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Ziprasidone Hydrochloride Capsules

Matched
Active ingredients (original)
ZIPRASIDONE 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 approval2001/02/05
ANDA applications9
RLD applicantVIATRIS SPECIALTY LLC

Currently marketed products: 32 · 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
A077560-001ZIPRASIDONE HYDROCHLORIDELUPIN PHARMACEUTICALS INCCAPSULEORALZIPRASIDONE HYDROCHLORIDE: EQ 20MG BASE2012/03/02N / NDISCONTINUEDopenFDA ↗
A077560-002ZIPRASIDONE HYDROCHLORIDELUPIN PHARMACEUTICALS INCCAPSULEORALZIPRASIDONE HYDROCHLORIDE: EQ 40MG BASE2012/03/02N / NDISCONTINUEDopenFDA ↗
A077560-003ZIPRASIDONE HYDROCHLORIDELUPIN PHARMACEUTICALS INCCAPSULEORALZIPRASIDONE HYDROCHLORIDE: EQ 60MG BASE2012/03/02N / NDISCONTINUEDopenFDA ↗
A077560-004ZIPRASIDONE HYDROCHLORIDELUPIN PHARMACEUTICALS INCCAPSULEORALZIPRASIDONE HYDROCHLORIDE: EQ 80MG BASE2012/03/02N / NDISCONTINUEDopenFDA ↗
A077561-001ZIPRASIDONE HYDROCHLORIDEAPOTEX INCCAPSULEORALZIPRASIDONE HYDROCHLORIDE: EQ 20MG BASE2012/03/02N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A077561-002ZIPRASIDONE HYDROCHLORIDEAPOTEX INCCAPSULEORALZIPRASIDONE HYDROCHLORIDE: EQ 40MG BASE2012/03/02N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A077561-003ZIPRASIDONE HYDROCHLORIDEAPOTEX INCCAPSULEORALZIPRASIDONE HYDROCHLORIDE: EQ 60MG BASE2012/03/02N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A077561-004ZIPRASIDONE HYDROCHLORIDEAPOTEX INCCAPSULEORALZIPRASIDONE HYDROCHLORIDE: EQ 80MG BASE2012/03/02N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A077562-001ZIPRASIDONE HYDROCHLORIDESANDOZ INCCAPSULEORALZIPRASIDONE HYDROCHLORIDE: EQ 20MG BASE2012/06/01N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A077562-002ZIPRASIDONE HYDROCHLORIDESANDOZ INCCAPSULEORALZIPRASIDONE HYDROCHLORIDE: EQ 40MG BASE2012/06/01N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A077562-003ZIPRASIDONE HYDROCHLORIDESANDOZ INCCAPSULEORALZIPRASIDONE HYDROCHLORIDE: EQ 60MG BASE2012/06/01N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A077562-004ZIPRASIDONE HYDROCHLORIDESANDOZ INCCAPSULEORALZIPRASIDONE HYDROCHLORIDE: EQ 80MG BASE2012/06/01N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A077565-001ZIPRASIDONE HYDROCHLORIDEDR REDDYS LABORATORIES INCCAPSULEORALZIPRASIDONE HYDROCHLORIDE: EQ 20MG BASE2012/03/02N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A077565-002ZIPRASIDONE HYDROCHLORIDEDR REDDYS LABORATORIES INCCAPSULEORALZIPRASIDONE HYDROCHLORIDE: EQ 40MG BASE2012/03/02N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A077565-003ZIPRASIDONE HYDROCHLORIDEDR REDDYS LABORATORIES INCCAPSULEORALZIPRASIDONE HYDROCHLORIDE: EQ 60MG BASE2012/03/02N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A077565-004ZIPRASIDONE HYDROCHLORIDEDR REDDYS LABORATORIES INCCAPSULEORALZIPRASIDONE HYDROCHLORIDE: EQ 80MG BASE2012/03/02N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A090348-001ZIPRASIDONE HYDROCHLORIDECHARTWELL RX SCIENCES LLCCAPSULEORALZIPRASIDONE HYDROCHLORIDE: EQ 20MG BASE2012/09/05N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A090348-002ZIPRASIDONE HYDROCHLORIDECHARTWELL RX SCIENCES LLCCAPSULEORALZIPRASIDONE HYDROCHLORIDE: EQ 40MG BASE2012/09/05N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A090348-003ZIPRASIDONE HYDROCHLORIDECHARTWELL RX SCIENCES LLCCAPSULEORALZIPRASIDONE HYDROCHLORIDE: EQ 60MG BASE2012/09/05N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A090348-004ZIPRASIDONE HYDROCHLORIDECHARTWELL RX SCIENCES LLCCAPSULEORALZIPRASIDONE HYDROCHLORIDE: EQ 80MG BASE2012/09/05N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A202395-001ZIPRASIDONE HYDROCHLORIDEMYLAN PHARMACEUTICALS INCCAPSULEORALZIPRASIDONE HYDROCHLORIDE: EQ 20MG BASE2013/10/10N / NDISCONTINUEDopenFDA ↗
