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Last Updated: March 28, 2024

ZIPRASIDONE HYDROCHLORIDE - Generic Drug Details


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What are the generic drug sources for ziprasidone hydrochloride and what is the scope of patent protection?

Ziprasidone hydrochloride is the generic ingredient in two branded drugs marketed by Viatris, Apotex, Aurobindo Pharma, Chartwell Rx, Dr Reddys Labs Inc, Lupin Pharms, Macleods Pharms Ltd, Mylan, Sandoz Inc, Zydus Lifesciences, and Pfizer Inc, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty drug master file entries for ziprasidone hydrochloride. Twenty-two suppliers are listed for this compound.

Summary for ZIPRASIDONE HYDROCHLORIDE
Recent Clinical Trials for ZIPRASIDONE HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
First Affiliated Hospital Xi'an Jiaotong UniversityN/A
Shanghai Jiao Tong University School of MedicinePhase 4
Shanghai Mental Health CenterPhase 4

See all ZIPRASIDONE HYDROCHLORIDE clinical trials

Pharmacology for ZIPRASIDONE HYDROCHLORIDE
Paragraph IV (Patent) Challenges for ZIPRASIDONE HYDROCHLORIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
GEODON Capsules ziprasidone hydrochloride 20 mg, 40 mg, 60 mg and 80 mg 020825 5 2005-02-07

US Patents and Regulatory Information for ZIPRASIDONE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan ZIPRASIDONE HYDROCHLORIDE ziprasidone hydrochloride CAPSULE;ORAL 202395-002 Oct 10, 2013 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Macleods Pharms Ltd ZIPRASIDONE HYDROCHLORIDE ziprasidone hydrochloride CAPSULE;ORAL 204375-002 Feb 17, 2017 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Macleods Pharms Ltd ZIPRASIDONE HYDROCHLORIDE ziprasidone hydrochloride CAPSULE;ORAL 204375-004 Feb 17, 2017 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Dr Reddys Labs Inc ZIPRASIDONE HYDROCHLORIDE ziprasidone hydrochloride CAPSULE;ORAL 077565-004 Mar 2, 2012 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Lupin Pharms ZIPRASIDONE HYDROCHLORIDE ziprasidone hydrochloride CAPSULE;ORAL 077560-003 Mar 2, 2012 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for ZIPRASIDONE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Viatris GEODON ziprasidone hydrochloride CAPSULE;ORAL 020825-004 Feb 5, 2001 ⤷  Try a Trial ⤷  Try a Trial
Viatris GEODON ziprasidone hydrochloride CAPSULE;ORAL 020825-003 Feb 5, 2001 ⤷  Try a Trial ⤷  Try a Trial
Viatris GEODON ziprasidone hydrochloride CAPSULE;ORAL 020825-001 Feb 5, 2001 ⤷  Try a Trial ⤷  Try a Trial
Viatris GEODON ziprasidone hydrochloride CAPSULE;ORAL 020825-003 Feb 5, 2001 ⤷  Try a Trial ⤷  Try a Trial
Viatris GEODON ziprasidone hydrochloride CAPSULE;ORAL 020825-004 Feb 5, 2001 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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