Monthly
US$200
Billed every month
Sign in to subscribeAdapalene And Benzoyl Peroxide Gel
Matched- Active ingredients (original)
- ADAPALENE · BENZOYL PEROXIDE
- 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 approval2008/12/08
ANDA applications11
RLD applicantGALDERMA LABORATORIES INC / GALDERMA LABORATORIES LP
Currently marketed products: 12 · 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 |
|---|---|---|---|---|---|---|---|---|---|
| A203790-001 | ADAPALENE AND BENZOYL PEROXIDE | ACTAVIS MID ATLANTIC LLC | GEL | TOPICAL | ADAPALENE: 0.1% BENZOYL PEROXIDE: 2.5% | 2015/09/30 | N / N | DISCONTINUED | openFDA ↗ |
| A205033-001 | ADAPALENE AND BENZOYL PEROXIDE | PADAGIS ISRAEL PHARMACEUTICALS LTD | GEL | TOPICAL | ADAPALENE: 0.1% BENZOYL PEROXIDE: 2.5% | 2018/01/23 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A206164-001 | ADAPALENE AND BENZOYL PEROXIDE | ENCUBE ETHICALS PRIVATE LTD | GEL | TOPICAL | ADAPALENE: 0.1% BENZOYL PEROXIDE: 2.5% | 2018/05/23 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A206959-001 | ADAPALENE AND BENZOYL PEROXIDE | SUN PHARMA CANADA INC | GEL | TOPICAL | ADAPALENE: 0.1% BENZOYL PEROXIDE: 2.5% | 2018/01/24 | N / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A208108-001 | ADAPALENE AND BENZOYL PEROXIDE | GLENMARK PHARMACEUTICALS LTD | GEL | TOPICAL | ADAPALENE: 0.1% BENZOYL PEROXIDE: 2.5% | 2019/11/08 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A209148-001 | ADAPALENE AND BENZOYL PEROXIDE | SUN PHARMA CANADA INC | GEL | TOPICAL | ADAPALENE: 0.3% BENZOYL PEROXIDE: 2.5% | 2018/10/17 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A209641-001 | ADAPALENE AND BENZOYL PEROXIDE | ACTAVIS LABORATORIES UT INC INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC | GEL | TOPICAL | ADAPALENE: 0.3% BENZOYL PEROXIDE: 2.5% | 2022/06/22 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A212464-001 | ADAPALENE AND BENZOYL PEROXIDE | PADAGIS ISRAEL PHARMACEUTICALS LTD | GEL | TOPICAL | ADAPALENE: 0.3% BENZOYL PEROXIDE: 2.5% | 2022/05/31 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A214185-001 | ADAPALENE AND BENZOYL PEROXIDE | ALEMBIC PHARMACEUTICALS LTD | GEL | TOPICAL | ADAPALENE: 0.3% BENZOYL PEROXIDE: 2.5% | 2022/08/04 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A214553-001 | ADAPALENE AND BENZOYL PEROXIDE | ZYDUS PHARMACEUTICALS USA INC | GEL | TOPICAL | ADAPALENE: 0.3% BENZOYL PEROXIDE: 2.5% | 2022/06/03 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A217384-001 | ADAPALENE AND BENZOYL PEROXIDE | AUROBINDO PHARMA LTD | GEL | TOPICAL | ADAPALENE: 0.3% BENZOYL PEROXIDE: 2.5% | 2026/07/22 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N022320-001 | EPIDUO | GALDERMA LABORATORIES LP | GEL | TOPICAL | ADAPALENE: 0.1% BENZOYL PEROXIDE: 2.5% | 2008/12/08 | Y / N | DISCONTINUED | openFDA ↗ |
| N207917-001 | EPIDUO FORTE | GALDERMA LABORATORIES INC | GEL | TOPICAL | ADAPALENE: 0.3% BENZOYL PEROXIDE: 2.5% | 2015/07/15 | Y / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N220736-001 | DIFFERIN EPIDUO | GALDERMA LABORATORIES LP | GEL | TOPICAL | ADAPALENE: 0.1% BENZOYL PEROXIDE: 2.5% | 2026/05/22 | Y / Y | HUMAN OTC 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 expiration2027/07/18
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 |
|---|---|---|---|---|---|---|
| N022320-001 | 8071644 | 2027/07/18 | — / Y | U-1078 | — | openFDA ↗ |
| N022320-001 | 8080537 | 2027/07/18 | — / — | U-1078 | — | openFDA ↗ |
| N022320-001 | 8129362 | 2027/07/18 | — / — | U-1078 | — | openFDA ↗ |
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 1
