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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, Sagent Pharms, Sun Pharma Global, and Usv North America, and is included in twenty-three 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-one patent family members in thirty-four 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

Tradenames:3
Patents:4
Applicants:16
NDAs:23
Drug Master File Entries: see list25
Suppliers: see list2
Therapeutic Class:Metabolic Bone Disease Agents
Formulation / Manufacturing:see details

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

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

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: 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

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
Akorn
ZOLEDRONIC ACID
zoledronic acid
INJECTABLE;IV (INFUSION)200918-001Aug 21, 2014RXNo<disabled><disabled>
Emcure Pharms Ltd
ZOLEDRONIC ACID
zoledronic acid
INJECTABLE;IV (INFUSION)201783-001Mar 12, 2013RXNo<disabled><disabled>
Pharmaceutics
ZOLEDRONIC ACID
zoledronic acid
INJECTABLE;IV (INFUSION)091170-001Mar 4, 2013RXNo<disabled><disabled>
Actavis Inc
ZOLEDRONIC ACID
zoledronic acid
INJECTABLE;IV (INFUSION)202472-001Mar 4, 2013RXNo<disabled><disabled>
Dr Reddys Labs Ltd
ZOLEDRONIC ACID
zoledronic acid
INJECTABLE;IV (INFUSION)091186-001Mar 4, 2013RXNo<disabled><disabled>
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International Patent Family for Ingredient: zoledronic acid

Country Document Number Publication Date
Russian Federation2358739Jun 20, 2009
South Korea20060087568Aug 02, 2006
Spain2247123Mar 01, 2006
Japan4802096Oct 26, 2011
Norway330459Apr 18, 2011
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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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