190008778 | 2024/03/15 | Official source ↗ |
| Jin Yao Pharma Co., Ltd. romanized | Y20190008276 | 2023/03/24 | Official source ↗ |
| Wan Te Pharmaceutical (Hainan) Co., Ltd. romanized | Y20190008174 | 2025/10/10 | Official source ↗ |
| Chongqing Sheng Kai Pharmaceutical Co., Ltd. romanized | Y20170002274 | 2025/06/21 | Official source ↗ |
| Sichuan Bai Li Pharma Co., Ltd. romanized | Y20170001351 | 2023/03/24 | 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 GEL / TOPICAL, based on the Chinese Pharmacopoeia general formulation provisions, rule CHP-FORM-061. Chinese Pharmacopoeia general chapter 0114
Comparison generated: 2026/11/13 18:41 · openFDA Orange Book ↗
Name and dosage-form matching sources
- NMPA reference-product directory, Shaanxi MPA republication ↗ · 29-9 · 2020/08/06
- Chinese Pharmacopoeia 2025, formulation chapter; site crosswalk ↗ · See source
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