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Sign in to subscribeBrivaracetam Tablets
Matched- Active ingredients (original)
- BRIVARACETAM
- 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 approval2016/05/12
ANDA applications9
RLD applicantUCB INC
Currently marketed products: 38 · 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 |
|---|---|---|---|---|---|---|---|---|---|
| A214501-001 | BRIVARACETAM | ZYDUS PHARMACEUTICALS USA INC | TABLET | ORAL | BRIVARACETAM: 10MG | 2022/10/03 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A214501-002 | BRIVARACETAM | ZYDUS PHARMACEUTICALS USA INC | TABLET | ORAL | BRIVARACETAM: 25MG | 2022/10/03 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A214501-003 | BRIVARACETAM | ZYDUS PHARMACEUTICALS USA INC | TABLET | ORAL | BRIVARACETAM: 50MG | 2022/10/03 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A214501-004 | BRIVARACETAM | ZYDUS PHARMACEUTICALS USA INC | TABLET | ORAL | BRIVARACETAM: 75MG | 2022/10/03 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A214501-005 | BRIVARACETAM | ZYDUS PHARMACEUTICALS USA INC | TABLET | ORAL | BRIVARACETAM: 100MG | 2022/10/03 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A214748-001 | BRIVARACETAM | SUNSHINE LAKE PHARMA CO LTD | TABLET | ORAL | BRIVARACETAM: 10MG | 2022/06/09 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A214748-002 | BRIVARACETAM | SUNSHINE LAKE PHARMA CO LTD | TABLET | ORAL | BRIVARACETAM: 25MG | 2022/06/09 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A214748-003 | BRIVARACETAM | SUNSHINE LAKE PHARMA CO LTD | TABLET | ORAL | BRIVARACETAM: 50MG | 2022/06/09 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A214748-004 | BRIVARACETAM | SUNSHINE LAKE PHARMA CO LTD | TABLET | ORAL | BRIVARACETAM: 75MG | 2022/06/09 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A214748-005 | BRIVARACETAM | SUNSHINE LAKE PHARMA CO LTD | TABLET | ORAL | BRIVARACETAM: 100MG | 2022/06/09 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A214848-001 | BRIVARACETAM | AUROBINDO PHARMA LTD | TABLET | ORAL | BRIVARACETAM: 50MG | 2023/01/06 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A214848-002 | BRIVARACETAM | AUROBINDO PHARMA LTD | TABLET | ORAL | BRIVARACETAM: 100MG | 2023/01/06 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A214848-003 | BRIVARACETAM | AUROBINDO PHARMA LTD | TABLET | ORAL | BRIVARACETAM: 10MG | 2026/07/13 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A214848-004 | BRIVARACETAM | AUROBINDO PHARMA LTD | TABLET | ORAL | BRIVARACETAM: 25MG | 2026/07/13 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A214848-005 | BRIVARACETAM | AUROBINDO PHARMA LTD | TABLET | ORAL | BRIVARACETAM: 75MG | 2026/07/13 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A214875-001 | BRIVARACETAM | APOTEX INC | TABLET | ORAL | BRIVARACETAM: 10MG | 2026/02/23 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A214875-002 | BRIVARACETAM | APOTEX INC | TABLET | ORAL | BRIVARACETAM: 25MG | 2026/02/23 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A214875-003 | BRIVARACETAM | APOTEX INC | TABLET | ORAL | BRIVARACETAM: 50MG | 2026/02/23 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A214875-004 | BRIVARACETAM | APOTEX INC | TABLET | ORAL | BRIVARACETAM: 75MG | 2026/02/23 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A214875-005 | BRIVARACETAM | APOTEX INC | TABLET | ORAL | BRIVARACETAM: 100MG | 2026/02/23 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A214918-001 | BRIVARACETAM | LUPIN LTD | TABLET | ORAL | BRIVARACETAM: 10MG | 2022/12/20 | N / N | DISCONTINUED | openFDA ↗ |
