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Matched- Active ingredients (original)
- GATIFLOXACIN
- Dosage form (original)
- SOLUTION/DROPS
- Route (original)
- OPHTHALMIC
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 approval2003/03/28
ANDA applications6
RLD applicantABBVIE INC / ALLERGAN INC
Currently marketed products: 3 · 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 |
|---|---|---|---|---|---|---|---|---|---|
| A079084-001 | GATIFLOXACIN | APOTEX INC | SOLUTION/DROPS | OPHTHALMIC | GATIFLOXACIN: 0.3% | 2011/08/19 | N / N | DISCONTINUED | openFDA ↗ |
| A202653-001 | GATIFLOXACIN | LUPIN LTD | SOLUTION/DROPS | OPHTHALMIC | GATIFLOXACIN: 0.5% | 2013/08/28 | N / N | DISCONTINUED | openFDA ↗ |
| A203189-001 | GATIFLOXACIN | HIKMA PHARMACEUTICALS USA INC | SOLUTION/DROPS | OPHTHALMIC | GATIFLOXACIN: 0.5% | 2014/09/03 | N / N | DISCONTINUED | openFDA ↗ |
| A204227-001 | GATIFLOXACIN | SANDOZ INC | SOLUTION/DROPS | OPHTHALMIC | GATIFLOXACIN: 0.5% | 2016/07/11 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A206446-001 | GATIFLOXACIN | RISING PHARMA HOLDINGS INC | SOLUTION/DROPS | OPHTHALMIC | GATIFLOXACIN: 0.5% | 2018/06/08 | N / N | DISCONTINUED | openFDA ↗ |
| A213542-001 | GATIFLOXACIN | CAPLIN STERILES LTD | SOLUTION/DROPS | OPHTHALMIC | GATIFLOXACIN: 0.5% | 2021/11/03 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N021493-001 | ZYMAR | ALLERGAN INC | SOLUTION/DROPS | OPHTHALMIC | GATIFLOXACIN: 0.3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 2003/03/28 | Y / N | DISCONTINUED | openFDA ↗ |
| N022548-001 | ZYMAXID | ABBVIE INC | SOLUTION/DROPS | OPHTHALMIC | GATIFLOXACIN: 0.5% | 2010/05/18 | 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 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 0
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| No matching records in this loaded source. | |||
NHSA approval numbers 12
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Yao Ming Cheng De (Guangzhou) Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H201200305ml:15mg | — | Official source ↗ |
| Zhongguo Da Zhong Pharmaceutical Co., Ltd. romanized | 国药准字H201101190.3% | — | Official source ↗ |
| Jiangsu Ji Bei Er Pharma Co., Ltd. romanized | 国药准字H200902360.3% | — | Official source ↗ |
| Jiangsu Yun Yang Group Pharma Co., Ltd. romanized | 国药准字H200600495ml:15mg | — | Official source ↗ |
| Yi Chang Nuo An Pharmaceutical Co., Ltd. romanized | 国药准字H201831580.3%(5ml:15mg) | — | Official source ↗ |
| Zhengzhou Zhuo Feng Pharmaceutical Co., Ltd. romanized | 国药准字H200806530.3% | — | Official source ↗ |
| Hefei Li Fang Pharmaceutical Co., Ltd. romanized | 国药准字H200518250.3%(g/ml) | — | Official source ↗ |
| Hefei Li Min Pharmaceutical Co., Ltd. romanized | 国药准字H202631970.3%(5ml:15mg) | — | Official source ↗ |
| Chu Xiong Lao Bo Yun Tang Pharma Co., Ltd. romanized | 国药准字H20060479See source | — | Official source ↗ |
| Ningxia Kang Ya Pharma Co., Ltd. romanized | 国药准字H202032010.3%(5ml:15mg) | — | Official source ↗ |
| Guangzhou Ren Heng Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202546110.3%(5ml:15mg) | — | Official source ↗ |
| Hefei Yuan Feng Shun Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202560850.3%(5ml:15mg) | — | Official source ↗ |
| Yi Chang Nuo An Pharmaceutical Co., Ltd. romanized | 国药准字H201831580.3%(5ml:15mg) | — | Official source ↗ |
| Hefei Li Min Pharmaceutical Co., Ltd. romanized | 国药准字H202631970.3%(5ml:15mg) | — | Official source ↗ |
| Zhongguo Da Zhong Pharmaceutical Co., Ltd. romanized | 国药准字H201101190.3% | — | Official source ↗ |
| Jiangsu Ji Bei Er Pharma Co., Ltd. romanized | 国药准字H200902360.3% | — | Official source ↗ |
| Zhengzhou Zhuo Feng Pharmaceutical Co., Ltd. romanized | 国药准字H200806530.3% | — | Official source ↗ |
| Hefei Li Fang Pharmaceutical Co., Ltd. romanized | 国药准字H200518250.3%(g/ml) | — | Official source ↗ |
