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Bromfenac Sodium Eye Drops

Matched
Active ingredients (original)
BROMFENAC SODIUM
Dosage form (original)
SOLUTION/DROPS
Route (original)
OPHTHALMIC

Read these limits

  1. US patent expiration does not establish Chinese patent expiration. Dates here come from the US Orange Book; Chinese patent status needs separate checking.
  2. The Orange Book lists holder-submitted patents and does not cover all related patents.
  3. “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.
  4. This page contains no sales or market-size data and cannot establish development value.
  5. 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 approval2005/03/24
ANDA applications16
RLD applicantBAUSCH AND LOMB INC / SUN PHARMACEUTICAL INDUSTRIES LTD

Currently marketed products: 12 · Counts FDA prescription and OTC marketing categories as listed; discontinued or unknown categories are excluded.

Application / product numberBrand name (original)Applicant (original)Dosage form (original)Route (original)Strength (original)Earliest approvalRLD / RSMarketing status (original)Official source
A201211-001BROMFENAC SODIUMCOASTAL PHARMACEUTICALSSOLUTION/DROPSOPHTHALMICBROMFENAC SODIUM: EQ 0.09% ACID2011/05/11N / NDISCONTINUEDopenFDA ↗
A201941-001BROMFENAC SODIUMCHARTWELL RX SCIENCES LLCSOLUTION/DROPSOPHTHALMICBROMFENAC SODIUM: EQ 0.09% ACID2015/02/10N / NDISCONTINUEDopenFDA ↗
A202030-001BROMFENAC SODIUMJ MOLNER HOLDINGS INCSOLUTION/DROPSOPHTHALMICBROMFENAC SODIUM: EQ 0.09% ACID2013/01/09N / NDISCONTINUEDopenFDA ↗
A202435-001BROMFENAC SODIUMAPOTEX INCSOLUTION/DROPSOPHTHALMICBROMFENAC SODIUM: EQ 0.09% ACID2014/06/19N / NDISCONTINUEDopenFDA ↗
A202620-001BROMFENAC SODIUMAPOTEX INCSOLUTION/DROPSOPHTHALMICBROMFENAC SODIUM: EQ 0.09% ACID2014/06/23N / NDISCONTINUEDopenFDA ↗
A202903-001BROMFENAC SODIUMLUPIN LTDSOLUTION/DROPSOPHTHALMICBROMFENAC SODIUM: EQ 0.09% ACID2023/08/15N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A203368-001BROMFENAC SODIUMRISING PHARMA HOLDING INCSOLUTION/DROPSOPHTHALMICBROMFENAC SODIUM: EQ 0.09% ACID2019/06/03N / NDISCONTINUEDopenFDA ↗
A203395-001BROMFENAC SODIUMSENTISS AGSOLUTION/DROPSOPHTHALMICBROMFENAC SODIUM: EQ 0.09% ACID2014/01/22N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A204813-001BROMFENAC SODIUMEUGIA PHARMA SPECIALITIES LTDSOLUTION/DROPSOPHTHALMICBROMFENAC SODIUM: EQ 0.09% ACID2022/03/18N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A206027-001BROMFENAC SODIUMLUPIN LTDSOLUTION/DROPSOPHTHALMICBROMFENAC SODIUM: EQ 0.07% ACID2023/11/22N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A207334-001BROMFENAC SODIUMAPOTEX INCSOLUTION/DROPSOPHTHALMICBROMFENAC SODIUM: EQ 0.07% ACID2024/07/08N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A210560-001BROMFENAC SODIUMALEMBIC PHARMACEUTICALS LTDSOLUTION/DROPSOPHTHALMICBROMFENAC SODIUM: EQ 0.09% ACID2019/06/21N / YHUMAN PRESCRIPTION DRUGopenFDA ↗
A210962-001BROMFENAC SODIUMAMNEAL EU LTDSOLUTION/DROPSOPHTHALMICBROMFENAC SODIUM: EQ 0.07% ACID2024/07/29N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A211029-001BROMFENAC SODIUMGLAND PHARMA LTDSOLUTION/DROPSOPHTHALMICBROMFENAC SODIUM: EQ 0.09% ACID2020/03/17N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A211239-001BROMFENAC SODIUMLUPIN LTDSOLUTION/DROPSOPHTHALMICBROMFENAC SODIUM: EQ 0.075% ACID2024/02/02N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A214340-001BROMFENAC SODIUMALEMBIC PHARMACEUTICALS LTDSOLUTION/DROPSOPHTHALMICBROMFENAC SODIUM: EQ 0.07% ACID2024/07/08N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
N021664-001XIBROMBAUSCH AND LOMB INCSOLUTION/DROPSOPHTHALMICBROMFENAC SODIUM: EQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**2005/03/24Y / NDISCONTINUEDopenFDA ↗
N021664-002BROMDAYBAUSCH AND LOMB INCSOLUTION/DROPSOPHTHALMICBROMFENAC SODIUM: EQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**2010/10/16Y / NDISCONTINUEDopenFDA ↗
N203168-001PROLENSABAUSCH AND LOMB INCSOLUTION/DROPSOPHTHALMICBROMFENAC SODIUM: EQ 0.07% ACID2013/04/05Y / YHUMAN PRESCRIPTION DRUGopenFDA ↗
N206911-001BROMSITESUN PHARMACEUTICAL INDUSTRIES LTDSOLUTION/DROPSOPHTHALMICBROMFENAC SODIUM: EQ 0.075% ACID2016/04/08Y / YHUMAN PRESCRIPTION DRUGopenFDA ↗

