YaoGeJu

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Estradiol Tablets

Matched
Active ingredients (original)
ESTRADIOL
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 applications12
RLD applicantBRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE

Currently marketed products: 9 · 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
A040114-001ESTRADIOLRUBICON RESEARCH LTDTABLETORALESTRADIOL: 1MG1996/03/14N / NDISCONTINUEDopenFDA ↗
A040114-002ESTRADIOLRUBICON RESEARCH LTDTABLETORALESTRADIOL: 2MG1996/03/14N / NDISCONTINUEDopenFDA ↗
A040114-003ESTRADIOLRUBICON RESEARCH LTDTABLETORALESTRADIOL: 0.5MG1996/03/14N / NDISCONTINUEDopenFDA ↗
A040138-001ESTRADIOLLANNETT CO INCTABLETORALESTRADIOL: 0.5MG1998/01/30N / NDISCONTINUEDopenFDA ↗
A040138-002ESTRADIOLLANNETT CO INCTABLETORALESTRADIOL: 1MG1998/01/30N / NDISCONTINUEDopenFDA ↗
A040138-003ESTRADIOLLANNETT CO INCTABLETORALESTRADIOL: 2MG1998/01/30N / NDISCONTINUEDopenFDA ↗
A040197-001ESTRADIOLBARR LABORATORIES INCTABLETORALESTRADIOL: 0.5MG1997/10/22N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A040197-002ESTRADIOLBARR LABORATORIES INCTABLETORALESTRADIOL: 1MG1997/10/22N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A040197-003ESTRADIOLBARR LABORATORIES INCTABLETORALESTRADIOL: 2MG1997/10/22N / YHUMAN PRESCRIPTION DRUGopenFDA ↗
A040212-001GYNODIOLDURAMED PHARMACEUTICALS INC SUB BARR LABORATORIES INCTABLETORALESTRADIOL: 0.5MG1997/12/29N / NDISCONTINUEDopenFDA ↗
A040212-002GYNODIOLDURAMED PHARMACEUTICALS INC SUB BARR LABORATORIES INCTABLETORALESTRADIOL: 1MG1997/12/29N / NDISCONTINUEDopenFDA ↗
A040212-003GYNODIOLDURAMED PHARMACEUTICALS INC SUB BARR LABORATORIES INCTABLETORALESTRADIOL: 1.5MG1997/12/29N / NDISCONTINUEDopenFDA ↗
A040212-004GYNODIOLDURAMED PHARMACEUTICALS INC SUB BARR LABORATORIES INCTABLETORALESTRADIOL: 2MG1997/12/29N / NDISCONTINUEDopenFDA ↗
A040275-001ESTRADIOLEPIC PHARMA LLCTABLETORALESTRADIOL: 0.5MG1998/12/29N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A040275-002ESTRADIOLEPIC PHARMA LLCTABLETORALESTRADIOL: 1MG1998/12/29N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A040275-003ESTRADIOLEPIC PHARMA LLCTABLETORALESTRADIOL: 2MG1998/12/29N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A040297-001ESTRADIOLUSL PHARMA INCTABLETORALESTRADIOL: 0.5MG2002/04/17N / NDISCONTINUEDopenFDA ↗
A040297-002ESTRADIOLUSL PHARMA INCTABLETORALESTRADIOL: 1MG2002/04/17N / NDISCONTINUEDopenFDA ↗
A040297-003ESTRADIOLUSL PHARMA INCTABLETORALESTRADIOL: 2MG2002/04/17N / NDISCONTINUEDopenFDA ↗
A040312-001INNOFEMNOVO NORDISK INCTABLETORALESTRADIOL: 0.5MG1999/11/19N / NDISCONTINUEDopenFDA ↗
A040312-002INNOFEMNOVO NORDISK INCTABLETORALESTRADIOL: 1MG1999/11/19N / NDISCONTINUEDopenFDA ↗
A040312-003INNOFEMNOVO NORDISK INCTABLETORALESTRADIOL: 2MG1999/11/19N / NDISCONTINUEDopenFDA ↗
A040326-001ESTRADIOLPHARMOBEDIENT CONSULTING LLCTABLETORALESTRADIOL: 0.5MG1999/04/21N / NDISCONTINUEDopenFDA ↗
A040326-002ESTRADIOLPHARMOBEDIENT CONSULTING LLCTABLETORALESTRADIOL: 1MG1999/04/21N / NDISCONTINUEDopenFDA ↗
A040326-003ESTRADIOLPHARMOBEDIENT CONSULTING LLCTABLETORALESTRADIOL: 2MG1999/04/21N / NDISCONTINUEDopenFDA ↗
A081295-001ESTRACEBRISTOL MYERS SQUIBB COTABLETORALESTRADIOL: 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**1993/06/30N / NDISCONTINUEDopenFDA ↗
A084499-001ESTRACEBRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTETABLETORALESTRADIOL: 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Approved before 1982Y / NDISCONTINUEDopenFDA ↗
A084500-001ESTRACEBRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTETABLETORALESTRADIOL: 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Approved before 1982Y / NDISCONTINUEDopenFDA ↗
A217334-001ESTRADIOLNOVITIUM PHARMA LLCTABLETORALESTRADIOL: 0.5MG2023/09/06N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A217334-002ESTRADIOLNOVITIUM PHARMA LLCTABLETORALESTRADIOL: 1MG2023/09/06N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A217334-003ESTRADIOLNOVITIUM PHARMA LLCTABLETORALESTRADIOL: 2MG2023/09/06N / NHUMAN 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 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
Zhejiang Xian Ju Pharmaceutical Co., Ltd. romanized国药准字H202554911mg2025/09/16Official source ↗

