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Sign in to subscribeBaloxavir Marboxil Tablets
As of 13 November 2026, for Baloxavir Marboxil Tablets, 12 applications are listed as under review at China's CDE; 3 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 3 holders.
Companies, stages and changes, with each record available on this page.
Listed in the US FDA Orange Book as XOFLUZA (NDA 210854, GENENTECH INC).
No changes recorded by this site in the last 90 days
Complete CDE snapshot: 2026/11/13 06:42
Current coverage may be incomplete
US Orange Book listing
The brand names come from the US FDA Orange Book and describe US listing records for this active ingredient. They do not indicate that products under these brand names are approved or sold in China, or that Chinese applicants are affiliated with US holders.
Orange Book source export date: 2026/11/06. Version: 2026-11-06.
Showing 1 of 1 distinct brand names.
A brand with different source forms or statuses can appear on multiple rows and in both groups. Distinct brand names are counted once globally, with a limit of five.
Verified official English dosage form: Tablets. Listings are grouped by the source dosage form and route; records without a clear correspondence are listed in the other group. Grouping does not establish product equivalence.
Same dosage form
| Brand name | Applicant (source text) | Application number | Dosage form (source text) | Route (source text) | Marketing status (source text) | Approval date |
|---|---|---|---|---|---|---|
| XOFLUZA | GENENTECH INC | NDA 210854 · Product no. 002 | TABLET | ORAL | HUMAN PRESCRIPTION DRUG | 2018/10/24 |
| XOFLUZA | GENENTECH INC | NDA 210854 · Product no. 003 | TABLET | ORAL | HUMAN PRESCRIPTION DRUG | 2021/03/18 |
| XOFLUZA | GENENTECH INC | NDA 210854 · Product no. 001 | TABLET | ORAL | DISCONTINUED | 2018/10/24 |
Other dosage forms of the same ingredient
| Brand name | Applicant (source text) | Application number | Dosage form (source text) | Route (source text) | Marketing status (source text) | Approval date |
|---|---|---|---|---|---|---|
| XOFLUZA | GENENTECH INC | NDA 214410 · Product no. 001 | FOR SUSPENSION | ORAL | HUMAN PRESCRIPTION DRUG | 2020/11/23 |
| XOFLUZA | GENENTECH INC | NDA 214410 · Product no. 002, 003 | FOR SUSPENSION | ORAL | HUMAN PRESCRIPTION DRUG | 2025/05/30 |
Same-form/route listings come first, followed by other forms/routes. Within each group, source prescription/OTC listings precede discontinued listings; unknown statuses are last. Each status bucket is ordered by earliest approval date, ascending: pre-1982 records first, missing dates last; ties by brand name, application number and product number. The first five distinct brands in this order are selected globally. All retained source facts for those brands are shown in their own groups; a brand spanning both groups counts once.
Which companies are listed, and at what stages?
Each source is counted separately. Expand a list to inspect companies, identifiers, dates and sources.
Legal reference identifiers are retained verbatim. Company labels use official English entries where available, or a visibly marked fixed romanization. Unverified drug names retain the Chinese source name with a No verified English name marker. Other Chinese free text is not displayed; use the source links or source-name columns in CSV exports.
Catalogue holders3View records ↓
Under-review filings12View records ↓
This year’s generic filers3View records ↓
NHSA approval numbers2View records ↓
API companies with A status9View records ↓
Chemical-drug catalogue
Loaded records: 3 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 3 in the new chemical-registration-classification generic category. Category counts may overlap.
| Marketing authorization holder | Manufacturer | Approval number | Approved | Strength / specification | Catalogue category (source text) | View source |
|---|---|---|---|---|---|---|
| Zhejiang Pu Li Pharma Co., Ltd. romanized | Zhejiang Pu Li Pharma Co., Ltd. romanized | 国药准字H20263286 | 2026/01/27 | 40mg | Generic approved under the new chemical-drug registration classification | CDE |
| Zhejiang Pu Li Pharma Co., Ltd. romanized | Zhejiang Pu Li Pharma Co., Ltd. romanized | 国药准字H20263285 | 2026/01/27 | 20mg | Generic approved under the new chemical-drug registration classification | CDE |
| Zhengzhou Tai Feng Pharmaceutical Co., Ltd. romanized | Zhengzhou Tai Feng Pharmaceutical Co., Ltd. romanized | 国药准字H20253114 | 2025/01/08 | 20mg | Generic approved under the new chemical-drug registration classification | CDE |
| CSPC OUYI PHARMACEUTICAL CO., LTD. | CSPC OUYI PHARMACEUTICAL CO., LTD. | 国药准字H20223746 | 2022/10/11 | 20mg | Generic approved under the new chemical-drug registration classification | CDE |
Distinct full holder names; manufacturers are used only where the holder is unstated. The catalogue covers only part of the chemical-drug market. Categories are counted as recorded, not as a complete market census.
