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Profile for Tradename: RECLAST

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Reclast 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 one Paragraph IV challenge.

This drug has thirty-eight patent family members in twenty-eight countries.

The generic ingredient in RECLAST 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: RECLAST

Suppliers / Packagers: see list1

Pharmacology for Tradename: RECLAST

Drug ClassBisphosphonate

Clinical Trials for: RECLAST

Impact on Reducing the Incidence of Low Serum Calcium by Providing Educational Materials on the Need to Take Daily Supplemental Calcium and Vitamin D to Patients With Paget's Disease Treated With Reclast®
Status: Completed Condition: Paget's Disease of the Bone; Hypocalcemia

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

Dasatinib in Combination With Zoledronic Acid for the Treatment of Breast Cancer With Bone Metastasis
Status: Active, not recruiting Condition: Breast Cancer; Bone Metastases

TCRαβ+/CD19+ Depleted Haploidentical HSCT + Zoledronate
Status: 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

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

Zoledronic Acid Administration in Acute Spinal Cord Injury
Status: Completed Condition: Disuse Osteoporosis

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

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

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

Efficacy Study of Zoledronic Acid and Teriparatide Combination Therapy in Women With Osteoporosis
Status: Completed Condition: Osteoporosis

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)021817-001Apr 16, 2007RXYes8,052,987<disabled> <disabled>
zoledronic acid
INJECTABLE;IV (INFUSION)021817-001Apr 16, 2007RXYes7,932,241*PED<disabled>Y<disabled>
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Expired Patents for Tradename: RECLAST

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
zoledronic acid
INJECTABLE;IV (INFUSION)021817-001Apr 16, 20074,939,130*PED<disabled>
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Paragraph IV activity for: RECLAST

Drugname Dosage Strength RLD Submissiondate
zoledronic acidInjection0.05 mg/mL, 100 mL vialReclast8/29/2008

International Patent Family for Tradename: RECLAST

Country Document Number Publication Date
Russian Federation2288722Dec 10, 2006
Hungary228400Mar 28, 2013
European Patent Office1296689Apr 02, 2003
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided information. There is no warranty that the information contained herein is error free. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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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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