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Ziconotide acetate - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for ziconotide acetate?

Ziconotide acetate is the generic ingredient in one branded drug marketed by Jazz Pharms Intl and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ziconotide acetate has fifteen patent family members in nine countries.

There is one drug master file entry for ziconotide acetate. One supplier is listed for this compound.

Summary for Generic Name: ziconotide acetate

Tradenames:1
Patents:3
Applicants:1
NDAs:1
Drug Master File Entries: see list1
Suppliers / Packagers: see list1
Bulk Api Vendors: see list8
Clinical Trials: see list440
Patent Applications: see list40
Drug Prices:see low prices
DailyMed Link:ziconotide acetate at DailyMed

Pharmacology for Ingredient: ziconotide acetate

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Jazz Pharms Intl
PRIALT
ziconotide acetate
INJECTABLE;INTRATHECAL021060-004Dec 28, 2004RXYesYes5,364,842► Subscribe ► Subscribe
Jazz Pharms Intl
PRIALT
ziconotide acetate
INJECTABLE;INTRATHECAL021060-003Dec 28, 2004DISCNNoNo8,765,680► Subscribe ► Subscribe
Jazz Pharms Intl
PRIALT
ziconotide acetate
INJECTABLE;INTRATHECAL021060-003Dec 28, 2004DISCNNoNo8,653,033► Subscribe ► Subscribe
Jazz Pharms Intl
PRIALT
ziconotide acetate
INJECTABLE;INTRATHECAL021060-002Dec 28, 2004RXYesYes5,364,842► Subscribe ► Subscribe
Jazz Pharms Intl
PRIALT
ziconotide acetate
INJECTABLE;INTRATHECAL021060-001Dec 28, 2004RXYesYes8,653,033► Subscribe ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: ziconotide acetate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Jazz Pharms Intl
PRIALT
ziconotide acetate
INJECTABLE;INTRATHECAL021060-004Dec 28, 20045,795,864► Subscribe
Jazz Pharms Intl
PRIALT
ziconotide acetate
INJECTABLE;INTRATHECAL021060-002Dec 28, 20045,364,842► Subscribe
Jazz Pharms Intl
PRIALT
ziconotide acetate
INJECTABLE;INTRATHECAL021060-003Dec 28, 20045,859,186► Subscribe
Jazz Pharms Intl
PRIALT
ziconotide acetate
INJECTABLE;INTRATHECAL021060-003Dec 28, 20045,364,842► Subscribe
Jazz Pharms Intl
PRIALT
ziconotide acetate
INJECTABLE;INTRATHECAL021060-001Dec 28, 20045,795,864► Subscribe
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Non-Orange Book Patents for Generic Ingredient: ziconotide acetate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,956,030Method for reducing pain with ziconotide and baclofen► Subscribe
5,587,454 Omega conopeptide compositions► Subscribe
7,268,109Method for reducing pain► Subscribe
7,977,307Method for reducing pain with ziconotide and morphine► Subscribe
6,136,786 Method for enhancing analgesia► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: ziconotide acetate

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)2005032556► Subscribe
Singapore50624► Subscribe
Austria165977► Subscribe
Canada2930900► Subscribe
European Patent Office0625162► Subscribe
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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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Supplementary Protection Certificates for Tradename: ZICONOTIDE ACETATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB05/033United Kingdom► SubscribePRODUCT NAME: ZICONOTIDE, OPTIONALLY IN THE FORM OF A SALT WITH A PHARMACEUTICALLY ACCEPTABLE ACID, INCLUDING ZICONOTIDE ACETATE; REGISTRATION NO/DATE: EU/1/04/302/001 - 003 20050224
C0027France► SubscribePRODUCT NAME: ZICONOTIDE; REGISTRATION NO/DATE IN FRANCE: EU/1/04/302/001 DU 20050221; REGISTRATION NO/DATE AT EEC: EU/1/04/302/001-003 DU 20050221
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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. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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