NHSA drug codes
Loaded records: 2 distinct approval numbers and 1 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| Roche Pharma(Schweiz) AG | 国药准字HJ20210027 | 20mg | Category B | XJ05AXM176A001010182682 | NHSA |
| Roche Pharma(Schweiz) AG | 国药准字HJ20210028 | 40mg | Category B | XJ05AXM176A001020182682 | NHSA |
Approval numbers and companies are deduplicated separately; packaging records remain individually listed. An empty insurance class means it is unstated. NHSA codes supply no approval date and do not establish the outcome of an acceptance number.
Current under-review applications
Loaded records: 12 filings and 8 distinct first applicants.
Generic 12
New generic filings in 2026
Loaded records: 5 filings and 3 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Hangzhou Minsheng Pharmaceutical Co., Ltd | CYHS2601781 | Generic | 2026/07/24 | Not stated by source | CDE |
| Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized | CYHS2601297 | Generic | 2026/06/04 | Not stated by source | CDE |
| Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized | CYHS2601296 | Generic | 2026/06/04 | Not stated by source | CDE |
| Hunan Ming Rui Pharmaceutical Co., Ltd. romanized | CYHS2600002 | Generic | 2026/01/05 | Not stated by source | CDE |
| Hunan Ming Rui Pharmaceutical Co., Ltd. romanized | CYHS2600001 | Generic | 2026/01/05 | Not stated by source | CDE |
API registrations
Non-component matches: 9 companies with A status and 12 I-status records. Component matches are listed separately and excluded from these counts.
| Name | Company / applicant | Registration number | Status | Name match | Source update date | View source |
|---|---|---|---|---|---|---|
| 玛巴洛沙韦 · No verified English name | Shandong Xin Shi Dai Pharma Co., Ltd. romanized | Y20260000672 | I | Exact ingredient | 2026/08/31 | CDE |
| 玛巴洛沙韦 · No verified English name | Shionogi & Co., Ltd. | Y20260000559 | I | Exact ingredient | 2026/08/18 | CDE |
| 玛巴洛沙韦 · No verified English name | Zhejiang Yong Ning Pharma Co., Ltd. romanized | Y20260000454 | I | Exact ingredient | 2026/07/30 | CDE |
| 玛巴洛沙韦 · No verified English name | Hebei Hua Chen Pharma Group Co., Ltd. romanized | Y20260000464 | I | Exact ingredient | 2026/06/16 | CDE |
| 玛巴洛沙韦 · No verified English name | Jing Hua Pharmaceutical Group Nan Tong Co., Ltd. romanized | Y20260000203 | I | Exact ingredient | 2026/04/15 | CDE |
| 玛巴洛沙韦 · No verified English name | Fujian Nan Fang Pharmaceutical Co., Ltd. romanized | Y20250001326 | I | Exact ingredient | 2026/03/26 | CDE |
| 玛巴洛沙韦 · No verified English name | Sichuan Tai En Kang Pharmaceutical Co., Ltd. romanized | Y20260000101 | I | Exact ingredient | 2026/03/19 | CDE |
| 玛巴洛沙韦 · No verified English name | Hunan Ou Ya Pharma Co., Ltd. romanized | Y20260000178 | I | Exact ingredient | 2026/03/18 | CDE |
| 玛巴洛沙韦 · No verified English name | Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized | Y20260000150 | I | Exact ingredient | 2026/03/10 | CDE |
| 玛巴洛沙韦 · No verified English name | Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. | Y20250001470 | I | Exact ingredient | 2026/01/06 | CDE |
| 玛巴洛沙韦 · No verified English name | Jin Hong Pharma Co., Ltd. romanized | Y20250001186 | I | Exact ingredient | 2025/11/13 | CDE |
| 玛巴洛沙韦 · No verified English name | Shandong Cheng Hui Shuang Da Pharma Co., Ltd. romanized | Y20250001001 | I | Exact ingredient | 2025/09/24 | CDE |
| 玛巴洛沙韦 · No verified English name | Heilongjiang Zhen Bao Dao Pharma Co., Ltd. Ji Xi Branch romanized | Y20250000333 | A | Exact ingredient | 2026/11/05 | CDE |
| 玛巴洛沙韦 · No verified English name | Dong Bei Pharmaceutical Group Co., Ltd. romanized | Y20250000151 | A | Exact ingredient | 2026/07/20 | CDE |
| 玛巴洛沙韦 · No verified English name | Chongqing Bo Teng Pharmaceutical Technology Co., Ltd. romanized | Y20250000045 | A | Exact ingredient | 2026/09/29 | CDE |
| 玛巴洛沙韦 · No verified English name | Anhui Ai Li De Pharmaceutical Co., Ltd. romanized | Y20240001330 | A | Exact ingredient | 2026/07/13 | CDE |
