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Sign in to subscribeTimolol Maleate Eye Drops
Matched- Active ingredients (original)
- TIMOLOL MALEATE
- 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 approvalApproved before 1982
ANDA applications27
RLD applicantBAUSCH AND LOMB INC
Currently marketed products: 26 · 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 |
|---|---|---|---|---|---|---|---|---|---|
| A074261-001 | TIMOLOL MALEATE | SANDOZ INC | SOLUTION/DROPS | OPHTHALMIC | TIMOLOL MALEATE: EQ 0.25% BASE | 1995/04/28 | N / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A074262-001 | TIMOLOL MALEATE | SANDOZ INC | SOLUTION/DROPS | OPHTHALMIC | TIMOLOL MALEATE: EQ 0.5% BASE | 1995/04/28 | N / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A074465-001 | TIMOLOL MALEATE | EPIC PHARMA LLC | SOLUTION/DROPS | OPHTHALMIC | TIMOLOL MALEATE: EQ 0.25% BASE | 1997/03/25 | N / N | DISCONTINUED | openFDA ↗ |
| A074466-001 | TIMOLOL MALEATE | PHARMOBEDIENT CONSULTING LLC | SOLUTION/DROPS | OPHTHALMIC | TIMOLOL MALEATE: EQ 0.5% BASE | 1997/03/25 | N / N | DISCONTINUED | openFDA ↗ |
| A074515-001 | TIMOLOL MALEATE | EPIC PHARMA LLC | SOLUTION/DROPS | OPHTHALMIC | TIMOLOL MALEATE: EQ 0.25% BASE | 1997/03/25 | N / N | DISCONTINUED | openFDA ↗ |
| A074516-001 | TIMOLOL MALEATE | EPIC PHARMA LLC | SOLUTION/DROPS | OPHTHALMIC | TIMOLOL MALEATE: EQ 0.5% BASE | 1997/03/25 | N / N | DISCONTINUED | openFDA ↗ |
| A074667-001 | TIMOLOL MALEATE | E FOUGERA DIV ALTANA INC | SOLUTION/DROPS | OPHTHALMIC | TIMOLOL MALEATE: EQ 0.25% BASE | 1997/03/25 | N / N | DISCONTINUED | openFDA ↗ |
| A074668-001 | TIMOLOL MALEATE | E FOUGERA DIV ALTANA INC | SOLUTION/DROPS | OPHTHALMIC | TIMOLOL MALEATE: EQ 0.5% BASE | 1997/03/25 | N / N | DISCONTINUED | openFDA ↗ |
| A074746-001 | TIMOLOL MALEATE | ABBVIE INC | SOLUTION/DROPS | OPHTHALMIC | TIMOLOL MALEATE: EQ 0.25% BASE | 1997/03/25 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A074747-001 | TIMOLOL MALEATE | ABBVIE INC | SOLUTION/DROPS | OPHTHALMIC | TIMOLOL MALEATE: EQ 0.5% BASE | 1997/03/25 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A074776-001 | TIMOLOL MALEATE | BAUSCH AND LOMB INC | SOLUTION/DROPS | OPHTHALMIC | TIMOLOL MALEATE: EQ 0.5% BASE | 1997/03/25 | N / N | DISCONTINUED | openFDA ↗ |
| A074778-001 | TIMOLOL MALEATE | BAUSCH AND LOMB PHARMACEUTICALS INC | SOLUTION/DROPS | OPHTHALMIC | TIMOLOL MALEATE: EQ 0.25% BASE | 1997/03/25 | N / N | DISCONTINUED | openFDA ↗ |
| A075163-001 | TIMOLOL MALEATE | HIKMA PHARMACEUTICALS USA INC | SOLUTION/DROPS | OPHTHALMIC | TIMOLOL MALEATE: EQ 0.5% BASE | 2002/09/10 | N / N | DISCONTINUED | openFDA ↗ |
| A075411-001 | TIMOLOL MALEATE | APOTEX INC | SOLUTION/DROPS | OPHTHALMIC | TIMOLOL MALEATE: EQ 0.25% BASE | 2000/09/08 | N / N | DISCONTINUED | openFDA ↗ |
| A075412-001 | TIMOLOL MALEATE | APOTEX INC | SOLUTION/DROPS | OPHTHALMIC | TIMOLOL MALEATE: EQ 0.5% BASE | 2000/09/08 | N / N | DISCONTINUED | openFDA ↗ |
| A077259-001 | TIMOLOL MALEATE | FDC LTD | SOLUTION/DROPS | OPHTHALMIC | TIMOLOL MALEATE: EQ 0.25% BASE | 2008/04/30 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A077259-002 | TIMOLOL MALEATE | FDC LTD | SOLUTION/DROPS | OPHTHALMIC | TIMOLOL MALEATE: EQ 0.5% BASE | 2008/04/30 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A078771-001 | TIMOLOL MALEATE | MANKIND PHARMA LTD | SOLUTION/DROPS | OPHTHALMIC | TIMOLOL MALEATE: EQ 0.25% BASE | 2009/09/28 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A078771-002 | TIMOLOL MALEATE | MANKIND PHARMA LTD | SOLUTION/DROPS | OPHTHALMIC | TIMOLOL MALEATE: EQ 0.5% BASE | 2009/09/28 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A204936-001 | TIMOLOL MALEATE | APOTEX INC | SOLUTION/DROPS | OPHTHALMIC | TIMOLOL MALEATE: EQ 0.5% BASE | 2015/04/17 | N / N | DISCONTINUED | openFDA ↗ |
