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Ziprasidone hydrochloride - Generic Drug Details

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Ziprasidone hydrochloride is the generic ingredient in two branded drugs marketed by Pfizer, Wockhardt Ltd, Lupin Pharms, Apotex Corp, Sandoz Inc, Dr Reddys Labs Inc, Pfizer Inc, and Mylan Pharms Inc, and is included in eight NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has one hundred and twenty-eight patent family members in fifty-three countries.

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

Summary for Generic Name: ziprasidone hydrochloride

Tradenames:2
Patents:3
Applicants:8
NDAs:8
Drug Master File Entries: see list19
Suppliers / Packaging: see list27
Therapeutic Class:Antipsychotics
Bipolar Agents
Formulation / Manufacturing:see details

Pharmacology for Ingredient: ziprasidone hydrochloride

Clinical Trials for: ziprasidone hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apotex Corp
ZIPRASIDONE HYDROCHLORIDE
ziprasidone hydrochloride
CAPSULE;ORAL077561-002Mar 2, 2012RXNo<disabled><disabled>
Pfizer
GEODON
ziprasidone hydrochloride
CAPSULE;ORAL020825-001Feb 5, 2001RXYes6,150,366<disabled>Y <disabled>
Mylan Pharms Inc
ZIPRASIDONE HYDROCHLORIDE
ziprasidone hydrochloride
CAPSULE;ORAL202395-003Oct 10, 2013RXNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: ziprasidone hydrochloride

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer Inc
GEODON
ziprasidone hydrochloride
SUSPENSION;ORAL021483-001Mar 29, 20065,312,925<disabled>
Pfizer
GEODON
ziprasidone hydrochloride
CAPSULE;ORAL020825-002Feb 5, 20014,831,031<disabled>
Pfizer Inc
GEODON
ziprasidone hydrochloride
SUSPENSION;ORAL021483-001Mar 29, 20064,831,031<disabled>
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International Patent Family for Ingredient: ziprasidone hydrochloride

Country Document Number Estimated Expiration
Australia739472<disabled in preview>
Poland195606<disabled in preview>
Taiwan520989<disabled in preview>
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