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Sign in to subscribeEntacapone,Levodopa and Carbidopa Tablets（Ⅱ）
Matched- Active ingredients (original)
- CARBIDOPA · ENTACAPONE · LEVODOPA
- 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 approval2003/06/11
ANDA applications7
RLD applicantORION PHARMA
Currently marketed products: 24 · 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 |
|---|---|---|---|---|---|---|---|---|---|
| A079085-001 | CARBIDOPA, LEVODOPA AND ENTACAPONE | SUN PHARMACEUTICAL INDUSTRIES LTD | TABLET | ORAL | CARBIDOPA: 25MG ENTACAPONE: 200MG LEVODOPA: 100MG | 2012/05/10 | N / N | DISCONTINUED | openFDA ↗ |
| A079085-002 | CARBIDOPA, LEVODOPA AND ENTACAPONE | SUN PHARMACEUTICAL INDUSTRIES LTD | TABLET | ORAL | CARBIDOPA: 37.5MG ENTACAPONE: 200MG LEVODOPA: 150MG | 2012/05/10 | N / N | DISCONTINUED | openFDA ↗ |
| A090786-001 | CARBIDOPA, LEVODOPA AND ENTACAPONE | WOCKHARDT LTD | TABLET | ORAL | CARBIDOPA: 12.5MG ENTACAPONE: 200MG LEVODOPA: 50MG | 2012/11/20 | N / N | DISCONTINUED | openFDA ↗ |
| A090833-001 | CARBIDOPA, LEVODOPA AND ENTACAPONE | WOCKHARDT LTD | TABLET | ORAL | CARBIDOPA: 18.75MG ENTACAPONE: 200MG LEVODOPA: 75MG | 2012/11/20 | N / N | DISCONTINUED | openFDA ↗ |
| A090833-002 | CARBIDOPA, LEVODOPA AND ENTACAPONE | WOCKHARDT LTD | TABLET | ORAL | CARBIDOPA: 25MG ENTACAPONE: 200MG LEVODOPA: 100MG | 2012/11/20 | N / N | DISCONTINUED | openFDA ↗ |
| A090833-003 | CARBIDOPA, LEVODOPA AND ENTACAPONE | WOCKHARDT LTD | TABLET | ORAL | CARBIDOPA: 31.25MG ENTACAPONE: 200MG LEVODOPA: 125MG | 2012/11/20 | N / N | DISCONTINUED | openFDA ↗ |
| A090833-004 | CARBIDOPA, LEVODOPA AND ENTACAPONE | WOCKHARDT LTD | TABLET | ORAL | CARBIDOPA: 37.5MG ENTACAPONE: 200MG LEVODOPA: 150MG | 2012/11/20 | N / N | DISCONTINUED | openFDA ↗ |
| A090833-005 | CARBIDOPA, LEVODOPA AND ENTACAPONE | WOCKHARDT LTD | TABLET | ORAL | CARBIDOPA: 50MG ENTACAPONE: 200MG LEVODOPA: 200MG | 2012/11/20 | N / N | DISCONTINUED | openFDA ↗ |
| A203424-001 | CARBIDOPA, LEVODOPA AND ENTACAPONE | PHARMOBEDIENT CONSULTING LLC | TABLET | ORAL | CARBIDOPA: 12.5MG ENTACAPONE: 200MG LEVODOPA: 50MG | 2020/08/13 | N / N | DISCONTINUED | openFDA ↗ |
| A203424-002 | CARBIDOPA, LEVODOPA AND ENTACAPONE | PHARMOBEDIENT CONSULTING LLC | TABLET | ORAL | CARBIDOPA: 18.75MG ENTACAPONE: 200MG LEVODOPA: 75MG | 2020/08/13 | N / N | DISCONTINUED | openFDA ↗ |
| A203424-003 | CARBIDOPA, LEVODOPA AND ENTACAPONE | PHARMOBEDIENT CONSULTING LLC | TABLET | ORAL | CARBIDOPA: 25MG ENTACAPONE: 200MG LEVODOPA: 100MG | 2020/08/13 | N / N | DISCONTINUED | openFDA ↗ |
| A203424-004 | CARBIDOPA, LEVODOPA AND ENTACAPONE | PHARMOBEDIENT CONSULTING LLC | TABLET | ORAL | CARBIDOPA: 31.25MG ENTACAPONE: 200MG LEVODOPA: 125MG | 2020/08/13 | N / N | DISCONTINUED | openFDA ↗ |
| A203424-005 | CARBIDOPA, LEVODOPA AND ENTACAPONE | PHARMOBEDIENT CONSULTING LLC | TABLET | ORAL | CARBIDOPA: 37.5MG ENTACAPONE: 200MG LEVODOPA: 150MG | 2020/08/13 | N / N | DISCONTINUED | openFDA ↗ |
| A203424-006 | CARBIDOPA, LEVODOPA AND ENTACAPONE | PHARMOBEDIENT CONSULTING LLC | TABLET | ORAL | CARBIDOPA: 50MG ENTACAPONE: 200MG LEVODOPA: 200MG | 2020/08/13 | N / N | DISCONTINUED | openFDA ↗ |
