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Details for Generic Name: zoledronic acid

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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

Tradenames:3
Patents:4
Applicants:15
NDAs:21
Drug Master File Entries: see list25
Suppliers: see list2
Therapeutic Class:Metabolic Bone Disease Agents

Pharmacology for Ingredient: zoledronic acid

Ingredient-typeDiphosphonates
Drug ClassBisphosphonate

Tentative approvals for ZOLEDRONIC ACID

Applicant Application No. Form Dosage
<disabled><disabled>INJECTABLE;INJECTION4MG/5ML(0.8MG/ML)
<disabled><disabled>INJECTABLE; IV (INFUSION)EQ 4MG BASE/5ML
<disabled><disabled>INJECTABLE; IV (INFUSION)EQ 4MG BASE/VIAL

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 ClinicalTrials.org
See more clinical trials for this drug
Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Actavis Inc
ZOLEDRONIC ACID
zoledronic acid
INJECTABLE;IV (INFUSION)202472Mar 4, 2013RXNo<disabled><disabled>
Hospira Inc
ZOLEDRONIC ACID
zoledronic acid
INJECTABLE;IV (INFUSION)202837Apr 5, 2013RXNo<disabled><disabled>
Pharmaceutics
ZOLEDRONIC ACID
zoledronic acid
INJECTABLE;IV (INFUSION)202163Aug 5, 2013RXNo<disabled><disabled>
Hikma Farmaceutica
ZOLEDRONIC ACID
zoledronic acid
INJECTABLE;IV (INFUSION)202182Jun 3, 2013RXNo<disabled><disabled>
Emcure Pharms Ltd
ZOLEDRONIC ACID
zoledronic acid
INJECTABLE;IV (INFUSION)201783Mar 12, 2013RXNo<disabled><disabled>
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