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Last Updated: November 21, 2019

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Zoledronic acid - Generic Drug Details

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What are the generic drug sources for zoledronic acid and what is the scope of patent protection?

Zoledronic acid is the generic ingredient in four branded drugs marketed by Novartis, Gland Pharma Ltd, 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, Hikma Farmaceutica, Hospira Inc, Inforlife, Mylan Labs Ltd, Sagent Pharms Inc, Shilpa Medicare Ltd, Sun Pharma Global, and USV, and is included in thirty-eight NDAs. There are four patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Zoledronic acid has eighty-two patent family members in thirty-seven countries.

There are twenty-five drug master file entries for zoledronic acid. Twenty-four suppliers are listed for this compound. There are eleven tentative approvals for this compound.

Drug Prices for zoledronic acid

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Recent Clinical Trials for zoledronic acid

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

SponsorPhase
Tung Wah Group of HospitalsPhase 3
Kwong Wah HospitalPhase 3
California Pacific Medical Center Research InstitutePhase 4

See all zoledronic acid clinical trials

Recent Litigation for zoledronic acid

Identify potential future generic entrants

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

Generic filers with tentative approvals for ZOLEDRONIC ACID
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial4MG/5ML(0.8MG/ML)INJECTABLE;INJECTION
  Start Trial  Start TrialEQ 4MG BASE/5MLINJECTABLE; IV (INFUSION)
  Start Trial  Start TrialEQ 4MG BASE/VIALINJECTABLE; IV (INFUSION)

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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
Emcure Pharms Ltd ZOLEDRONIC ACID zoledronic acid INJECTABLE;INTRAVENOUS 201801-001 Mar 29, 2013 AP RX No No   Start Trial   Start Trial   Start Trial
Mylan Labs Ltd ZOLEDRONIC ACID zoledronic acid INJECTABLE;INTRAVENOUS 202650-001 Mar 4, 2013 AP RX No No   Start Trial   Start Trial   Start Trial
Sagent Pharms Inc ZOLEDRONIC ACID zoledronic acid INJECTABLE;INTRAVENOUS 091493-001 Nov 24, 2014 AP RX No 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
Akorn Inc ZOLEDRONIC ACID zoledronic acid INJECTABLE;INTRAVENOUS 202548-001 May 22, 2014 AP RX No No   Start Trial   Start Trial   Start Trial
Novartis RECLAST zoledronic acid INJECTABLE;INTRAVENOUS 021817-001 Apr 16, 2007 AP RX Yes Yes   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
>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 zoledronic acid

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis RECLAST zoledronic acid INJECTABLE;INTRAVENOUS 021817-001 Apr 16, 2007   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 021223-002 Mar 7, 2003   Start Trial   Start Trial
Novartis ZOMETA zoledronic acid INJECTABLE;INTRAVENOUS 021223-003 Jun 17, 2011   Start Trial   Start Trial
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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for zoledronic acid

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1591122 C01591122/01 Switzerland   Start Trial PRODUCT NAME: ZOLEDRONSAEURE; REGISTRATION NO/DATE: SWISSMEDIC 57363 27.09.2007
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
1591122 300582 Netherlands   Start Trial PRODUCT NAME: ZOLEDRONZUUR, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, DAN WEL IEDER HYDRAAT DAARVAN; REGISTRATION NO/DATE: C(2007)4619 20071003
1591122 C300582 Netherlands   Start Trial PRODUCT NAME: ZOLEDRONZUUR, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, DAN WEL IEDER HYDRAAT DAARVAN; REGISTRATION NO/DATE: C(2007)4619 20071003
1591122 2013C/022 Belgium   Start Trial PRODUCT NAME: ACIDE ZOLEDRONIQUE; AUTHORISATION NUMBER AND DATE: C(2007)4619 20071003
0275821 01C0035 France   Start Trial PRODUCT NAME: ZOLEDRONIC ACID; NAT REG. NO/DATE: EU/1/01/176/001 20010320; FIRST REG.: LI IKS N 55 463 20001128
1591122 CA 2013 00016 Denmark   Start Trial PRODUCT NAME: ZOLEDRONSYRE ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF ELLER ET VILKARLIGT HYDRAT DERAF; NAT. REG. NO/DATE: EU/1/05/308, C(2007)4619 20071003; FIRST REG. NO/DATE: CH 57363 20070927
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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