Izba is a drug owned by Novartis Pharmaceuticals Corp. It is protected by 4 US drug patents filed from 2014 to 2015 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 10, 2029. Details of Izba'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). | |||
| US8722735 | Pharmaceutical compositions having desirable bioavailability |
Oct, 2029
(3 years from now) | Active |
| US8178582 | Pharmaceutical compositions having desirable bioavailability |
Oct, 2029
(3 years from now) | Active |
| US8754123 | Pharmaceutical compositions having desirable bioavailability |
May, 2029
(3 years from now) | Active |
| US9144561 | Pharmaceutical compositions having desirable bioavailability |
Mar, 2029
(3 years from now) | Active |
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 Izba's patents.
Latest Legal Activities on Izba's Patents
Given below is the list of recent legal activities going on the following patents of Izba.
| Activity | Date | Patent Number |
|---|---|---|
| ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 01 Nov, 2023 | US8178582 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 15 Mar, 2023 | US9144561 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 01 Dec, 2021 | US8754123 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 31 Oct, 2019 | US8178582 (Litigated) |
| Payment of Maintenance Fee, 4th Year, Large Entity | 14 Mar, 2019 | US9144561 (Litigated) |
| Payment of Maintenance Fee, 4th Year, Large Entity | 30 Nov, 2017 | US8754123 (Litigated) |
| PARALEGAL OR ELECTRONIC TERMINAL DISCLAIMER APPROVED
Critical | 17 Nov, 2016 | US8754123 (Litigated) |
| PARALEGAL OR ELECTRONIC TERMINAL DISCLAIMER APPROVED
Critical | 17 Nov, 2016 | US8178582 (Litigated) |
| Terminal Disclaimer Filed
Critical | 10 Nov, 2016 | US8178582 (Litigated) |
| Terminal Disclaimer Filed
Critical | 10 Nov, 2016 | US8754123 (Litigated) |
FDA has granted several exclusivities to Izba. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Izba, 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
Izba.
Exclusivity Information
Izba holds 1 exclusivities. All of its exclusivities have expired in 2017. Details of Izba's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | May 15, 2017 |
Several oppositions have been filed on Izba'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 Izba's generic, the next section provides detailed information on
ongoing and past
EP oppositions related to Izba patents.
Izba's Oppositions Filed in EPO
Izba has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Feb 12, 2016, by Pohlman, Sandra M.. This opposition was filed on patent number EP09722278A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
| |||
| EP15202422A | Feb, 2018 | actrevo GmbH | Granted and Under Opposition |
| EP15202422A | Feb, 2018 | Generics [UK] Limited (trading as Mylan) | Granted and Under Opposition |
| EP15202422A | Feb, 2018 | ZAKLADY FARMACEUTYCZNE POLPHARMA S.A. | Granted and Under Opposition |
| EP15202422A | Feb, 2018 | Bausch & Lomb Incorporated | Granted and Under Opposition |
| EP15202422A | Feb, 2018 | Instone, Terry/Appleyard Lees IP LLP/Read, Howard | Granted and Under Opposition |
| EP12193597A | Jan, 2018 | Alfred E. Tiefenbacher (GmbH & Co. KG) | Granted and Under Opposition |
| EP12193597A | Jan, 2018 | Generics [UK] Limited (trading as Mylan) | Granted and Under Opposition |
| EP09722278A | Feb, 2016 | Generics [UK] Limited (trading as Mylan) | Granted and Under Opposition |
| EP09722278A | Feb, 2016 | Alfred E. Tiefenbacher (GmbH & Co. KG) | Granted and Under Opposition |
| EP09722278A | Feb, 2016 | Pohlman, Sandra M. | Granted and Under Opposition |
US patents provide insights into the exclusivity only within the United States, but
Izba 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 Izba's family patents as well as insights into
ongoing legal events
on those patents.
Izba's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Izba's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 10, 2029 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Izba Generic API suppliers:
Travoprost is the generic name for the brand Izba. 8 different companies have already filed for the generic of Izba, with Alembic having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Izba's generic
How can I launch a generic of Izba before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Izba's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Izba'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 Izba -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.00003 | 30 Dec, 2015 | 1 | 10 Oct, 2029 | Extinguished |
Alternative Brands for Izba
There are several other brand drugs using the same active ingredient (Travoprost) as Izba. 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 | |
|---|---|---|
| Alcon Pharms Ltd |
| |
| Glaukos |
| |
| Sandoz |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Travoprost, Izba's active ingredient. Check the complete list of approved generic manufacturers for Izba
About Izba
Izba is a drug owned by Novartis Pharmaceuticals Corp. Izba uses Travoprost as an active ingredient. Izba was launched by Novartis in 2014.
Approval Date:
Izba was approved by FDA for market use on 15 May, 2014.
Active Ingredient:
Izba uses Travoprost as the active ingredient. Check out other Drugs and Companies using Travoprost ingredient
Dosage:
Izba is available in solution/drops form for ophthalmic use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.003% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS | Discontinued | OPHTHALMIC |