A202395-002ZIPRASIDONE HYDROCHLORIDEMYLAN PHARMACEUTICALS INCCAPSULEORALZIPRASIDONE HYDROCHLORIDE: EQ 40MG BASE2013/10/10N / NDISCONTINUEDopenFDA ↗
A202395-003ZIPRASIDONE HYDROCHLORIDEMYLAN PHARMACEUTICALS INCCAPSULEORALZIPRASIDONE HYDROCHLORIDE: EQ 60MG BASE2013/10/10N / NDISCONTINUEDopenFDA ↗
A202395-004ZIPRASIDONE HYDROCHLORIDEMYLAN PHARMACEUTICALS INCCAPSULEORALZIPRASIDONE HYDROCHLORIDE: EQ 80MG BASE2013/10/10N / NDISCONTINUEDopenFDA ↗
A204117-001ZIPRASIDONE HYDROCHLORIDEAUROBINDO PHARMA LTDCAPSULEORALZIPRASIDONE HYDROCHLORIDE: EQ 20MG BASE2016/12/27N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A204117-002ZIPRASIDONE HYDROCHLORIDEAUROBINDO PHARMA LTDCAPSULEORALZIPRASIDONE HYDROCHLORIDE: EQ 40MG BASE2016/12/27N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A204117-003ZIPRASIDONE HYDROCHLORIDEAUROBINDO PHARMA LTDCAPSULEORALZIPRASIDONE HYDROCHLORIDE: EQ 60MG BASE2016/12/27N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A204117-004ZIPRASIDONE HYDROCHLORIDEAUROBINDO PHARMA LTDCAPSULEORALZIPRASIDONE HYDROCHLORIDE: EQ 80MG BASE2016/12/27N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A204375-001ZIPRASIDONE HYDROCHLORIDEMACLEODS PHARMACEUTICALS LTDCAPSULEORALZIPRASIDONE HYDROCHLORIDE: EQ 20MG BASE2017/02/17N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A204375-002ZIPRASIDONE HYDROCHLORIDEMACLEODS PHARMACEUTICALS LTDCAPSULEORALZIPRASIDONE HYDROCHLORIDE: EQ 40MG BASE2017/02/17N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A204375-003ZIPRASIDONE HYDROCHLORIDEMACLEODS PHARMACEUTICALS LTDCAPSULEORALZIPRASIDONE HYDROCHLORIDE: EQ 60MG BASE2017/02/17N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A204375-004ZIPRASIDONE HYDROCHLORIDEMACLEODS PHARMACEUTICALS LTDCAPSULEORALZIPRASIDONE HYDROCHLORIDE: EQ 80MG BASE2017/02/17N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A208988-001ZIPRASIDONE HYDROCHLORIDEZYDUS LIFESCIENCES LTDCAPSULEORALZIPRASIDONE HYDROCHLORIDE: EQ 20MG BASE2017/08/22N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A208988-002ZIPRASIDONE HYDROCHLORIDEZYDUS LIFESCIENCES LTDCAPSULEORALZIPRASIDONE HYDROCHLORIDE: EQ 40MG BASE2017/08/22N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A208988-003ZIPRASIDONE HYDROCHLORIDEZYDUS LIFESCIENCES LTDCAPSULEORALZIPRASIDONE HYDROCHLORIDE: EQ 60MG BASE2017/08/22N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A208988-004ZIPRASIDONE HYDROCHLORIDEZYDUS LIFESCIENCES LTDCAPSULEORALZIPRASIDONE HYDROCHLORIDE: EQ 80MG BASE2017/08/22N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
N020825-001GEODONVIATRIS SPECIALTY LLCCAPSULEORALZIPRASIDONE HYDROCHLORIDE: EQ 20MG BASE2001/02/05Y / YHUMAN PRESCRIPTION DRUGopenFDA ↗
N020825-002GEODONVIATRIS SPECIALTY LLCCAPSULEORALZIPRASIDONE HYDROCHLORIDE: EQ 40MG BASE2001/02/05Y / NHUMAN PRESCRIPTION DRUGopenFDA ↗
N020825-003GEODONVIATRIS SPECIALTY LLCCAPSULEORALZIPRASIDONE HYDROCHLORIDE: EQ 60MG BASE2001/02/05Y / NHUMAN PRESCRIPTION DRUGopenFDA ↗
N020825-004GEODONVIATRIS SPECIALTY LLCCAPSULEORALZIPRASIDONE HYDROCHLORIDE: EQ 80MG BASE2001/02/05Y / 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 2

