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Last Updated: January 30, 2023

Ziprasidone hydrochloride - Generic Drug Details


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What are the generic drug sources for ziprasidone hydrochloride and what is the scope of freedom to operate?

Ziprasidone hydrochloride is the generic ingredient in two branded drugs marketed by Viatris, Apotex, Aurobindo Pharma, Cadila, Chartwell Rx, Dr Reddys Labs Inc, Lupin Pharms, Macleods Pharms Ltd, Mylan, Sandoz Inc, 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-one 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
Shanghai Jiao Tong University School of MedicinePhase 4
Shanghai Mental Health CenterPhase 4
Astellas Pharma Global Development, Inc.Phase 2

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
Chartwell Rx ZIPRASIDONE HYDROCHLORIDE ziprasidone hydrochloride CAPSULE;ORAL 090348-002 Sep 5, 2012 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Lupin Pharms ZIPRASIDONE HYDROCHLORIDE ziprasidone hydrochloride CAPSULE;ORAL 077560-002 Mar 2, 2012 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Cadila ZIPRASIDONE HYDROCHLORIDE ziprasidone hydrochloride CAPSULE;ORAL 208988-001 Aug 22, 2017 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Viatris GEODON ziprasidone hydrochloride CAPSULE;ORAL 020825-002 Feb 5, 2001 See Plans and Pricing See Plans and Pricing
Pfizer Inc GEODON ziprasidone hydrochloride SUSPENSION;ORAL 021483-001 Mar 29, 2006 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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