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Matched- Active ingredients (original)
- BRIMONIDINE TARTRATE
- 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 approval1996/09/06
ANDA applications21
RLD applicantABBVIE INC / ALLERGAN INC / BAUSCH AND LOMB INC / SANDOZ INC
Currently marketed products: 25 · 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 |
|---|---|---|---|---|---|---|---|---|---|
| A076254-001 | BRIMONIDINE TARTRATE | SANDOZ INC | SOLUTION/DROPS | OPHTHALMIC | BRIMONIDINE TARTRATE: 0.2% | 2003/09/16 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A076260-001 | BRIMONIDINE TARTRATE | BAUSCH AND LOMB INC | SOLUTION/DROPS | OPHTHALMIC | BRIMONIDINE TARTRATE: 0.2% | 2003/05/28 | N / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A076372-001 | BRIMONIDINE TARTRATE | TEVA PARENTERAL MEDICINES INC | SOLUTION/DROPS | OPHTHALMIC | BRIMONIDINE TARTRATE: 0.2% | 2004/09/10 | N / N | DISCONTINUED | openFDA ↗ |
| A076439-001 | BRIMONIDINE TARTRATE | RISING PHARMA HOLDINGS INC | SOLUTION/DROPS | OPHTHALMIC | BRIMONIDINE TARTRATE: 0.2% | 2006/03/14 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A078075-001 | BRIMONIDINE TARTRATE | SANDOZ INC | SOLUTION/DROPS | OPHTHALMIC | BRIMONIDINE TARTRATE: 0.2% | 2008/01/30 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A078479-001 | BRIMONIDINE TARTRATE | APOTEX INC | SOLUTION/DROPS | OPHTHALMIC | BRIMONIDINE TARTRATE: 0.15% | 2022/01/31 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A078480-001 | BRIMONIDINE TARTRATE | APOTEX INC | SOLUTION/DROPS | OPHTHALMIC | BRIMONIDINE TARTRATE: 0.1% | 2022/12/21 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A091691-001 | BRIMONIDINE TARTRATE | REGCON HOLDINGS LLC | SOLUTION/DROPS | OPHTHALMIC | BRIMONIDINE TARTRATE: 0.2% | 2014/11/18 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A203172-001 | BRIMONIDINE TARTRATE | SANDOZ INC | SOLUTION/DROPS | OPHTHALMIC | BRIMONIDINE TARTRATE: 0.1% | 2024/03/04 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A208992-001 | BRIMONIDINE TARTRATE | SOMERSET THERAPEUTICS LLC | SOLUTION/DROPS | OPHTHALMIC | BRIMONIDINE TARTRATE: 0.2% | 2019/03/11 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A213215-001 | BRIMONIDINE TARTRATE | LUPIN LTD | SOLUTION/DROPS | OPHTHALMIC | BRIMONIDINE TARTRATE: 0.1% | 2024/08/26 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A215225-001 | BRIMONIDINE TARTRATE | ALEMBIC PHARMACEUTICALS LTD | SOLUTION/DROPS | OPHTHALMIC | BRIMONIDINE TARTRATE: 0.15% | 2023/03/29 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A216361-001 | BRIMONIDINE TARTRATE | DR REDDYS LABORATORIES SA | SOLUTION/DROPS | OPHTHALMIC | BRIMONIDINE TARTRATE: 0.025% | 2024/02/16 | N / N | HUMAN OTC DRUG | openFDA ↗ |
| A216772-001 | BRIMONIDINE TARTRATE | UPSHER SMITH LABORATORIES LLC | SOLUTION/DROPS | OPHTHALMIC | BRIMONIDINE TARTRATE: 0.15% | 2024/06/12 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A216906-001 | BRIMONIDINE TARTRATE | SOMERSET THERAPEUTICS LLC | SOLUTION/DROPS | OPHTHALMIC | BRIMONIDINE TARTRATE: 0.1% | 2024/08/09 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A216909-001 | BRIMONIDINE TARTRATE | ALEMBIC PHARMACEUTICALS LTD | SOLUTION/DROPS | OPHTHALMIC | BRIMONIDINE TARTRATE: 0.1% | 2023/08/01 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A217599-001 | BRIMONIDINE TARTRATE | UPSHER SMITH LABORATORIES LLC | SOLUTION/DROPS | OPHTHALMIC | BRIMONIDINE TARTRATE: 0.1% | 2025/07/30 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A217846-001 | BRIMONIDINE TARTRATE | MICRO LABS LTD | SOLUTION/DROPS | OPHTHALMIC | BRIMONIDINE TARTRATE: 0.2% | 2023/11/22 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A218558-001 | BRIMONIDINE TARTRATE | MICRO LABS LTD | SOLUTION/DROPS | OPHTHALMIC | BRIMONIDINE TARTRATE: 0.1% | 2026/05/07 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A219219-001 | BRIMONIDINE TARTRATE | GLAND PHARMA LTD | SOLUTION/DROPS | OPHTHALMIC | BRIMONIDINE TARTRATE: 0.1% | 2026/03/11 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A220398-001 | BRIMONIDINE TARTRATE | MANKIND PHARMA LTD | SOLUTION/DROPS | OPHTHALMIC | BRIMONIDINE TARTRATE: 0.1% | 2026/04/16 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N020490-001 | ALPHAGAN | ALLERGAN INC | SOLUTION/DROPS | OPHTHALMIC | BRIMONIDINE TARTRATE: 0.5% | 1997/03/13 | N / N | DISCONTINUED | openFDA ↗ |
| N020613-001 | ALPHAGAN | ALLERGAN INC | SOLUTION/DROPS | OPHTHALMIC | BRIMONIDINE TARTRATE: 0.2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 1996/09/06 | Y / N | DISCONTINUED | openFDA ↗ |
| N021262-001 | ALPHAGAN P | ABBVIE INC | SOLUTION/DROPS | OPHTHALMIC | BRIMONIDINE TARTRATE: 0.15% | 2001/03/16 | Y / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N021764-001 | QOLIANA | SANDOZ INC | SOLUTION/DROPS | OPHTHALMIC | BRIMONIDINE TARTRATE: 0.15% | 2006/05/22 | Y / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N021770-001 | ALPHAGAN P | ABBVIE INC | SOLUTION/DROPS | OPHTHALMIC | BRIMONIDINE TARTRATE: 0.1% | 2005/08/19 | Y / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N208144-001 | LUMIFY | BAUSCH AND LOMB INC | SOLUTION/DROPS | OPHTHALMIC | BRIMONIDINE TARTRATE: 0.025% | 2017/12/22 | Y / Y | HUMAN OTC DRUG | openFDA ↗ |
| N218424-001 | LUMIFY PRESERVATIVE FREE | BAUSCH AND LOMB INC | SOLUTION/DROPS | OPHTHALMIC | BRIMONIDINE TARTRATE: 0.025% | 2024/04/19 | Y / Y | HUMAN OTC 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 expiration2030/07/14
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 |
|---|---|---|---|---|---|---|
| N208144-001 | 11596600 | 2029/07/27 | — / — | U-2222 | — | openFDA ↗ |
| N208144-001 | 11833245 | 2029/07/27 | — / — | U-2222 | — | openFDA ↗ |
| N208144-001 | 12514857 | 2029/07/27 | — / — | U-2222 | — | openFDA ↗ |
| N208144-001 | 8293742 | 2030/07/14 | — / — | U-2222 | — | openFDA ↗ |
| N208144-001 | 9259425 | 2030/07/14 | — / — | U-2222 | — | openFDA ↗ |
| N218424-001 | 11596600 | 2029/07/27 | — / — | U-2222 | — | openFDA ↗ |
| N218424-001 | 12311050 | 2029/07/27 | — / — | U-2222 | — | openFDA ↗ |
| N218424-001 | 12514857 | 2029/07/27 | — / — | U-2222 | — | openFDA ↗ |
| N218424-001 | 8293742 | 2030/07/14 | — / — | U-2222 | — | openFDA ↗ |
| N218424-001 | 9259425 | 2030/07/14 | — / — | U-2222 | — | 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 2
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Allergan Inc. | H201604250.15% | 2009/08/19 | Official source ↗ |
| Allergan Inc. | H201604260.15% | 2009/08/19 | Official source ↗ |
| Allergan Pharmaceuticals Ireland | H201606815ml:10mg | 2003/06/02 | Official source ↗ |
NHSA approval numbers 18
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Guangdong Zhong Sheng Pharma Co., Ltd. romanized | 国药准字H202531210.2%(5ml∶10mg) | — | Official source ↗ |
| Wuxi Ji Yu Shan He Pharma Co., Ltd. romanized | 国药准字H200804390.2%(5ml:10mg) | — | Official source ↗ |
| Shijiazhuang Gree Pharmaceutical Co., Ltd | 国药准字H202537300.2%(5ml:10mg) | — | Official source ↗ |
