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Sign in to subscribeApalutamide Tablets
Matched- Active ingredients (original)
- APALUTAMIDE
- Dosage form (original)
- TABLET
- 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 approval2018/02/14
ANDA applications1
RLD applicantJANSSEN BIOTECH INC
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 |
|---|---|---|---|---|---|---|---|---|---|
| A217113-001 | APALUTAMIDE | ZYDUS LIFESCIENCES GLOBAL FZE | TABLET | ORAL | APALUTAMIDE: 60MG | 2025/03/17 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N210951-001 | ERLEADA | JANSSEN BIOTECH INC | TABLET | ORAL | APALUTAMIDE: 60MG | 2018/02/14 | Y / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N210951-002 | ERLEADA | JANSSEN BIOTECH INC | TABLET | ORAL | APALUTAMIDE: 240MG | 2023/02/17 | 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 expiration2041/01/14
Substance patent expiration (DS flag)2033/06/04
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 |
|---|---|---|---|---|---|---|
| N210951-001 | 10702508 | 2038/04/30 | — / — | U-3012 | — | openFDA ↗ |
| N210951-001 | 10849888 | 2033/09/23 | — / — | U-3013 | — | openFDA ↗ |
| N210951-001 | 11723898 | 2041/01/14 | — / — | U-4449 | — | openFDA ↗ |
| N210951-001 | 11963952 | 2040/01/30 | — / — | U-3901 | — | openFDA ↗ |
| N210951-001 | 12303493 | 2035/12/03 | — / Y | — | — | openFDA ↗ |
| N210951-001 | 12303497 | 2040/01/30 | — / — | U-4448 | — | openFDA ↗ |
| N210951-001 | 8445507 | 2032/02/14 | Y / Y | U-2237 | — | openFDA ↗ |
| N210951-001 | 8802689 | 2027/03/27 | — / — | U-2624 | — | openFDA ↗ |
| N210951-001 | 9388159 | 2027/03/27 | Y / Y | — | — | openFDA ↗ |
| N210951-001 | 9481663 | 2033/06/04 | Y / Y | U-2237 | — | openFDA ↗ |
| N210951-001 | 9884054 | 2033/09/23 | — / — | U-2237 | — | openFDA ↗ |
| N210951-001 | 9987261 | 2027/03/27 | — / Y | — | — | openFDA ↗ |
| N210951-001 | RE49353 | 2033/09/23 | — / — | U-2381 | — | openFDA ↗ |
| N210951-001 | RE50642 | 2033/09/23 | — / — | U-4450 | — | openFDA ↗ |
| N210951-002 | 10702508 | 2038/04/30 | — / — | U-3012 | — | openFDA ↗ |
| N210951-002 | 10849888 | 2033/09/23 | — / — | U-3013 | — | openFDA ↗ |
| N210951-002 | 11723898 | 2041/01/14 | — / — | U-4449 | — | openFDA ↗ |
| N210951-002 | 11963952 | 2040/01/30 | — / — | U-3901 | — | openFDA ↗ |
| N210951-002 | 12303493 | 2035/12/03 | — / Y | — | — | openFDA ↗ |
| N210951-002 | 12303497 | 2040/01/30 | — / — | U-4448 | — | openFDA ↗ |
| N210951-002 | 8445507 | 2032/02/14 | Y / Y | U-2624 | — | openFDA ↗ |
| N210951-002 | 8802689 | 2027/03/27 | — / — | U-2624 | — | openFDA ↗ |
| N210951-002 | 9388159 | 2027/03/27 | Y / Y | — | — | openFDA ↗ |
| N210951-002 | 9481663 | 2033/06/04 | Y / Y | U-2237 | — | openFDA ↗ |
| N210951-002 | 9884054 | 2033/09/23 | — / — | U-2237 | — | openFDA ↗ |
| N210951-002 | 9987261 | 2027/03/27 | — / Y | — | — | openFDA ↗ |
| N210951-002 | RE49353 | 2033/09/23 | — / — | U-2381 | — | openFDA ↗ |
| N210951-002 | RE50642 | 2033/09/23 | — / — | U-4450 | — | 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 9
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Chengdu Brilliant Pharmaceutical Co., Ltd. | 国药准字H2026515060mg | 2026/07/14 | Official source ↗ |
| Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized | 国药准字H2026486460mg | 2026/06/17 | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2026486260mg | 2026/06/17 | Official source ↗ |
| Zhejiang Hai Zheng Pharma Co., Ltd. romanized | 国药准字H2026446060mg | 2026/05/19 | Official source ↗ |
| Jiangxi Ke Rui Pharma Co., Ltd. romanized | 国药准字H2026446560mg | 2026/05/19 | Official source ↗ |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H2025312760mg | 2025/01/14 | Official source ↗ |
| Qilu Pharmaceutical (Hainan) Co., Ltd | 国药准字H2024966860mg | 2024/12/01 | Official source ↗ |
| Janssen-Cilag International NV | 国药准字HJ2020002960mg | 2019/09/05 | Official source ↗ |
| Chengdu Easton Biopharmaceuticals Co.,Ltd. | 国药准字H2025435360mg | 2025/05/27 | Official source ↗ |
NHSA approval numbers 4
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H2025312760mg | — | Official source ↗ |
| Zhejiang Hai Zheng Pharma Co., Ltd. romanized | 国药准字H2026446060mg | — | Official source ↗ |
| Janssen-Cilag International NV | H2019005060mg | — | Official source ↗ |
| Zhejiang Hai Zheng Pharma Co., Ltd. romanized | 国药准字H2026446060mg | — | Official source ↗ |
| Zhejiang Hai Zheng Pharma Co., Ltd. romanized | 国药准字H2026446060mg | — | Official source ↗ |
| Janssen-Cilag International NV | 国药准字HJ2020002960mg | — | Official source ↗ |
Under review 18
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Janssen-Cilag International NV; Janssen Ortho LLC; Catalent Pharma Solutions LLC | JYHB2600530 | 2026/09/22 | Official source ↗ |
| Jiangsu He Chen Pharma Co., Ltd. romanized | CYHS2602260 | 2026/09/10 | Official source ↗ |
| Zhengzhou De Mai Pharma Co., Ltd. romanized | CYHS2601856 | 2026/08/03 | Official source ↗ |
| Janssen-Cilag International NV; Janssen Ortho LLC; Catalent Pharma Solutions LLC; Xian Janssen Pharmaceutical Ltd. | JXHS2600061 | 2026/06/10 | Official source ↗ |
| Shenyang Hong Qi Pharmaceutical Co., Ltd. romanized; Suzhou Erye Pharmaceutical Co., Ltd | CYHS2600896 | 2026/04/18 | Official source ↗ |
| Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. | CYHS2600764 | 2026/04/01 | Official source ↗ |
| Jiangsu Li Tai Er Pharma Co., Ltd. romanized | CYHS2600413 | 2026/02/10 | Official source ↗ |
| Jiangsu Lianhuan Pharmaceutical Co.,Ltd.; Yao Yuan Bio Technology (Qi Dong) Co., Ltd. romanized | CYHS2503875 | 2025/11/06 | Official source ↗ |
| Kun Shan Long Deng Rui Di Pharmaceutical Co., Ltd. romanized | CYHS2503601 | 2025/10/09 | Official source ↗ |
| Wuxi Zi Shan Pharma Co., Ltd. romanized; Shanghai Chuang Nuo Pharmaceutical Co., Ltd. romanized | CYHS2503188 | 2025/08/30 | Official source ↗ |
| Shanxi Zhen Dong Pharmaceutical Co., Ltd. romanized | CYHS2504478 | 2025/12/30 | Official source ↗ |
| Wuhan Jiu Long Ren Fu Pharma Co., Ltd. romanized; Chongqing Bo Teng Pharma Co., Ltd. romanized | CYHS2504153 | 2025/12/03 | Official source ↗ |
| Shandong Xin Lu Pharmaceuticals Technology Co., Ltd. romanized; Shanghai Chuang Nuo Pharmaceutical Co., Ltd. romanized | CYHS2504064 | 2025/11/25 | Official source ↗ |
| Chongqing Hua Sen Pharmaceutical Co., Ltd. romanized | CYHS2503468 | 2025/09/19 | Official source ↗ |
| Hainan Zhuo Tai Pharmaceutical Co., Ltd. romanized; Shanghai Chuang Nuo Pharmaceutical Co., Ltd. romanized | CYHS2503133 | 2025/08/27 | Official source ↗ |
