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Zoledronic acid - Generic Drug Details

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Zoledronic acid is the generic ingredient in three branded drugs marketed by Emcure Pharms Ltd, Fresenius Kabi Usa, Hospira Inc, Novartis, Akorn, Sun Pharma Global, Usv North America, Acs Dobfar Info Sa, Gland Pharma Ltd, Akorn Inc, Mylan Labs Ltd, Dr Reddys Labs Ltd, Pharmaceutics, Apotex Inc, Pharms, Actavis Inc, Hikma Farmaceutica, and Sagent Pharms, and is included in twenty-six 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-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

Tradenames:3
Patents:4
Applicants:18
NDAs:26
Drug Master File Entries: see list25
Suppliers / Packaging: see list19
Therapeutic Class:Metabolic Bone Disease Agents
Formulation / Manufacturing:see details

Pharmacology for Ingredient: zoledronic acid

Ingredient-typeDiphosphonates
Drug ClassBisphosphonate

Tentative approvals for ZOLEDRONIC ACID

Applicant Application No. Form Dosage
<disabled><disabled>INJECTABLE;INJECTION4MG/5ML(0.8MG/ML)
<disabled><disabled>INJECTABLE; IV (INFUSION)EQ 4MG BASE/5ML
<disabled><disabled>INJECTABLE; IV (INFUSION)EQ 4MG BASE/VIAL

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
Akorn Inc
ZOLEDRONIC ACID
zoledronic acid
INJECTABLE;IV (INFUSION)202548-001May 22, 2014RXNo<disabled><disabled>
Apotex Inc
ZOLEDRONIC ACID
zoledronic acid
INJECTABLE;IV (INFUSION)204367-001Dec 24, 2015RXNo<disabled><disabled>
Acs Dobfar Info Sa
ZOLEDRONIC ACID
zoledronic acid
INJECTABLE;IV (INFUSION)202828-001Sep 23, 2013RXNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: zoledronic acid

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis
ZOMETA
zoledronic acid
INJECTABLE;IV (INFUSION)021223-001Aug 20, 20014,777,163<disabled>
Novartis
ZOMETA
zoledronic acid
INJECTABLE;IV (INFUSION)021223-002Mar 7, 20034,777,163<disabled>
Novartis
RECLAST
zoledronic acid
INJECTABLE;IV (INFUSION)021817-001Apr 16, 20074,939,130*PED<disabled>
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International Patent Family for Ingredient: zoledronic acid

Country Document Number Estimated Expiration
Canada2536206<disabled in preview>
Brazil0111806<disabled in preview>
MexicoPA02012682<disabled in preview>
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Supplementary Protection Certificates for Tradename: ZOLEDRONIC ACID

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB01/039United Kingdom<disabled>PRODUCT NAME: ZOLEDRONIC ACID OPTIONALLY IN THE FORM OF A SALT THEREOF; NATIONAL REGISTRATION NO/DATE: EU/1/01/176/001-003 20010320; FIRST REGISTRATION: CH 55463 20001128
C0035France<disabled>PRODUCT NAME: ZOLEDRONIC ACID; NAT REG. NO/DATE: EU/1/01/176/001 20010320; FIRST REG.: LI IKS N 55 463 20001128
00582Netherlands<disabled>PRODUCT NAME: ZOLEDRONZUUR, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, DAN WEL IEDER HYDRAAT DAARVAN; REGISTRATION NO/DATE: C(2007)4619 20071003
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