| A212291-001 | TIMOLOL MALEATE | EPIC PHARMA LLC | SOLUTION/DROPS | OPHTHALMIC | TIMOLOL MALEATE: EQ 0.5% BASE | 2020/09/11 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A212592-001 | TIMOLOL MALEATE | J MOLNER HOLDINGS INC | SOLUTION/DROPS | OPHTHALMIC | TIMOLOL MALEATE: EQ 0.25% BASE | 2021/12/13 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A212592-002 | TIMOLOL MALEATE | J MOLNER HOLDINGS INC | SOLUTION/DROPS | OPHTHALMIC | TIMOLOL MALEATE: EQ 0.5% BASE | 2021/12/13 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A216533-001 | TIMOLOL MALEATE | INGENUS PHARMACEUTICALS LLC | SOLUTION/DROPS | OPHTHALMIC | TIMOLOL MALEATE: EQ 0.25% BASE | 2022/09/13 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A216533-002 | TIMOLOL MALEATE | INGENUS PHARMACEUTICALS LLC | SOLUTION/DROPS | OPHTHALMIC | TIMOLOL MALEATE: EQ 0.5% BASE | 2022/09/13 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A216596-001 | TIMOLOL MALEATE | MICRO LABS LTD | SOLUTION/DROPS | OPHTHALMIC | TIMOLOL MALEATE: EQ 0.5% BASE | 2022/09/07 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A216653-001 | TIMOLOL MALEATE | SOMERSET THERAPEUTICS LLC | SOLUTION/DROPS | OPHTHALMIC | TIMOLOL MALEATE: EQ 0.5% BASE | 2024/07/03 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A217195-001 | TIMOLOL MALEATE | SENTISS PHARMA PRIVATE LTD | SOLUTION/DROPS | OPHTHALMIC | TIMOLOL MALEATE: EQ 0.5% BASE | 2023/05/08 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A217343-001 | TIMOLOL MALEATE | MICRO LABS LTD | SOLUTION/DROPS | OPHTHALMIC | TIMOLOL MALEATE: EQ 0.25% BASE | 2023/05/26 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A217343-002 | TIMOLOL MALEATE | MICRO LABS LTD | SOLUTION/DROPS | OPHTHALMIC | TIMOLOL MALEATE: EQ 0.5% BASE | 2023/05/26 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A217764-001 | TIMOLOL MALEATE | SOMERSET THERAPEUTICS LLC | SOLUTION/DROPS | OPHTHALMIC | TIMOLOL MALEATE: EQ 0.5% BASE | 2024/07/03 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A217764-002 | TIMOLOL MALEATE | SOMERSET THERAPEUTICS LLC | SOLUTION/DROPS | OPHTHALMIC | TIMOLOL MALEATE: EQ 0.25% BASE | 2024/07/03 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A218460-001 | TIMOLOL MALEATE | CAPLIN STERILES LTD | SOLUTION/DROPS | OPHTHALMIC | TIMOLOL MALEATE: EQ 0.5% BASE | 2024/08/07 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N018086-001 | TIMOPTIC | BAUSCH AND LOMB INC | SOLUTION/DROPS | OPHTHALMIC | TIMOLOL MALEATE: EQ 0.25% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Approved before 1982 | Y / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N018086-002 | TIMOPTIC | BAUSCH AND LOMB INC | SOLUTION/DROPS | OPHTHALMIC | TIMOLOL MALEATE: EQ 0.5% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Approved before 1982 | Y / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N019463-001 | TIMOPTIC IN OCUDOSE | BAUSCH AND LOMB INC | SOLUTION/DROPS | OPHTHALMIC | TIMOLOL MALEATE: EQ 0.25% BASE | 1986/11/05 | Y / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N019463-002 | TIMOPTIC IN OCUDOSE | BAUSCH AND LOMB INC | SOLUTION/DROPS | OPHTHALMIC | TIMOLOL MALEATE: EQ 0.5% BASE | 1986/11/05 | Y / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N021516-001 | ISTALOL | BAUSCH AND LOMB INC | SOLUTION/DROPS | OPHTHALMIC | TIMOLOL MALEATE: EQ 0.5% BASE | 2004/06/04 | 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 33
