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Serving 500+ biopharmaceutical companies globally:

Harvard Business School
QuintilesIMS
Citi
Healthtrust
Merck
Medtronic
McKinsey
Fuji
US Army
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Generated: June 24, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021060

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NDA 021060 describes PRIALT, which is a drug marketed by Jazz Pharms Intl 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 NDA: 021060

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1

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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRATHECALStrength500MCG/20ML (25MCG/ML)
Approval Date:Dec 28, 2004TE:RLD:Yes
Patent:5,364,842Patent Expiration:Dec 30, 2016Product Flag?Substance Flag?Delist Request?
Patented Use:ANALGESIA
Patent:8,653,033Patent Expiration:Oct 1, 2024Product Flag?Substance Flag?Delist Request?
Patented Use:ANALGESIA
Patent:8,765,680Patent Expiration:Oct 1, 2024Product Flag?Substance Flag?Delist Request?
Patented Use:ANALGESIA

Expired Orange Book Patents for NDA: 021060

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Jazz Pharms Intl
PRIALT
ziconotide acetate
INJECTABLE;INTRATHECAL021060-004Dec 28, 20045,795,864► Subscribe
Jazz Pharms Intl
PRIALT
ziconotide acetate
INJECTABLE;INTRATHECAL021060-003Dec 28, 20045,859,186► Subscribe
Jazz Pharms Intl
PRIALT
ziconotide acetate
INJECTABLE;INTRATHECAL021060-004Dec 28, 20045,364,842► Subscribe
Jazz Pharms Intl
PRIALT
ziconotide acetate
INJECTABLE;INTRATHECAL021060-002Dec 28, 20045,364,842► Subscribe
Jazz Pharms Intl
PRIALT
ziconotide acetate
INJECTABLE;INTRATHECAL021060-001Dec 28, 20045,795,864► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Teva
Fuji
Federal Trade Commission
McKesson
Covington
Deloitte
Farmers Insurance
Dow
Harvard Business School
US Department of Justice

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 verifification 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.

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