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Last Updated: May 13, 2021

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ZOLEDRONIC ACID - Generic Drug Details

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What are the generic sources for zoledronic acid and what is the scope of freedom to operate?

Zoledronic acid is the generic ingredient in four branded drugs marketed by Novartis, Gland Pharma Ltd, Accord Hlthcare, Actavis Inc, Akorn, Apotex, Aurobindo Pharma Ltd, Bpi Labs Llc, Breckenridge, Dr Reddys Labs Ltd, Emcure Pharms Ltd, Fresenius Kabi Usa, Hikma Farmaceutica, Hospira Inc, Inforlife, Ingenus Pharms Llc, Mylan Labs Ltd, Puniska, Sagent Pharms Inc, Shilpa, Sun Pharma Global, and USV, and is included in thirty-nine 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

See drug prices for ZOLEDRONIC ACID

Recent Clinical Trials for ZOLEDRONIC ACID

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

SponsorPhase
Peking University Third HospitalPhase 4
Department of Radiology and Nuclear Medicine, Hospital of Southwest Jutland, 6700 Esbjerg, DenmarkPhase 2
Research Unit of Health Sciences, Hospital of South West JutlandPhase 2

See all ZOLEDRONIC ACID clinical trials

Generic filers with tentative approvals for ZOLEDRONIC ACID
Applicant Application No. Strength Dosage Form
  Get Started for $10  Get Started for $104MG/5ML(0.8MG/ML)INJECTABLE;INJECTION
  Get Started for $10  Get Started for $10EQ 4MG BASE/5MLINJECTABLE; IV (INFUSION)
  Get Started for $10  Get Started for $10EQ 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
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
Gland Pharma Ltd ZOLEDRONIC zoledronic acid INJECTABLE;INTRAVENOUS 205749-001 Jun 29, 2018 AP RX No No   Get Started for $10   Get Started for $10   Get Started for $10
Accord Hlthcare ZOLEDRONIC ACID zoledronic acid INJECTABLE;INTRAVENOUS 205279-001 Nov 28, 2016 AP RX No No   Get Started for $10   Get Started for $10   Get Started for $10
Bpi Labs Llc ZOLEDRONIC ACID zoledronic acid INJECTABLE;INTRAVENOUS 207341-001 Dec 29, 2017 AP RX No No   Get Started for $10   Get Started for $10   Get Started for $10
Hospira Inc ZOLEDRONIC ACID zoledronic acid INJECTABLE;INTRAVENOUS 090621-001 Mar 19, 2015 AP RX No No   Get Started for $10   Get Started for $10   Get Started for $10
Novartis RECLAST zoledronic acid INJECTABLE;INTRAVENOUS 021817-001 Apr 16, 2007 AP RX Yes Yes   Get Started for $10   Get Started for $10   Get Started for $10
Aurobindo Pharma Ltd ZOLEDRONIC ACID zoledronic acid INJECTABLE;INTRAVENOUS 207751-001 Sep 26, 2016 AP RX No No   Get Started for $10   Get Started for $10   Get Started for $10
>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 ZOMETA zoledronic acid INJECTABLE;INTRAVENOUS 021223-003 Jun 17, 2011   Get Started for $10   Get Started for $10
Novartis ZOMETA zoledronic acid INJECTABLE;INTRAVENOUS 021223-001 Aug 20, 2001   Get Started for $10   Get Started for $10
Novartis RECLAST zoledronic acid INJECTABLE;INTRAVENOUS 021817-001 Apr 16, 2007   Get Started for $10   Get Started for $10
Novartis ZOMETA zoledronic acid INJECTABLE;INTRAVENOUS 021223-002 Mar 7, 2003   Get Started for $10   Get Started for $10
Novartis ZOMETA zoledronic acid INJECTABLE;INTRAVENOUS 021223-001 Aug 20, 2001   Get Started for $10   Get Started for $10
Novartis ZOMETA zoledronic acid INJECTABLE;INTRAVENOUS 021223-002 Mar 7, 2003   Get Started for $10   Get Started for $10
>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
0275821 01C0035 France   Get Started for $10 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   Get Started for $10 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
1591122 132013902140458 Italy   Get Started for $10 PRODUCT NAME: ACIDO ZOLEDRONICO(ACLASTA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/05/308/002, 20071003;57363, 20070927
0258618 SPC/GB01/042 United Kingdom   Get Started for $10 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 122013000031 Germany   Get Started for $10 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 C300582 Netherlands   Get Started for $10 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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