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Guangdong Zhong Sheng Pharma Co., Ltd. romanized | 国药准字H20178006See source | — | Official source ↗ |
| Tianjin Shi Zhong Yang Pharma Co., Ltd. romanized | 国药准字H120200545ml:12.5mg | — | Official source ↗ |
| Ya Bang Pharmaceuticals Co., Ltd. romanized | 国药准字H320203775ml:12.5mg | — | Official source ↗ |
| Jiangsu Yun Yang Group Pharma Co., Ltd. romanized | 国药准字H32020313See source | — | Official source ↗ |
| Jiangsu Yi Hai Pharma Co., Ltd. romanized | 国药准字H320205355ml:12.5mg | — | Official source ↗ |
| Hubei Yuan Da Tian Tian Ming Pharmaceutical Co., Ltd. romanized | 国药准字H200534590.4ml:1mg | — | Official source ↗ |
| Hubei Qian Jiang Pharmaceutical Co., Ltd. romanized | 国药准字H20065130See source | — | Official source ↗ |
| Hubei Yuan Da Tian Tian Ming Pharmaceutical Co., Ltd. romanized | 国药准字H200459475ml:12.5mg | — | Official source ↗ |
| Wuhan Wu Jing Pharma Co., Ltd. romanized | 国药准字H42021078See source | — | Official source ↗ |
| Chengdu Heng Rui Pharmaceutical Co., Ltd. romanized | 国药准字H20063099See source | — | Official source ↗ |
| Shijiazhuang Gree Pharmaceutical Co., Ltd | 国药准字H20243071See source | — | Official source ↗ |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20254418See source | — | Official source ↗ |
| Jin Yao Yong Guang (Hebei) Pharmaceutical Co., Ltd. romanized | 国药准字H200639205ml:25mg | — | Official source ↗ |
| Kai Feng Pharmaceutical (Group) Co., Ltd. romanized | 国药准字H20093786See source | — | Official source ↗ |
| Changchun Zhang Qing Pharma Group Co., Ltd. romanized | 国药准字H220204315ml:25mg | — | Official source ↗ |
| Shandong Bo Shi Lun Fu Rui Da Pharmaceutical Co., Ltd. romanized | 国药准字H200231095ml:25mg;8ml:40mg;10ml:50mg | — | Official source ↗ |
| Shandong Chen Xin Fu Dou Pharma Co., Ltd. romanized | 国药准字H37022028See source | — | Official source ↗ |
| Anhui Sheng Shuang Ke Pharma Co., Ltd. romanized | 国药准字H200454185ml:25mg | — | Official source ↗ |
| Hefei Li Fang Pharmaceutical Co., Ltd. romanized | 国药准字H20253876See source | — | Official source ↗ |
| Hefei Li Min Pharmaceutical Co., Ltd. romanized | 国药准字H340227635ml:25mg | — | Official source ↗ |
| Ningxia Kang Ya Pharma Co., Ltd. romanized | 国药准字H200939050.25% | — | Official source ↗ |
| Jiangsu Yuan Heng Pharma Co., Ltd. romanized | 国药准字H20249112See source | — | Official source ↗ |
| Guangdong Hong Ying Technology Co., Ltd. romanized | 国药准字H20133308See source | — | Official source ↗ |
| Yang Zhou Zhong Bao Pharma Co., Ltd. romanized | 国药准字H20254927See source | — | Official source ↗ |
| Tianjin Shi Zhong Yang Pharma Co., Ltd. romanized | 国药准字H120200535ml:25mg | — | Official source ↗ |
| Hubei Yuan Da Tian Tian Ming Pharmaceutical Co., Ltd. romanized | 国药准字H200534590.4ml:1mg | — | Official source ↗ |
| Shandong Chen Xin Fu Dou Pharma Co., Ltd. romanized | 国药准字H37022028See source | — | Official source ↗ |
| Yang Zhou Zhong Bao Pharma Co., Ltd. romanized | 国药准字H20254927See source | — | Official source ↗ |
| Guangdong Song Xia Pharma Co., Ltd. romanized | 国药准字H440240665ml:12.5mg | — | Official source ↗ |