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Galderma SA | 国药准字HJ20250054See source | — | Official source ↗ |
Under review 30
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Beijing Nuo Bo Te Bio Technology Co., Ltd. romanized; Jiangsu Ziyond Pharmaceutical Co., Ltd. | CYHS2504194 | 2025/12/06 | Official source ↗ |
| Jiangsu Ziyond Pharmaceutical Co., Ltd. | CYHS2501886 | 2025/05/27 | Official source ↗ |
| Jiangsu Ziyond Pharmaceutical Co., Ltd. | CYHS2501885 | 2025/05/27 | Official source ↗ |
| Le Fu Si Health Industry Shareholding Company romanized; Yao Yuan Bio Technology (Qi Dong) Co., Ltd. romanized | CYHS2601240 | 2026/06/01 | Official source ↗ |
| Suzhou Gao Mai Pharma Co., Ltd. romanized; Yao Yuan Bio Technology (Qi Dong) Co., Ltd. romanized | CYHS2401869 | 2024/06/22 | Official source ↗ |
| Jiangsu Ying Ke Biopharmaceutical Co., Ltd. romanized | CYHS2503635 | 2025/10/11 | Official source ↗ |
| TC Pharmaceuticals (Jiangsu) Co., Ltd | CYHS2600161 | 2026/01/13 | Official source ↗ |
| Yao Zhi Da (Wuhan) Pharmaceuticals Co., Ltd. romanized; Jiangsu Wan He Pharmaceutical Co., Ltd. romanized | CYHS2601489 | 2026/06/24 | Official source ↗ |
| Shanghai Xin Ya Pharma Min Xing Co., Ltd. romanized | CYHS2602230 | 2026/09/07 | Official source ↗ |
| Shanghai Xin Ya Pharma Min Xing Co., Ltd. romanized | CYHS2602229 | 2026/09/07 | Official source ↗ |
| Anhui Jia He Pharma Co., Ltd. romanized; Hainan Kai Jian Pharmaceutical Co., Ltd. romanized | CYHS2602202 | 2026/09/03 | Official source ↗ |
| Anhui Jie Xi Pharmaceuticals Co., Ltd. romanized | CYHS2601862 | 2026/08/03 | Official source ↗ |
| Guangdong Jiang Zheng Pharma Co., Ltd. romanized; Hainan Kai Jian Pharmaceutical Co., Ltd. romanized | CYHS2601562 | 2026/07/02 | Official source ↗ |
| Sui Cheng Pharma Co., Ltd. romanized | CYHS2601561 | 2026/07/01 | Official source ↗ |
| Sui Cheng Pharma Co., Ltd. romanized | CYHS2601560 | 2026/07/01 | Official source ↗ |
| Sui Cheng Pharma Co., Ltd. romanized | CYHS2601559 | 2026/07/01 | Official source ↗ |
| Sichuan Ke Rui De Pharmaceutical Co., Ltd. romanized; Hunan Pai Ge Lan Pharma Co., Ltd. romanized | CYHS2601352 | 2026/06/09 | Official source ↗ |
| Fu Yuan Pharma Co., Ltd. romanized | CYHS2601185 | 2026/05/20 | Official source ↗ |
| Fu Yuan Pharma Co., Ltd. romanized | CYHS2601184 | 2026/05/20 | Official source ↗ |
| Hubei Cheng Tian Pharma Co., Ltd. romanized | CYHS2601179 | 2026/05/20 | Official source ↗ |
| Shanxi Zhen Dong An Xin Biopharmaceutical Co., Ltd. romanized | CYHS2600728 | 2026/03/27 | Official source ↗ |
| Sichuan Ming Xin Pharma Co., Ltd. romanized | CYHS2600695 | 2026/03/21 | Official source ↗ |
| Zhejiang Hao Ge Pharma Co., Ltd. romanized; Huadong Medicine (Xi’an)Bodyguard Pharmaceutical Co.,Ltd. | CYHS2600236 | 2026/01/21 | Official source ↗ |
| Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized | CYHS2600160 | 2026/01/13 | Official source ↗ |
| Hangzhou Ling Ye Pharmaceuticals Technology Co., Ltd. romanized | CYHS2503865 | 2025/11/05 | Official source ↗ |
| Hangzhou He Ze Kun Yuan Pharma Co., Ltd. romanized; Huadong Medicine (Xi’an)Bodyguard Pharmaceutical Co.,Ltd. | CYHS2503124 | 2025/08/26 | Official source ↗ |
| Guangdong Ren Xiang Pharma Co., Ltd. romanized; Ru Yuan Dong Yang Guang Pharma Co., Ltd. romanized | CYHS2501867 | 2025/05/23 | Official source ↗ |
| Guangdong Ren Xiang Pharma Co., Ltd. romanized; Ru Yuan Dong Yang Guang Pharma Co., Ltd. romanized | CYHS2501866 | 2025/05/23 | Official source ↗ |