Company (original)Identifier (original)Source dateOfficial source
Hunan Jiudian Pharmaceutical Co., Ltd国药准字H20253410See source2025/02/20Official source ↗
Pfizer Australia Pty LimitedH2016041020mg2007/01/10Official source ↗
Pfizer Australia Pty LimitedH2016041380mg2007/01/10Official source ↗
Pfizer Australia Pty LimitedH2016041260mg2007/01/10Official source ↗
Pfizer Australia Pty LimitedH2016041140mg2007/01/10Official source ↗

NHSA approval numbers 4

Company (original)Identifier (original)Source dateOfficial source
Jiangsu En Hua Pharma Co., Ltd. romanized国药准字H20061142See source—Official source ↗
Hunan Jiudian Pharmaceutical Co., Ltd国药准字H20253410See source—Official source ↗
Viatris Pharma GmbH国药准字HJ20160410See source—Official source ↗
Viatris Pharma GmbH国药准字HJ20160410See source—Official source ↗
Viatris Pharma GmbH国药准字HJ20160411See source—Official source ↗

Under review 9

Company (original)Identifier (original)Source dateOfficial source
Jiangsu En Hua Pharma Co., Ltd. romanizedCYHB26501572026/07/13Official source ↗
Hefei Ying Tai Pharmaceutical Co., Ltd. romanizedCYHS26022572026/09/10Official source ↗
Hefei Ying Tai Pharmaceutical Co., Ltd. romanizedCYHS26022562026/09/10Official source ↗
Chongqing Sheng Hua Xi Pharma Co., Ltd. romanizedCYHS26018142026/07/28Official source ↗
Chongqing Sheng Hua Xi Pharma Co., Ltd. romanizedCYHS26018132026/07/28Official source ↗
Chongqing Rui En Pharmaceuticals Co., Ltd. romanized; Zhi En Bio Technology Co., Ltd. romanizedCYHS26002632026/01/23Official source ↗
Chongqing Rui En Pharmaceuticals Co., Ltd. romanized; Zhi En Bio Technology Co., Ltd. romanizedCYHS26002622026/01/23Official source ↗
Anhui Pioneer Pharmaceutical Co., LtdCYHS26027302026/11/06Official source ↗
Anhui Pioneer Pharmaceutical Co., LtdCYHS26027292026/11/06Official source ↗

Generic-filing companies this year 4

Company (original)Identifier (original)Source dateOfficial source
Hefei Ying Tai Pharmaceutical Co., Ltd. romanizedCYHS26022572026/09/10Official source ↗
Hefei Ying Tai Pharmaceutical Co., Ltd. romanizedCYHS26022562026/09/10Official source ↗
Chongqing Sheng Hua Xi Pharma Co., Ltd. romanizedCYHS26018142026/07/28Official source ↗
Chongqing Sheng Hua Xi Pharma Co., Ltd. romanizedCYHS26018132026/07/28Official source ↗
Chongqing Rui En Pharmaceuticals Co., Ltd. romanized; Zhi En Bio Technology Co., Ltd. romanizedCYHS26002632026/01/23Official source ↗
Chongqing Rui En Pharmaceuticals Co., Ltd. romanized; Zhi En Bio Technology Co., Ltd. romanizedCYHS26002622026/01/23Official source ↗
Anhui Pioneer Pharmaceutical Co., LtdCYHS26027302026/11/06Official source ↗
Anhui Pioneer Pharmaceutical Co., LtdCYHS26027292026/11/06Official source ↗

API companies with A status 7

Company (original)Identifier (original)Source dateOfficial source
Zhejiang Guo Bang Pharma Co., Ltd. romanizedY202500003592026/11/04Official source ↗
Hebei Guo Long Pharmaceutical Co., Ltd. romanizedY202500002652026/11/08Official source ↗
Hebei Guo Long Pharmaceutical Co., Ltd. romanizedY202500001492026/10/11Official source ↗
Chongqing Sheng Hua Xi Pharma Co., Ltd. romanizedY202300011162025/04/09Official source ↗
Jiangsu Yu Tian Pharmaceuticals Co., Ltd. romanizedY202300006762026/10/16Official source ↗
Hunan Jiu Dian Hong Yang Pharmaceutical Co., Ltd. romanizedY202300003642026/08/14Official source ↗
Jiangsu En Hua Pharma Co., Ltd. romanizedY20190009730—Official source ↗
Jiangsu En Hua Pharma Co., Ltd. romanizedY201900073932024/10/09Official source ↗
Chongqing Sheng Hua Xi Pharma Co., Ltd. romanizedY201900055502025/11/29Official source ↗
Chongqing Sheng Hua Xi Pharma Co., Ltd. romanizedY201900047482026/01/09Official source ↗
Jiangsu En Hua Pharma Co., Ltd. romanizedY201700020142026/01/23Official source ↗
Xiamen En Cheng Pharmaceutical Co., Ltd. romanizedY201700013462024/04/02Official 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