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Last Updated: May 17, 2022

ZOMETA Drug Patent Profile


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When do Zometa patents expire, and when can generic versions of Zometa launch?

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 thirty-nine patent family members in twenty-four countries.

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.

DrugPatentWatch® Litigation and Generic Entry Outlook for Zometa

A generic version of ZOMETA was approved as zoledronic acid by BRECKENRIDGE on March 4th, 2013.

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Drug patent expirations by year for ZOMETA
Drug Prices for ZOMETA

See drug prices for ZOMETA

Recent Clinical Trials for ZOMETA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Assiut UniversityPhase 3
Australian and New Zealand Intensive Care Research CentrePhase 2
Lund University HospitalN/A

See all ZOMETA clinical trials

Paragraph IV (Patent) Challenges for ZOMETA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ZOMETA Injection zoledronic acid 4 mg/100 mL, 100 mL vial 021223 1 2012-01-31
ZOMETA Injection zoledronic acid 0.8 mg (base) /mL 021223 1 2008-06-11

US Patents and Regulatory Information for ZOMETA

ZOMETA is protected by one US patents.

Patents protecting ZOMETA

Pharmaceutical products comprising bisphosphonates
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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;INTRAVENOUS 021223-001 Aug 20, 2001 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Novartis ZOMETA zoledronic acid INJECTABLE;INTRAVENOUS 021223-003 Jun 17, 2011 AP RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Novartis ZOMETA zoledronic acid INJECTABLE;INTRAVENOUS 021223-002 Mar 7, 2003 AP RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Novartis ZOMETA zoledronic acid INJECTABLE;INTRAVENOUS 021223-003 Jun 17, 2011 AP RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for ZOMETA

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

International Patents for ZOMETA

See the table below for patents covering ZOMETA around the world.

Country Patent Number Title Estimated Expiration
Mexico 9427 ACIDOS ALCANDIFOSFONICOS SUBSTITUIDOS Y PROCEDIMIENTO PARA SU PREPARACION See Plans and Pricing
Germany 3776880 See Plans and Pricing
Japan 2004501104 See Plans and Pricing
European Patent Office 1286665 SCHEMA DE TRAITEMENT DU ZOLEDRONATE POUR LES MALADIES DE METABOLISME OSSEUX (TREATMENT REGIMEN OF INTRAVENOUS ZOLEDRONATE FOR THE TREATMENT OF BONE METABOLISM DISEASES) See Plans and Pricing
Finland 875096 See Plans and Pricing
Austria 72816 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ZOMETA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0275821 27/2001 Austria See Plans and Pricing PRODUCT NAME: ZOLEDRONSAEURE UND DEREN SALZE UND HYDRATE; NAT. REGISTRATION NO/DATE: EU/1/01/176/001-003 20010320; FIRST REGISTRATION: LI 55463.01 20001128
0275821 C300058 Netherlands See Plans and Pricing PRODUCT NAME: ZOLEDRONINEZUUR, DESGEWENST IN DE VORM VAN EEN ZOUT OF SOLVAAT, IN HET BIJZONDER ZOLEDRONINE-ZUUR-MONOHYDRAAT; REGISTRATION NO/DATE: EU/1/01/176/001-003 20010320
0258618 C300059 Netherlands See Plans and Pricing PRODUCT NAME: ZOLEDRONINEZUUR, DESGEWENST IN DE VORM VAN EEN FARMACOLOGISCH A ANVAARDBAAR ZOUT OF HYDRAAT OF VAN EEN FARMACOLOGISCH AANVAARDB ARE ESTER MET EEN ALKANOL MET DE FORMULE ROH, WAARIN R C1-C4 AL KYL VOORSTELT, IN HET BIJZONDER ZOLEDRONINEZUUR-MONOHYDRAAT; REGISTRATION NO/DATE: EU/1/01/176/001-EU/1/01/176/003 20010320
0258618 26/2001 Austria See Plans and Pricing PRODUCT NAME: ZOLEDRONSAEURE; NAT. REGISTRATION NO/DATE: EU/1/01/176/001-003 20010320; FIRST REGISTRATION: LI 55463 20001128
0258618 SPC/GB01/042 United Kingdom See Plans and Pricing 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
0275821 2001C/035 Belgium See Plans and Pricing PRODUCT NAME: ACIDE ZOLEDRONIQUE; NAT. REGISTRATION NO/DATE: EU/1/01/176/001 20010321; FIRST REGISTRATION: CH 55463 20001128
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKinsey
Mallinckrodt
Colorcon
Medtronic
Johnson and Johnson
AstraZeneca

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