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Matched- Active ingredients (original)
- EPLERENONE
- 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 approval2002/09/27
ANDA applications9
RLD applicantUPJOHN US 2 LLC
Currently marketed products: 18 · 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 |
|---|---|---|---|---|---|---|---|---|---|
| A078482-001 | EPLERENONE | CHARTWELL RX SCIENCES LLC | TABLET | ORAL | EPLERENONE: 25MG | 2008/07/30 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A078482-002 | EPLERENONE | CHARTWELL RX SCIENCES LLC | TABLET | ORAL | EPLERENONE: 50MG | 2008/07/30 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A078510-001 | EPLERENONE | SANDOZ INC | TABLET | ORAL | EPLERENONE: 25MG | 2008/08/01 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A078510-002 | EPLERENONE | SANDOZ INC | TABLET | ORAL | EPLERENONE: 50MG | 2008/08/01 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A203896-001 | EPLERENONE | ANDAS 5 HOLDING LLC | TABLET | ORAL | EPLERENONE: 25MG | 2017/02/02 | N / N | DISCONTINUED | openFDA ↗ |
| A203896-002 | EPLERENONE | ANDAS 5 HOLDING LLC | TABLET | ORAL | EPLERENONE: 50MG | 2017/02/02 | N / N | DISCONTINUED | openFDA ↗ |
| A206922-001 | EPLERENONE | ACCORD HEALTHCARE INC | TABLET | ORAL | EPLERENONE: 25MG | 2017/07/13 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A206922-002 | EPLERENONE | ACCORD HEALTHCARE INC | TABLET | ORAL | EPLERENONE: 50MG | 2017/07/13 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A207842-001 | EPLERENONE | EVEREST LIFESCIENCES LLC | TABLET | ORAL | EPLERENONE: 25MG | 2021/10/25 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A207842-002 | EPLERENONE | EVEREST LIFESCIENCES LLC | TABLET | ORAL | EPLERENONE: 50MG | 2021/10/25 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A208283-001 | EPLERENONE | BRECKENRIDGE PHARMACEUTICAL INC | TABLET | ORAL | EPLERENONE: 25MG | 2018/09/14 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A208283-002 | EPLERENONE | BRECKENRIDGE PHARMACEUTICAL INC | TABLET | ORAL | EPLERENONE: 50MG | 2018/09/14 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A212765-001 | EPLERENONE | PHARMAZONE | TABLET | ORAL | EPLERENONE: 25MG | 2020/08/10 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A212765-002 | EPLERENONE | PHARMAZONE | TABLET | ORAL | EPLERENONE: 50MG | 2020/08/10 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A213812-001 | EPLERENONE | ANNORA PHARMA PRIVATE LTD | TABLET | ORAL | EPLERENONE: 25MG | 2023/06/02 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A213812-002 | EPLERENONE | ANNORA PHARMA PRIVATE LTD | TABLET | ORAL | EPLERENONE: 50MG | 2023/06/02 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A214663-001 | EPLERENONE | RISING PHARMA HOLDINGS INC | TABLET | ORAL | EPLERENONE: 25MG | 2022/03/23 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A214663-002 | EPLERENONE | RISING PHARMA HOLDINGS INC | TABLET | ORAL | EPLERENONE: 50MG | 2022/03/23 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N021437-001 | INSPRA | UPJOHN US 2 LLC | TABLET | ORAL | EPLERENONE: 25MG | 2002/09/27 | Y / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N021437-002 | INSPRA | UPJOHN US 2 LLC | TABLET | ORAL | EPLERENONE: 50MG | 2002/09/27 | Y / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N021437-003 | INSPRA | UPJOHN US 2 LLC | TABLET | ORAL | EPLERENONE: 100MG | 2002/09/27 | N / N | DISCONTINUED | 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 1