| Lu Nan Bei Te Pharmaceutical Co., Ltd. romanized | 国药准字H200800765ml :10mg | — | Official source ↗ |
| Qilu Pharmaceutical Co., Ltd. | 国药准字H202132790.15%(0.3ml:0.45mg) | — | Official source ↗ |
| Beijing Hui En Lan De Pharmaceutical Co., Ltd. romanized | 国药准字H201632415ml:10mg | — | Official source ↗ |
| Sandoz Inc. | H201505045ml:10mg | — | Official source ↗ |
| AbbVie Inc. | 国药准字HJ201604260.15%(5ml:7.5mg) | — | Official source ↗ |
| AbbVie Limited | 国药准字HJ201606815ml:10mg | — | Official source ↗ |
| Nanjing Hai Na Pharmaceutical Co., Ltd. romanized | 国药准字H202555130.15%(0.3ml:0.45mg) | — | Official source ↗ |
| Lu Nan Pharmaceutical Group Co., Ltd. romanized | 国药准字H202647560.2%(5ml:10mg) | — | Official source ↗ |
| Shandong Wei Zhi Bai Ke Pharma Co., Ltd. romanized | 国药准字H202433470.2%(5ml:10mg) | — | Official source ↗ |
| Shan Tou Jing Ji Te Qu Ming Zhi Pharmaceuticals Co., Ltd. romanized | 国药准字H202532720.2%(5ml:10mg) | — | Official source ↗ |
| Suzhou Ou Kang Wei Shi Bio Technology Co., Ltd. romanized | 国药准字H20249123See source | — | Official source ↗ |
| Beijing Nuo Si Lan De Bio Technology Co., Ltd. romanized | 国药准字H202431520.2%(5ml:10mg) | — | Official source ↗ |
| Ai Er Health Yan Yao (Liaoning) Co., Ltd. romanized | 国药准字H202437480.2%(5ml:10mg) | — | Official source ↗ |
| Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202543080.2%(5ml:10mg) | — | Official source ↗ |
| Sichuan Zhi Qiang Pharmaceuticals Technology Kai Fa Co., Ltd. romanized | 国药准字H202494280.15%(0.3ml:0.45mg) | — | Official source ↗ |
Under review 4
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Jiangsu Fu Bang Pharma Co., Ltd. romanized | CYHS2602311 | 2026/09/17 | Official source ↗ |
| Fu Xing Pharmaceuticals (Xu Zhou) Co., Ltd. romanized | CYHS2600159 | 2026/01/13 | Official source ↗ |
| Jiangsu Tian Ping Pharma Co., Ltd. romanized | CYHS2602385 | 2026/09/22 | Official source ↗ |
| Da Bang (Hunan) Biopharmaceutical Co., Ltd. romanized | CYHL2600102 | 2026/09/22 | Official source ↗ |
Generic-filing companies this year 5
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Jiangsu Fu Bang Pharma Co., Ltd. romanized | CYHS2602311 | 2026/09/17 | Official source ↗ |
| Fu Xing Pharmaceuticals (Xu Zhou) Co., Ltd. romanized | CYHS2600159 | 2026/01/13 | Official source ↗ |
| Jiangsu Tian Ping Pharma Co., Ltd. romanized | CYHS2602385 | 2026/09/22 | Official source ↗ |
| Da Bang (Hunan) Biopharmaceutical Co., Ltd. romanized | CYHL2600102 | 2026/09/22 | Official source ↗ |
| Beijing Hui En Lan De Pharmaceutical Co., Ltd. romanized | CYHL2600009 | 2026/01/13 | Official source ↗ |
| Beijing Hui En Lan De Pharmaceutical Co., Ltd. romanized | CYHL2600008 | 2026/01/13 | Official source ↗ |
API companies with A status 7
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| C-SQUARED PHARMA LIMITED | Y20240000181 | 2026/02/25 | Official source ↗ |
| Shijiazhuang Gree Pharmaceutical Co., Ltd | Y20230001184 | 2026/06/02 | Official source ↗ |
| CZECH-GEN, a.s. | Y20210000747 | 2026/10/16 | Official source ↗ |
| Changzhou Ya Bang Pharmaceutical Co., Ltd. romanized | Y20190007214 | — | Official source ↗ |
| Lu Nan Bei Te Pharmaceutical Co., Ltd. romanized | Y20190007183 | 2025/12/04 | Official source ↗ |
| Nanjing Heng Sheng Pharmaceutical Co., Ltd. romanized | Y20190007132 | — | Official source ↗ |
| Indoco Remedies Ltd. (Kilo Lab) | Y20170000909 | 2026/04/02 | 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 ↗ · 29-65 · 2020/08/06
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