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Last Updated: June 14, 2021

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PRIALT Drug Profile


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Which patents cover Prialt, and when can generic versions of Prialt launch?

Prialt is a drug marketed by Tersera and is included in one NDA. There are three patents protecting this drug.

This drug has six patent family members in four countries.

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

DrugPatentWatch® Generic Entry Outlook for Prialt

Prialt was eligible for patent challenges on December 28, 2008.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 1, 2024. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for PRIALT
International Patents:6
US Patents:3
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 2
Raw Ingredient (Bulk) Api Vendors: 20
Clinical Trials: 6
Patent Applications: 1,779
Drug Prices: Drug price information for PRIALT
What excipients (inactive ingredients) are in PRIALT?PRIALT excipients list
DailyMed Link:PRIALT at DailyMed
Drug patent expirations by year for PRIALT
Drug Prices for PRIALT

See drug prices for PRIALT

DrugPatentWatch® Estimated Generic Entry Opportunity Date for PRIALT
Generic Entry Date for PRIALT*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
INJECTABLE;INTRATHECAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for PRIALT

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Albany Medical CollegePhase 4
Aaron BosterPhase 4
Jazz PharmaceuticalsN/A

See all PRIALT clinical trials

Pharmacology for PRIALT

US Patents and Regulatory Information for PRIALT

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Tersera PRIALT ziconotide acetate INJECTABLE;INTRATHECAL 021060-002 Dec 28, 2004 RX Yes Yes   Get Started Free   Get Started Free   Get Started Free
Tersera PRIALT ziconotide acetate INJECTABLE;INTRATHECAL 021060-003 Dec 28, 2004 DISCN No No   Get Started Free   Get Started Free   Get Started Free
Tersera PRIALT ziconotide acetate INJECTABLE;INTRATHECAL 021060-002 Dec 28, 2004 RX Yes Yes   Get Started Free   Get Started Free   Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for PRIALT

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Tersera PRIALT ziconotide acetate INJECTABLE;INTRATHECAL 021060-003 Dec 28, 2004   Get Started Free   Get Started Free
Tersera PRIALT ziconotide acetate INJECTABLE;INTRATHECAL 021060-004 Dec 28, 2004   Get Started Free   Get Started Free
Tersera PRIALT ziconotide acetate INJECTABLE;INTRATHECAL 021060-002 Dec 28, 2004   Get Started Free   Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for PRIALT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0835126 SPC/GB05/033 United Kingdom   Get Started Free PRODUCT 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
0835126 SPC019/2005 Ireland   Get Started Free SPC019/2005: 20060407, EXPIRES: 20200220
0835126 CA 2005 00033 Denmark   Get Started Free
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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