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Serving leading biopharmaceutical companies globally:

McKinsey
AstraZeneca
Farmers Insurance
QuintilesIMS
Colorcon
Harvard Business School
Covington
Cantor Fitzgerald
Cerilliant
Chubb

Generated: October 24, 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, Breckenridge Pharm, Dr Reddys Labs Ltd, Apotex Inc, 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.

Zoledronic acid has sixty-nine patent family members in thirty-six countries and nine supplementary protection certificates in seven countries.

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

Summary for Generic Name: zoledronic acid

US Patents:4
Tradenames:3
Applicants:19
NDAs:30
Drug Master File Entries: see list25
Suppliers / Packagers: see list22
Bulk Api Vendors: see list86
Clinical Trials: see list4,926
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

Ingredient-typeDiphosphonates
Drug ClassBisphosphonate

Tentative approvals for ZOLEDRONIC ACID

Applicant Application No. Strength Dosage Form
u► Subscribe4MG/5ML(0.8MG/ML)INJECTABLE;INJECTION
u► SubscribeEQ 4MG BASE/5MLINJECTABLE; IV (INFUSION)
u► SubscribeEQ 4MG BASE/VIALINJECTABLE; IV (INFUSION)
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sun Pharma Global
ZOLEDRONIC ACID
zoledronic acid
INJECTABLE;IV (INFUSION)090018-001Mar 4, 2013APRXNoYes► Subscribe► Subscribe► Subscribe
Mylan Labs Ltd
ZOLEDRONIC ACID
zoledronic acid
INJECTABLE;IV (INFUSION)203841-001Feb 14, 2017APRXNoNo► Subscribe► Subscribe► Subscribe
Hospira Inc
ZOLEDRONIC ACID
zoledronic acid
INJECTABLE;IV (INFUSION)090621-001Mar 19, 2015APRXNoNo► Subscribe► Subscribe► Subscribe
Aurobindo Pharma Ltd
ZOLEDRONIC ACID
zoledronic acid
INJECTABLE;IV (INFUSION)207751-001Sep 26, 2016APRXNoNo► Subscribe► Subscribe► Subscribe
Hospira Inc
ZOLEDRONIC ACID
zoledronic acid
INJECTABLE;IV (INFUSION)202837-001Apr 5, 2013APRXNoNo► Subscribe► Subscribe► Subscribe
Emcure Pharms Ltd
ZOLEDRONIC ACID
zoledronic acid
INJECTABLE;IV (INFUSION)201801-001Mar 29, 2013APRXNoNo► Subscribe► Subscribe► Subscribe
Novartis
ZOMETA
zoledronic acid
INJECTABLE;IV (INFUSION)021223-001Aug 20, 2001DISCNYesNo► Subscribe► Subscribe► Subscribe
Breckenridge Pharm
ZOLEDRONIC ACID
zoledronic acid
INJECTABLE;IV (INFUSION)202571-001May 7, 2013APRXNoNo► Subscribe► Subscribe► Subscribe
Novartis
RECLAST
zoledronic acid
INJECTABLE;IV (INFUSION)021817-001Apr 16, 2007APRXYesYes► Subscribe► Subscribe ► Subscribe
Usv North America
ZOLEDRONIC ACID
zoledronic acid
INJECTABLE;IV (INFUSION)202923-001Sep 4, 2014APRXNoNo► Subscribe► 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
RECLAST
zoledronic acid
INJECTABLE;IV (INFUSION)021817-001Apr 16, 2007► Subscribe► Subscribe
Novartis
ZOMETA
zoledronic acid
INJECTABLE;IV (INFUSION)021223-003Jun 17, 2011► Subscribe► Subscribe
Novartis
ZOMETA
zoledronic acid
INJECTABLE;IV (INFUSION)021223-002Mar 7, 2003► Subscribe► Subscribe
Novartis
ZOMETA
zoledronic acid
INJECTABLE;IV (INFUSION)021223-001Aug 20, 2001► Subscribe► Subscribe
Novartis
ZOMETA
zoledronic acid
INJECTABLE;IV (INFUSION)021223-002Mar 7, 2003► Subscribe► Subscribe
Novartis
ZOMETA
zoledronic acid
INJECTABLE;IV (INFUSION)021223-001Aug 20, 2001► Subscribe► Subscribe
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International Patent Family for Ingredient: zoledronic acid

Country Document Number Estimated Expiration
Denmark1591122► Subscribe
European Patent Office1591122► Subscribe
Russian Federation2006112596► Subscribe
SloveniaEP1591122► Subscribe
South Korea20030015283► Subscribe
MexicoPA02012682► Subscribe
Iceland8351► Subscribe
Czech Republic20024134► Subscribe
Australia2001274109► Subscribe
SloveniaEP1296689► 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
0582Netherlands► SubscribePRODUCT NAME: ZOLEDRONZUUR, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, DAN WEL IEDER HYDRAAT DAARVAN; REGISTRATION NO/DATE: C(2007)4619 20071003
2013000031Germany► SubscribePRODUCT NAME: ZOLEDRONSAEURE ODER PHARMAZEUTISCH UNBEDENKLICHES SALZ DAVON ODER BELIEBIGES HYDRAT DAVON; NAT. REGISTRATION NO/DATE: EU/1/05/308/001-002 20071003; FIRST REGISTRATION: SCHWEIZ 57363 20070927
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
2013 00016Denmark► Subscribe
1591122/01Switzerland► SubscribePRODUCT NAME: ZOLEDRONSAEURE; REGISTRATION NO/DATE: SWISSMEDIC 57363 27.09.2007
C0035France► SubscribePRODUCT NAME: ZOLEDRONIC ACID; NAT REG. NO/DATE: EU/1/01/176/001 20010320; FIRST REG.: LI IKS N 55 463 20001128
00582Netherlands► SubscribePRODUCT NAME: ZOLEDRONZUUR, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, DAN WEL IEDER HYDRAAT DAARVAN; REGISTRATION NO/DATE: C(2007)4619 20071003
C/GB01/039United Kingdom► SubscribePRODUCT 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
174Luxembourg► SubscribePRODUCT NAME: ACIDE ZOLEDRONIQUE OU SON SEL PHARMACEUTIQUEMENT ACCEPTABLE OU TOUT HYDRATE DE CELUI-CI
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

AstraZeneca
Cerilliant
US Department of Justice
Chinese Patent Office
Fish and Richardson
Covington
Accenture
Boehringer Ingelheim
Federal Trade Commission
Moodys

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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