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Details for Generic Name: ziprasidone hydrochloride

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Ziprasidone hydrochloride is the generic ingredient in two branded drugs marketed by Pfizer, Apotex Corp, Dr Reddys Labs Inc, Lupin Pharms, Mylan Pharms Inc, Sandoz Inc, Wockhardt Ltd, and Pfizer 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-five patent family members in fifty-two countries.

There are nineteen drug master file entries for ziprasidone hydrochloride. Ten suppliers are listed for this compound.

Summary for Generic Name: ziprasidone hydrochloride

Drug Master File Entries: see list19
Suppliers: see list10
Therapeutic Class:Antipsychotics
Bipolar Agents
Formulation / Manufacturing:see details

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
Mylan Pharms Inc
ziprasidone hydrochloride
CAPSULE;ORAL202395-003Oct 10, 2013RXNo<disabled><disabled>
Pfizer Inc
ziprasidone hydrochloride
SUSPENSION;ORAL021483-001Mar 29, 2006RXYes6,150,366<disabled>Y<disabled>
Mylan Pharms Inc
ziprasidone hydrochloride
CAPSULE;ORAL202395-004Oct 10, 2013RXNo<disabled><disabled>
Wockhardt Ltd
ziprasidone hydrochloride
CAPSULE;ORAL090348-002Sep 5, 2012RXNo<disabled><disabled>
Lupin Pharms
ziprasidone hydrochloride
CAPSULE;ORAL077560-004Mar 2, 2012RXNo<disabled><disabled>
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International Patent Family for Ingredient: ziprasidone hydrochloride

Country Document Number Publication Date
African Regional IP Organization (ARIPO)1409Jun 13, 2005
Poland333737Dec 20, 1999
Denmark0965343Aug 04, 2003
CroatiaP990193Aug 31, 2003
Czech Republic9902127Sep 13, 2000
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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