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Generated: May 26, 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-seven 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-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
Generic filers with tentative approvals for ZOLEDRONIC ACID
Applicant Application No. Strength Dosage Form
➤ Sign Up➤ Sign Up4MG/5ML(0.8MG/ML)INJECTABLE;INJECTION
➤ Sign Up➤ Sign UpEQ 4MG BASE/5MLINJECTABLE; IV (INFUSION)
➤ Sign Up➤ Sign UpEQ 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.

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
Inforlife ZOLEDRONIC ACID zoledronic acid INJECTABLE;IV (INFUSION) 203231-001 Aug 2, 2013 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Dr Reddys Labs Ltd ZOLEDRONIC ACID zoledronic acid INJECTABLE;IV (INFUSION) 091363-001 Mar 29, 2013 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Hospira Inc ZOLEDRONIC ACID zoledronic acid INJECTABLE;IV (INFUSION) 202837-001 Apr 5, 2013 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Accord Hlthcare ZOLEDRONIC ACID zoledronic acid INJECTABLE;IV (INFUSION) 205279-001 Nov 28, 2016 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Fresenius Kabi Usa ZOLEDRONIC ACID zoledronic acid INJECTABLE;IV (INFUSION) 091516-001 Apr 23, 2015 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Dr Reddys Labs Ltd ZOLEDRONIC ACID zoledronic acid INJECTABLE;IV (INFUSION) 204344-001 Nov 19, 2018 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Sagent Pharms ZOLEDRONIC ACID zoledronic acid INJECTABLE;IV (INFUSION) 091493-001 Nov 24, 2014 AP RX No No ➤ Sign Up ➤ Sign Up ➤ 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 ZOLEDRONIC ACID

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis ZOMETA zoledronic acid INJECTABLE;IV (INFUSION) 021223-003 Jun 17, 2011 ➤ Sign Up ➤ Sign Up
Novartis ZOMETA zoledronic acid INJECTABLE;IV (INFUSION) 021223-001 Aug 20, 2001 ➤ Sign Up ➤ Sign Up
Novartis RECLAST zoledronic acid INJECTABLE;IV (INFUSION) 021817-001 Apr 16, 2007 ➤ 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) 021223-002 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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Supplementary Protection Certificates for ZOLEDRONIC ACID

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1591122 CA 2013 00016 Denmark ➤ Sign Up
1591122 C300582 Netherlands ➤ Sign Up 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 ➤ Sign Up PRODUCT NAME: ACIDE ZOLEDRONIQUE; AUTHORISATION NUMBER AND DATE: C(2007)4619 20071003
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
1591122 92174 Luxembourg ➤ Sign Up PRODUCT NAME: ACIDE ZOLEDRONIQUE OU SON SEL PHARMACEUTIQUEMENT ACCEPTABLE OU TOUT HYDRATE DE CELUI-CI
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
1591122 300582 Netherlands ➤ Sign Up PRODUCT NAME: ZOLEDRONZUUR, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, DAN WEL IEDER HYDRAAT DAARVAN; REGISTRATION NO/DATE: C(2007)4619 20071003
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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