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PRIALT Drug Profile

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Prialt is a drug marketed by Jazz Pharms Intl and is included in one NDA. It is available from one supplier. There are three patents protecting this drug.

This drug has fifteen patent family members in nine countries.

The generic ingredient in PRIALT is ziconotide acetate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the ziconotide acetate profile page.

Summary for Tradename: PRIALT

Patents:3
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Drug Prices: :see details

Pharmacology for Tradename: PRIALT

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Jazz Pharms Intl
PRIALT
ziconotide acetate
INJECTABLE;INTRATHECAL021060-002Dec 28, 2004RXYes5,364,842► subscribe ► subscribe
Jazz Pharms Intl
PRIALT
ziconotide acetate
INJECTABLE;INTRATHECAL021060-003Dec 28, 2004DISCNNo5,364,842► subscribe ► subscribe
Jazz Pharms Intl
PRIALT
ziconotide acetate
INJECTABLE;INTRATHECAL021060-004Dec 28, 2004RXYes5,364,842► subscribe ► subscribe
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Expired Patents for Tradename: PRIALT

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

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
7,977,307Method for reducing pain with ziconotide and morphine► subscribe
5,587,454 Omega conopeptide compositions► subscribe
6,087,091 Method of selecting a compound for producing 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 Tradename: PRIALT

Country Document Number Estimated Expiration
Canada2930900► subscribe
European Patent Office0625162► subscribe
World Intellectual Property Organization (WIPO)2005032556► 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: PRIALT

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
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
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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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