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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

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
European Patent Office1296689Feb 13, 2013
Japan5005188Aug 22, 2012
Canada2410201Oct 26, 2010
Poland358224Aug 09, 2004
Hong Kong1072539Nov 24, 2006
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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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