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Last Updated: August 10, 2022

PRIALT Drug Patent 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: 24
Clinical Trials: 6
Patent Applications: 1,923
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 Pharmaceuticals

See all PRIALT clinical trials

Pharmacology for PRIALT

US Patents and Regulatory Information for PRIALT

PRIALT is protected by five US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of PRIALT is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting PRIALT

Method for administering omega-conopeptide
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PAIN

Method for administering omega-conopeptide
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: ANALGESIA

Method for administering omega-conopeptide
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PAIN

Method for administering omega-conopeptide
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: ANALGESIA

Method for administering .omega.-conopeptide
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SEVERE CHRONIC PAIN VIA INTRATHECAL INFUSION OF ZICONOTIDE IN PATIENTS ALSO RECEIVING MORPHINE

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Tersera PRIALT ziconotide acetate INJECTABLE;INTRATHECAL 021060-004 Dec 28, 2004 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Tersera PRIALT ziconotide acetate INJECTABLE;INTRATHECAL 021060-003 Dec 28, 2004 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Tersera PRIALT ziconotide acetate INJECTABLE;INTRATHECAL 021060-002 Dec 28, 2004 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Tersera PRIALT ziconotide acetate INJECTABLE;INTRATHECAL 021060-001 Dec 28, 2004 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Tersera PRIALT ziconotide acetate INJECTABLE;INTRATHECAL 021060-004 Dec 28, 2004 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 021060-004 Dec 28, 2004 See Plans and Pricing See Plans and Pricing
Tersera PRIALT ziconotide acetate INJECTABLE;INTRATHECAL 021060-002 Dec 28, 2004 See Plans and Pricing See Plans and Pricing
Tersera PRIALT ziconotide acetate INJECTABLE;INTRATHECAL 021060-003 Dec 28, 2004 See Plans and Pricing See Plans and Pricing
Tersera PRIALT ziconotide acetate INJECTABLE;INTRATHECAL 021060-001 Dec 28, 2004 See Plans and Pricing See Plans and Pricing
Tersera PRIALT ziconotide acetate INJECTABLE;INTRATHECAL 021060-001 Dec 28, 2004 See Plans and Pricing See Plans and Pricing
Tersera PRIALT ziconotide acetate INJECTABLE;INTRATHECAL 021060-002 Dec 28, 2004 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for PRIALT

See the table below for patents covering PRIALT around the world.

Country Patent Number Title Estimated Expiration
Spain 2194998 See Plans and Pricing
Australia 3428093 See Plans and Pricing
Canada 2151741 METHODE ANALGESIQUE ET AMELIORATION D'UNE METHODE ANALGESIQUE UTILISANT UN OPIACE (METHODS OF PRODUCING ANALGESIA AND ENHANCING OPIATE ANALGESIA) See Plans and Pricing
Germany 69627153 See Plans and Pricing
European Patent Office 0835126 COMPOSITIONS ET FORMULATIONS PERMETTANT DE PRODUIRE UNE ANALGESIE ET D'INHIBER LA PROGRESSION DE TROUBLES LIES A DES DOULEURS NEUROPATHIQUES (COMPOSITIONS AND FORMULATIONS FOR PRODUCING ANALGESIA AND FOR INHIBITING PROGRESSION OF NEUROPATHIC PAIN DISORDERS) See Plans and Pricing
Canada 2540895 METHODE DE SOULAGEMENT DE LA DOULEUR (METHOD FOR REDUCING PAIN) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for PRIALT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0835126 91181 Luxembourg See Plans and Pricing 91181, EXPIRES: 20200221
0835126 300201 Netherlands See Plans and Pricing 300201, 20160626, EXPIRES: 20200220
0835126 05C0027 France See Plans and Pricing PRODUCT 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
0835126 CA 2005 00033 Denmark See Plans and Pricing
0835126 SPC019/2005 Ireland See Plans and Pricing SPC019/2005: 20060407, EXPIRES: 20200220
0835126 C00835126/01 Switzerland See Plans and Pricing PRODUCT NAME: ZICONOTIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 56855 11.04.2006
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Merck
Baxter
McKinsey
Mallinckrodt
Express Scripts

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 verification 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.