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Ertugliflozin Tablets

Matched
Active ingredients (original)
ERTUGLIFLOZIN
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 approval2017/12/19
ANDA applications3
RLD applicantMERCK SHARP AND DOHME LLC A SUB OF MERCK AND CO INC

Currently marketed products: 2 · 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
A216842-001ERTUGLIFLOZINHIKMA PHARMACEUTICALS USA INCTABLETORALERTUGLIFLOZIN: 5MG2025/01/21N / NDISCONTINUEDopenFDA ↗
A216842-002ERTUGLIFLOZINHIKMA PHARMACEUTICALS USA INCTABLETORALERTUGLIFLOZIN: 15MG2025/01/21N / NDISCONTINUEDopenFDA ↗
A216947-001ERTUGLIFLOZINAUROBINDO PHARMA LTDTABLETORALERTUGLIFLOZIN: 5MG2023/07/13N / NDISCONTINUEDopenFDA ↗
A216947-002ERTUGLIFLOZINAUROBINDO PHARMA LTDTABLETORALERTUGLIFLOZIN: 15MG2023/07/13N / NDISCONTINUEDopenFDA ↗
A217071-001ERTUGLIFLOZINHETERO LABS LTD UNIT VTABLETORALERTUGLIFLOZIN: 5MG2024/09/17N / NDISCONTINUEDopenFDA ↗
A217071-002ERTUGLIFLOZINHETERO LABS LTD UNIT VTABLETORALERTUGLIFLOZIN: 15MG2024/09/17N / NDISCONTINUEDopenFDA ↗
N209803-001STEGLATROMERCK SHARP AND DOHME LLC A SUB OF MERCK AND CO INCTABLETORALERTUGLIFLOZIN: 5MG2017/12/19Y / NHUMAN PRESCRIPTION DRUGopenFDA ↗
N209803-002STEGLATROMERCK SHARP AND DOHME LLC A SUB OF MERCK AND CO INCTABLETORALERTUGLIFLOZIN: 15MG2017/12/19Y / 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 expiration2031/12/19
Substance patent expiration (DS flag)2031/12/19

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
N209803-00180805802031/12/19Y / YU-2214—openFDA ↗
N209803-00280805802031/12/19Y / YU-2214—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
Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized国药准字H20265153See source2026/07/14Official source ↗

NHSA approval numbers 2

Company (original)Identifier (original)Source dateOfficial source
Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized国药准字H20265153See source—Official source ↗
Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized国药准字H20265153See source—Official source ↗
Merck Sharp & Dohme B.V.国药准字HJ20200023See source—Official source ↗
Merck Sharp & Dohme B.V.国药准字HJ20200023See source—Official source ↗

Under review 13

Company (original)Identifier (original)Source dateOfficial source
Jiangsu Deyuan Pharmaceutical Co.,Ltd.CYHS26015202026/06/29Official source ↗
NANJING ZENKOM PHARMACEUTICAL CO.,LTD.CYHS26023752026/09/21Official source ↗
Anhui Hong Ye Pharma Co., Ltd. romanizedCYHS26023632026/09/21Official source ↗
Anhui Tai En Kang Pharmaceutical Co., Ltd. romanizedCYHS26023502026/09/20Official source ↗
Xian Wan Long Pharmaceutical Co., Ltd. romanizedCYHS26020912026/08/24Official source ↗
Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.CYHS26017832026/07/24Official source ↗
Shandong Nuo Ming Kang Drug Research Institute Co., Ltd. romanized; Shandong Nuo He Kang Pharma Co., Ltd. romanizedCYHS26014912026/06/24Official source ↗
Ningbo Menovo Tiankang Pharmaceutical Co., Ltd.CYHS26005722026/02/27Official source ↗
Jiangxi Tai Ji Li Biopharmaceutical Co., Ltd. romanizedCYHS26001312026/01/10Official source ↗
Hua Run Sai Ke Pharma Co., Ltd. romanizedCYHS26000412026/01/06Official source ↗
Nan Tong Lian Ya Pharma Co., Ltd. romanizedCYHS26027182026/11/05Official source ↗
Yi Chang Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanized; Yi Lv Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanizedCYHS26027462026/11/09Official source ↗
NORTH CHINA PHARMACEUTICAL COMPANY.LTDCYHS26027342026/11/09Official source ↗

Generic-filing companies this year 14

Company (original)Identifier (original)Source dateOfficial source
Jiangsu Deyuan Pharmaceutical Co.,Ltd.CYHS26015202026/06/29Official source ↗
NANJING ZENKOM PHARMACEUTICAL CO.,LTD.CYHS26023752026/09/21Official source ↗
Lan Xi Ha San Lian Pharmaceutical Co., Ltd. romanizedCYHS26024322026/09/29Official source ↗
Anhui Hong Ye Pharma Co., Ltd. romanizedCYHS26023632026/09/21Official source ↗
Anhui Tai En Kang Pharmaceutical Co., Ltd. romanizedCYHS26023502026/09/20Official source ↗
Xian Wan Long Pharmaceutical Co., Ltd. romanizedCYHS26020912026/08/24Official source ↗
Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.CYHS26017832026/07/24Official source ↗
Shandong Nuo Ming Kang Drug Research Institute Co., Ltd. romanized; Shandong Nuo He Kang Pharma Co., Ltd. romanizedCYHS26014912026/06/24Official source ↗
Ningbo Menovo Tiankang Pharmaceutical Co., Ltd.CYHS26005722026/02/27Official source ↗
Jiangxi Tai Ji Li Biopharmaceutical Co., Ltd. romanizedCYHS26001312026/01/10Official source ↗
Hua Run Sai Ke Pharma Co., Ltd. romanizedCYHS26000412026/01/06Official source ↗
Nan Tong Lian Ya Pharma Co., Ltd. romanizedCYHS26027182026/11/05Official source ↗
Yi Chang Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanized; Yi Lv Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanizedCYHS26027462026/11/09Official source ↗
NORTH CHINA PHARMACEUTICAL COMPANY.LTDCYHS26027342026/11/09Official source ↗

API companies with A status 2

Company (original)Identifier (original)Source dateOfficial source
Hua Run Shuang He Pharma Co., Ltd. romanizedY202500000832026/07/31Official source ↗
Shandong Lang Nuo Pharmaceutical Co., Ltd. romanizedY202300012962025/08/22Official 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