| A213212-001 | CARBIDOPA, LEVODOPA AND ENTACAPONE | RISING PHARMA HOLDINGS INC | TABLET | ORAL | CARBIDOPA: 12.5MG ENTACAPONE: 200MG LEVODOPA: 50MG | 2022/01/25 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A213212-002 | CARBIDOPA, LEVODOPA AND ENTACAPONE | RISING PHARMA HOLDINGS INC | TABLET | ORAL | CARBIDOPA: 18.75MG ENTACAPONE: 200MG LEVODOPA: 75MG | 2022/01/25 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A213212-003 | CARBIDOPA, LEVODOPA AND ENTACAPONE | RISING PHARMA HOLDINGS INC | TABLET | ORAL | CARBIDOPA: 25MG ENTACAPONE: 200MG LEVODOPA: 100MG | 2022/01/25 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A213212-004 | CARBIDOPA, LEVODOPA AND ENTACAPONE | RISING PHARMA HOLDINGS INC | TABLET | ORAL | CARBIDOPA: 31.25MG ENTACAPONE: 200MG LEVODOPA: 125MG | 2022/01/25 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A213212-005 | CARBIDOPA, LEVODOPA AND ENTACAPONE | RISING PHARMA HOLDINGS INC | TABLET | ORAL | CARBIDOPA: 37.5MG ENTACAPONE: 200MG LEVODOPA: 150MG | 2022/01/25 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A213212-006 | CARBIDOPA, LEVODOPA AND ENTACAPONE | RISING PHARMA HOLDINGS INC | TABLET | ORAL | CARBIDOPA: 50MG ENTACAPONE: 200MG LEVODOPA: 200MG | 2022/01/25 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A214495-001 | CARBIDOPA, LEVODOPA AND ENTACAPONE | MACLEODS PHARMACEUTICALS LTD | TABLET | ORAL | CARBIDOPA: 12.5MG ENTACAPONE: 200MG LEVODOPA: 50MG | 2025/04/15 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A214495-002 | CARBIDOPA, LEVODOPA AND ENTACAPONE | MACLEODS PHARMACEUTICALS LTD | TABLET | ORAL | CARBIDOPA: 18.75MG ENTACAPONE: 200MG LEVODOPA: 75MG | 2025/04/15 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A214495-003 | CARBIDOPA, LEVODOPA AND ENTACAPONE | MACLEODS PHARMACEUTICALS LTD | TABLET | ORAL | CARBIDOPA: 25MG ENTACAPONE: 200MG LEVODOPA: 100MG | 2025/04/15 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A214495-004 | CARBIDOPA, LEVODOPA AND ENTACAPONE | MACLEODS PHARMACEUTICALS LTD | TABLET | ORAL | CARBIDOPA: 31.25MG ENTACAPONE: 200MG LEVODOPA: 125MG | 2025/04/15 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A214495-005 | CARBIDOPA, LEVODOPA AND ENTACAPONE | MACLEODS PHARMACEUTICALS LTD | TABLET | ORAL | CARBIDOPA: 37.5MG ENTACAPONE: 200MG LEVODOPA: 150MG | 2025/04/15 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A214495-006 | CARBIDOPA, LEVODOPA AND ENTACAPONE | MACLEODS PHARMACEUTICALS LTD | TABLET | ORAL | CARBIDOPA: 50MG ENTACAPONE: 200MG LEVODOPA: 200MG | 2025/04/15 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A218535-001 | CARBIDOPA, LEVODOPA AND ENTACAPONE | ALEMBIC PHARMACEUTICALS LTD | TABLET | ORAL | CARBIDOPA: 12.5MG ENTACAPONE: 200MG LEVODOPA: 50MG | 2026/02/05 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A218535-002 | CARBIDOPA, LEVODOPA AND ENTACAPONE | ALEMBIC PHARMACEUTICALS LTD | TABLET | ORAL | CARBIDOPA: 18.75MG ENTACAPONE: 200MG LEVODOPA: 75MG | 2026/02/05 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A218535-003 | CARBIDOPA, LEVODOPA AND ENTACAPONE | ALEMBIC PHARMACEUTICALS LTD | TABLET | ORAL | CARBIDOPA: 25MG ENTACAPONE: 200MG LEVODOPA: 100MG | 2026/02/05 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A218535-004 | CARBIDOPA, LEVODOPA AND ENTACAPONE | ALEMBIC PHARMACEUTICALS LTD | TABLET | ORAL | CARBIDOPA: 31.25MG ENTACAPONE: 200MG LEVODOPA: 125MG | 2026/02/05 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A218535-005 | CARBIDOPA, LEVODOPA AND ENTACAPONE | ALEMBIC PHARMACEUTICALS LTD | TABLET | ORAL | CARBIDOPA: 37.5MG ENTACAPONE: 200MG LEVODOPA: 150MG | 2026/02/05 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A218535-006 | CARBIDOPA, LEVODOPA AND ENTACAPONE | ALEMBIC PHARMACEUTICALS LTD | TABLET | ORAL | CARBIDOPA: 50MG ENTACAPONE: 200MG LEVODOPA: 200MG | 2026/02/05 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N021485-001 | STALEVO 50 | ORION PHARMA | TABLET | ORAL | CARBIDOPA: 12.5MG ENTACAPONE: 200MG LEVODOPA: 50MG | 2003/06/11 | Y / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N021485-002 | STALEVO 100 | ORION PHARMA | TABLET | ORAL | CARBIDOPA: 25MG ENTACAPONE: 200MG LEVODOPA: 100MG | 2003/06/11 | Y / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N021485-003 | STALEVO 150 | ORION PHARMA | TABLET | ORAL | CARBIDOPA: 37.5MG ENTACAPONE: 200MG LEVODOPA: 150MG | 2003/06/11 | Y / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N021485-004 | STALEVO 200 | ORION PHARMA | TABLET | ORAL | CARBIDOPA: 50MG ENTACAPONE: 200MG LEVODOPA: 200MG | 2007/08/02 | Y / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N021485-005 | STALEVO 75 | ORION PHARMA | TABLET | ORAL | CARBIDOPA: 18.75MG ENTACAPONE: 200MG LEVODOPA: 75MG | 2008/08/29 | Y / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N021485-006 | STALEVO 125 | ORION PHARMA | TABLET | ORAL | CARBIDOPA: 31.25MG ENTACAPONE: 200MG LEVODOPA: 125MG | 2008/08/29 | Y / N | 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 3
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20264081See source | 2026/04/21 | Official source ↗ |
| Qilu Pharmaceutical Co., Ltd. | 国药准字H20255859See source | 2025/11/04 | Official source ↗ |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20244519See source | 2024/07/30 | Official source ↗ |
NHSA approval numbers 4
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20264081See source | — | Official source ↗ |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20244519See source | — | Official source ↗ |
| Qilu Pharmaceutical Co., Ltd. | 国药准字H20255859See source | — | Official source ↗ |
| Orion Corporation | 国药准字HJ20171148See source | — | Official source ↗ |
Under review 5
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Jewim Pharmaceutical (Shandong) Co., Ltd. | CYHS2601000 | 2026/04/29 | Official source ↗ |
| Nanjing Hai Na Pharmaceutical Co., Ltd. romanized | CYHS2601591 | 2026/07/06 | Official source ↗ |
| Fu Xing Wan Bang (Jiangsu) Pharmaceuticals Group Co., Ltd. romanized | CYHS2501940 | 2025/05/30 | Official source ↗ |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | CYHS2602499 | 2026/10/12 | Official source ↗ |
| Ningbo Menovo Tiankang Pharmaceutical Co., Ltd. | CYHS2600204 | 2026/01/16 | Official source ↗ |
Generic-filing companies this year 4
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Jewim Pharmaceutical (Shandong) Co., Ltd. | CYHS2601000 | 2026/04/29 | Official source ↗ |
| Nanjing Hai Na Pharmaceutical Co., Ltd. romanized | CYHS2601591 | 2026/07/06 | Official source ↗ |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | CYHS2602499 | 2026/10/12 | Official source ↗ |
| Ningbo Menovo Tiankang Pharmaceutical Co., Ltd. | CYHS2600204 | 2026/01/16 | 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 ↗ · 45-2 · 2021/10/18
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