| A214918-002 | BRIVARACETAM | LUPIN LTD | TABLET | ORAL | BRIVARACETAM: 25MG | 2022/12/20 | N / N | DISCONTINUED | openFDA ↗ |
| A214918-003 | BRIVARACETAM | LUPIN LTD | TABLET | ORAL | BRIVARACETAM: 50MG | 2022/12/20 | N / N | DISCONTINUED | openFDA ↗ |
| A214918-004 | BRIVARACETAM | LUPIN LTD | TABLET | ORAL | BRIVARACETAM: 75MG | 2022/12/20 | N / N | DISCONTINUED | openFDA ↗ |
| A214918-005 | BRIVARACETAM | LUPIN LTD | TABLET | ORAL | BRIVARACETAM: 100MG | 2022/12/20 | N / N | DISCONTINUED | openFDA ↗ |
| A214921-001 | BRIVARACETAM | MSN LABORATORIES PRIVATE LTD | TABLET | ORAL | BRIVARACETAM: 10MG | 2025/11/13 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A214921-002 | BRIVARACETAM | MSN LABORATORIES PRIVATE LTD | TABLET | ORAL | BRIVARACETAM: 25MG | 2025/11/13 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A214921-003 | BRIVARACETAM | MSN LABORATORIES PRIVATE LTD | TABLET | ORAL | BRIVARACETAM: 50MG | 2025/11/13 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A214921-004 | BRIVARACETAM | MSN LABORATORIES PRIVATE LTD | TABLET | ORAL | BRIVARACETAM: 75MG | 2025/11/13 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A214921-005 | BRIVARACETAM | MSN LABORATORIES PRIVATE LTD | TABLET | ORAL | BRIVARACETAM: 100MG | 2025/11/13 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A219952-001 | BRIVARACETAM | SCIEGEN PHARMACEUTICALS INC | TABLET | ORAL | BRIVARACETAM: 10MG | 2026/07/01 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A219952-002 | BRIVARACETAM | SCIEGEN PHARMACEUTICALS INC | TABLET | ORAL | BRIVARACETAM: 25MG | 2026/07/01 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A219952-003 | BRIVARACETAM | SCIEGEN PHARMACEUTICALS INC | TABLET | ORAL | BRIVARACETAM: 50MG | 2026/07/01 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A219952-004 | BRIVARACETAM | SCIEGEN PHARMACEUTICALS INC | TABLET | ORAL | BRIVARACETAM: 75MG | 2026/07/01 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A219952-005 | BRIVARACETAM | SCIEGEN PHARMACEUTICALS INC | TABLET | ORAL | BRIVARACETAM: 100MG | 2026/07/01 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A220136-001 | BRIVARACETAM | ZHEJIANG JUTAI PHARMACEUTICAL CO LTD | TABLET | ORAL | BRIVARACETAM: 25MG | 2026/09/08 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A220136-002 | BRIVARACETAM | ZHEJIANG JUTAI PHARMACEUTICAL CO LTD | TABLET | ORAL | BRIVARACETAM: 50MG | 2026/09/08 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A220136-003 | BRIVARACETAM | ZHEJIANG JUTAI PHARMACEUTICAL CO LTD | TABLET | ORAL | BRIVARACETAM: 100MG | 2026/09/08 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A220470-001 | BRIVARACETAM | BRECKENRIDGE PHARMACEUTICAL INC | TABLET | ORAL | BRIVARACETAM: 10MG | 2026/02/23 | N / N | DISCONTINUED | openFDA ↗ |
| A220470-002 | BRIVARACETAM | BRECKENRIDGE PHARMACEUTICAL INC | TABLET | ORAL | BRIVARACETAM: 25MG | 2026/02/23 | N / N | DISCONTINUED | openFDA ↗ |
| A220470-003 | BRIVARACETAM | BRECKENRIDGE PHARMACEUTICAL INC | TABLET | ORAL | BRIVARACETAM: 50MG | 2026/02/23 | N / N | DISCONTINUED | openFDA ↗ |
| A220470-004 | BRIVARACETAM | BRECKENRIDGE PHARMACEUTICAL INC | TABLET | ORAL | BRIVARACETAM: 75MG | 2026/02/23 | N / N | DISCONTINUED | openFDA ↗ |
| A220470-005 | BRIVARACETAM | BRECKENRIDGE PHARMACEUTICAL INC | TABLET | ORAL | BRIVARACETAM: 100MG | 2026/02/23 | N / N | DISCONTINUED | openFDA ↗ |
