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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 Theraps Llc and is included in one NDA. There are three patents protecting this drug.

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 PRIALT

US Patents:	3
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	16
Clinical Trials:	6
Drug Prices:	Drug price information for PRIALT
DailyMed Link:	PRIALT at DailyMed

Generic Entry Opportunity Date for PRIALT

NDA:

021060

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 PRIALT

Drug Class	N-type Calcium Channel Antagonist
Mechanism of Action	N-Calcium Channel Receptor Antagonists

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 Theraps Llc	PRIALT	ziconotide acetate	INJECTABLE;INTRATHECAL	021060-002	Dec 28, 2004		RX	Yes	Yes
Tersera Theraps Llc	PRIALT	ziconotide acetate	INJECTABLE;INTRATHECAL	021060-004	Dec 28, 2004		RX	Yes	Yes
Tersera Theraps Llc	PRIALT	ziconotide acetate	INJECTABLE;INTRATHECAL	021060-004	Dec 28, 2004		RX	Yes	Yes
Tersera Theraps Llc	PRIALT	ziconotide acetate	INJECTABLE;INTRATHECAL	021060-003	Dec 28, 2004		DISCN	No	No
Tersera Theraps Llc	PRIALT	ziconotide acetate	INJECTABLE;INTRATHECAL	021060-004	Dec 28, 2004		RX	Yes	Yes
Tersera Theraps Llc	PRIALT	ziconotide acetate	INJECTABLE;INTRATHECAL	021060-002	Dec 28, 2004		RX	Yes	Yes
Tersera Theraps Llc	PRIALT	ziconotide acetate	INJECTABLE;INTRATHECAL	021060-003	Dec 28, 2004		DISCN	No	No

Expired US Patents for PRIALT

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

International Patents for PRIALT

Country	Document Number	Estimated Expiration
Japan	2007507538
Japan	2011173931
Canada	2930900
Canada	2540895
World Intellectual Property Organization (WIPO)	2005032556
European Patent Office	1689401

Supplementary Protection Certificates for PRIALT

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C0027	France		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
C/GB05/033	United Kingdom		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