YaoGeJu

← Back to list

Probucol Tablets

Matched
Active ingredients (original)
PROBUCOL
Dosage form (original)
TABLET
Route (original)
ORAL

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 approvalApproved before 1982
ANDA applications0
RLD applicant—

Currently marketed products: 0 · 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
N017535-001LORELCOSANOFI AVENTIS US LLCTABLETORALPROBUCOL: 250MGApproved before 1982N / NDISCONTINUEDopenFDA ↗
N017535-002LORELCOSANOFI AVENTIS US LLCTABLETORALPROBUCOL: 500MG1988/07/06N / 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 1

Company (original)Identifier (original)Source dateOfficial source
Qilu Pharmaceutical Co., Ltd.国药准字H202370190.25g2023/02/10Official source ↗

NHSA approval numbers 3

Company (original)Identifier (original)Source dateOfficial source
Jing Fu Kang Pharma Group Co., Ltd. romanized国药准字H109601610.25g—Official source ↗
Qilu Pharmaceutical Co., Ltd.国药准字H109800540.125g—Official source ↗
Jing Fu Kang Pharma Group Co., Ltd. romanized国药准字H109601610.25g—Official source ↗
Jing Fu Kang Pharma Group Co., Ltd. romanized国药准字H109601610.25g—Official source ↗
Qilu Pharmaceutical Co., Ltd.国药准字H202370190.25g—Official source ↗

Under review 4

Company (original)Identifier (original)Source dateOfficial source
Zhejiang Jiang Bei Pharma Co., Ltd. romanizedCYHS26019482026/08/10Official source ↗
Ningxia Kang Ya Pharma Co., Ltd. romanizedCYHS26012262026/06/01Official source ↗
Shanxi Hua Xia Tai Kang Pharmaceuticals Group Co., Ltd. romanized; Zhejiang Pu Li Pharma Co., Ltd. romanizedCYHS26001902026/01/16Official source ↗
Beijing Foyou Pharma CO.,LTDCYHS26000142026/01/05Official source ↗

Generic-filing companies this year 4

Company (original)Identifier (original)Source dateOfficial source
Zhejiang Jiang Bei Pharma Co., Ltd. romanizedCYHS26019482026/08/10Official source ↗
Ningxia Kang Ya Pharma Co., Ltd. romanizedCYHS26012262026/06/01Official source ↗
Shanxi Hua Xia Tai Kang Pharmaceuticals Group Co., Ltd. romanized; Zhejiang Pu Li Pharma Co., Ltd. romanizedCYHS26001902026/01/16Official source ↗
Beijing Foyou Pharma CO.,LTDCYHS26000142026/01/05Official source ↗

API companies with A status 2

Company (original)Identifier (original)Source dateOfficial source
Shandong An Hong Pharmaceutical Co., Ltd. romanizedY201900068412026/10/23Official source ↗
Wu Yi Ci Hang Pharma Co., Ltd. romanizedY201900053012025/01/17Official 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