Listed US patents

*PED rows, substance/product flags, use codes and delisting-request flags are retained without determining legal effect.

Latest listed patent expiration2033/11/11
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 numberPatent numberListed expirationSubstance / product flagsUse codeDelisting requestOfficial source
N203168-001100859582032/11/19— / Y——openFDA ↗
N203168-00195172202033/11/11— / —U-1933—openFDA ↗
N206911-001RE502182029/03/05— / YU-1834—openFDA ↗

Exclusivity source records

FDA exclusivity code list ↗

Latest exclusivity expiration: —

Application / product numberExclusivity codeListed expirationOfficial 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 1

Company (original)Identifier (original)Source dateOfficial source
SENJU PHARMACEUTICAL CO., LTD.H20150243See source2009/09/29Official source ↗

NHSA approval numbers 29

Company (original)Identifier (original)Source dateOfficial source
Guangdong Zhong Sheng Pharma Co., Ltd. romanized国药准字H20233262See source—Official source ↗
Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized国药准字H20213053See source—Official source ↗
Shenyang Xing Qi Yan Yao Co., Ltd. romanized国药准字H20244468See source—Official source ↗
Jiangsu Vanguard Pharmaceutical Co., Ltd.国药准字H20234193See source—Official source ↗
Wuhan Wu Jing Pharma Co., Ltd. romanized国药准字H20244284See source—Official source ↗
Chengdu Pusch Pharmaceutical Co., Ltd.国药准字H20256506See source—Official source ↗
Qilu Pharmaceutical Co., Ltd.国药准字H20183490See source—Official source ↗
Jinan Chen Xin Pharmaceuticals Technology Co., Ltd. romanized国药准字H201500225ml:5mg(0.1%)—Official source ↗
Hefei Hua Wei Pharma Co., Ltd. romanized国药准字H20244569See source—Official source ↗
Zhejiang Sha Pu Ai Si Pharma Co., Ltd. romanized国药准字H20253221See source—Official source ↗
Jiangxi Ma Ying Long Mei Kang Pharma Co., Ltd. romanized国药准字H20264422See source—Official source ↗
Qi Lu Pharmaceutical (Hainan) Co., Ltd. romanized国药准字H20233640See source—Official source ↗
Liaoning Mei Zi Lin Pharma Co., Ltd. romanized国药准字H20193244See source—Official source ↗
Zhongshan Wanhan Pharmaceuticals Co., Ltd.国药准字H20243868See source—Official source ↗
Hebei Chuang Jian Pharma Co., Ltd. romanized国药准字H20243677See source—Official source ↗
SENJU PHARMACEUTICAL CO.,LTD.国药准字HJ20150243See source—Official source ↗
Wuhan Xian Lu Pharmaceuticals Technology Co., Ltd. romanized国药准字H20213554See source—Official source ↗
Suzhou Ou Kang Wei Shi Bio Technology Co., Ltd. romanized国药准字H20253042See source—Official source ↗
Guangzhou Ren Heng Pharmaceuticals Technology Co., Ltd. romanized国药准字H20255727See source—Official source ↗
Wuhan Xian Lu Pharmaceuticals Technology Co., Ltd. romanized国药准字H20247205See source—Official source ↗
Chengdu Pusch Pharmaceutical Co., Ltd.国药准字H20256506See source—Official source ↗
