Zometa is a drug owned by Novartis Pharmaceuticals Corp. It is protected by 5 US drug patents filed in 2013. Out of these, 3 drug patents are active and 2 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 05, 2028. Details of Zometa's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US7932241 | Pharmaceutical products comprising bisphosphonates |
Feb, 2028
(3 years from now) | Active |
|
US8324189 (Pediatric) | Use of zolendronate for the manufacture of a medicament for the treatment of bone metabolism diseases |
Nov, 2025
(1 year, 13 days from now) | Active |
| US8324189 | Use of zolendronate for the manufacture of a medicament for the treatment of bone metabolism diseases |
May, 2025
(6 months from now) | Active |
|
US4939130 (Pediatric) | Substituted alkanediphosphonic acids and pharmaceutical use |
Mar, 2013
(11 years ago) |
Expired
|
| US4939130 | Substituted alkanediphosphonic acids and pharmaceutical use |
Sep, 2012
(12 years ago) |
Expired
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Zometa's patents.
Latest Legal Activities on Zometa's Patents
Given below is the list of recent legal activities going on the following patents of Zometa.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 22 May, 2024 | US8324189 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 21 May, 2020 | US8324189 |
| Expire Patent Critical | 03 Jun, 2019 | US7932241 |
| Maintenance Fee Reminder Mailed Critical | 17 Dec, 2018 | US7932241 |
| Recordation of Patent Grant Mailed Critical | 04 Dec, 2012 | US8324189 |
| Patent Issue Date Used in PTA Calculation Critical | 04 Dec, 2012 | US8324189 |
| Email Notification Critical | 15 Nov, 2012 | US8324189 |
| Issue Notification Mailed Critical | 14 Nov, 2012 | US8324189 |
| Dispatch to FDC | 09 Nov, 2012 | US8324189 |
| Mail Response to 312 Amendment (PTO-271) Critical | 02 Nov, 2012 | US8324189 |
FDA has granted several exclusivities to Zometa. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Zometa, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Zometa.
Exclusivity Information
Zometa holds 1 exclusivities. All of its exclusivities have expired in 2011. Details of Zometa's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| Pediatric Exclusivity(PED) | Sep 20, 2011 |
Several oppositions have been filed on Zometa's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Zometa's generic, the next section provides detailed information on ongoing and past EP oppositions related to Zometa patents.
Zometa's Oppositions Filed in EPO
Zometa has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Apr 17, 2013, by Generics [Uk] Limited. This opposition was filed on patent number EP01935167A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP01935167A | Jan, 2014 | Taylor Wessing LLP | Revoked |
| EP01935167A | Jan, 2014 | BIOGARAN | Revoked |
| EP01935167A | Jan, 2014 | Synthon B.V. | Revoked |
| EP01935167A | Jan, 2014 | Accord Healthcare Ltd | Revoked |
| EP01935167A | Jan, 2014 | Sanovel IIaç San. ve Tic. A.S. | Revoked |
| EP01935167A | Dec, 2013 | Genericon Pharma Gesellschaft m.b.H. | Revoked |
| EP01935167A | Nov, 2013 | STADA Arzneimittel AG | Revoked |
| EP01935167A | Sep, 2013 | PFIZER LIMITED | Revoked |
| EP01935167A | Sep, 2013 | Hikma Pharma GmbH | Revoked |
| EP01935167A | Aug, 2013 | Fresenius Kabi Deutschland GmbH | Revoked |
| EP01935167A | Jun, 2013 | medac Gesellschaft für klinische Spezialpräparate mbH | Revoked |
| EP01935167A | Jun, 2013 | Dr. Reddy's Laboratories Ltd. / Betapharm Arznei- mittel GmbH | Revoked |
| EP01935167A | May, 2013 | CHEMI SPA | Revoked |
| EP01935167A | May, 2013 | Actavis Group Ptc Ehf | Revoked |
| EP01935167A | May, 2013 | hameln rds gmbh | Revoked |
| EP01935167A | Apr, 2013 | Teva Pharmaceutical Industries LTD. | Revoked |
| EP01935167A | Apr, 2013 | Generics [UK] Limited | Revoked |
US patents provide insights into the exclusivity only within the United States, but Zometa is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Zometa's family patents as well as insights into ongoing legal events on those patents.
Zometa's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Zometa's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Feb 05, 2028 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Zometa Generic API suppliers:
Zoledronic Acid is the generic name for the brand Zometa. 26 different companies have already filed for the generic of Zometa, with Mylan Labs Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Zometa's generic
How can I launch a generic of Zometa before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Zometa's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Zometa's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Zometa -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.8 mg (base) /mL | 11 Jun, 2008 | 1 | 02 Sep, 2012 | Extinguished | |
| 4 mg/100 mL, 100 mL vial | 31 Jan, 2012 | 1 | 05 Feb, 2028 | Extinguished |
Alternative Brands for Zometa
Zometa which is used for treating hypercalcemia of malignancy., has several other brand drugs using the same active ingredient (Zoledronic Acid). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | |
|---|---|---|
| Sandoz |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Zoledronic Acid, Zometa's active ingredient. Check the complete list of approved generic manufacturers for Zometa
About Zometa
Zometa is a drug owned by Novartis Pharmaceuticals Corp. It is used for treating hypercalcemia of malignancy. Zometa uses Zoledronic Acid as an active ingredient. Zometa was launched by Novartis in 2001.
Approval Date:
Zometa was approved by FDA for market use on 20 August, 2001.
Active Ingredient:
Zometa uses Zoledronic Acid as the active ingredient. Check out other Drugs and Companies using Zoledronic Acid ingredient
Treatment:
Zometa is used for treating hypercalcemia of malignancy.
Dosage:
Zometa is available in injectable form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 4MG BASE/100ML | INJECTABLE | Discontinued | INTRAVENOUS |
| EQ 4MG BASE/5ML | INJECTABLE | Discontinued | INTRAVENOUS |
| EQ 4MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE | Discontinued | INTRAVENOUS |