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Dydrogesterone Tablets

Matched
Active ingredients (original)
DYDROGESTERONE
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 applicantSOLVAY PHARMACEUTICALS

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
N017388-001GYNORESTSOLVAY PHARMACEUTICALSTABLETORALDYDROGESTERONE: 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Approved before 1982Y / NDISCONTINUEDopenFDA ↗
N017388-002GYNORESTSOLVAY PHARMACEUTICALSTABLETORALDYDROGESTERONE: 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Approved before 1982Y / NDISCONTINUEDopenFDA ↗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 17

Company (original)Identifier (original)Source dateOfficial source
Hefei Guo Gao Pharma Co., Ltd. romanized国药准字H2026516210mg2026/07/14Official source ↗
Henan Tai Feng Bio Technology Co., Ltd. romanized国药准字H2026502610mg2026/06/30Official source ↗
Cipla Ltd.国药准字HJ2026006510mg2026/06/30Official source ↗
Beijing Fa Mo Si Da Pharmaceutical Technology Co., Ltd. romanized国药准字H2026432610mg2026/05/12Official source ↗
Beijing Jin Cheng Tai Er Pharmaceutical Co., Ltd. romanized国药准字H2026406710mg2026/04/21Official source ↗
Jia Heng (Zhuhai Heng Qin) Pharmaceuticals Technology Co., Ltd. romanized国药准字H2026406810mg2026/04/21Official source ↗
Guangzhou Lang Sheng Pharma Co., Ltd. romanized国药准字H2026386710mg2026/04/07Official source ↗
Xinjiang Te Feng Pharma Co., Ltd. romanized国药准字H2026322210mg2026/01/27Official source ↗
Zhu Zhou Qian Jin Pharma Co., Ltd. romanized国药准字H2025650810mg2025/12/30Official source ↗
Gui Lin Lang Ke Pharmaceutical Co., Ltd. romanized国药准字H2025650210mg2025/12/30Official source ↗
Zhejiang Ai Sheng Pharma Co., Ltd. romanized国药准字H2025568710mg2025/10/14Official source ↗
Zhejiang Xian Ju Pharmaceutical Co., Ltd. romanized国药准字H2025405210mg2025/04/30Official source ↗
Sichuan Kelun Pharmaceutical Co., Ltd.国药准字H2024487210mg2024/09/10Official source ↗
Hangzhou He Ze Kun Yuan Pharma Co., Ltd. romanized国药准字H2024316310mg2024/02/06Official source ↗
Ao Rui Te Pharma Co., Ltd. romanized国药准字H2023376910mg2023/06/21Official source ↗
Abbott Healthcare Products B.V.H2017022110mg2002/12/31Official source ↗
Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized国药准字H2025494210mg2025/07/22Official source ↗