| N205836-001 | BRIVIACT | UCB INC | TABLET | ORAL | BRIVARACETAM: 10MG | 2016/05/12 | Y / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N205836-002 | BRIVIACT | UCB INC | TABLET | ORAL | BRIVARACETAM: 25MG | 2016/05/12 | Y / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N205836-003 | BRIVIACT | UCB INC | TABLET | ORAL | BRIVARACETAM: 50MG | 2016/05/12 | Y / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N205836-004 | BRIVIACT | UCB INC | TABLET | ORAL | BRIVARACETAM: 75MG | 2016/05/12 | Y / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N205836-005 | BRIVIACT | UCB INC | TABLET | ORAL | BRIVARACETAM: 100MG | 2016/05/12 | 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 expiration2030/04/09
Substance patent expiration (DS flag)2026/02/21
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 |
|---|---|---|---|---|---|---|
| N205836-001 | 10729653 | 2030/04/09 | — / Y | — | — | openFDA ↗ |
| N205836-001 | 6911461 | 2026/02/21 | Y / Y | U-2295 | — | openFDA ↗ |
| N205836-002 | 10729653 | 2030/04/09 | — / Y | — | — | openFDA ↗ |
| N205836-002 | 6911461 | 2026/02/21 | Y / Y | U-2295 | — | openFDA ↗ |
| N205836-003 | 10729653 | 2030/04/09 | — / Y | — | — | openFDA ↗ |
| N205836-003 | 6911461 | 2026/02/21 | Y / Y | U-2295 | — | openFDA ↗ |
| N205836-004 | 10729653 | 2030/04/09 | — / Y | — | — | openFDA ↗ |
| N205836-004 | 6911461 | 2026/02/21 | Y / Y | U-2295 | — | openFDA ↗ |
| N205836-005 | 10729653 | 2030/04/09 | — / Y | — | — | openFDA ↗ |
| N205836-005 | 6911461 | 2026/02/21 | Y / Y | U-2295 | — | 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 1
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Jiangxi Qing Feng Pharma Co., Ltd. romanized | 国药准字H2024427250mg | 2024/06/28 | Official source ↗ |
| Jiangxi Qing Feng Pharma Co., Ltd. romanized | 国药准字H2024427125mg | 2024/06/28 | Official source ↗ |
NHSA approval numbers 2
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Jiangxi Ke Rui Pharma Co., Ltd. romanized | 国药准字H2024427250mg | — | Official source ↗ |
| Jiangxi Ke Rui Pharma Co., Ltd. romanized | 国药准字H2024427125mg | — | Official source ↗ |
Under review 19
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Zhejiang Nord Pharmaceutical Co., Ltd | CYHS2602090 | 2026/08/21 | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | CYHS2602089 | 2026/08/21 | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | CYHS2602088 | 2026/08/21 | Official source ↗ |
| Xi Nan Pharma Co., Ltd. romanized | CYHS2602507 | 2026/10/13 | Official source ↗ |
| Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized | CYHS2602456 | 2026/10/09 | Official source ↗ |
| Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized | CYHS2602455 | 2026/10/09 | Official source ↗ |
| Jiangxi Ke Rui Pharma Co., Ltd. romanized | CYHB2601498 | 2026/08/04 | Official source ↗ |
| Jiangxi Ke Rui Pharma Co., Ltd. romanized | CYHB2601497 | 2026/08/04 | Official source ↗ |
| Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. | CYHS2601699 | 2026/07/16 | Official source ↗ |
| Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. | CYHS2601698 | 2026/07/16 | Official source ↗ |
| Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. | CYHS2601697 | 2026/07/16 | Official source ↗ |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | CYHS2600068 | 2026/01/08 | Official source ↗ |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | CYHS2600067 | 2026/01/08 | Official source ↗ |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | CYHS2600065 | 2026/01/08 | Official source ↗ |
