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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, Gland Pharma Ltd, Akorn, Sun Pharma Global, Usv North America, Acs Dobfar Info Sa, 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-seven 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:27
Drug Master File Entries: see list25
Suppliers / Packaging: see list19
Therapeutic Class:Metabolic Bone Disease Agents
Drug Prices:see low prices

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
Fresenius Kabi Usa
ZOLEDRONIC ACID
zoledronic acid
INJECTABLE;IV (INFUSION)091516-001Apr 23, 2015RXNo
Akorn
ZOLEDRONIC ACID
zoledronic acid
INJECTABLE;IV (INFUSION)200918-001Aug 21, 2014RXNo
Novartis
ZOMETA
zoledronic acid
INJECTABLE;IV (INFUSION)021223-001Aug 20, 2001DISCNNo
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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)021223-003Jun 17, 20114,939,130*PED<disabled>
Novartis
ZOMETA
zoledronic acid
INJECTABLE;IV (INFUSION)021223-002Mar 7, 20034,939,130*PED<disabled>
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International Patent Family for Ingredient: zoledronic acid

Country Document Number Estimated Expiration
Russian Federation2006112596<disabled in preview>
Morocco28078<disabled in preview>
Japan2007505861<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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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
1591122/01Switzerland<disabled>PRODUCT NAME: ZOLEDRONSAEURE; REGISTRATION NO/DATE: SWISSMEDIC 57363 27.09.2007
174Luxembourg<disabled>PRODUCT NAME: ACIDE ZOLEDRONIQUE OU SON SEL PHARMACEUTIQUEMENT ACCEPTABLE OU TOUT HYDRATE DE CELUI-CI
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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