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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.

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 twelve 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: 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

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

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

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

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

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

Tamoxifen Versus Anastrozole, Alone or in Combination With Zoledronic Acid
Status: Active, not recruiting Condition: Breast Cancer

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

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

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
RECLAST
zoledronic acid
INJECTABLE;IV (INFUSION)021817Apr 16, 2007RXYes8,052,987<disabled><disabled>
Novartis
RECLAST
zoledronic acid
INJECTABLE;IV (INFUSION)021817Apr 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
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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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