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Sign in to subscribeBaloxavir Marboxil Tablets
Matched- Active ingredients (original)
- BALOXAVIR MARBOXIL
- 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 approval2018/10/24
ANDA applications1
RLD applicantGENENTECH INC
Currently marketed products: 4 · 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 |
|---|---|---|---|---|---|---|---|---|---|
| A217449-001 | BALOXAVIR MARBOXIL | NORWICH PHARMACEUTICALS INC | TABLET | ORAL | BALOXAVIR MARBOXIL: 40MG | 2026/06/17 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A217449-002 | BALOXAVIR MARBOXIL | NORWICH PHARMACEUTICALS INC | TABLET | ORAL | BALOXAVIR MARBOXIL: 80MG | 2026/06/17 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N210854-001 | XOFLUZA | GENENTECH INC | TABLET | ORAL | BALOXAVIR MARBOXIL: 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 2018/10/24 | Y / N | DISCONTINUED | openFDA ↗ |
| N210854-002 | XOFLUZA | GENENTECH INC | TABLET | ORAL | BALOXAVIR MARBOXIL: 40MG | 2018/10/24 | Y / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N210854-003 | XOFLUZA | GENENTECH INC | TABLET | ORAL | BALOXAVIR MARBOXIL: 80MG | 2021/03/18 | 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 expiration2039/10/09
Substance patent expiration (DS flag)2037/08/09
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 |
|---|---|---|---|---|---|---|
| N210854-001 | 10392406 | 2036/04/27 | Y / — | — | — | openFDA ↗ |
| N210854-001 | 10633397 | 2036/04/27 | — / — | U-3000 | — | openFDA ↗ |
| N210854-001 | 10759814 | 2037/08/09 | Y / Y | — | — | openFDA ↗ |
| N210854-001 | 11261198 | 2038/09/25 | — / Y | — | — | openFDA ↗ |
| N210854-001 | 11306106 | 2037/08/09 | — / — | U-3000 | — | openFDA ↗ |
| N210854-001 | 12064438 | 2039/10/09 | — / Y | — | — | openFDA ↗ |
| N210854-001 | 8927710 | 2031/05/05 | — / Y | — | — | openFDA ↗ |
| N210854-001 | 8987441 | 2032/10/24 | Y / Y | — | — | openFDA ↗ |
| N210854-001 | 9815835 | 2030/06/14 | — / Y | — | — | openFDA ↗ |
| N210854-002 | 10392406 | 2036/04/27 | Y / — | — | — | openFDA ↗ |
| N210854-002 | 10633397 | 2036/04/27 | — / — | U-3000 | — | openFDA ↗ |
| N210854-002 | 10759814 | 2037/08/09 | Y / Y | — | — | openFDA ↗ |
| N210854-002 | 11261198 | 2038/09/25 | — / Y | — | — | openFDA ↗ |
| N210854-002 | 11306106 | 2037/08/09 | — / — | U-3000 | — | openFDA ↗ |
| N210854-002 | 12064438 | 2039/10/09 | — / Y | — | — | openFDA ↗ |
| N210854-002 | 8927710 | 2031/05/05 | — / Y | — | — | openFDA ↗ |
| N210854-002 | 8987441 | 2032/10/24 | Y / Y | — | — | openFDA ↗ |
| N210854-002 | 9815835 | 2030/06/14 | — / Y | — | — | openFDA ↗ |
| N210854-003 | 10392406 | 2036/04/27 | Y / — | — | — | openFDA ↗ |
| N210854-003 | 10633397 | 2036/04/27 | — / — | U-2816 | — | openFDA ↗ |
| N210854-003 | 10759814 | 2037/08/09 | Y / Y | — | — | openFDA ↗ |
| N210854-003 | 11261198 | 2038/09/25 | — / Y | — | — | openFDA ↗ |
| N210854-003 | 11306106 | 2037/08/09 | — / — | U-3000 | — | openFDA ↗ |
| N210854-003 | 12064438 | 2039/10/09 | — / Y | — | — | openFDA ↗ |
| N210854-003 | 8927710 | 2031/05/05 | — / Y | — | — | openFDA ↗ |
| N210854-003 | 8987441 | 2032/10/24 | Y / Y | — | — | openFDA ↗ |
| N210854-003 | 9815835 | 2030/06/14 | — / Y | — | — | openFDA ↗ |
Exclusivity source records
FDA exclusivity code list ↗Latest exclusivity expiration: 2027/12/19
| Application / product number | Exclusivity code | Listed expiration | Official source |
|---|---|---|---|
| N210854-001 | M-187 | 2027/12/19 | openFDA ↗ |
| N210854-002 | M-187 | 2027/12/19 | openFDA ↗ |
| N210854-003 | M-187 | 2027/12/19 | openFDA ↗ |
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 |
|---|---|---|---|
