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Profile for Tradename: ZOMETA

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Zometa is a drug marketed by Novartis and is included in one NDA. It is available from one supplier. There are two patents protecting this drug and two Paragraph IV challenges.

The generic ingredient in ZOMETA is zoledronic acid. There are twenty-five drug master file entries for this compound. Two suppliers are listed for this compound. There are twelve tentative approvals for this compound. Additional details are available on the zoledronic acid profile page.

Summary for Tradename: ZOMETA

Patents:2
Applicants:1
NDAs:1
Suppliers: see list1

Pharmacology for Tradename: ZOMETA

Ingredient-typeDiphosphonates
Drug ClassBisphosphonate

Clinical Trials for: ZOMETA

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

Zometa on Bone Mineral Density in Prostate Cancer Patients Undergoing Androgen Ablation Therapy
Status: Completed Condition: Prostate Cancer

Evaluation of Chemotherapy Prior to Surgery With or Without Zometa for Women With Locally Advanced Breast Cancer
Status: Completed Condition: Breast Neoplasms

Zometa and Circulating Vascular Endothelial Growth Factor (VEGF) in Breast Cancer Patients With Bone Metastasis
Status: Completed Condition: Metastatic Breast Cancer; Bone Metastases

Zometa Adjuvant Treatment of Malignant Pleural Effusion Due To Non-Small Cell Lung Cancer
Status: Terminated Condition: Malignant Pleural Effusion; Non Small Cell Lung Cancer

ZOMETA® (Zoledronic Acid) for Prevention of Bone Metastases
Status: Terminated Condition: Prostate Cancer

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

Zoledronic Acid to Prevent Bone Loss During Androgen Deprivation Therapy for Prostate Cancer
Status: Completed Condition: Bone Loss; Prostate Cancer

Pre-operative Zoledronate in Triple Negative Breast Cancer
Status: Recruiting Condition: Breast Cancer

Tamoxifen Versus Anastrozole, Alone or in Combination With Zoledronic Acid
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
Novartis
ZOMETA
zoledronic acid
INJECTABLE;IV (INFUSION)021223Aug 20, 2001DISCNNo<disabled><disabled>
Novartis
ZOMETA
zoledronic acid
INJECTABLE;IV (INFUSION)021223Jun 17, 2011RXYes8,324,189*PED<disabled>Y<disabled>
Novartis
ZOMETA
zoledronic acid
INJECTABLE;IV (INFUSION)021223Mar 7, 2003RXYes8,324,189*PED<disabled>Y<disabled>
Novartis
ZOMETA
zoledronic acid
INJECTABLE;IV (INFUSION)021223Jun 17, 2011RXYes7,932,241<disabled>Y<disabled>
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Paragraph IV activity for: ZOMETA

Drugname Dosage Strength RLD Submissiondate
zoledronic acidInjection4 mg/100 mg, 100 mL vialZometa1/31/2012
zoledronic acidInjection0.8 mg (base) /mLZometa6/11/2008
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Preferred citation:

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

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