Qilu Pharmaceutical Co., Ltd.国药准字H20183490See source—Official source ↗
Jinan Chen Xin Pharmaceuticals Technology Co., Ltd. romanized国药准字H201500225ml:5mg(0.1%)—Official source ↗
Guangzhou Ren Heng Pharmaceuticals Technology Co., Ltd. romanized国药准字H20255727See source—Official source ↗
Wuhan Xian Lu Pharmaceuticals Technology Co., Ltd. romanized国药准字H20247205See source—Official source ↗
Run Er Yan Ke Drug (Guangzhou) Co., Ltd. romanized国药准字H20244161See source—Official source ↗
Chengdu Pusch Pharmaceutical Co., Ltd.国药准字H20256506See source—Official source ↗
Jinan Chen Xin Pharmaceuticals Technology Co., Ltd. romanized国药准字H201500225ml:5mg(0.1%)—Official source ↗
Guangzhou Ren Heng Pharmaceuticals Technology Co., Ltd. romanized国药准字H20255727See source—Official source ↗
Wuhan Xian Lu Pharmaceuticals Technology Co., Ltd. romanized国药准字H20247205See source—Official source ↗
Chengdu Pusch Pharmaceutical Co., Ltd.国药准字H20256506See source—Official source ↗
Jinan Chen Xin Pharmaceuticals Technology Co., Ltd. romanized国药准字H201500225ml:5mg(0.1%)—Official source ↗
Guangzhou Ren Heng Pharmaceuticals Technology Co., Ltd. romanized国药准字H20255727See source—Official source ↗
Wuhan Xian Lu Pharmaceuticals Technology Co., Ltd. romanized国药准字H20247205See source—Official source ↗
Guangzhou Ren Heng Pharmaceuticals Technology Co., Ltd. romanized国药准字H20255727See source—Official source ↗
Wuhan Xian Lu Pharmaceuticals Technology Co., Ltd. romanized国药准字H20247205See source—Official source ↗
Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized国药准字H20223699See source—Official source ↗
Qilu Pharmaceutical Co., Ltd.国药准字H20183491See source—Official source ↗
Shandong Chen Xin Fu Dou Pharma Co., Ltd. romanized国药准字H20233366See source—Official source ↗
Zhejiang Sha Pu Ai Si Pharma Co., Ltd. romanized国药准字H20253220See source—Official source ↗
Zhongshan Wanhan Pharmaceuticals Co., Ltd.国药准字H20243922See source—Official source ↗
Suzhou Ou Kang Wei Shi Bio Technology Co., Ltd. romanized国药准字H20263589See source—Official source ↗
Shandong Chen Xin Fu Dou Pharma Co., Ltd. romanized国药准字H20233366See source—Official source ↗
Shandong Chen Xin Fu Dou Pharma Co., Ltd. romanized国药准字H20233366See source—Official source ↗
Shandong Chen Xin Fu Dou Pharma Co., Ltd. romanized国药准字H20233366See source—Official source ↗
Zhongshan Wanhan Pharmaceuticals Co., Ltd.国药准字H20243868See source—Official source ↗
Zhongshan Wanhan Pharmaceuticals Co., Ltd.国药准字H20243868See source—Official source ↗
Zhongshan Wanhan Pharmaceuticals Co., Ltd.国药准字H20243868See source—Official source ↗
Zhongshan Wanhan Pharmaceuticals Co., Ltd.国药准字H20243868See source—Official source ↗
Zhongshan Wanhan Pharmaceuticals Co., Ltd.国药准字H20243868See source—Official source ↗
Ai Shi Pharmaceutical Co., Ltd. romanized国药准字H20264661See source—Official source ↗
Ai Shi Pharmaceutical Co., Ltd. romanized国药准字H20264662See source—Official source ↗

