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Generated: January 17, 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 zoledronic acid 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 Pharm, Cipla, Dr Reddys Labs Ltd, Emcure Pharms Ltd, Fresenius Kabi Usa, Hikma Farmaceutica, Hospira Inc, Inforlife, Mylan Labs Ltd, Sagent Pharms, Sun Pharma Global, and Usv North America, and is included in thirty-six 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-six suppliers are listed for this compound. There are eleven tentative approvals for this compound.

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-phosphono-ethyl)phosphonic acid
(1-hydroxy-2-imidazol-1-yl-1-phosphonoethyl)phosphonic acid
(1-hydroxy-2-imidazol-1-yl-phosphonoethyl)phosphonic acid monohydrate
(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)-1,1-ETHANEDIYL]BIS(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
2-(imidazol-1-yl)-1-hydroxyethylidene-1,1-bisphosphonic 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 (TN)
Aclasta and Reclast
AK-81486
AKOS005145739
AN-5259
Anhydrous Zoledronic Acid
ANW-57498
API0004654
BC206233
BDBM12578
BIDD:GT0292
BIDD:PXR0134
Bio-0112
Bisphosphonate 3
BPH 91
C-17113
C5H10N2O7P2
CAS-118072-93-8
CGP 42'446
CGP 42446
CGP-42'446
CGP-42446
CGP-42446A
CHEBI:46557
CHEMBL924
CS-1829
CTK8A6898
D08689
D0VM2L
DB00399
DSSTox_CID_22668
DSSTox_GSID_42668
DSSTox_RID_80065
DTXSID0042668
EBD33252
FT-0082657
FT-0601384
GP9100
GTPL3177
HE004088
HE299812
HMS2089O09
HS-0091
HY-13777
I06-0710
JMC515594 Compound 55
KB-62427
KS-00000NZ4
KS-1132
LS-181815
MCULE-1604726355
MFCD00867791
MolPort-002-885-874
NCGC00159521-02
NCGC00159521-03
NCGC00159521-04
NCGC00159521-05
Novartis brand of zoledronic acid
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-
Phosphonic acid, P,P'-[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
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
Zomera (TN)
Zometa
Zometa (Novartis)
Zometa (TN)
Zometa Concentrate
Zometa, Zomera, Aclasta and Reclast, Zoledronic Acid
Tentative approvals for ZOLEDRONIC ACID
Applicant Application No. Strength Dosage Form
➤ Try a Free Trial➤ Try a Free Trial4MG/5ML(0.8MG/ML)INJECTABLE;INJECTION
➤ Try a Free Trial➤ Try a Free TrialEQ 4MG BASE/5MLINJECTABLE; IV (INFUSION)
➤ Try a Free Trial➤ Try a Free TrialEQ 4MG BASE/VIALINJECTABLE; IV (INFUSION)

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
Cipla ZOLEDRONIC ACID zoledronic acid INJECTABLE;IV (INFUSION) 210174-001 Oct 27, 2017 AP RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Gland Pharma Ltd ZOLEDRONIC ACID zoledronic acid INJECTABLE;IV (INFUSION) 204217-001 Aug 18, 2016 AP RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Novartis ZOMETA zoledronic acid INJECTABLE;IV (INFUSION) 021223-001 Aug 20, 2001 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Mylan Labs Ltd ZOLEDRONIC ACID zoledronic acid INJECTABLE;IV (INFUSION) 203841-001 Feb 14, 2017 AP RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Novartis RECLAST zoledronic acid INJECTABLE;IV (INFUSION) 021817-001 Apr 16, 2007 AP RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free 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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Expired US Patents for ZOLEDRONIC ACID

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis ZOMETA zoledronic acid INJECTABLE;IV (INFUSION) 021223-002 Mar 7, 2003 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis RECLAST zoledronic acid INJECTABLE;IV (INFUSION) 021817-001 Apr 16, 2007 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis ZOMETA zoledronic acid INJECTABLE;IV (INFUSION) 021223-002 Mar 7, 2003 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis ZOMETA zoledronic acid INJECTABLE;IV (INFUSION) 021223-001 Aug 20, 2001 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis ZOMETA zoledronic acid INJECTABLE;IV (INFUSION) 021223-001 Aug 20, 2001 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Supplementary Protection Certificates for ZOLEDRONIC ACID

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB01/042 United Kingdom ➤ Try a Free 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
2013000031 Germany ➤ Try a Free Trial PRODUCT NAME: ZOLEDRONSAEURE ODER PHARMAZEUTISCH UNBEDENKLICHES SALZ DAVON ODER BELIEBIGES HYDRAT DAVON; NAT. REGISTRATION NO/DATE: EU/1/05/308/001-002 20071003; FIRST REGISTRATION: SCHWEIZ 57363 20070927
1591122/01 Switzerland ➤ Try a Free Trial PRODUCT NAME: ZOLEDRONSAEURE; REGISTRATION NO/DATE: SWISSMEDIC 57363 27.09.2007
2013 00016 Denmark ➤ Try a Free Trial
C/GB01/039 United Kingdom ➤ Try a Free Trial 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
US Department of Justice
Boehringer Ingelheim
Argus Health
McKinsey
Chubb
Express Scripts
Baxter
Queensland Health

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