| 玛巴洛沙韦 · No verified English name | Hebei Guo Long Pharmaceutical Co., Ltd. romanized | Y20240001563 | A | Exact ingredient | 2026/09/29 | CDE |
| 玛巴洛沙韦 · No verified English name | Hunan Ming Rui Pharmaceutical Co., Ltd. romanized | Y20240001437 | A | Exact ingredient | 2026/10/23 | CDE |
| 玛巴洛沙韦 · No verified English name | Jiangsu Deyuan Pharmaceutical Co.,Ltd. | Y20240001428 | A | Exact ingredient | 2026/07/16 | CDE |
| 玛巴洛沙韦 · No verified English name | Nan Tong Chang You Pharma Technology Co., Ltd. romanized | Y20220000381 | A | Exact ingredient | 2024/02/27 | CDE |
| 玛巴洛沙韦 · No verified English name | CSPC OUYI PHARMACEUTICAL CO., LTD. | Y20210000518 | A | Exact ingredient | 2022/10/20 | CDE |
A/I are source statuses. Matching uses exact ingredients, salt-normalized names and maintained combination components, without fuzzy matching. A-status companies are deduplicated by the first registered company. Components are excluded from headline counts; the register does not identify the associated formulation.
What changed recently?
Last 90 days, ordered by fact date. Marketing approvals, trial registrations, supplements, notices and review changes are labelled separately.
Trial registration does not mean an application will follow.
This product is outside the trial-registration backfill scope. New registrations after daily collection started remain in scope. Historical rows may also be found by another product search; neither implies complete historical coverage for this product.
NHSA edition maintained to 2026-10-23; latest successful catalogue check: 2026/11/13 06:39. NHSA records lack approval dates; only an earlier edition or observation establishes precedence.
This source was last successfully updated at 2026/11/12 18:32; current coverage may be incomplete.
- No matching records were found in the currently loaded source data; coverage dates are listed below.
How current is each source?
- CDE acceptances and review
- Last successful update: 2026/11/13 06:42
- Chemical-drug catalogue
- Last successful update: 2026/11/13 06:39
Distinct full holder names; manufacturers are used only where the holder is unstated. The catalogue covers only part of the chemical-drug market. Categories are counted as recorded, not as a complete market census.
- Full API register
- Last successful update: 2026/11/13 06:41
- NHSA drug codes
- Last successful update: 2026/11/05 06:45
The fully loaded edition was maintained to 2026-10-23. Publication lags maintenance: the verified 2026-10-16 edition was published on 10-28, a 12-day gap. This is not a fixed lag for every edition.
- NMPA drug delivery notices
- Last successful update: 2026/11/12 18:32 · Current coverage may be incomplete
First index-page publication dates: 2026-10-29 to 2026-11-13; 2 pages pending. Covers loaded notices only, not a complete historical approval database.
- Drug Clinical Trial Registry and Information Disclosure Platform
- Last successful update: 2026/11/13 08:09 · Current coverage may be incomplete
Daily collection reads new registrations. Backfill covers registration numbers from 2025 onward (CTR2025/CTR2026), not first-publication years. States are dated observations; revisions are not tracked.
This product is outside the trial-registration backfill scope. New registrations after daily collection started remain in scope. Historical rows may also be found by another product search; neither implies complete historical coverage for this product.
Public-product searches scanned: 7/30; discovered pending details: 13. Record counts in unscanned portions remain unknown.
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.
Fact dates are approval dates, acceptance dates, trial first-publication dates or complete-snapshot observation dates, as applicable. Publication and site-observation dates are separate. Historical backfills are not current-period new events. Exit records cover currently inactive applications with an identifiable complete snapshot, not a full review history.
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