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Generated: April 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021817

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NDA 021817 describes RECLAST, which 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. Additional details are available on the RECLAST profile page.

The generic ingredient in RECLAST is zoledronic acid. There are twenty-five drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the zoledronic acid profile page.
Summary for 021817
Tradename:RECLAST
Applicant:Novartis
Ingredient:zoledronic acid
Patents:2
Therapeutic Class:Metabolic Bone Disease Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 021817
Ingredient-typeDiphosphonates
Suppliers and Packaging for NDA: 021817
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RECLAST zoledronic acid INJECTABLE;IV (INFUSION) 021817 NDA Novartis Pharmaceuticals Corporation 0078-0435 N 0078-0435-61

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)StrengthEQ 5MG BASE/100ML
Approval Date:Apr 16, 2007TE:APRLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Aug 5, 2028Product Flag?Substance Flag?Delist Request?Y
Patent:➤ Try a Free TrialPatent Expiration:Oct 27, 2023Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT AND PREVENTION OF POSTMENOPAUSAL OR GLUCOCORTICOID-INDUCED OSTEOPOROSIS AND TREATMENT TO INCREASE BONE MASS IN MEN WITH OSTEOPOROSIS

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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
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Argus Health
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Fish and Richardson
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McKesson
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