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Serving leading biopharmaceutical companies globally:

Express Scripts
Harvard Business School
Daiichi Sankyo
Baxter
Queensland Health
McKinsey
Cerilliant
Medtronic
Farmers Insurance
Chubb

Generated: February 24, 2018

DrugPatentWatch Database Preview

ZOMETA Drug Profile

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When do Zometa patents expire, and what generic 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.

The generic ingredient in ZOMETA is zoledronic acid. There are twenty-five drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the zoledronic acid profile page.
Drug patent expirations by year for ZOMETA
Pharmacology for ZOMETA
Ingredient-typeDiphosphonates
Drug ClassBisphosphonate

US Patents and Regulatory Information for ZOMETA

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) 021223-001 Aug 20, 2001 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Novartis ZOMETA zoledronic acid INJECTABLE;IV (INFUSION) 021223-003 Jun 17, 2011 AP RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Novartis ZOMETA zoledronic acid INJECTABLE;IV (INFUSION) 021223-002 Mar 7, 2003 AP RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Novartis ZOMETA zoledronic acid INJECTABLE;IV (INFUSION) 021223-003 Jun 17, 2011 AP RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for ZOMETA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis ZOMETA zoledronic acid INJECTABLE;IV (INFUSION) 021223-001 Aug 20, 2001 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis ZOMETA zoledronic acid INJECTABLE;IV (INFUSION) 021223-002 Mar 7, 2003 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis ZOMETA zoledronic acid INJECTABLE;IV (INFUSION) 021223-003 Jun 17, 2011 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis ZOMETA zoledronic acid INJECTABLE;IV (INFUSION) 021223-001 Aug 20, 2001 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis ZOMETA zoledronic acid INJECTABLE;IV (INFUSION) 021223-002 Mar 7, 2003 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for ZOMETA
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Injection 4 mg/100 mg, 100 mL vial ➤ Subscribe 1/31/2012
➤ Subscribe Injection 0.8 mg (base) /mL ➤ Subscribe 6/11/2008

International Patents for ZOMETA

Supplementary Protection Certificates for ZOMETA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB01/039 United Kingdom ➤ Try a Free Trial 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
C/GB01/042 United Kingdom ➤ Try a Free Trial 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
C0035 France ➤ Try a Free Trial PRODUCT NAME: ZOLEDRONIC ACID; NAT REG. NO/DATE: EU/1/01/176/001 20010320; FIRST REG.: LI IKS N 55 463 20001128
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Merck
Moodys
Teva
QuintilesIMS
Dow
Boehringer Ingelheim
Fuji
Accenture

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