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Generated: April 26, 2019

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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 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-seven 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
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-phosphono-ethyl)phosphonic 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
AC1L2ACJ
AC1Q6RN3
Aclasta
Aclasta and Reclast
AK-81486
AKOS005145739
AN-5259
Anhydrous Zoledronic Acid
ANW-57498
API0004654
BC206233
BCP22750
BDBM12578
BIDD:GT0292
BIDD:PXR0134
Bisphosphonate 3
BPH 91
C-17113
C5H10N2O7P2
CAS-118072-93-8
CGP 42446
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
I06-0710
JMC515594 Compound 55
KB-62427
KS-00000NZ4
LS-181815
MCULE-1604726355
MolPort-002-885-874
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
Reclast
Reclast (TN)
RP06507
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
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)
Zometa Concentrate

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 ➤ Sign Up ➤ Sign Up ➤ Sign Up
Novartis ZOMETA zoledronic acid INJECTABLE;IV (INFUSION) 021223-003 Jun 17, 2011 AP RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novartis ZOMETA zoledronic acid INJECTABLE;IV (INFUSION) 021223-002 Mar 7, 2003 AP RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
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) 021223-002 Mar 7, 2003 ➤ Sign Up ➤ Sign Up
Novartis ZOMETA zoledronic acid INJECTABLE;IV (INFUSION) 021223-002 Mar 7, 2003 ➤ Sign Up ➤ Sign Up
Novartis ZOMETA zoledronic acid INJECTABLE;IV (INFUSION) 021223-001 Aug 20, 2001 ➤ Sign Up ➤ Sign Up
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 Date
➤ Subscribe Injection 4 mg/100 mg, 100 mL vial ➤ Subscribe ➤ Sign Up
➤ Subscribe Injection 0.8 mg (base) /mL ➤ Subscribe ➤ Sign Up

Supplementary Protection Certificates for ZOMETA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0275821 SPC/GB01/039 United Kingdom ➤ Sign Up 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
0275821 01C0035 France ➤ Sign Up PRODUCT NAME: ZOLEDRONIC ACID; NAT REG. NO/DATE: EU/1/01/176/001 20010320; FIRST REG.: LI IKS N 55 463 20001128
0258618 SPC/GB01/042 United Kingdom ➤ Sign Up 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
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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