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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
Drug Prices:see low prices

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
Mylan Pharms Inc
ZIPRASIDONE HYDROCHLORIDE
ziprasidone hydrochloride
CAPSULE;ORAL202395-004Oct 10, 2013RXNo
Lupin Pharms
ZIPRASIDONE HYDROCHLORIDE
ziprasidone hydrochloride
CAPSULE;ORAL077560-003Mar 2, 2012RXNo
Lupin Pharms
ZIPRASIDONE HYDROCHLORIDE
ziprasidone hydrochloride
CAPSULE;ORAL077560-001Mar 2, 2012RXNo
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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
GEODON
ziprasidone hydrochloride
CAPSULE;ORAL020825-001Feb 5, 20014,831,031<disabled>
Pfizer
GEODON
ziprasidone hydrochloride
CAPSULE;ORAL020825-003Feb 5, 20014,831,031<disabled>
Pfizer
GEODON
ziprasidone hydrochloride
CAPSULE;ORAL020825-002Feb 5, 20015,312,925<disabled>
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International Patent Family for Ingredient: ziprasidone hydrochloride

Country Document Number Estimated Expiration
Taiwan520989<disabled in preview>
Colombia5070579<disabled in preview>
Brazil0010990<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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