| Chu Xiong Lao Bo Yun Tang Pharma Co., Ltd. romanized | 国药准字H20060479See source | — | Official source ↗ |
| Zhongguo Da Zhong Pharmaceutical Co., Ltd. romanized | 国药准字H201101190.3% | — | Official source ↗ |
| Hefei Li Fang Pharmaceutical Co., Ltd. romanized | 国药准字H200518250.3%(g/ml) | — | Official source ↗ |
| Chu Xiong Lao Bo Yun Tang Pharma Co., Ltd. romanized | 国药准字H20060479See source | — | Official source ↗ |
| Zhongguo Da Zhong Pharmaceutical Co., Ltd. romanized | 国药准字H201101190.3% | — | Official source ↗ |
Under review 3
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Run Er Yan Ke Drug (Guangzhou) Co., Ltd. romanized | CYHS2601932 | 2026/08/07 | Official source ↗ |
| Zhuhai Qian Lie Pharma Co., Ltd. romanized; HUNAN WARRANT PHARMACEUTICAL CO.,LTD | CYHS2601710 | 2026/07/17 | Official source ↗ |
| Zhuhai Qian Lie Pharma Co., Ltd. romanized; HUNAN WARRANT PHARMACEUTICAL CO.,LTD | CYHS2601709 | 2026/07/17 | Official source ↗ |
Generic-filing companies this year 2
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Run Er Yan Ke Drug (Guangzhou) Co., Ltd. romanized | CYHS2601932 | 2026/08/07 | Official source ↗ |
| Zhuhai Qian Lie Pharma Co., Ltd. romanized; HUNAN WARRANT PHARMACEUTICAL CO.,LTD | CYHS2601710 | 2026/07/17 | Official source ↗ |
| Zhuhai Qian Lie Pharma Co., Ltd. romanized; HUNAN WARRANT PHARMACEUTICAL CO.,LTD | CYHS2601709 | 2026/07/17 | Official source ↗ |
API companies with A status 18
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Jiangsu Ji Bei Er Pharma Co., Ltd. romanized | Y20240000024 | 2025/10/22 | Official source ↗ |
| Hefei Li Fang Pharmaceutical Co., Ltd. romanized | Y20230000214 | 2024/12/20 | Official source ↗ |
| Hubei Hua Dan Pharmaceuticals Technology Co., Ltd. romanized | Y20190008909 | 2023/03/24 | Official source ↗ |
| Sichuan Ren An Pharma Co., Ltd. romanized | Y20190007219 | 2023/05/31 | Official source ↗ |
| Jiangsu Yong Da Pharma Co., Ltd. romanized | Y20190007165 | — | Official source ↗ |
| Yue Kang Pharma Group Anhui Tian Ran Pharmaceutical Co., Ltd. romanized | Y20190006482 | 2026/03/19 | Official source ↗ |
| Jiangsu Yong Da Pharma Co., Ltd. romanized | Y20190006468 | — | Official source ↗ |
| Xiu Zheng Pharma Group Liu He Pharmaceutical Co., Ltd. romanized | Y20190006024 | 2025/03/29 | Official source ↗ |
| Shao Xing Jing Xin Pharma Co., Ltd. romanized | Y20190005424 | 2024/06/12 | Official source ↗ |
| Jiangsu Ao Sai Kang Pharma Co., Ltd. romanized | Y20190004764 | — | Official source ↗ |
| Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | Y20190004678 | — | Official source ↗ |
| Su Zhong Pharma Group Co., Ltd. romanized | Y20190004063 | 2025/10/16 | Official source ↗ |
| Hubei Heng Di Pharma Co., Ltd. romanized | Y20190003106 | 2025/06/06 | Official source ↗ |
| Yang Zi Jiang Pharma Group Jiangsu Hai Ci Bio Pharma Co., Ltd. romanized | Y20190002698 | — | Official source ↗ |
| Zhejiang Pharmaceuticals Co., Ltd. Xin Chang Pharmaceutical Factory romanized | Y20190002634 | 2025/02/13 | Official source ↗ |
| Sichuan Bai Li Pharma Co., Ltd. romanized | Y20190002633 | 2025/10/30 | Official source ↗ |
| Zhejiang Jian Feng Pharma Co., Ltd. romanized | Y20190002485 | — | Official source ↗ |
| Henan Kang Tai Pharma Co., Ltd. romanized | Y20190001775 | 2024/09/11 | Official source ↗ |
| Zhejiang Zhe Bang Pharmaceutical Co., Ltd. romanized | Y20190001764 | — | 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.
Formulation crosswalk to SOLUTION/DROPS / OPHTHALMIC, based on the Chinese Pharmacopoeia general formulation provisions, rule CHP-FORM-039. Chinese Pharmacopoeia general chapter 0105
Comparison generated: 2026/11/13 18:41 · openFDA Orange Book ↗
Name and dosage-form matching sources
- NMPA reference-product directory, Shaanxi MPA republication ↗ · 23-31 · 2020/01/03
- Chinese Pharmacopoeia 2025, formulation chapter; site crosswalk ↗ · See source
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