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Last Updated: July 3, 2020

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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 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, Cipla, Dr Reddys Labs Ltd, Emcure Pharms Ltd, Fresenius Kabi Usa, Hikma Farmaceutica, Hospira Inc, Inforlife, Ingenus Pharms Llc, Mylan Labs Ltd, 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-six 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
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Phase 2
Hormone Laboratory, Aker University Hospital, Oslo, NorwayPhase 3
University of OsloPhase 3

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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
Hospira Inc ZOLEDRONIC ACID zoledronic acid SOLUTION;INTRAVENOUS 204016-001 Dec 28, 2015 RX No No   Start Trial   Start Trial   Start Trial
Sun Pharma Global ZOLEDRONIC ACID zoledronic acid INJECTABLE;INTRAVENOUS 202746-001 Mar 4, 2013 DISCN No No   Start Trial   Start Trial   Start Trial
Apotex ZOLEDRONIC ACID zoledronic acid INJECTABLE;INTRAVENOUS 204367-001 Dec 24, 2015 AP RX No No   Start Trial   Start Trial   Start Trial
Shilpa Medicare Ltd ZOLEDRONIC ACID zoledronic acid INJECTABLE;INTRAVENOUS 208513-001 May 15, 2019 DISCN 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 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
Novartis RECLAST zoledronic acid INJECTABLE;INTRAVENOUS 021817-001 Apr 16, 2007   Start Trial   Start Trial
Novartis ZOMETA zoledronic acid INJECTABLE;INTRAVENOUS 021223-003 Jun 17, 2011   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 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 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
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
>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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