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Nanjing Ka Wen Di Xu Bio Gong Cheng Technology Co., Ltd. romanized | 国药准字H2023398050mg | 2023/08/01 | Official source ↗ |
| Nanjing Ka Wen Di Xu Bio Gong Cheng Technology Co., Ltd. romanized | 国药准字H2023397425mg | 2023/08/01 | Official source ↗ |
NHSA approval numbers 2
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Nanjing Ka Wen Di Xu Bio Gong Cheng Technology Co., Ltd. romanized | 国药准字H2023397425mg | — | Official source ↗ |
| Nanjing Ka Wen Di Xu Bio Gong Cheng Technology Co., Ltd. romanized | 国药准字H2023397425mg | — | Official source ↗ |
| Nanjing Ka Wen Di Xu Bio Gong Cheng Technology Co., Ltd. romanized | 国药准字H2023397425mg | — | Official source ↗ |
| Nanjing Ka Wen Di Xu Bio Gong Cheng Technology Co., Ltd. romanized | 国药准字H2023397425mg | — | Official source ↗ |
| Nanjing Ka Wen Di Xu Bio Gong Cheng Technology Co., Ltd. romanized | 国药准字H2023397425mg | — | Official source ↗ |
| Nanjing Ka Wen Di Xu Bio Gong Cheng Technology Co., Ltd. romanized | 国药准字H2023397425mg | — | Official source ↗ |
| Nanjing Ka Wen Di Xu Bio Gong Cheng Technology Co., Ltd. romanized | 国药准字H2023397425mg | — | Official source ↗ |
| Nanjing Ka Wen Di Xu Bio Gong Cheng Technology Co., Ltd. romanized | 国药准字H2023398050mg | — | Official source ↗ |
| Nanjing Ka Wen Di Xu Bio Gong Cheng Technology Co., Ltd. romanized | 国药准字H2023398050mg | — | Official source ↗ |
| Nanjing Ka Wen Di Xu Bio Gong Cheng Technology Co., Ltd. romanized | 国药准字H2023398050mg | — | Official source ↗ |
| Nanjing Ka Wen Di Xu Bio Gong Cheng Technology Co., Ltd. romanized | 国药准字H2023398050mg | — | Official source ↗ |
| Nanjing Ka Wen Di Xu Bio Gong Cheng Technology Co., Ltd. romanized | 国药准字H2023398050mg | — | Official source ↗ |
| Nanjing Ka Wen Di Xu Bio Gong Cheng Technology Co., Ltd. romanized | 国药准字H2023398050mg | — | Official source ↗ |
| Nanjing Ka Wen Di Xu Bio Gong Cheng Technology Co., Ltd. romanized | 国药准字H2023398050mg | — | Official source ↗ |
Under review 4
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized | CYHS2602158 | 2026/08/31 | Official source ↗ |
| Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized | CYHS2602157 | 2026/08/31 | Official source ↗ |
| Chengdu Brilliant Pharmaceutical Co., Ltd. | CYHS2601535 | 2026/06/30 | Official source ↗ |
| Chengdu Brilliant Pharmaceutical Co., Ltd. | CYHS2601534 | 2026/06/30 | Official source ↗ |
Generic-filing companies this year 2
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized | CYHS2602158 | 2026/08/31 | Official source ↗ |
| Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized | CYHS2602157 | 2026/08/31 | Official source ↗ |
| Chengdu Brilliant Pharmaceutical Co., Ltd. | CYHS2601535 | 2026/06/30 | Official source ↗ |
| Chengdu Brilliant Pharmaceutical Co., Ltd. | CYHS2601534 | 2026/06/30 | Official source ↗ |
| Chengdu Brilliant Pharmaceutical Co., Ltd. | CYHL2600031 | 2026/02/27 | Official source ↗ |
| Chengdu Brilliant Pharmaceutical Co., Ltd. | CYHL2600030 | 2026/02/27 | Official source ↗ |
API companies with A status 4
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Ka Wen Di Xu (Tai Zhou) Pharma Co., Ltd. romanized | Y20240001202 | 2026/10/20 | Official source ↗ |
| Sichuan Ren An Pharma Co., Ltd. romanized | Y20240001541 | 2026/07/20 | Official source ↗ |
| Ao Rui Te Pharma Co., Ltd. romanized | Y20240001120 | 2026/10/09 | Official source ↗ |
| Jiangsu Yun Yang Group Pharma Co., Ltd. romanized | Y20200001280 | 2023/08/11 | 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 ↗ · 39-40 · 2021/03/03
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