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Last Updated: December 5, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021223

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NDA 021223 describes ZOMETA, which is a drug marketed by Novartis and is included in one NDA. It is available from one supplier. There are two patents protecting this drug and two Paragraph IV challenges. Additional details are available on the ZOMETA profile page.

The generic ingredient in ZOMETA is zoledronic acid. There are twenty-five drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the zoledronic acid profile page.
Summary for 021223
Tradename:ZOMETA
Applicant:Novartis
Ingredient:zoledronic acid
Patents:2
Formulation / Manufacturing:see details
Pharmacology for NDA: 021223
Suppliers and Packaging for NDA: 021223
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZOMETA zoledronic acid INJECTABLE;INTRAVENOUS 021223 NDA Novartis Pharmaceuticals Corporation 0078-0387 0078-0387-25 1 VIAL in 1 CARTON (0078-0387-25) > 5 mL in 1 VIAL
ZOMETA zoledronic acid INJECTABLE;INTRAVENOUS 021223 NDA Novartis Pharmaceuticals Corporation 0078-0590 0078-0590-61 1 BOTTLE in 1 CARTON (0078-0590-61) > 100 mL in 1 BOTTLE
Paragraph IV (Patent) Challenges for 021223
Tradename Dosage Ingredient NDA Submissiondate
ZOMETA INJECTABLE;INTRAVENOUS zoledronic acid 021223 2012-01-31
ZOMETA INJECTABLE;INTRAVENOUS zoledronic acid 021223 2008-06-11

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INTRAVENOUSStrengthEQ 4MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Aug 20, 2001TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrengthEQ 4MG BASE/5ML
Approval Date:Mar 7, 2003TE:APRLD:Yes
Patent:  Start TrialPatent Expiration:Nov 29, 2025Product Flag?Substance Flag?Delist Request?Y

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrengthEQ 4MG BASE/100ML
Approval Date:Jun 17, 2011TE:APRLD:Yes
Patent:  Start TrialPatent Expiration:Feb 5, 2028Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 021223

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis ZOMETA zoledronic acid INJECTABLE;INTRAVENOUS 021223-001 Aug 20, 2001   Start Trial   Start Trial
Novartis ZOMETA zoledronic acid INJECTABLE;INTRAVENOUS 021223-003 Jun 17, 2011   Start Trial   Start Trial
Novartis ZOMETA zoledronic acid INJECTABLE;INTRAVENOUS 021223-002 Mar 7, 2003   Start Trial   Start Trial
Novartis ZOMETA zoledronic acid INJECTABLE;INTRAVENOUS 021223-002 Mar 7, 2003   Start Trial   Start Trial
Novartis ZOMETA zoledronic acid INJECTABLE;INTRAVENOUS 021223-001 Aug 20, 2001   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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