PRIALT Drug Patent Profile

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

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

See drug prices for PRIALT

DrugPatentWatch^® Estimated 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.

Recent Clinical Trials for PRIALT

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

Sponsor	Phase
Albany Medical College	Phase 4
Aaron Boster	Phase 4
Jazz Pharmaceuticals

See all PRIALT clinical trials

Pharmacology for PRIALT

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

Anatomical Therapeutic Chemical (ATC) Classes for PRIALT

N02BG	Other analgesics and antipyretics
N02B	OTHER ANALGESICS AND ANTIPYRETICS
N02	ANALGESICS
N	Nervous system

US Patents and Regulatory Information for PRIALT

PRIALT is protected by five US patents.

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

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
Tersera	PRIALT	ziconotide acetate	INJECTABLE;INTRATHECAL	021060-004	Dec 28, 2004		RX	Yes	Yes
Tersera	PRIALT	ziconotide acetate	INJECTABLE;INTRATHECAL	021060-003	Dec 28, 2004		DISCN	No	No
Tersera	PRIALT	ziconotide acetate	INJECTABLE;INTRATHECAL	021060-002	Dec 28, 2004		RX	Yes	Yes
Tersera	PRIALT	ziconotide acetate	INJECTABLE;INTRATHECAL	021060-001	Dec 28, 2004		RX	Yes	Yes
Tersera	PRIALT	ziconotide acetate	INJECTABLE;INTRATHECAL	021060-004	Dec 28, 2004		RX	Yes	Yes

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
Tersera	PRIALT	ziconotide acetate	INJECTABLE;INTRATHECAL	021060-002	Dec 28, 2004
Tersera	PRIALT	ziconotide acetate	INJECTABLE;INTRATHECAL	021060-003	Dec 28, 2004
Tersera	PRIALT	ziconotide acetate	INJECTABLE;INTRATHECAL	021060-001	Dec 28, 2004
Tersera	PRIALT	ziconotide acetate	INJECTABLE;INTRATHECAL	021060-001	Dec 28, 2004
Tersera	PRIALT	ziconotide acetate	INJECTABLE;INTRATHECAL	021060-002	Dec 28, 2004

International Patents for PRIALT

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

Country	Patent Number	Title	Estimated Expiration
Spain	2194998
Australia	3428093
Canada	2151741	METHODE ANALGESIQUE ET AMELIORATION D'UNE METHODE ANALGESIQUE UTILISANT UN OPIACE (METHODS OF PRODUCING ANALGESIA AND ENHANCING OPIATE ANALGESIA)
Germany	69627153
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)
Canada	2540895	METHODE DE SOULAGEMENT DE LA DOULEUR (METHOD FOR REDUCING PAIN)

Supplementary Protection Certificates for PRIALT

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