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Zoledronic acid - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for zoledronic acid?

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 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. Eighteen suppliers are listed for this compound. There are twelve tentative approvals for this compound.

Summary for Generic Name: zoledronic acid

Tradenames:3
Patents:5
Applicants:20
NDAs:30
Drug Master File Entries: see list25
Suppliers / Packagers: see list18
Bulk Api Vendors: see list86
Clinical Trials: see list2,082
Patent Applications: see list2,770
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

Ingredient-typeDiphosphonates
Drug ClassBisphosphonate

Tentative approvals for ZOLEDRONIC ACID

Applicant Application No. Form Dosage
► Subscribe► SubscribeINJECTABLE;INJECTION4MG/5ML(0.8MG/ML)
► Subscribe► SubscribeINJECTABLE; IV (INFUSION)EQ 4MG BASE/5ML
► Subscribe► SubscribeINJECTABLE; IV (INFUSION)EQ 4MG BASE/VIAL
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Akorn
ZOLEDRONIC ACID
zoledronic acid
INJECTABLE;IV (INFUSION)200918-001Aug 21, 2014RXNoNo► Subscribe► Subscribe
Hospira Inc
ZOLEDRONIC ACID
zoledronic acid
INJECTABLE;IV (INFUSION)202837-001Apr 5, 2013RXNoNo► Subscribe► Subscribe
Acs Dobfar Info Sa
ZOLEDRONIC ACID
zoledronic acid
INJECTABLE;IV (INFUSION)202828-001Sep 23, 2013RXNoNo► Subscribe► Subscribe
Emcure Pharms Ltd
ZOLEDRONIC ACID
zoledronic acid
INJECTABLE;IV (INFUSION)201783-001Mar 12, 2013RXNoNo► Subscribe► Subscribe
Actavis Inc
ZOLEDRONIC ACID
zoledronic acid
INJECTABLE;IV (INFUSION)202472-001Mar 4, 2013RXNoNo► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: zoledronic acid

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► Subscribe
Novartis
ZOMETA
zoledronic acid
INJECTABLE;IV (INFUSION)021223-001Aug 20, 20014,939,130*PED► Subscribe
Novartis
RECLAST
zoledronic acid
INJECTABLE;IV (INFUSION)021817-001Apr 16, 20074,939,130*PED► Subscribe
Novartis
ZOMETA
zoledronic acid
INJECTABLE;IV (INFUSION)021223-002Mar 7, 20034,939,130*PED► Subscribe
Novartis
ZOMETA
zoledronic acid
INJECTABLE;IV (INFUSION)021223-002Mar 7, 20034,777,163► Subscribe
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International Patent Family for Ingredient: zoledronic acid

Country Document Number Estimated Expiration
New Zealand523086► Subscribe
Morocco28078► Subscribe
Cyprus1113740► Subscribe
MexicoPA02012682► Subscribe
China1852739► Subscribe
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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
1591122/01Switzerland► SubscribePRODUCT NAME: ZOLEDRONSAEURE; REGISTRATION NO/DATE: SWISSMEDIC 57363 27.09.2007
2013 00016Denmark► Subscribe
C0035France► SubscribePRODUCT NAME: ZOLEDRONIC ACID; NAT REG. NO/DATE: EU/1/01/176/001 20010320; FIRST REG.: LI IKS N 55 463 20001128
C/GB01/042United Kingdom► SubscribePRODUCT NAME: ZOLEDRONIC ACID 2-(IMIDAZOL-1-YL)-1-HYDROXYETHANE-1,1-DIPHOSPHONIC ACID; REGISTERED: CH 55463 20001128; UK EU/1/01/176/001 20010320; UK EU/1/01/176/002 20010320; UK EU/1/01/176/003 20010320
174Luxembourg► SubscribePRODUCT 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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