| Guangdong Ren Xiang Pharma Co., Ltd. romanized; Ru Yuan Dong Yang Guang Pharma Co., Ltd. romanized | CYHS2501865 | 2025/05/23 | Official source ↗ |
| Hunan Ke Rui Biopharmaceutical Co., Ltd. romanized; Huadong Medicine (Xi’an)Bodyguard Pharmaceutical Co.,Ltd. | CYHB2601988 | 2026/11/02 | Official source ↗ |
Generic-filing companies this year 15
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Le Fu Si Health Industry Shareholding Company romanized; Yao Yuan Bio Technology (Qi Dong) Co., Ltd. romanized | CYHS2601240 | 2026/06/01 | Official source ↗ |
| TC Pharmaceuticals (Jiangsu) Co., Ltd | CYHS2600161 | 2026/01/13 | Official source ↗ |
| Yao Zhi Da (Wuhan) Pharmaceuticals Co., Ltd. romanized; Jiangsu Wan He Pharmaceutical Co., Ltd. romanized | CYHS2601489 | 2026/06/24 | Official source ↗ |
| Shanghai Xin Ya Pharma Min Xing Co., Ltd. romanized | CYHS2602230 | 2026/09/07 | Official source ↗ |
| Shanghai Xin Ya Pharma Min Xing Co., Ltd. romanized | CYHS2602229 | 2026/09/07 | Official source ↗ |
| Anhui Jia He Pharma Co., Ltd. romanized; Hainan Kai Jian Pharmaceutical Co., Ltd. romanized | CYHS2602202 | 2026/09/03 | Official source ↗ |
| Anhui Jie Xi Pharmaceuticals Co., Ltd. romanized | CYHS2601862 | 2026/08/03 | Official source ↗ |
| Guangdong Jiang Zheng Pharma Co., Ltd. romanized; Hainan Kai Jian Pharmaceutical Co., Ltd. romanized | CYHS2601562 | 2026/07/02 | Official source ↗ |
| Sui Cheng Pharma Co., Ltd. romanized | CYHS2601561 | 2026/07/01 | Official source ↗ |
| Sui Cheng Pharma Co., Ltd. romanized | CYHS2601560 | 2026/07/01 | Official source ↗ |
| Sui Cheng Pharma Co., Ltd. romanized | CYHS2601559 | 2026/07/01 | Official source ↗ |
| Sichuan Ke Rui De Pharmaceutical Co., Ltd. romanized; Hunan Pai Ge Lan Pharma Co., Ltd. romanized | CYHS2601352 | 2026/06/09 | Official source ↗ |
| Fu Yuan Pharma Co., Ltd. romanized | CYHS2601185 | 2026/05/20 | Official source ↗ |
| Fu Yuan Pharma Co., Ltd. romanized | CYHS2601184 | 2026/05/20 | Official source ↗ |
| Hubei Cheng Tian Pharma Co., Ltd. romanized | CYHS2601179 | 2026/05/20 | Official source ↗ |
| Shanxi Zhen Dong An Xin Biopharmaceutical Co., Ltd. romanized | CYHS2600728 | 2026/03/27 | Official source ↗ |
| Sichuan Ming Xin Pharma Co., Ltd. romanized | CYHS2600695 | 2026/03/21 | Official source ↗ |
| Zhejiang Hao Ge Pharma Co., Ltd. romanized; Huadong Medicine (Xi’an)Bodyguard Pharmaceutical Co.,Ltd. | CYHS2600236 | 2026/01/21 | Official source ↗ |
| Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized | CYHS2600160 | 2026/01/13 | Official source ↗ |
API companies with A status 0
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| No matching records in this loaded 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 ↗ · 56-61 · 2022/09/13
Subscriptions
Next-day facts and deliverable timelines
- One email the next day when new facts are collected for your followed products.
- Export the complete loaded event timeline for each followed product as CSV.
- Add up to 4 additional recipients, each confirmed by email.
- Increase your follow limit from 3 to 10 products.
Quarterly
US$540
Billed every three months
US$180 per month
Sign in to subscribeYearly
US$1,920
Billed every year
US$160 per month
Sign in to subscribeNeed more than 10 followed products or more than 5 recipients? Contact us.
Separate one-time purchase
US Orange Book × China records comparison
Full table and CSV export for 12 months from payment, with monthly data updates. No automatic renewal.
Subscriptions and comparison-table access are purchased separately. Neither includes the other.
Billed by Creem, our merchant of record · Terms · Refund policy