NHSA approval numbers 1

Company (original)Identifier (original)Source dateOfficial source
Zhejiang Xian Ju Pharmaceutical Co., Ltd. romanized国药准字H202554911mg—Official source ↗

Under review 3

Company (original)Identifier (original)Source dateOfficial source
Yang Zhou Ao Rui Te Pharma Co., Ltd. romanizedCYHS26019082026/08/05Official source ↗
Beijing Jin Cheng Tai Er Pharmaceutical Co., Ltd. romanizedCYHS26025652026/10/19Official source ↗
Hangzhou Bei Te Biopharmaceuticals Co., Ltd. romanizedCYHS26026492026/10/29Official source ↗

Generic-filing companies this year 3

Company (original)Identifier (original)Source dateOfficial source
Yang Zhou Ao Rui Te Pharma Co., Ltd. romanizedCYHS26019082026/08/05Official source ↗
Beijing Jin Cheng Tai Er Pharmaceutical Co., Ltd. romanizedCYHS26025652026/10/19Official source ↗
Hangzhou Bei Te Biopharmaceuticals Co., Ltd. romanizedCYHS26026492026/10/29Official source ↗

API companies with A status 7

Company (original)Identifier (original)Source dateOfficial source
Shaanxi Han Jiang Pharma Group Co., Ltd. romanizedY202500001022026/10/10Official source ↗
Hunan Ke Yi Xin Biopharmaceuticals Co., Ltd. romanizedY202400013362026/04/21Official source ↗
Aspen Oss B.V.Y202200001422024/04/16Official source ↗
Beijing Shi Ke Yi Feng Bio Technology Development Co., Ltd. romanizedY20190008488—Official source ↗
Zhejiang Xian Ju Pharmaceutical Co., Ltd. romanizedY201900075362024/01/27Official source ↗
Zhejiang Xian Ju Pharmaceutical Co., Ltd. romanizedY201900075332024/01/17Official source ↗
Qin Huang Dao Zi Zhu Pharma Co., Ltd. romanizedY201900064432026/09/01Official source ↗
Hubei Ge Dian Ren Fu Pharma Co., Ltd. romanizedY201700005272025/12/03Official 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