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Generated: May 29, 2017

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Zoledronic acid - Generic Drug Details

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What are the generic drug sources for zoledronic acid and what is the scope of zoledronic acid patent protection?

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

Zoledronic acid has sixty-three patent family members in thirty-five countries.

There are twenty-five drug master file entries for zoledronic acid. Nineteen 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 / Packagers: see list19
Bulk Api Vendors: see list86
Clinical Trials: see list2,082
Patent Applications: see list4,899
Therapeutic Class:Metabolic Bone Disease Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:zoledronic acid at DailyMed

Pharmacology for Ingredient: zoledronic acid

Drug ClassBisphosphonate

Tentative approvals for ZOLEDRONIC ACID

Applicant Application No. Strength Dosage Form
► Subscribe► Subscribe4MG/5ML(0.8MG/ML)INJECTABLE;INJECTION
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Gland Pharma Ltd
zoledronic acid
INJECTABLE;IV (INFUSION)202930-001Aug 5, 2013APRXNoNo► Subscribe► Subscribe
Usv North America
zoledronic acid
INJECTABLE;IV (INFUSION)202923-001Sep 4, 2014APRXNoNo► Subscribe► Subscribe
Hospira Inc
zoledronic acid
SOLUTION;IV (INFUSION)204016-001Dec 28, 2015RXNoNo► Subscribe► Subscribe
zoledronic acid
INJECTABLE;IV (INFUSION)202163-001Aug 5, 2013APRXNoNo► Subscribe► Subscribe
Dr Reddys Labs Ltd
zoledronic acid
INJECTABLE;IV (INFUSION)091363-001Mar 29, 2013APRXNoNo► Subscribe► Subscribe
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