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Last Updated: April 10, 2020

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

US ANDA Litigation and Generic Entry Outlook for Zometa

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

  Start Trial

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
Chi Lin, MDPhase 2
Ottawa Hospital Research InstitutePhase 4
University of Wisconsin, MadisonPhase 1

See all ZOMETA clinical trials

Recent Litigation for ZOMETA

Identify potential future generic entrants

District Court Litigation
Case NameDate
NOVARTIS PHARMACEUTICALS CORPORATION v. BPI LABS LLC2015-02-05
NOVARTIS PHARMACEUTICALS CORPORATION v. PAR STERILE PRODUCTS, LLC2014-12-03
NOVARTIS PHARMACEUTICALS CORPORATION v. SAGENT PHARMACEUTICALS, INC.2014-12-03

See all ZOMETA litigation

Pharmacology for ZOMETA
Drug ClassBisphosphonate
Synonyms for ZOMETA
(1-hydroxy-2-(1H-imidazol-1-yl)ethane-1,1-diyl)bis(phosphonic acid)
(1-Hydroxy-2-(1H-imidazol-1-yl)ethane-1,1-diyl)diphosphonic acid
(1-hydroxy-2-(1H-imidazol-1-yl)ethylidene)bisphosphonic acid
(1-hydroxy-2-imidazol-1-yl-1-phosphonoethyl)phosphonic acid
(1-Hydroxy-2-imidazol-1-ylethylidene)diphosphonic acid
[1-hydroxy-(1H-imidazol-1-yl)-phosphonoethyl] phos
[1-hydroxy-2-(1H-imidazol-1-yl)-1-phosphonoethyl]phosphonic acid
[1-HYDROXY-2-(1H-IMIDAZOL-1-YL)-ETHYLIDENE]BISPHOSPHONIC ACID
[1-hydroxy-2-(1H-imidazol-1-yl)ethane-1,1-diyl]bis(phosphonic acid)
[1-Hydroxy-2-(1H-imidazol-1-yl)ethylidene]bisphosphonic acid
072Z938
1-Hydroxy-2-(1-imidazolyl)ethane-1,1-diphosphonic Acid
1-hydroxy-2-(1H-imidazol-1-yl)ethane-1,1-diyldiphosphonic acid
118072-93-8
2-(imidazol-1-yl)-1-hydroxyethane-1,1-diphosphonic acid
42181-EP2270008A1
42181-EP2292617A1
42181-EP2295426A1
42181-EP2295427A1
42181-EP2308855A1
42181-EP2311808A1
42181-EP2311829A1
4CH-021386
70HZ18PH24
AB0013187
AB01273947_04
AB01273947-01
AB01273947-02
AB01273947-03
AB07564
AC-1092
Aclasta
Aclasta and Reclast
AK-81486
AKOS005145739
Anhydrous Zoledronic Acid
ANW-57498
API0004654
BCP22750
BDBM12578
BIDD:GT0292
BIDD:PXR0134
Bisphosphonate 3
BPH 91
C-17113
C5H10N2O7P2
CAS-118072-93-8
CGP 42446
CGP-4244
CGP-42446
CGP-42446A
CHEBI:46557
CHEMBL924
CS-1829
CTK8A6898
D08689
DB00399
DSSTox_CID_22668
DSSTox_GSID_42668
DSSTox_RID_80065
DTXSID0042668
EBD33252
FT-0082657
FT-0601384
GP9100
GTPL3177
HMS2089O09
HS-0091
HY-13777
JMC515594 Compound 55
KS-00000NZ4
LS-181815
MCULE-1604726355
NCGC00159521-02
NCGC00159521-03
NCGC00159521-04
NCGC00159521-05
NSC-721517
NSC721517
Orazol
PHO012
Phosphonic acid, (1-hydroxy-2-(1H-imidazol-1-yl)ethylidene)bis-
Phosphonic acid, [1-hydroxy-2-(1H-imidazol-1-yl)ethylidene]bis-
PubChem14894
Q-201946
Q218507
Reclast
Reclast (TN)
RTA-01011
S00092
s1314
SC-14082
SCHEMBL19054
SR-05000001436
SR-05000001436-1
ST24033505
STL452893
Tox21_111739
UNII-70HZ18PH24
XRASPMIURGNCCH-UHFFFAOYSA-N
Y1607
Z-1463
Z1691545083
ZINC000003803652
ZINC3803652
ZOL
ZOL 446
Zoledronate
Zoledronic acid
Zoledronic acid (INN)
Zoledronic Acid (Zoledronate)
Zoledronic acid [USAN:INN:BAN]
Zoledronic acid [USAN:INN]
Zoledronic Acid Anhydrous
Zoledronic Acid, Anhydrous
Zoledronic acid, Zoledronate
Zomera
Zometa (Novartis)
Zometa (TN)
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   Start Trial   Start Trial   Start Trial
Novartis ZOMETA zoledronic acid INJECTABLE;INTRAVENOUS 021223-003 Jun 17, 2011 AP RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Novartis ZOMETA zoledronic acid INJECTABLE;INTRAVENOUS 021223-002 Mar 7, 2003 AP RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>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   Start Trial   Start Trial
Novartis ZOMETA zoledronic acid INJECTABLE;INTRAVENOUS 021223-001 Aug 20, 2001   Start Trial   Start Trial
Novartis ZOMETA zoledronic acid INJECTABLE;INTRAVENOUS 021223-003 Jun 17, 2011   Start Trial   Start Trial
>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
1591122 132013902140458 Italy   Start Trial PRODUCT NAME: ACIDO ZOLEDRONICO(ACLASTA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/05/308/002, 20071003;57363, 20070927
0258618 SPC/GB01/042 United Kingdom   Start 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
0275821 2001C/035 Belgium   Start Trial 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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