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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, Akorn, Akorn Inc, Dr Reddys Labs Ltd, Emcure Pharms Ltd, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma Farmaceutica, Hospira Inc, Mylan Labs Ltd, Pharmaceutics, Pharms, Sagent Pharms, Sun Pharma Global, and Usv North America, and is included in twenty-four NDAs. There are four patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has sixty-two patent family members in thirty-five countries.

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

Summary for Generic Name: zoledronic acid

Drug Master File Entries: see list25
Suppliers / Packaging: see list6
Therapeutic Class:Metabolic Bone Disease Agents
Formulation / Manufacturing:see details

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

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

Pilot Study of Bisphosphonate Therapy (Zoledronic Acid) in Patients With Malignant Mesothelioma (UAB 0901)
Status: Active, not 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

The Use of Zoledronic Acid to Prevent Cancer-treatment Bone Loss in Post-menopausal Women Receiving Adjuvant Letrozole for Breast Cancer
Status: Completed Condition: Breast Cancer

Double-blind Extension of HORIZON Pivotal Fracture Trial (Zoledronic Acid in the Treatment of Postmenopausal Osteoporosis)
Status: Completed Condition: Osteoporosis

Postoperative Use of Zoledronic Acid in Breast Cancer Patients After Neoadjuvant Chemotherapy
Status: Completed 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
Hospira Inc
zoledronic acid
INJECTABLE;IV (INFUSION)202837-001Apr 5, 2013RXNo<disabled><disabled>
zoledronic acid
INJECTABLE;IV (INFUSION)202163-001Aug 5, 2013RXNo<disabled><disabled>
zoledronic acid
INJECTABLE;IV (INFUSION)021817-001Apr 16, 2007RXYes8,052,987<disabled> <disabled>
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International Patent Family for Ingredient: zoledronic acid

Country Document Number Publication Date
Japan2003535889Dec 02, 2003
South Africa200601209Apr 25, 2007
Poland203087Aug 31, 2009
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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