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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. Nineteen suppliers are listed for this compound. There are twelve tentative approvals for this compound. Additional details are available on the zoledronic acid profile page.

Summary for NDA: 021223

zoledronic acid
Therapeutic Class:Metabolic Bone Disease Agents
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
zoledronic acid
INJECTABLE;IV (INFUSION) 021223 NDA Novartis Pharmaceuticals Corporation 0078-0387 0078-0387-25 1 VIAL in 1 CARTON (0078-0387-25) > 5 mL in 1 VIAL
zoledronic acid
INJECTABLE;IV (INFUSION) 021223 NDA Novartis Pharmaceuticals Corporation 0078-0590 0078-0590-61 1 BOTTLE in 1 CARTON (0078-0590-61) > 100 mL in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;IV (INFUSION)StrengthEQ 4MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)StrengthEQ 4MG BASE/5ML
Approval Date:Mar 7, 2003TE:APRLD:Yes
Patent:8,324,189*PEDPatent Expiration:Nov 29, 2025Product Flag?Substance Flag?Delist Request?Y

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)StrengthEQ 4MG BASE/100ML
Approval Date:Jun 17, 2011TE:APRLD:Yes
Patent:7,932,241Patent Expiration:Feb 5, 2028Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 021223

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
zoledronic acid
INJECTABLE;IV (INFUSION)021223-001Aug 20, 20014,777,163► subscribe
zoledronic acid
INJECTABLE;IV (INFUSION)021223-002Mar 7, 20034,939,130*PED► subscribe
zoledronic acid
INJECTABLE;IV (INFUSION)021223-001Aug 20, 20014,939,130*PED► subscribe
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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 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.