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Last Updated: September 25, 2020

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ZOLEDRONIC Drug Profile

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Which patents cover Zoledronic, and what generic alternatives are available?

Zoledronic is a drug marketed by 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-seven NDAs.

The generic ingredient in ZOLEDRONIC is zoledronic acid. There are twenty-five drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the zoledronic acid profile page.

US ANDA Litigation and Generic Entry Outlook for Zoledronic

A generic version of ZOLEDRONIC was approved as zoledronic acid by BRECKENRIDGE on March 4th, 2013.

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Drug patent expirations by year for ZOLEDRONIC
Drug Prices for ZOLEDRONIC

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Recent Clinical Trials for ZOLEDRONIC

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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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Pharmacology for ZOLEDRONIC
Drug ClassBisphosphonate

US Patents and Regulatory Information for ZOLEDRONIC

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sagent Pharms Inc ZOLEDRONIC ACID zoledronic acid INJECTABLE;INTRAVENOUS 091493-001 Nov 24, 2014 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
Shilpa Medicare Ltd ZOLEDRONIC ACID zoledronic acid INJECTABLE;INTRAVENOUS 208513-001 May 15, 2019 DISCN No No   Start Trial   Start Trial   Start Trial
Mylan Labs Ltd ZOLEDRONIC ACID zoledronic acid INJECTABLE;INTRAVENOUS 203841-001 Feb 14, 2017 AP RX No No   Start Trial   Start Trial   Start Trial
Gland Pharma Ltd ZOLEDRONIC zoledronic acid INJECTABLE;INTRAVENOUS 205749-001 Jun 29, 2018 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

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