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Last Updated: July 13, 2024

Ziconotide acetate - Generic Drug Details


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What are the generic drug sources for ziconotide acetate and what is the scope of freedom to operate?

Ziconotide acetate is the generic ingredient in one branded drug marketed by Tersera 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 six patent family members in four countries.

One supplier is listed for this compound.

Summary for ziconotide acetate
International Patents:6
US Patents:3
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 25
Patent Applications: 76
What excipients (inactive ingredients) are in ziconotide acetate?ziconotide acetate excipients list
DailyMed Link:ziconotide acetate at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ziconotide acetate
Generic Entry Date for ziconotide acetate*:
Constraining patent/regulatory exclusivity:
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.

Pharmacology for ziconotide acetate
Anatomical Therapeutic Chemical (ATC) Classes for ziconotide acetate

US Patents and Regulatory Information for ziconotide acetate

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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Tersera PRIALT ziconotide acetate INJECTABLE;INTRATHECAL 021060-001 Dec 28, 2004 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Tersera PRIALT ziconotide acetate INJECTABLE;INTRATHECAL 021060-003 Dec 28, 2004 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Tersera PRIALT ziconotide acetate INJECTABLE;INTRATHECAL 021060-003 Dec 28, 2004 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Tersera PRIALT ziconotide acetate INJECTABLE;INTRATHECAL 021060-002 Dec 28, 2004 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Tersera PRIALT ziconotide acetate INJECTABLE;INTRATHECAL 021060-001 Dec 28, 2004 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 ziconotide acetate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Tersera PRIALT ziconotide acetate INJECTABLE;INTRATHECAL 021060-003 Dec 28, 2004 ⤷  Sign Up ⤷  Sign Up
Tersera PRIALT ziconotide acetate INJECTABLE;INTRATHECAL 021060-004 Dec 28, 2004 ⤷  Sign Up ⤷  Sign Up
Tersera PRIALT ziconotide acetate INJECTABLE;INTRATHECAL 021060-002 Dec 28, 2004 ⤷  Sign Up ⤷  Sign Up
Tersera PRIALT ziconotide acetate INJECTABLE;INTRATHECAL 021060-001 Dec 28, 2004 ⤷  Sign Up ⤷  Sign Up
Tersera PRIALT ziconotide acetate INJECTABLE;INTRATHECAL 021060-002 Dec 28, 2004 ⤷  Sign Up ⤷  Sign Up
Tersera PRIALT ziconotide acetate INJECTABLE;INTRATHECAL 021060-004 Dec 28, 2004 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for ziconotide acetate

Country Patent Number Title Estimated Expiration
Canada 2930900 METHODE DE REDUCTION DE LA DOULEUR (COMBINATION OF ZICONOTIDE AND OPIOIDS FOR REDUCING PAIN) ⤷  Sign Up
Japan 2011173931 METHOD FOR REDUCING PAIN ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2005032556 ⤷  Sign Up
European Patent Office 1689401 METHODE DE SOULAGEMENT DE LA DOULEUR (METHOD FOR REDUCING PAIN) ⤷  Sign Up
Canada 2540895 METHODE DE SOULAGEMENT DE LA DOULEUR (METHOD FOR REDUCING PAIN) ⤷  Sign Up
Japan 2007507538 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ziconotide acetate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0835126 05C0027 France ⤷  Sign Up 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 SPC/GB05/033 United Kingdom ⤷  Sign Up 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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 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.