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. 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-two 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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INTRAVENOUS			Strength	EQ 4MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Aug 20, 2001	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INTRAVENOUS			Strength	EQ 4MG BASE/5ML
Approval Date:	Mar 7, 2003	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Nov 29, 2025	Product Flag?		Substance Flag?		Delist Request?	Y

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INTRAVENOUS			Strength	EQ 4MG BASE/100ML
Approval Date:	Jun 17, 2011	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Feb 5, 2028	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 021223

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

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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.