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Last Updated: November 19, 2019

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Details for New Drug Application (NDA): 021060

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NDA 021060 describes PRIALT, which is a drug marketed by Tersera Theraps Llc 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 Theraps Llc
Ingredient:ziconotide acetate
Patents:3
Generic Entry Opportunity Date for 021060
Generic Entry Date for 021060*:
Constraining patent/regulatory exclusivity:
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
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:RXDosage:INJECTABLE;INTRATHECALStrength500MCG/20ML (25MCG/ML)
Approval Date:Dec 28, 2004TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Oct 1, 2024Product Flag?Substance Flag?Delist Request?
Patented Use:ANALGESIA
Patent:  Start TrialPatent Expiration:Oct 1, 2024Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF PAIN
Patent:  Start TrialPatent Expiration:Oct 1, 2024Product Flag?Substance Flag?Delist Request?
Patented Use:ANALGESIA

Expired US Patents for NDA 021060

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

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