Details for New Drug Application (NDA): 021060

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NDA 021060 describes PRIALT, which is a drug marketed by Tersera and is included in one NDA. It is available from two suppliers. There are three patents protecting this drug. Additional details are available on the PRIALT profile page.

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.

Summary for 021060

Tradename:	PRIALT
Applicant:	Tersera
Ingredient:	ziconotide acetate
Patents:	3

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for 021060

Generic Entry Date for 021060^: Get Started Free* Constraining patent/regulatory exclusivity: Get Started Free 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 NDA: 021060

Mechanism of Action	N-Calcium Channel Receptor Antagonists

Suppliers and Packaging for NDA: 021060

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PRIALT	ziconotide acetate	INJECTABLE;INTRATHECAL	021060	NDA	Jazz Pharmaceuticals, Inc.	18860-720	18860-720-10	1 VIAL, GLASS in 1 CARTON (18860-720-10) > 1 mL in 1 VIAL, GLASS
PRIALT	ziconotide acetate	INJECTABLE;INTRATHECAL	021060	NDA	Jazz Pharmaceuticals, Inc.	18860-722	18860-722-10	1 VIAL, GLASS in 1 CARTON (18860-722-10) > 5 mL in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRATHECAL			Strength	500MCG/20ML (25MCG/ML)
Approval Date:	Dec 28, 2004	TE:		RLD:	Yes
Patent:	Get Started Free	Patent Expiration:	Oct 1, 2024	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	ANALGESIA
Patent:	Get Started Free	Patent Expiration:	Oct 1, 2024	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF PAIN
Patent:	Get Started Free	Patent Expiration:	Oct 1, 2024	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	ANALGESIA

Expired US Patents for NDA 021060

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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	021060-002	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

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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.