.

Flexible Flat-Rate Plans

Flat-rate pricing for predictable budgeting

Short-term plans for project- or client-based billing

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

Zoledronic acid - Generic Drug Details

« Back to Dashboard
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
Hospira Inc
ZOLEDRONIC ACID
zoledronic acid
INJECTABLE;IV (INFUSION)090621-001Mar 19, 2015RXNo<disabled><disabled>
Usv North America
ZOLEDRONIC ACID
zoledronic acid
INJECTABLE;IV (INFUSION)202923-001Sep 4, 2014RXNo<disabled><disabled>
Novartis
ZOMETA
zoledronic acid
INJECTABLE;IV (INFUSION)021223-003Jun 17, 2011RXYes7,932,241<disabled>Y <disabled>
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Expired Orange Book Patents for Generic Ingredient: zoledronic acid

These historical archives are available as an add-on to one-year subscriptions.
See the Signup Form for more information.

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis
ZOMETA
zoledronic acid
INJECTABLE;IV (INFUSION)021223-002Mar 7, 20034,939,130*PED<disabled>
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>
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Ingredient: zoledronic acid

Country Document Number Estimated Expiration
Norway330459<disabled in preview>
Slovenia1591122<disabled in preview>
Portugal1591122<disabled in preview>
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

Supplementary Protection Certificates for Tradename: ZOLEDRONIC ACID

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00582Netherlands<disabled>PRODUCT 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<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
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

How are People Using DrugPatentWatch?

`abc