Giazo is a drug owned by Valeant Pharmaceuticals International. It is protected by 5 US drug patents filed from 2013 to 2016. Out of these, 4 drug patents are active and 1 has expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 23, 2031. Details of Giazo'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). | |||
| US8497256 | Formulations and uses of 2-hydroxy-5-phenylazobenzoic acid derivatives for the treatment of males |
Jun, 2031
(6 years from now) | Active |
| US7452872 | Formulations and uses of 2-hydroxy-5-phenylazobenzoic acid derivatives |
Aug, 2026
(1 year, 3 months from now) | Active |
| US7625884 | Formulations and uses of 2-hydroxy-5-phenylazobenzoic acid derivatives |
Aug, 2026
(1 year, 3 months from now) | Active |
| US9192616 | Formulations and uses of 2-hydroxy-5-phenylazobenzoic acid derivatives |
Aug, 2026
(1 year, 2 months from now) | Active |
| US6197341 | Formulations of balsalazide and its derivatives |
Mar, 2018
(7 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 Giazo's patents.
Latest Legal Activities on Giazo's Patents
Given below is the list of recent legal activities going on the following patents of Giazo.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 20 Apr, 2023 | US9192616 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 25 May, 2021 | US7625884 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 04 Jan, 2021 | US8497256 (Litigated) |
| Payment of Maintenance Fee, 12th Year, Large Entity | 27 Apr, 2020 | US7452872 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 01 May, 2019 | US9192616 |
| Entity Status Set To Undiscounted (Initial Default Setting or Status Change) | 11 May, 2017 | US7625884 |
| Entity Status Set To Undiscounted (Initial Default Setting or Status Change) | 03 May, 2016 | US7452872 |
| Recordation of Patent Grant Mailed Critical | 24 Nov, 2015 | US9192616 |
| Patent Issue Date Used in PTA Calculation Critical | 24 Nov, 2015 | US9192616 |
| Email Notification Critical | 05 Nov, 2015 | US9192616 |
FDA has granted several exclusivities to Giazo. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Giazo, 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 Giazo.
Exclusivity Information
Giazo holds 1 exclusivities. All of its exclusivities have expired in 2015. Details of Giazo's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Dosage Form(NDF) | Feb 03, 2015 |
US patents provide insights into the exclusivity only within the United States, but Giazo 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 Giazo's family patents as well as insights into ongoing legal events on those patents.
Giazo's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Giazo's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 23, 2031 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Giazo Generic API suppliers:
Balsalazide Disodium is the generic name for the brand Giazo. 6 different companies have already filed for the generic of Giazo, with Apotex Inc having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Giazo's generic
How can I launch a generic of Giazo before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Giazo's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Giazo'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 Giazo -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 1.1 g | 05 Nov, 2013 | 1 | 08 Sep, 2015 | 23 Jun, 2031 | Eligible |
Alternative Brands for Giazo
Giazo which is used for treating mildly to moderately active ulcerative colitis in male patients., has several other brand drugs using the same active ingredient (Balsalazide Disodium). 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 | |
|---|---|---|
| Valeant Pharms Intl |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Balsalazide Disodium, Giazo's active ingredient. Check the complete list of approved generic manufacturers for Giazo
About Giazo
Giazo is a drug owned by Valeant Pharmaceuticals International. It is used for treating mildly to moderately active ulcerative colitis in male patients. Giazo uses Balsalazide Disodium as an active ingredient. Giazo was launched by Valeant Pharms Intl in 2012.
Approval Date:
Giazo was approved by FDA for market use on 03 February, 2012.
Active Ingredient:
Giazo uses Balsalazide Disodium as the active ingredient. Check out other Drugs and Companies using Balsalazide Disodium ingredient
Treatment:
Giazo is used for treating mildly to moderately active ulcerative colitis in male patients.
Dosage:
Giazo is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 1.1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |