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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.

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

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
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
Sandoz Inc
ziprasidone hydrochloride
CAPSULE;ORAL077562-001Jun 1, 2012RXNo<disabled><disabled>
Lupin Pharms
ziprasidone hydrochloride
CAPSULE;ORAL077560-003Mar 2, 2012RXNo<disabled><disabled>
Lupin Pharms
ziprasidone hydrochloride
CAPSULE;ORAL077560-002Mar 2, 2012RXNo<disabled><disabled>
ziprasidone hydrochloride
CAPSULE;ORAL020825-001Feb 5, 2001RXYes6,150,366<disabled>Y<disabled>
ziprasidone hydrochloride
CAPSULE;ORAL020825-004Feb 5, 2001RXNo6,245,766<disabled><disabled>
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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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