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 one supplier. 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. One supplier is 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

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	TerSera Therapeutics LLC	70720-720	70720-720-10	1 VIAL, GLASS in 1 CARTON (70720-720-10) / 1 mL in 1 VIAL, GLASS
PRIALT	ziconotide acetate	INJECTABLE;INTRATHECAL	021060	NDA	TerSera Therapeutics LLC	70720-722	70720-722-10	1 VIAL, GLASS in 1 CARTON (70720-722-10) / 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:	⤷ Sign Up	Patent Expiration:	Oct 1, 2024	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	ANALGESIA
Patent:	⤷ Sign Up	Patent Expiration:	Oct 1, 2024	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF PAIN
Patent:	⤷ Sign Up	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	021060-001	Dec 28, 2004	⤷ Sign Up	⤷ Sign Up
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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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