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Last Updated: November 19, 2019

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ZOLEDRONIC ACID Drug Profile

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

Zoledronic Acid is a drug marketed by Accord Hlthcare, Actavis Inc, Akorn, Akorn Inc, Apotex Inc, Aurobindo Pharma Ltd, Bpi Labs Llc, Breckenridge, Cipla, Dr Reddys Labs Ltd, Emcure Pharms Ltd, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma Farmaceutica, Hospira Inc, Inforlife, Mylan Labs Ltd, Sagent Pharms Inc, Shilpa Medicare Ltd, Sun Pharma Global, and USV. and is included in thirty-five NDAs.

The generic ingredient in ZOLEDRONIC ACID is zoledronic acid. There are twenty-five drug master file entries for this compound. Twenty-four suppliers are listed for this compound. There are eleven tentative approvals for this compound. Additional details are available on the zoledronic acid profile page.

Drug patent expirations by year for ZOLEDRONIC ACID
Drug Prices for ZOLEDRONIC ACID

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Recent Clinical Trials for ZOLEDRONIC ACID

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SponsorPhase
Tung Wah Group of HospitalsPhase 3
Kwong Wah HospitalPhase 3
Parkinson's FoundationPhase 4

See all ZOLEDRONIC ACID clinical trials

Recent Litigation for ZOLEDRONIC ACID

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

See all ZOLEDRONIC ACID litigation

Pharmacology for ZOLEDRONIC ACID
Drug ClassBisphosphonate
Synonyms for ZOLEDRONIC ACID
(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 (INN)
Zoledronic Acid (Zoledronate)
Zoledronic acid [USAN:INN:BAN]
Zoledronic acid [USAN:INN]
Zoledronic Acid Anhydrous
Zoledronic Acid, Anhydrous
Zoledronic acid, Zoledronate
Zomera
Zometa
Zometa (Novartis)
Zometa (TN)
Zometa Concentrate
Paragraph IV (Patent) Challenges for ZOLEDRONIC ACID
Tradename Dosage Ingredient NDA Submissiondate
ZOMETA INJECTABLE;INTRAVENOUS zoledronic acid 021223 2012-01-31
RECLAST INJECTABLE;INTRAVENOUS zoledronic acid 021817 2008-08-29
ZOMETA INJECTABLE;INTRAVENOUS zoledronic acid 021223 2008-06-11

US Patents and Regulatory Information for ZOLEDRONIC ACID

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sun Pharma Global ZOLEDRONIC ACID zoledronic acid INJECTABLE;INTRAVENOUS 090018-001 Mar 4, 2013 DISCN No No   Start Trial   Start Trial   Start Trial
Mylan Labs Ltd ZOLEDRONIC ACID zoledronic acid INJECTABLE;INTRAVENOUS 203841-001 Feb 14, 2017 AP RX No No   Start Trial   Start Trial   Start Trial
Sun Pharma Global ZOLEDRONIC ACID zoledronic acid INJECTABLE;INTRAVENOUS 202746-001 Mar 4, 2013 DISCN No No   Start Trial   Start Trial   Start Trial
Mylan Labs Ltd ZOLEDRONIC ACID zoledronic acid INJECTABLE;INTRAVENOUS 205254-001 Oct 27, 2017 AP RX No No   Start Trial   Start Trial   Start 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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