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Details for Generic Name: zoledronic acid

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Zoledronic acid is the generic ingredient in three branded drugs marketed by Novartis, Acs Dobfar Info Sa, Actavis Inc, Agila Speclts, Akorn, Akorn Inc, Dr Reddys Labs Ltd, Emcure Pharms Ltd, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma Farmaceutica, Hospira Inc, Pharmaceutics, Pharms, Sagent Pharms, Sun Pharma Global, and Usv North America, and is included in twenty-four NDAs. There are four patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has sixty-one patent family members in thirty-four countries.

There are twenty-five drug master file entries for zoledronic acid. Two suppliers are listed for this compound. There are eleven tentative approvals for this compound.

Summary for Generic Name: zoledronic acid

Drug Master File Entries: see list25
Suppliers: see list2
Therapeutic Class:Metabolic Bone Disease Agents
Formulation / Manufacturing:see details

Pharmacology for Ingredient: zoledronic acid

Drug ClassBisphosphonate

Tentative approvals for ZOLEDRONIC ACID

Applicant Application No. Form Dosage
<disabled><disabled>INJECTABLE; IV (INFUSION)EQ 4MG BASE/5ML

Clinical Trials for: zoledronic acid

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Fresenius Kabi Usa
zoledronic acid
INJECTABLE;IV (INFUSION)091516-001Apr 23, 2015RXNo<disabled><disabled>
Actavis Inc
zoledronic acid
INJECTABLE;IV (INFUSION)202472-001Mar 4, 2013RXNo<disabled><disabled>
zoledronic acid
INJECTABLE;IV (INFUSION)021223-003Jun 17, 2011RXYes8,324,189*PED<disabled>Y<disabled>
Hikma Farmaceutica
zoledronic acid
INJECTABLE;IV (INFUSION)202182-001Jun 3, 2013RXNo<disabled><disabled>
Acs Dobfar Info Sa
zoledronic acid
INJECTABLE;IV (INFUSION)203231-001Aug 2, 2013RXNo<disabled><disabled>
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International Patent Family for Ingredient: zoledronic acid

Country Document Number Publication Date
World Intellectual Property Organization (WIPO)2005025551Mar 24, 2005
TaiwanI289451Nov 11, 2007
Luxembourg92174May 22, 2013
Russian Federation2358739Jun 20, 2009
World Intellectual Property Organization (WIPO)0197788Dec 27, 2001
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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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