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Palonosetron Hydrochloride Soft Capsules

Matched
Active ingredients (original)
PALONOSETRON HYDROCHLORIDE
Dosage form (original)
CAPSULE
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 approval2008/08/22
ANDA applications0
RLD applicantHELSINN HEALTHCARE SA

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
N022233-001ALOXIHELSINN HEALTHCARE SACAPSULEORALPALONOSETRON HYDROCHLORIDE: EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**2008/08/22Y / NDISCONTINUEDopenFDA ↗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 3

Company (original)Identifier (original)Source dateOfficial source
CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD国药准字H20264646See source2026/06/03Official source ↗
Henan Tai Feng Bio Technology Co., Ltd. romanized国药准字H20263093See source2026/01/14Official source ↗
Kunming Ji Da Pharmaceutical Co., Ltd. romanized国药准字H20255897See source2025/11/12Official source ↗

NHSA approval numbers 3

Company (original)Identifier (original)Source dateOfficial source
CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD国药准字H20264646See source—Official source ↗
Zhengzhou Tai Feng Pharmaceutical Co., Ltd. romanized国药准字H20263093See source—Official source ↗
CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD国药准字H20264646See source—Official source ↗
Zhengzhou Tai Feng Pharmaceutical Co., Ltd. romanized国药准字H20263093See source—Official source ↗
CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD国药准字H20264646See source—Official source ↗
CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD国药准字H20264646See source—Official source ↗
Kunming Ji Da Pharmaceutical Co., Ltd. romanized国药准字H20255897See source—Official source ↗
Kunming Ji Da Pharmaceutical Co., Ltd. romanized国药准字H20255897See source—Official source ↗

Under review 2

Company (original)Identifier (original)Source dateOfficial source
Qilu Pharmaceutical Co., Ltd.CYHS26002412026/01/20Official source ↗
Yi Chang Ren Fu Pharma Co., Ltd. romanized; Ren Fu Pu Ke Pharma (Wuhan) Co., Ltd. romanizedCYHS26000842026/01/07Official source ↗

Generic-filing companies this year 2

Company (original)Identifier (original)Source dateOfficial source
Qilu Pharmaceutical Co., Ltd.CYHS26002412026/01/20Official source ↗
Yi Chang Ren Fu Pharma Co., Ltd. romanized; Ren Fu Pu Ke Pharma (Wuhan) Co., Ltd. romanizedCYHS26000842026/01/07Official source ↗

API companies with A status 21

Company (original)Identifier (original)Source dateOfficial source
Yi Chang Tian Ren Pharma Co., Ltd. romanizedY202300007422025/01/06Official source ↗
Qilu Pharmaceutical Co., Ltd.Y202300001682025/08/01Official source ↗
Wuhan Ai Min Pharmaceutical Co., Ltd. romanizedY202200001312024/07/03Official source ↗
Guang An Kai Te Pharmaceutical Co., Ltd. romanizedY202100006312023/06/22Official source ↗
Shandong Qidu Pharmaceutical Co., Ltd.Y202100005242024/01/26Official source ↗
Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.Y202000012772024/09/15Official source ↗
Chengdu Xin Heng Chuang Pharma Co., Ltd. romanizedY202000004252026/07/27Official source ↗
MSN Laboratories Private Limited, Unit - II romanizedY201900008522024/05/11Official source ↗
Lian Yun Gang Run Zhong Pharmaceutical Co., Ltd. romanizedY20190009860—Official source ↗
Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanizedY20190007478—Official source ↗
Nanjing Hai Run Pharmaceuticals Co., Ltd. romanizedY20190007381—Official source ↗
Bei Da Pharmaceuticals Co., Ltd. romanizedY201900073272023/08/29Official source ↗
Hangzhou Jiu Yuan Ji Yin Gong Cheng Co., Ltd. romanizedY201900073072023/04/19Official source ↗
Yang Zi Jiang Pharma Group Jiangsu Hai Ci Bio Pharma Co., Ltd. romanizedY201900072762024/01/17Official source ↗
Shanghai Hua Yuan Pharma (Ningxia) Sha Sai Pharmaceutical Co., Ltd. romanizedY20190007272—Official source ↗
Qilu Pharmaceutical Co., Ltd.Y201900066312026/06/11Official source ↗
Chongqing Sheng Kai Pharmaceutical Co., Ltd. romanizedY201900031872025/06/12Official source ↗
Kunming Ji Da Pharmaceutical Co., Ltd. romanizedY201900025302025/05/10Official source ↗
Xian Sheng Pharma Co., Ltd. romanizedY201900024352025/05/24Official source ↗
Lian Yun Gang Run Zhong Pharmaceutical Co., Ltd. romanizedY201800004952025/12/24Official source ↗
Sichuan Xin Kai Yuan Pharmaceutical Co., Ltd. romanizedY201700011792026/06/16Official source ↗
Sichuan Hai Si Ke Pharmaceutical Co., Ltd. romanizedY201700010132023/04/21Official source ↗
Shandong Ke Yuan Pharmaceutical Co., Ltd. romanizedY201700007952025/01/17Official 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.

Formulation crosswalk to CAPSULE / ORAL, based on the Chinese Pharmacopoeia general formulation provisions, rule CHP-FORM-022. Chinese Pharmacopoeia general chapter 0103

Comparison generated: 2026/11/13 18:41 · openFDA Orange Book ↗

Name and dosage-form matching sources