| Jiangsu Yi Hai Pharma Co., Ltd. romanized | 国药准字H320205345ml:25mg | — | Official source ↗ |
| Hubei Yuan Da Tian Tian Ming Pharmaceutical Co., Ltd. romanized | 国药准字H200459485ml:25mg | — | Official source ↗ |
| Wuhan Xin Rui Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20234367See source | — | Official source ↗ |
| Shijiazhuang Gree Pharmaceutical Co., Ltd | 国药准字H20243072See source | — | Official source ↗ |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20254432See source | — | Official source ↗ |
| Shandong Bo Shi Lun Fu Rui Da Pharmaceutical Co., Ltd. romanized | 国药准字H200231095ml:25mg;8ml:40mg;10ml:50mg | — | Official source ↗ |
| Shandong Chen Xin Fu Dou Pharma Co., Ltd. romanized | 国药准字H37022028See source | — | Official source ↗ |
| Jiangsu Yuan Heng Pharma Co., Ltd. romanized | 国药准字H20249113See source | — | Official source ↗ |
| Guangdong Hong Ying Technology Co., Ltd. romanized | 国药准字H20133308See source | — | Official source ↗ |
| Guangdong Song Xia Pharma Co., Ltd. romanized | 国药准字H440240675ml:25mg | — | Official source ↗ |
| Shandong Chen Xin Fu Dou Pharma Co., Ltd. romanized | 国药准字H37022028See source | — | Official source ↗ |
| Shandong Bo Shi Lun Fu Rui Da Pharmaceutical Co., Ltd. romanized | 国药准字H200231095ml:25mg;8ml:40mg;10ml:50mg | — | Official source ↗ |
| Shandong Chen Xin Fu Dou Pharma Co., Ltd. romanized | 国药准字H37022028See source | — | Official source ↗ |
| Guangdong Hong Ying Technology Co., Ltd. romanized | 国药准字H20133308See source | — | Official source ↗ |
| Shandong Chen Xin Fu Dou Pharma Co., Ltd. romanized | 国药准字H37022028See source | — | Official source ↗ |
| Guangdong Hong Ying Technology Co., Ltd. romanized | 国药准字H20133308See source | — | Official source ↗ |
Under review 4
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Chengdu Pusch Pharmaceutical Co., Ltd. | CYHS2602494 | 2026/10/12 | Official source ↗ |
| Chengdu Pusch Pharmaceutical Co., Ltd. | CYHS2602493 | 2026/10/12 | Official source ↗ |
| Guangdong Nan Guo Pharma Co., Ltd. romanized | CYHS2601324 | 2026/06/08 | Official source ↗ |
| Guangdong Nan Guo Pharma Co., Ltd. romanized | CYHS2502062 | 2025/06/11 | Official source ↗ |
Generic-filing companies this year 2
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Chengdu Pusch Pharmaceutical Co., Ltd. | CYHS2602494 | 2026/10/12 | Official source ↗ |
| Chengdu Pusch Pharmaceutical Co., Ltd. | CYHS2602493 | 2026/10/12 | Official source ↗ |
| Guangdong Nan Guo Pharma Co., Ltd. romanized | CYHS2601324 | 2026/06/08 | Official source ↗ |
API companies with A status 7
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Tianjin Min Xiang Pharma Co., Ltd. romanized | Y20230001317 | 2025/05/20 | Official source ↗ |
| Jiangsu Ci Xing Pharma Co., Ltd. romanized | Y20220001347 | 2024/01/17 | Official source ↗ |
| Shijiazhuang Gree Pharmaceutical Co., Ltd | Y20220000253 | 2024/11/05 | Official source ↗ |
| Fareva La Vallee | Y20190000119 | 2024/11/07 | Official source ↗ |
| TIANJIN LISHENG PHARMACEUTICAL CO., LTD | Y20190007964 | 2025/06/28 | Official source ↗ |
| Tianjin Min Xiang Biopharmaceuticals Co., Ltd. romanized | Y20170002259 | 2024/05/01 | Official source ↗ |
| Centaur Pharmaceuticals Private Limited | Y20170000577 | 2024/12/31 | 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 ↗ · 27-144 · 2020/06/04
- Chinese Pharmacopoeia 2025, formulation chapter; site crosswalk ↗ · See source
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