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ZOMETA Drug Profile

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Zometa 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.

This drug has twenty-five patent family members in twenty-one countries.

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 eleven tentative approvals for this compound. Additional details are available on the zoledronic acid profile page.

Summary for Tradename: ZOMETA

Patents:2
Applicants:1
NDAs:1
Suppliers / Packagers: see list1

Pharmacology for Tradename: ZOMETA

Ingredient-typeDiphosphonates
Drug ClassBisphosphonate

Clinical Trials for: ZOMETA

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis
ZOMETA
zoledronic acid
INJECTABLE;IV (INFUSION)021223-001Aug 20, 2001DISCNNo<disabled><disabled>
Novartis
ZOMETA
zoledronic acid
INJECTABLE;IV (INFUSION)021223-003Jun 17, 2011RXYes8,324,189*PED<disabled>Y<disabled>
Novartis
ZOMETA
zoledronic acid
INJECTABLE;IV (INFUSION)021223-002Mar 7, 2003RXYes8,324,189*PED<disabled>Y<disabled>
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Expired Patents for Tradename: ZOMETA

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis
ZOMETA
zoledronic acid
INJECTABLE;IV (INFUSION)021223-001Aug 20, 20014,777,163<disabled>
Novartis
ZOMETA
zoledronic acid
INJECTABLE;IV (INFUSION)021223-002Mar 7, 20034,777,163<disabled>
Novartis
ZOMETA
zoledronic acid
INJECTABLE;IV (INFUSION)021223-003Jun 17, 20114,939,130*PED<disabled>
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Paragraph IV activity for: ZOMETA

Drugname Dosage Strength RLD Submissiondate
zoledronic acidInjection4 mg/100 mg, 100 mL vialZometa1/31/2012
zoledronic acidInjection0.8 mg (base) /mLZometa6/11/2008

International Patent Family for Tradename: ZOMETA

Country Document Number Estimated Expiration
Malaysia141763<disabled in preview>
Russian Federation2006112596<disabled in preview>
Japan2007505861<disabled in preview>
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Supplementary Protection Certificates for Tradename: ZOMETA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB01/039United Kingdom<disabled>PRODUCT NAME: ZOLEDRONIC ACID OPTIONALLY IN THE FORM OF A SALT THEREOF; NATIONAL REGISTRATION NO/DATE: EU/1/01/176/001-003 20010320; FIRST REGISTRATION: CH 55463 20001128
C0035France<disabled>PRODUCT NAME: ZOLEDRONIC ACID; NAT REG. NO/DATE: EU/1/01/176/001 20010320; FIRST REG.: LI IKS N 55 463 20001128
C/GB01/042United Kingdom<disabled>PRODUCT NAME: ZOLEDRONIC ACID 2-(IMIDAZOL-1-YL)-1-HYDROXYETHANE-1,1-DIPHOSPHONIC ACID; REGISTERED: CH 55463 20001128; UK EU/1/01/176/001 20010320; UK EU/1/01/176/002 20010320; UK EU/1/01/176/003 20010320
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