NHSA approval numbers 16

Company (original)Identifier (original)Source dateOfficial source
Beijing Jin Cheng Tai Er Pharmaceutical Co., Ltd. romanized国药准字H2026406710mg—Official source ↗
Sichuan Kelun Pharmaceutical Co., Ltd.国药准字H2024487210mg—Official source ↗
Henan Tai Feng Bio Technology Co., Ltd. romanized国药准字H2026502610mg—Official source ↗
Zhejiang Ai Sheng Pharma Co., Ltd. romanized国药准字H2025568710mg—Official source ↗
Zhejiang Xian Ju Pharmaceutical Co., Ltd. romanized国药准字H2025405210mg—Official source ↗
Zhu Zhou Qian Jin Pharma Co., Ltd. romanized国药准字H2025650810mg—Official source ↗
Xinjiang Te Feng Pharma Co., Ltd. romanized国药准字H2026322210mg—Official source ↗
Guangzhou Lang Sheng Pharma Co., Ltd. romanized国药准字H2026386710mg—Official source ↗
Beijing Fa Mo Si Da Pharmaceutical Technology Co., Ltd. romanized国药准字H2026432610mg—Official source ↗
Ao Rui Te Pharma Co., Ltd. romanized国药准字H2023376910mg—Official source ↗
Abbott B.V.国药准字HJ2017022110mg—Official source ↗
Hefei Guo Gao Pharma Co., Ltd. romanized国药准字H2026516210mg—Official source ↗
Jia Heng (Zhuhai Heng Qin) Pharmaceuticals Technology Co., Ltd. romanized国药准字H2026406810mg—Official source ↗
Jiangsu He Chen Pharma Co., Ltd. romanized国药准字H2024316310mg—Official source ↗
Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized国药准字H2025494210mg—Official source ↗
Gui Lin Lang Ke Pharmaceutical Co., Ltd. romanized国药准字H2025650210mg—Official source ↗
Sichuan Kelun Pharmaceutical Co., Ltd.国药准字H2024487210mg—Official source ↗
Henan Tai Feng Bio Technology Co., Ltd. romanized国药准字H2026502610mg—Official source ↗
Zhejiang Ai Sheng Pharma Co., Ltd. romanized国药准字H2025568710mg—Official source ↗
Beijing Fa Mo Si Da Pharmaceutical Technology Co., Ltd. romanized国药准字H2026432610mg—Official source ↗
Ao Rui Te Pharma Co., Ltd. romanized国药准字H2023376910mg—Official source ↗
Sichuan Kelun Pharmaceutical Co., Ltd.国药准字H2024487210mg—Official source ↗
Henan Tai Feng Bio Technology Co., Ltd. romanized国药准字H2026502610mg—Official source ↗
Beijing Fa Mo Si Da Pharmaceutical Technology Co., Ltd. romanized国药准字H2026432610mg—Official source ↗
Ao Rui Te Pharma Co., Ltd. romanized国药准字H2023376910mg—Official source ↗
Sichuan Kelun Pharmaceutical Co., Ltd.国药准字H2024487210mg—Official source ↗
Beijing Fa Mo Si Da Pharmaceutical Technology Co., Ltd. romanized国药准字H2026432610mg—Official source ↗
Beijing Fa Mo Si Da Pharmaceutical Technology Co., Ltd. romanized国药准字H2026432610mg—Official source ↗

Under review 8

Company (original)Identifier (original)Source dateOfficial source
Shanghai Yan An Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanizedCYHS26022732026/09/15Official source ↗
Abbott B. V.; Abbott Biologicals B. V.JYHB26004762026/08/17Official source ↗
Abbott B. V.; Abbott Biologicals B. V.JYHB26003792026/07/13Official source ↗
Wuhan Jiu Long Ren Fu Pharma Co., Ltd. romanized; Sichuan Kelun Pharmaceutical Co., Ltd.CYHS26010522026/05/08Official source ↗
Hubei Min Kang Pharma Group Co., Ltd. romanized; Hunan Chun Jian Pharmaceutical Technology Co., Ltd. romanizedCYHS26001262026/01/10Official source ↗
Zhejiang Shen Zhou Pharma Co., Ltd. romanizedCYHS25043862025/12/25Official source ↗
Zhejiang Mei Di Shen Biopharmaceuticals Co., Ltd. romanized; Zhejiang Xian Ju Pharmaceutical Co., Ltd. romanizedCYHS25035702025/09/29Official source ↗
Beijing Si Li An Pharma Co., Ltd. romanizedCYHS25022702025/06/25Official source ↗

Generic-filing companies this year 4

Company (original)Identifier (original)Source dateOfficial source
Jiangsu Nuo Tai Ao Sai Nuo Biopharmaceutical Co., Ltd. romanizedCYHS26025662026/10/19Official source ↗
Shanghai Yan An Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanizedCYHS26022732026/09/15Official source ↗
Wuhan Jiu Long Ren Fu Pharma Co., Ltd. romanized; Sichuan Kelun Pharmaceutical Co., Ltd.CYHS26010522026/05/08Official source ↗
Hubei Min Kang Pharma Group Co., Ltd. romanized; Hunan Chun Jian Pharmaceutical Technology Co., Ltd. romanizedCYHS26001262026/01/10Official source ↗

API companies with A status 4

Company (original)Identifier (original)Source dateOfficial source
Hunan Ke Yi Xin Biopharmaceuticals Co., Ltd. romanizedY202400009002026/03/31Official source ↗
Jiangsu Jia Er Ke Pharma Group Co., Ltd. romanizedY202400000582025/07/18Official source ↗
Zhejiang Xian Ju Pharmaceutical Co., Ltd. romanizedY202300008832025/04/28Official source ↗
Yang Zhou Ao Rui Te Pharma Co., Ltd. romanizedY202100012532023/06/29Official 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