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Landiolol Hydrochloride for Injection

Matched
Active ingredients (original)
LANDIOLOL HYDROCHLORIDE
Dosage form (original)
POWDER
Route (original)
INTRAVENOUS

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 approval2024/11/22
ANDA applications0
RLD applicantAOP HEALTH US LLC

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
N217202-001RAPIBLYKAOP HEALTH US LLCPOWDERINTRAVENOUSLANDIOLOL HYDROCHLORIDE: EQ 280MG BASE/VIAL2024/11/22Y / 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 expiration2034/04/25
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
N217202-001107225162034/04/25— / —U-4235—openFDA ↗

Exclusivity source records

FDA exclusivity code list ↗

Latest exclusivity expiration: 2029/11/22

Application / product numberExclusivity codeListed expirationOfficial source
N217202-001NCE2029/11/22openFDA ↗
N217202-001NPP2029/02/13openFDA ↗

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
Nanjing Hai Chen Pharma Co., Ltd. romanized国药准字H20247263150mg2024/11/01Official source ↗
Nanjing Hai Chen Pharma Co., Ltd. romanized国药准字H2020366950mg2023/11/29Official source ↗

NHSA approval numbers 2

Company (original)Identifier (original)Source dateOfficial source
Nanjing Hai Chen Pharma Co., Ltd. romanized国药准字H2020366950mg—Official source ↗
Nanjing Hai Chen Pharma Co., Ltd. romanized国药准字H2020366950mg—Official source ↗
Nanjing Hai Chen Pharma Co., Ltd. romanized国药准字H20247263150mg—Official source ↗

Under review 19

Company (original)Identifier (original)Source dateOfficial source
Nanjing Yi Heng Pharmaceutical Co., Ltd. romanizedCYHS26014352026/06/17Official source ↗
Suzhou Tian Ma Pharmaceuticals Group Tian Ji Biopharmaceutical Co., Ltd. romanizedCYHS26020462026/08/18Official source ↗
Hainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanizedCYHS26025742026/10/19Official source ↗
Hebei Yi Pin Pharmaceutical Co., Ltd. romanizedCYHS26022012026/09/03Official source ↗
Tianjin Tian Shi Li Zhi Jiao Pharma Co., Ltd. romanizedCYHS26020492026/08/18Official source ↗
Hainan Ling Kang Pharmaceutical Co., Ltd. romanizedCYHS26019492026/08/10Official source ↗
Guangdong Long Fu Pharma Co., Ltd. romanizedCYHS26018632026/08/03Official source ↗
Zhongshan Wanhan Pharmaceuticals Co., Ltd.; Guangdong Sunho Pharmaceutical Co., Ltd.CYHS26017752026/07/24Official source ↗
Kang Pu Pharma Co., Ltd. romanizedCYHS26015572026/07/01Official source ↗
Fu An Pharma Group Hubei Ren Min Pharmaceutical Co., Ltd. romanizedCYHS26015332026/06/30Official source ↗
NORTH CHINA PHARMACEUTICAL COMPANY.LTDCYHS26014232026/06/16Official source ↗
Chengdu Easton Biopharmaceuticals Co.,Ltd.CYHS26014212026/06/16Official source ↗
HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.CYHS26013622026/06/10Official source ↗
Lang Tian Pharma (Hubei) Co., Ltd. romanizedCYHS26013142026/06/05Official source ↗
Sichuan Ao Bang Gu De Pharma Co., Ltd. romanized; Sichuan Hong Ming Bo Si Pharma Co., Ltd. romanizedCYHS26012762026/06/04Official source ↗
Yi Chang Ren Fu Pharma Co., Ltd. romanizedCYHS26012362026/06/01Official source ↗
Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized; Chengdu Tong De Pharma Co., Ltd. romanizedCYHS26011952026/05/26Official source ↗
Hainan He Rui Pharmaceutical Co., Ltd. romanizedCYHS25020802025/06/12Official source ↗
Nanjing Hai Chen Pharma Co., Ltd. romanizedCYHB26019362026/10/22Official source ↗

Generic-filing companies this year 17

Company (original)Identifier (original)Source dateOfficial source
Nanjing Yi Heng Pharmaceutical Co., Ltd. romanizedCYHS26014352026/06/17Official source ↗
Suzhou Tian Ma Pharmaceuticals Group Tian Ji Biopharmaceutical Co., Ltd. romanizedCYHS26020462026/08/18Official source ↗
Hainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanizedCYHS26025742026/10/19Official source ↗
Hebei Yi Pin Pharmaceutical Co., Ltd. romanizedCYHS26022012026/09/03Official source ↗
Tianjin Tian Shi Li Zhi Jiao Pharma Co., Ltd. romanizedCYHS26020492026/08/18Official source ↗
Hainan Ling Kang Pharmaceutical Co., Ltd. romanizedCYHS26019492026/08/10Official source ↗
Guangdong Long Fu Pharma Co., Ltd. romanizedCYHS26018632026/08/03Official source ↗
Zhongshan Wanhan Pharmaceuticals Co., Ltd.; Guangdong Sunho Pharmaceutical Co., Ltd.CYHS26017752026/07/24Official source ↗
Kang Pu Pharma Co., Ltd. romanizedCYHS26015572026/07/01Official source ↗
Fu An Pharma Group Hubei Ren Min Pharmaceutical Co., Ltd. romanizedCYHS26015332026/06/30Official source ↗
NORTH CHINA PHARMACEUTICAL COMPANY.LTDCYHS26014232026/06/16Official source ↗
Chengdu Easton Biopharmaceuticals Co.,Ltd.CYHS26014212026/06/16Official source ↗
HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.CYHS26013622026/06/10Official source ↗
Lang Tian Pharma (Hubei) Co., Ltd. romanizedCYHS26013142026/06/05Official source ↗
Sichuan Ao Bang Gu De Pharma Co., Ltd. romanized; Sichuan Hong Ming Bo Si Pharma Co., Ltd. romanizedCYHS26012762026/06/04Official source ↗
Yi Chang Ren Fu Pharma Co., Ltd. romanizedCYHS26012362026/06/01Official source ↗
Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized; Chengdu Tong De Pharma Co., Ltd. romanizedCYHS26011952026/05/26Official source ↗

API companies with A status 8

Company (original)Identifier (original)Source dateOfficial source
Kang Pu Pharma Co., Ltd. romanizedY202500005692026/10/21Official source ↗
Hunan Fu Rui Biopharmaceuticals Technology Co., Ltd. romanizedY202500004412026/10/29Official source ↗
Chengdu Ao Bang Pharma Co., Ltd. romanizedY202400007012026/02/25Official source ↗
Zhongshan Wanhan Pharmaceuticals Co., Ltd.Y202400008892026/07/21Official source ↗
Lan Xi Ha San Lian Pharmaceutical Co., Ltd. romanizedY202300013302025/07/22Official source ↗
Sichuan Qing Mu Pharmaceutical Co., Ltd. romanizedY202300010292025/11/21Official source ↗
Hainan He Rui Pharmaceutical Co., Ltd. romanizedY202300005702025/02/14Official source ↗
Nanjing Hai Chen Pharma Co., Ltd. romanizedY201700012892025/05/21Official 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