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Sign in to subscribeAxitinib Tablets
Matched- Active ingredients (original)
- AXITINIB
- 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 approval2012/01/27
ANDA applications1
RLD applicantPF PRISM CV
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 |
|---|---|---|---|---|---|---|---|---|---|
| A211650-001 | AXITINIB | APOTEX INC | TABLET | ORAL | AXITINIB: 1MG | 2025/10/30 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A211650-002 | AXITINIB | APOTEX INC | TABLET | ORAL | AXITINIB: 5MG | 2025/10/30 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N202324-001 | INLYTA | PF PRISM CV | TABLET | ORAL | AXITINIB: 1MG | 2012/01/27 | Y / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N202324-002 | INLYTA | PF PRISM CV | TABLET | ORAL | AXITINIB: 5MG | 2012/01/27 | 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 expiration2037/07/12This latest date comes from a *PED row in the source and is displayed as listed.
Substance patent expiration (DS flag)2030/12/14
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 |
|---|---|---|---|---|---|---|
| N202324-001 | 10570202 | 2035/02/03 | — / — | U-2844 | — | openFDA ↗ |
| N202324-001 | 10570202*PED | 2035/08/03 | — / — | — | — | openFDA ↗ |
| N202324-001 | 10869924 | 2037/01/12 | — / — | U-3044 | — | openFDA ↗ |
| N202324-001 | 10869924*PED | 2037/07/12 | — / — | — | — | openFDA ↗ |
| N202324-001 | 12534530 | 2035/02/03 | — / — | U-4412 | — | openFDA ↗ |
| N202324-001 | 12534530*PED | 2035/08/03 | — / — | — | — | openFDA ↗ |
| N202324-001 | 8791140 | 2030/12/14 | Y / — | — | — | openFDA ↗ |
| N202324-001 | 8791140*PED | 2031/06/14 | — / — | — | — | openFDA ↗ |
| N202324-002 | 10570202 | 2035/02/03 | — / — | U-2844 | — | openFDA ↗ |
| N202324-002 | 10570202*PED | 2035/08/03 | — / — | — | — | openFDA ↗ |
| N202324-002 | 10869924 | 2037/01/12 | — / — | U-3044 | — | openFDA ↗ |
| N202324-002 | 10869924*PED | 2037/07/12 | — / — | — | — | openFDA ↗ |
| N202324-002 | 12534530 | 2035/02/03 | — / — | U-4412 | — | openFDA ↗ |
| N202324-002 | 12534530*PED | 2035/08/03 | — / — | — | — | openFDA ↗ |
| N202324-002 | 8791140 | 2030/12/14 | Y / — | — | — | openFDA ↗ |
| N202324-002 | 8791140*PED | 2031/06/14 | — / — | — | — | 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 3
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Guangzhou Ke Rui Te Pharma Co., Ltd. romanized | 国药准字H202639895mg | 2026/04/14 | Official source ↗ |
| Chengdu Easton Biopharmaceuticals Co.,Ltd. | 国药准字H202543315mg | 2025/05/27 | Official source ↗ |
| Pfizer Limited | H20150221; H201502225mg | 2015/04/29 | Official source ↗ |
| Pfizer Limited | H20150219; H201502201mg | 2015/04/29 | Official source ↗ |
NHSA approval numbers 4
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Chengdu Easton Biopharmaceuticals Co.,Ltd. | 国药准字H202543315mg | — | Official source ↗ |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H202134065mg | — | Official source ↗ |
| Pfizer Europe MA EEIG | 国药准字HJ201502201mg | — | Official source ↗ |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H202134065mg | — | Official source ↗ |
| Pfizer Europe MA EEIG | 国药准字HJ201502201mg | — | Official source ↗ |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H202134065mg | — | Official source ↗ |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H202134065mg | — | Official source ↗ |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H202134065mg | — | Official source ↗ |
| Pfizer Europe MA EEIG | 国药准字HJ201502215mg | — | Official source ↗ |
| Pfizer Europe MA EEIG | 国药准字HJ201502215mg | — | Official source ↗ |
Under review 5
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. | CYHS2601231 | 2026/06/01 | Official source ↗ |
| Jin Hong Pharma Co., Ltd. romanized | CYHS2602382 | 2026/09/22 | Official source ↗ |
| Jin Hong Pharma Co., Ltd. romanized | CYHS2602381 | 2026/09/22 | Official source ↗ |
| Jiangxi Shan Xiang Pharma Co., Ltd. romanized | CYHS2602235 | 2026/09/08 | Official source ↗ |
| Chengdu Easton Biopharmaceuticals Co.,Ltd. | CYHB2601267 | 2026/07/06 | Official source ↗ |
Generic-filing companies this year 3
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. | CYHS2601231 | 2026/06/01 | Official source ↗ |
| Jin Hong Pharma Co., Ltd. romanized | CYHS2602382 | 2026/09/22 | Official source ↗ |
| Jin Hong Pharma Co., Ltd. romanized | CYHS2602381 | 2026/09/22 | Official source ↗ |
| Jiangxi Shan Xiang Pharma Co., Ltd. romanized | CYHS2602235 | 2026/09/08 | Official source ↗ |
API companies with A status 3
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Guangzhou Ke Rui Te Pharma Co., Ltd. romanized | Y20240000536 | 2026/10/05 | Official source ↗ |
| Sichuan Qing Mu Pharmaceutical Co., Ltd. romanized | Y20230000186 | 2024/07/23 | Official source ↗ |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | Y20190021244 | 2025/08/08 | 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 ↗ · 8-193 · 2022/03/31
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