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Last Updated: April 11, 2021

DrugPatentWatch Database Preview

Zoledronic acid - Generic Drug Details

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What are the generic drug 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, Akorn Inc, 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 Medicare Ltd, 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

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Recent Clinical Trials for zoledronic acid

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SponsorPhase
Peking University Third HospitalPhase 4
Department of Regional Health Research, University of Southern DenmarkPhase 2
Stinus Gadegaard HansenPhase 2

See all zoledronic acid clinical trials

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
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
Aurobindo Pharma Ltd ZOLEDRONIC ACID zoledronic acid INJECTABLE;INTRAVENOUS 209125-001 Dec 8, 2017 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
>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 021223-002 Mar 7, 2003   Start Trial   Start Trial
Novartis ZOMETA zoledronic acid INJECTABLE;INTRAVENOUS 021223-002 Mar 7, 2003   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 2013C/022 Belgium   Start Trial PRODUCT NAME: ACIDE ZOLEDRONIQUE; AUTHORISATION NUMBER AND DATE: C(2007)4619 20071003
1591122 132013902140458 Italy   Start Trial 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   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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Colorcon
Johnson and Johnson
Harvard Business School
Express Scripts
Dow

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