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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-seven patent family members in fifty-three countries.

There are nineteen drug master file entries for ziprasidone hydrochloride. Ten 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 list55
Therapeutic Class:Antipsychotics
Bipolar Agents
Formulation / Manufacturing:see details

Pharmacology for Ingredient: ziprasidone hydrochloride

Clinical Trials for: ziprasidone hydrochloride

A 12-Week, Placebo Controlled Trial of Ziprasidone as Monotherapy for Major Depressive Disorder
Status: Completed Condition: Major Depressive Disorder

Bioequivalence Study of Ziprasidone HCL Capsules, 20 mg Under Fasting Conditions
Status: Completed Condition: Healthy

Bioequivalence Study of Ziprasidone HCL Capsules, 20 mg of Dr. Reddy's Under Fed Conditions
Status: Completed Condition: Healthy

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pfizer
GEODON
ziprasidone hydrochloride
CAPSULE;ORAL020825-004Feb 5, 2001RXNo6,150,366<disabled>Y<disabled>
Wockhardt Ltd
ZIPRASIDONE HYDROCHLORIDE
ziprasidone hydrochloride
CAPSULE;ORAL090348-003Sep 5, 2012RXNo<disabled><disabled>
Apotex Corp
ZIPRASIDONE HYDROCHLORIDE
ziprasidone hydrochloride
CAPSULE;ORAL077561-001Mar 2, 2012RXNo<disabled><disabled>
Pfizer Inc
GEODON
ziprasidone hydrochloride
SUSPENSION;ORAL021483-001Mar 29, 2006RXYes7,175,855<disabled>Y<disabled>
Apotex Corp
ZIPRASIDONE HYDROCHLORIDE
ziprasidone hydrochloride
CAPSULE;ORAL077561-004Mar 2, 2012RXNo<disabled><disabled>
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International Patent Family for Ingredient: ziprasidone hydrochloride

Country Document Number Publication Date
Japan3441676Sep 02, 2003
Norway992892Jun 14, 1999
Austria234097Mar 15, 2003
Japan4187423Nov 26, 2008
Cuba23223Aug 30, 2007
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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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