| Zhejiang Pu Li Pharma Co., Ltd. romanized | 国药准字H2026328640mg | 2026/01/27 | Official source ↗ |
| Zhejiang Pu Li Pharma Co., Ltd. romanized | 国药准字H2026328520mg | 2026/01/27 | Official source ↗ |
| Zhengzhou Tai Feng Pharmaceutical Co., Ltd. romanized | 国药准字H2025311420mg | 2025/01/08 | Official source ↗ |
| CSPC OUYI PHARMACEUTICAL CO., LTD. | 国药准字H2022374620mg | 2022/10/11 | Official source ↗ |
NHSA approval numbers 2
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Roche Pharma(Schweiz) AG | 国药准字HJ2021002720mg | — | Official source ↗ |
| Roche Pharma(Schweiz) AG | 国药准字HJ2021002840mg | — | Official source ↗ |
Under review 12
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Changzhou Pharmaceutical Factory Co., Ltd. romanized | CYHS2501820 | 2025/05/20 | Official source ↗ |
| Changzhou Pharmaceutical Factory Co., Ltd. romanized | CYHS2501819 | 2025/05/20 | Official source ↗ |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | CYHS2504408 | 2025/12/26 | Official source ↗ |
| Hangzhou Minsheng Pharmaceutical Co., Ltd | CYHS2601781 | 2026/07/24 | Official source ↗ |
| Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized | CYHS2601297 | 2026/06/04 | Official source ↗ |
| Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized | CYHS2601296 | 2026/06/04 | Official source ↗ |
| Hunan Ming Rui Pharmaceutical Co., Ltd. romanized | CYHS2600002 | 2026/01/05 | Official source ↗ |
| Hunan Ming Rui Pharmaceutical Co., Ltd. romanized | CYHS2600001 | 2026/01/05 | Official source ↗ |
| Chongqing Lai Mei Pharma Co., Ltd. romanized; Chongqing Bo Teng Pharma Co., Ltd. romanized | CYHS2504401 | 2025/12/25 | Official source ↗ |
| Yuan Da Pharmaceuticals (Hubei) Co., Ltd. romanized; Yuan Da Pharmaceuticals (Zhongguo) Co., Ltd. romanized | CYHS2503574 | 2025/09/29 | Official source ↗ |
| Jiu Zhou Biopharmaceuticals (Tai Zhou) Co., Ltd. romanized | CYHS2502794 | 2025/08/02 | Official source ↗ |
| Jiu Zhou Biopharmaceuticals (Tai Zhou) Co., Ltd. romanized | CYHS2502793 | 2025/08/02 | Official source ↗ |
Generic-filing companies this year 3
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Hangzhou Minsheng Pharmaceutical Co., Ltd | CYHS2601781 | 2026/07/24 | Official source ↗ |
| Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized | CYHS2601297 | 2026/06/04 | Official source ↗ |
| Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized | CYHS2601296 | 2026/06/04 | Official source ↗ |
| Hunan Ming Rui Pharmaceutical Co., Ltd. romanized | CYHS2600002 | 2026/01/05 | Official source ↗ |
| Hunan Ming Rui Pharmaceutical Co., Ltd. romanized | CYHS2600001 | 2026/01/05 | Official source ↗ |
API companies with A status 9
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Heilongjiang Zhen Bao Dao Pharma Co., Ltd. Ji Xi Branch romanized | Y20250000333 | 2026/11/05 | Official source ↗ |
| Dong Bei Pharmaceutical Group Co., Ltd. romanized | Y20250000151 | 2026/07/20 | Official source ↗ |
| Chongqing Bo Teng Pharmaceutical Technology Co., Ltd. romanized | Y20250000045 | 2026/09/29 | Official source ↗ |
| Anhui Ai Li De Pharmaceutical Co., Ltd. romanized | Y20240001330 | 2026/07/13 | Official source ↗ |
| Hebei Guo Long Pharmaceutical Co., Ltd. romanized | Y20240001563 | 2026/09/29 | Official source ↗ |
| Hunan Ming Rui Pharmaceutical Co., Ltd. romanized | Y20240001437 | 2026/10/23 | Official source ↗ |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | Y20240001428 | 2026/07/16 | Official source ↗ |
| Nan Tong Chang You Pharma Technology Co., Ltd. romanized | Y20220000381 | 2024/02/27 | Official source ↗ |
| CSPC OUYI PHARMACEUTICAL CO., LTD. | Y20210000518 | 2022/10/20 | 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 ↗ · 60-49 · 2022/10/11
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