Details for New Drug Application (NDA): 021060

✉ Email this page to a colleague

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:	⤷ Subscribe	Patent Expiration:	Oct 1, 2024	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	ANALGESIA
Patent:	⤷ Subscribe	Patent Expiration:	Oct 1, 2024	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF PAIN
Patent:	⤷ Subscribe	Patent Expiration:	Oct 1, 2024	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	ANALGESIA

Expired US Patents for NDA 021060

Subscribe to access the full database, or Subscribe
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Tersera	PRIALT	ziconotide acetate	INJECTABLE;INTRATHECAL	021060-004	Dec 28, 2004	⤷ Subscribe	⤷ Subscribe
Tersera	PRIALT	ziconotide acetate	INJECTABLE;INTRATHECAL	021060-004	Dec 28, 2004	⤷ Subscribe	⤷ Subscribe
Tersera	PRIALT	ziconotide acetate	INJECTABLE;INTRATHECAL	021060-003	Dec 28, 2004	⤷ Subscribe	⤷ Subscribe
Tersera	PRIALT	ziconotide acetate	INJECTABLE;INTRATHECAL	021060-004	Dec 28, 2004	⤷ Subscribe	⤷ Subscribe
Tersera	PRIALT	ziconotide acetate	INJECTABLE;INTRATHECAL	021060-001	Dec 28, 2004	⤷ Subscribe	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

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.