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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-seven patent family members in twenty-seven 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

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

Pharmacology for Tradename: RECLAST

Ingredient-typeDiphosphonates
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

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

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

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 ClinicalTrials.org
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
Novartis
RECLAST
zoledronic acid
INJECTABLE;IV (INFUSION)021817-001Apr 16, 2007RXYes8,052,987<disabled><disabled>
Novartis
RECLAST
zoledronic acid
INJECTABLE;IV (INFUSION)021817-001Apr 16, 2007RXYes7,932,241*PED<disabled>Y<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
Israel153229Jul 24, 2007
Norway330459Apr 18, 2011
Germany60113537May 29, 2013
Hungary228400Mar 28, 2013
TaiwanI289451Nov 11, 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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