Competitive intelligence on 
 small-molecule drugs and 
 the 90,000 global patents 
 covering them 

Start your free trial now

DrugPatentWatch Ultimate Plan Preview

Details for Generic Name: zoledronic acid

« Back to Dashboard

Zoledronic acid is the generic ingredient in three branded drugs marketed by Novartis, Acs Dobfar Info Sa, Actavis Inc, Agila Speclts, Akorn, Akorn Inc, Dr Reddys Labs Ltd, Emcure Pharms Ltd, Gland Pharma Ltd, Hikma Farmaceutica, Hospira Inc, Pharmaceutics, Pharms, Sun Pharma Global, and Usv North America, and is included in twenty-one NDAs. There are four patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are twenty-five drug master file entries for zoledronic acid. Two suppliers are listed for this compound. There are twelve tentative approvals for this compound.

Summary for Generic Name: zoledronic acid

Drug Master File Entries: see list25
Suppliers: see list2
Therapeutic Class:Metabolic Bone Disease Agents

Pharmacology for Ingredient: zoledronic acid

Drug ClassBisphosphonate

Tentative approvals for ZOLEDRONIC ACID

Applicant Application No. Form Dosage
<disabled><disabled>INJECTABLE; IV (INFUSION)EQ 4MG BASE/5ML

Clinical Trials for: zoledronic acid

PET Scanning to Evaluate Zoledronate Efficacy in Metastatic Prostate Cancer
Status: Active, not recruiting Condition: Prostate Cancer

Perioperative Treatment With Zoledronic Acid in Patients With Resectable Pancreas Cancer
Status: Terminated Condition: Adenocarcinoma

The Use of Zoledronic Acid to Complex Regional Pain Syndrome
Status: Not yet recruiting Condition: Complex Regional Pain Syndromes

Pilot Study of Bisphosphonate Therapy (Zoledronic Acid) in Patients With Malignant Mesothelioma (UAB 0901)
Status: Recruiting Condition: Mesothelioma

Continued Efficacy and Safety of Zoledronic Acid (q 4 Wks vs. q 12 Wks) in the 2nd Year of Treatment in Patients With Bone Metastases From Breast Cancer
Status: Completed Condition: Breast Cancer

Postoperative Use of Zoledronic Acid in Breast Cancer Patients After Neoadjuvant Chemotherapy
Status: Active, not recruiting Condition: Breast Cancer

Courtesy of
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Actavis Inc
zoledronic acid
INJECTABLE;IV (INFUSION)202472Mar 4, 2013RXNo<disabled><disabled>
Hospira Inc
zoledronic acid
INJECTABLE;IV (INFUSION)202837Apr 5, 2013RXNo<disabled><disabled>
zoledronic acid
INJECTABLE;IV (INFUSION)202163Aug 5, 2013RXNo<disabled><disabled>
Hikma Farmaceutica
zoledronic acid
INJECTABLE;IV (INFUSION)202182Jun 3, 2013RXNo<disabled><disabled>
Emcure Pharms Ltd
zoledronic acid
INJECTABLE;IV (INFUSION)201783Mar 12, 2013RXNo<disabled><disabled>
This preview shows a limited data set
Subscribe for full access, or try a free trial

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

DrugPatentWatch Archives

You are viewing the current data set
Select a link below to view the archives:

 2000   2001   2002   2003   2004   2005   2006   2007   2008   2009   2010   2011   2012   2013  

For more information try a free trial or see the plan comparison

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 information. There is no warranty that the information contained herein is error free. 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.

Connect with Social Media:

Follow DrugPatentWatch on Twitter Connect with DrugPatentWatch on Linkedin Drug Patents on LinkedIn

Copyright © 2002-2014 thinkBiotech LLC. ISSN: 2162-2639

Other thinkBiotech sites: PatentStatBiotechBlogJournal of Commercial Biotechnology