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Last Updated: July 5, 2020

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ZOLEDRONIC ACID Drug Profile


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Which patents cover Zoledronic Acid, and when can generic versions of Zoledronic Acid launch?

Zoledronic Acid is a drug marketed by 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, Gland Pharma Ltd, 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-six NDAs.

The generic ingredient in ZOLEDRONIC ACID is zoledronic acid. There are twenty-five drug master file entries for this compound. Twenty-six 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 Acid

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

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Drug patent expirations by year 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
University of OsloPhase 3
Martina Hansen's HospitalPhase 3

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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
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 202650-001 Mar 4, 2013 AP RX No No   Start Trial   Start Trial   Start Trial
Sun Pharma Global ZOLEDRONIC ACID zoledronic acid INJECTABLE;INTRAVENOUS 090018-001 Mar 4, 2013 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
Accord Hlthcare ZOLEDRONIC ACID zoledronic acid INJECTABLE;INTRAVENOUS 205279-001 Nov 28, 2016 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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Serving leading biopharmaceutical companies globally:

McKinsey
Johnson and Johnson
AstraZeneca
Baxter
McKesson
Boehringer Ingelheim

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.