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Serving leading biopharmaceutical companies globally:

McKesson
Cantor Fitzgerald
Baxter
Boehringer Ingelheim
AstraZeneca
UBS
QuintilesIMS
Queensland Health
Colorcon
Dow

Generated: October 17, 2017

DrugPatentWatch Database Preview

ZOMETA Drug Profile

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What is the patent landscape for Zometa, and what generic Zometa alternatives are available?

Zometa is a drug marketed by Novartis and is included in one NDA. There are two patents protecting this drug and two Paragraph IV challenges.

This drug has twenty-six patent family members in twenty-two countries and three supplementary protection certificates in two countries.

The generic ingredient in ZOMETA is zoledronic acid. There are twenty-five drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the zoledronic acid profile page.

Summary for Tradename: ZOMETA

US Patents:2
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Bulk Api Vendors: see list86
Clinical Trials: see list65
Patent Applications: see list2,770
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:ZOMETA at DailyMed

Pharmacology for Tradename: ZOMETA

Ingredient-typeDiphosphonates
Drug ClassBisphosphonate
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis
ZOMETA
zoledronic acid
INJECTABLE;IV (INFUSION)021223-001Aug 20, 2001DISCNYesNo► Subscribe► Subscribe► Subscribe
Novartis
ZOMETA
zoledronic acid
INJECTABLE;IV (INFUSION)021223-003Jun 17, 2011APRXYesYes► Subscribe► SubscribeY► Subscribe
Novartis
ZOMETA
zoledronic acid
INJECTABLE;IV (INFUSION)021223-002Mar 7, 2003APRXYesYes► Subscribe► SubscribeY► Subscribe
Novartis
ZOMETA
zoledronic acid
INJECTABLE;IV (INFUSION)021223-003Jun 17, 2011APRXYesYes► Subscribe► SubscribeY ► Subscribe
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Expired Patents for Tradename: ZOMETA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis
ZOMETA
zoledronic acid
INJECTABLE;IV (INFUSION)021223-003Jun 17, 2011► Subscribe► Subscribe
Novartis
ZOMETA
zoledronic acid
INJECTABLE;IV (INFUSION)021223-001Aug 20, 2001► Subscribe► Subscribe
Novartis
ZOMETA
zoledronic acid
INJECTABLE;IV (INFUSION)021223-002Mar 7, 2003► Subscribe► Subscribe
Novartis
ZOMETA
zoledronic acid
INJECTABLE;IV (INFUSION)021223-002Mar 7, 2003► Subscribe► Subscribe
Novartis
ZOMETA
zoledronic acid
INJECTABLE;IV (INFUSION)021223-001Aug 20, 2001► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges 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
Iceland8351► Subscribe
Malaysia141763► Subscribe
Australia2004271731► Subscribe
Russian Federation2358739► Subscribe
Russian Federation2006112596► Subscribe
China1852739► Subscribe
TunisiaSN06084► Subscribe
Colombia5680461► Subscribe
TaiwanI345977► Subscribe
Japan2007505861► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: ZOMETA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0035France► SubscribePRODUCT NAME: ZOLEDRONIC ACID; NAT REG. NO/DATE: EU/1/01/176/001 20010320; FIRST REG.: LI IKS N 55 463 20001128
C/GB01/039United Kingdom► SubscribePRODUCT 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
C/GB01/042United Kingdom► SubscribePRODUCT 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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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

McKesson
Medtronic
QuintilesIMS
Covington
Federal Trade Commission
Merck
Daiichi Sankyo
Colorcon
Deloitte
Chubb

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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