Under review 7

Company (original)Identifier (original)Source dateOfficial source
Jiangsu Yuan Heng Pharma Co., Ltd. romanizedCYHS26023222026/09/17Official source ↗
Shandong Hai Shan Pharma Co., Ltd. romanized; Shandong Wei Zhi Bai Ke Pharma Co., Ltd. romanizedCYHS26021112026/08/25Official source ↗
Shijiazhuang No.4 Pharmaceutical Co., Ltd.CYHS26015172026/06/26Official source ↗
Guangdong Nan Guo Pharma Co., Ltd. romanizedCYHS26010812026/05/12Official source ↗
Shijiazhuang Gree Pharmaceutical Co., LtdCYHS25044442025/12/27Official source ↗
Shijiazhuang Gree Pharmaceutical Co., LtdCYHS25044432025/12/27Official source ↗
Hubei Mei Lin Pharma Co., Ltd. romanizedCYHS25031612025/08/29Official source ↗

Generic-filing companies this year 4

Company (original)Identifier (original)Source dateOfficial source
Jiangsu Yuan Heng Pharma Co., Ltd. romanizedCYHS26023222026/09/17Official source ↗
Shandong Hai Shan Pharma Co., Ltd. romanized; Shandong Wei Zhi Bai Ke Pharma Co., Ltd. romanizedCYHS26021112026/08/25Official source ↗
Shijiazhuang No.4 Pharmaceutical Co., Ltd.CYHS26015172026/06/26Official source ↗
Guangdong Nan Guo Pharma Co., Ltd. romanizedCYHS26010812026/05/12Official source ↗

API companies with A status 14

Company (original)Identifier (original)Source dateOfficial source
Shijiazhuang Gree Pharmaceutical Co., LtdY202500003202026/10/12Official source ↗
Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanizedY202400005022025/12/17Official source ↗
Medilux Laboratories Pvt. LtdY202300003722026/07/12Official source ↗
Zhongshan Wanhan Pharmaceuticals Co., Ltd.Y202200004332024/03/11Official source ↗
Hebei An Jian Cheng Yi Pharmaceuticals Technology Co., Ltd. romanizedY202100007782024/04/09Official source ↗
Guangzhou Hua Sheng Pharmaceutical Co., Ltd. romanizedY202100000062025/04/16Official source ↗
Guangdong Xian Qiang Pharma Co., Ltd. romanizedY202000010492025/03/27Official source ↗
YS Life Science Co., Ltd.Y201900212492024/07/27Official source ↗
Wuhan Xian Lu Pharmaceuticals Technology Co., Ltd. romanizedY201900008752026/06/02Official source ↗
Shandong Chen Long Pharma Co., Ltd. romanizedY201900019712024/09/27Official source ↗
Jin Yao Pharma Co., Ltd. romanizedY201700021212025/06/12Official source ↗
Indoco Remedies Ltd. (Kilo Lab)Y201700013162026/05/06Official source ↗
Qilu Pharmaceutical Co., Ltd.Y201700005692024/09/04Official source ↗
Liaoning Tian Long Pharma Co., Ltd. romanizedY201700002492024/09/12Official 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