| Zhejiang He Ze Pharmaceuticals Technology Co., Ltd. romanized; ZHEJIANG JINGXIN PHARMACEUTICAL CO.，LTD. | CYHS2501808 | 2025/05/17 | Official source ↗ |
| Zhejiang He Ze Pharmaceuticals Technology Co., Ltd. romanized; ZHEJIANG JINGXIN PHARMACEUTICAL CO.，LTD. | CYHS2501807 | 2025/05/17 | Official source ↗ |
| Yi Chang Ren Fu Pharma Co., Ltd. romanized | CYHS2602745 | 2026/11/09 | Official source ↗ |
| Yi Chang Ren Fu Pharma Co., Ltd. romanized | CYHS2602744 | 2026/11/09 | Official source ↗ |
| Yi Chang Ren Fu Pharma Co., Ltd. romanized | CYHS2602743 | 2026/11/09 | Official source ↗ |
Generic-filing companies this year 7
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Zhejiang Nord Pharmaceutical Co., Ltd | CYHS2602090 | 2026/08/21 | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | CYHS2602089 | 2026/08/21 | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | CYHS2602088 | 2026/08/21 | Official source ↗ |
| Xi Nan Pharma Co., Ltd. romanized | CYHS2602507 | 2026/10/13 | Official source ↗ |
| Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized | CYHS2602456 | 2026/10/09 | Official source ↗ |
| Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized | CYHS2602455 | 2026/10/09 | Official source ↗ |
| Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. | CYHS2601699 | 2026/07/16 | Official source ↗ |
| Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. | CYHS2601698 | 2026/07/16 | Official source ↗ |
| Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. | CYHS2601697 | 2026/07/16 | Official source ↗ |
| Chengdu Ao Bang Pharma Co., Ltd. romanized | CYHS2600146 | 2026/01/13 | Official source ↗ |
| Chengdu Ao Bang Pharma Co., Ltd. romanized | CYHS2600145 | 2026/01/13 | Official source ↗ |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | CYHS2600068 | 2026/01/08 | Official source ↗ |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | CYHS2600067 | 2026/01/08 | Official source ↗ |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | CYHS2600066 | 2026/01/08 | Official source ↗ |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | CYHS2600065 | 2026/01/08 | Official source ↗ |
| Yi Chang Ren Fu Pharma Co., Ltd. romanized | CYHS2602745 | 2026/11/09 | Official source ↗ |
| Yi Chang Ren Fu Pharma Co., Ltd. romanized | CYHS2602744 | 2026/11/09 | Official source ↗ |
| Yi Chang Ren Fu Pharma Co., Ltd. romanized | CYHS2602743 | 2026/11/09 | Official source ↗ |
API companies with A status 7
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Zhejiang Dong Ya Pharma Co., Ltd. romanized | Y20250000038 | 2026/10/10 | Official source ↗ |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | Y20240001376 | 2026/06/24 | Official source ↗ |
| Zhejiang Mei Nuo Hua Drug Chemical Co., Ltd. romanized | Y20240000959 | 2026/06/04 | Official source ↗ |
| Zhejiang Tian Yu Pharma Co., Ltd. romanized | Y20240000776 | 2026/06/01 | Official source ↗ |
| Shanghai Di Sai Nuo Chemical Pharmaceutical Co., Ltd. romanized | Y20240000746 | 2026/05/07 | Official source ↗ |
| Shandong Chen Long Pharma Co., Ltd. romanized | Y20230000549 | 2025/12/29 | Official source ↗ |
| Jiangxi Ke Rui Pharma Co., Ltd. romanized | Y20220001288 | 2024/12/27 | Official source ↗ |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | Y20220001275 | 2026/03/31 | 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 ↗ · 24-109 · 2020/01/03
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