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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.

This drug has twenty-four patent family members in twenty-one countries.

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 eleven tentative approvals for this compound. Additional details are available on the zoledronic acid profile page.

Summary for Tradename: ZOMETA

Suppliers / Packagers: see list2

Pharmacology for Tradename: ZOMETA

Drug ClassBisphosphonate

Clinical Trials for: ZOMETA

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

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

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

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

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

TCRαβ+/CD19+ Depleted Haploidentical HSCT + Zoledronate
Status: Not yet recruiting Condition: Acute Myeloid Leukemia; Acute Lymphoblastic Leukemia; Hodgkin Lymphoma; Non-Hodgkin Lymphoma; Myelodysplastic Syndrome; Myeloproliferative Syndrome; Rhabdomyosarcoma; Ewing Sarcoma; Primitive Neuroectodermal Tumor; Osteosarcoma; Neuroblastoma

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

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

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
zoledronic acid
INJECTABLE;IV (INFUSION)021223-001Aug 20, 2001DISCNNo<disabled><disabled>
zoledronic acid
INJECTABLE;IV (INFUSION)021223-003Jun 17, 2011RXYes8,324,189*PED<disabled>Y<disabled>
zoledronic acid
INJECTABLE;IV (INFUSION)021223-002Mar 7, 2003RXYes8,324,189*PED<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

International Patent Family for Tradename: ZOMETA

Country Document Number Publication Date
European Patent Office1663314Jun 07, 2006
China1852739Oct 25, 2006
South Africa200601209Apr 25, 2007
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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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