| Chengdu Kang Hong Pharma Group Co., Ltd. romanized; Chongqing Bo Teng Pharma Co., Ltd. romanized | CYHS2503102 | 2025/08/23 | Official source ↗ |
| Beijing Kang Li Sheng Pharmaceuticals Technology Kai Fa Co., Ltd. romanized; Tong Fang Pharma (Beijing) Co., Ltd. romanized | CYHS2602665 | 2026/10/30 | Official source ↗ |
| Guangdong Dong Yang Guang Pharma Co., Ltd. romanized; Ru Yuan Dong Yang Guang Pharma Co., Ltd. romanized | CYHS2602717 | 2026/11/05 | Official source ↗ |
Generic-filing companies this year 7
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Jiangsu He Chen Pharma Co., Ltd. romanized | CYHS2602260 | 2026/09/10 | Official source ↗ |
| Zhengzhou De Mai Pharma Co., Ltd. romanized | CYHS2601856 | 2026/08/03 | Official source ↗ |
| Shenyang Hong Qi Pharmaceutical Co., Ltd. romanized; Suzhou Erye Pharmaceutical Co., Ltd | CYHS2600896 | 2026/04/18 | Official source ↗ |
| Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. | CYHS2600764 | 2026/04/01 | Official source ↗ |
| Jiangsu Li Tai Er Pharma Co., Ltd. romanized | CYHS2600413 | 2026/02/10 | Official source ↗ |
| Beijing Kang Li Sheng Pharmaceuticals Technology Kai Fa Co., Ltd. romanized; Tong Fang Pharma (Beijing) Co., Ltd. romanized | CYHS2602665 | 2026/10/30 | Official source ↗ |
| Guangdong Dong Yang Guang Pharma Co., Ltd. romanized; Ru Yuan Dong Yang Guang Pharma Co., Ltd. romanized | CYHS2602717 | 2026/11/05 | Official source ↗ |
API companies with A status 17
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Ru Yuan Dong Yang Guang Pharma Co., Ltd. romanized | Y20250000542 | 2026/10/30 | Official source ↗ |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | Y20250000313 | 2026/08/07 | Official source ↗ |
| Jiangsu Xi Di Pharmaceutical Co., Ltd. romanized | Y20240001342 | 2026/08/28 | Official source ↗ |
| Lian Yun Gang Run Zhong Pharmaceutical Co., Ltd. romanized | Y20240001476 | 2026/05/28 | Official source ↗ |
| Chongqing Rui Po Lai Pharmaceutical Co., Ltd. romanized | Y20250000003 | 2026/09/16 | Official source ↗ |
| Ao Rui Te Pharma Co., Ltd. romanized | Y20240000148 | 2026/03/26 | Official source ↗ |
| Shandong Cheng Hui Shuang Da Pharma Co., Ltd. romanized | Y20240001176 | 2026/03/12 | Official source ↗ |
| Zhejiang Jing Sheng Pharma Co., Ltd. romanized | Y20240000773 | 2026/01/05 | Official source ↗ |
| Sichuan Ren An Pharma Co., Ltd. romanized | Y20240000748 | 2025/11/19 | Official source ↗ |
| Shijiazhuang Long Ze Pharmaceutical Co., Ltd. romanized | Y20240000638 | 2026/01/07 | Official source ↗ |
| Jiangxi Ke Rui Pharma Co., Ltd. romanized | Y20230001081 | 2026/06/27 | Official source ↗ |
| Shandong An Hong Pharmaceutical Co., Ltd. romanized | Y20230000241 | 2024/12/05 | Official source ↗ |
| Chongqing Bo Teng Pharmaceutical Technology Co., Ltd. romanized | Y20230000753 | 2026/06/02 | Official source ↗ |
| Shanxi Zhen Dong Pharmaceutical Co., Ltd. romanized | Y20230000373 | 2025/03/29 | Official source ↗ |
| Fujian Nan Fang Pharmaceutical Co., Ltd. romanized | Y20220001262 | 2026/03/26 | Official source ↗ |
| Sichuan Kelun Pharmaceutical Co., Ltd. | Y20220001255 | 2024/08/05 | Official source ↗ |
| Sichuan Qing Mu Pharmaceutical Co., Ltd. romanized | Y20220000932 | 2024/06/21 | 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 ↗ · 48-17 · 2021/11/12
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