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Flurbiprofen Sodium Eye Drops

Matched
Active ingredients (original)
FLURBIPROFEN 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 approval1986/12/31
ANDA applications1
RLD applicantALLERGAN PHARMACEUTICAL

Currently marketed products: 1 · 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
A074447-001FLURBIPROFEN SODIUMBAUSCH AND LOMB INCSOLUTION/DROPSOPHTHALMICFLURBIPROFEN SODIUM: 0.03%1995/01/04N / YHUMAN PRESCRIPTION DRUGopenFDA ↗
N019404-001OCUFENALLERGAN PHARMACEUTICALSOLUTION/DROPSOPHTHALMICFLURBIPROFEN SODIUM: 0.03% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**1986/12/31Y / NDISCONTINUEDopenFDA ↗

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 numberPatent numberListed expirationSubstance / product flagsUse codeDelisting requestOfficial source
Not listed

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 0

Company (original)Identifier (original)Source dateOfficial source
No matching records in this loaded source.

NHSA approval numbers 2

Company (original)Identifier (original)Source dateOfficial source
Yang Zhou Zhong Bao Pharma Co., Ltd. romanized国药准字H202564380.03%(0.4ml:0.12mg)—Official source ↗
Wuhan Xian Lu Pharmaceuticals Technology Co., Ltd. romanized国药准字H202496140.03%(0.4ml:0.12mg)—Official source ↗
Wuhan Xian Lu Pharmaceuticals Technology Co., Ltd. romanized国药准字H202496140.03%(0.4ml:0.12mg)—Official source ↗

Under review 5

Company (original)Identifier (original)Source dateOfficial source
Nanjing Hai Na Pharmaceutical Co., Ltd. romanizedCYHS26021152026/08/25Official source ↗
Jiangsu Fu Bang Pharma Co., Ltd. romanizedCYHS26002472026/01/22Official source ↗
Nanjing Di Chang Pharmaceuticals Technology Co., Ltd. romanized; Wuhan Wu Jing Pharma Co., Ltd. romanizedCYHS25041732025/12/05Official source ↗
Ningxia Kang Ya Pharma Co., Ltd. romanizedCYHS26008012026/04/08Official source ↗
Lang Tian Pharma (Hubei) Co., Ltd. romanized; Ningxia Kang Ya Pharma Co., Ltd. romanizedCYHS26007472026/03/30Official source ↗

Generic-filing companies this year 4

Company (original)Identifier (original)Source dateOfficial source
Nanjing Hai Na Pharmaceutical Co., Ltd. romanizedCYHS26021152026/08/25Official source ↗
Jiangsu Fu Bang Pharma Co., Ltd. romanizedCYHS26002472026/01/22Official source ↗
Ningxia Kang Ya Pharma Co., Ltd. romanizedCYHS26008012026/04/08Official source ↗
Lang Tian Pharma (Hubei) Co., Ltd. romanized; Ningxia Kang Ya Pharma Co., Ltd. romanizedCYHS26007472026/03/30Official source ↗

API companies with A status 13

Company (original)Identifier (original)Source dateOfficial source
Hunan Ou Ya Pharma Co., Ltd. romanizedY202500002212026/08/13Official source ↗
Hebei Hua Chen Pharma Group Co., Ltd. romanizedY202400014552026/09/21Official source ↗
Hebei Ding Tai Pharmaceutical Co., Ltd. romanizedY202400012742026/04/10Official source ↗
Yuan Da Sheng Ming Ke Xue (An Shan) Co., Ltd. romanizedY202300013742026/07/31Official source ↗
Ningxia Kang Ya Pharma Co., Ltd. romanizedY202300012952025/09/22Official source ↗
Shanghai Wan Xiang Pharmaceutical Co., Ltd. romanizedY202300002232025/07/31Official source ↗
GMFC Labs Private LimitedY202300007512025/10/24Official source ↗
Hunan Jiu Dian Hong Yang Pharmaceutical Co., Ltd. romanizedY202100003372025/08/02Official source ↗
Hunan Jiu Dian Hong Yang Pharmaceutical Co., Ltd. romanizedY202000011212025/07/28Official source ↗
Shijiazhuang Zhong Shuo Pharmaceutical Co., Ltd. romanizedY202000010482022/10/31Official source ↗
Hy-Gro Chemicals Pharmtek Pvt LtdY202000009712025/06/28Official source ↗
PHARMARON MANUFACTURING SERVICES (UK) LTDY201900099742025/03/19Official source ↗
Daito Pharmaceutical Co.,Ltd.Y201900090182024/12/20Official source ↗
Wuhan Xian Lu Pharmaceuticals Technology Co., Ltd. romanizedY201800013712024/12/04Official 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