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Last Updated: May 8, 2021

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ZOMETA Drug 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-four suppliers are listed for this compound. Additional details are available on the zoledronic acid profile page.

Drug patent expirations by year for ZOMETA
Drug Prices for ZOMETA

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Recent Clinical Trials for ZOMETA

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SponsorPhase
Australian and New Zealand Intensive Care Research CentrePhase 2
Lund University HospitalN/A
Lithuanian University of Health SciencesN/A

See all ZOMETA clinical trials

Paragraph IV (Patent) Challenges for ZOMETA
Tradename Dosage Ingredient NDA Submissiondate
ZOMETA INJECTABLE;INTRAVENOUS zoledronic acid 021223 2012-01-31
ZOMETA INJECTABLE;INTRAVENOUS zoledronic acid 021223 2008-06-11

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;INTRAVENOUS 021223-001 Aug 20, 2001 DISCN Yes No   Get Started for $10   Get Started for $10   Get Started for $10
Novartis ZOMETA zoledronic acid INJECTABLE;INTRAVENOUS 021223-003 Jun 17, 2011 AP RX Yes Yes   Get Started for $10   Get Started for $10 Y   Get Started for $10
Novartis ZOMETA zoledronic acid INJECTABLE;INTRAVENOUS 021223-002 Mar 7, 2003 AP RX Yes Yes   Get Started for $10   Get Started for $10 Y   Get Started for $10
Novartis ZOMETA zoledronic acid INJECTABLE;INTRAVENOUS 021223-003 Jun 17, 2011 AP RX Yes Yes   Get Started for $10   Get Started for $10 Y   Get Started for $10
>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 021223-003 Jun 17, 2011   Get Started for $10   Get Started for $10
Novartis ZOMETA zoledronic acid INJECTABLE;INTRAVENOUS 021223-002 Mar 7, 2003   Get Started for $10   Get Started for $10
Novartis ZOMETA zoledronic acid INJECTABLE;INTRAVENOUS 021223-001 Aug 20, 2001   Get Started for $10   Get Started for $10
Novartis ZOMETA zoledronic acid INJECTABLE;INTRAVENOUS 021223-002 Mar 7, 2003   Get Started for $10   Get Started for $10
Novartis ZOMETA zoledronic acid INJECTABLE;INTRAVENOUS 021223-001 Aug 20, 2001   Get Started for $10   Get Started for $10
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for ZOMETA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0275821 01C0035 France   Get Started for $10 PRODUCT NAME: ZOLEDRONIC ACID; NAT REG. NO/DATE: EU/1/01/176/001 20010320; FIRST REG.: LI IKS N 55 463 20001128
0275821 27/2001 Austria   Get Started for $10 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   Get Started for $10 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 26/2001 Austria   Get Started for $10 PRODUCT NAME: ZOLEDRONSAEURE; NAT. REGISTRATION NO/DATE: EU/1/01/176/001-003 20010320; FIRST REGISTRATION: LI 55463 20001128
0258618 2001C/036 Belgium   Get Started for $10 PRODUCT NAME: ACIDE ZOLEDRONIQUE; NATL REGISTRATION NO/DATE: EU/1/01/176/001 20010321; FIRST REGISTRATION: CH 55463 20001128
0258618 C300059 Netherlands   Get Started for $10 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
1591122 132013902140458 Italy   Get Started for $10 PRODUCT NAME: ACIDO ZOLEDRONICO(ACLASTA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/05/308/002, 20071003;57363, 20070927
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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