Colazal is a drug owned by Valeant Pharmaceuticals International. It is protected by 4 US drug patents filed in 2013 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 24, 2027. Details of Colazal'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 active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US7625884 | Formulations and uses of 2-hydroxy-5-phenylazobenzoic acid derivatives |
Aug, 2026
(2 years from now) | Active |
| US7452872 | Formulations and uses of 2-hydroxy-5-phenylazobenzoic acid derivatives |
Aug, 2026
(2 years from now) | Active |
|
US7452872 (Pediatric) | Formulations and uses of 2-hydroxy-5-phenylazobenzoic acid derivatives |
Feb, 2027
(2 years from now) | Active |
|
US7625884 (Pediatric) | Formulations and uses of 2-hydroxy-5-phenylazobenzoic acid derivatives |
Feb, 2027
(2 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 Colazal's patents.
Latest Legal Activities on Colazal's Patents
Given below is the list of recent legal activities going on the following patents of Colazal.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 25 May, 2021 | US7625884 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 27 Apr, 2020 | US7452872 |
| 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 |
| Change in Power of Attorney (May Include Associate POA) | 14 Sep, 2010 | US7452872 |
| Change in Power of Attorney (May Include Associate POA) | 10 Sep, 2010 | US7625884 |
| Correspondence Address Change | 09 Sep, 2010 | US7452872 |
| Correspondence Address Change | 08 Sep, 2010 | US7625884 |
| Recordation of Patent Grant Mailed | 01 Dec, 2009 | US7625884 |
| Patent Issue Date Used in PTA Calculation | 01 Dec, 2009 | US7625884 |
FDA has granted several exclusivities to Colazal. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Colazal, 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 Colazal.
Exclusivity Information
Colazal holds 2 exclusivities. All of its exclusivities have expired in 2014. Details of Colazal's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| Orphan Drug Exclusivity(ODE) | Dec 20, 2013 |
| Pediatric Exclusivity(PED) | Jun 20, 2014 |
US patents provide insights into the exclusivity only within the United States, but Colazal 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 Colazal's family patents as well as insights into ongoing legal events on those patents.
Colazal's family patents
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Generic Launch
Generic Release Date:
Colazal's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Feb 24, 2027 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Colazal Generics:
Balsalazide Disodium is the generic name for the brand Colazal. 5 different companies have already filed for the generic of Colazal, with Apotex Inc having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Colazal's generic
How can I launch a generic of Colazal before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Colazal's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Colazal'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 Colazal -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 750 mg | 26 May, 2022 | 1 | 24 Aug, 2026 |
About Colazal
Colazal is a drug owned by Valeant Pharmaceuticals International. It is used for treating ulcerative colitis. Colazal uses Balsalazide Disodium as an active ingredient. Colazal was launched by Valeant Pharms Intl in 2000.
Market Authorisation Date:
Colazal was approved by FDA for market use on 18 July, 2000.
Active Ingredient:
Colazal uses Balsalazide Disodium as the active ingredient. Check out other Drugs and Companies using Balsalazide Disodium ingredient
Treatment:
Colazal is used for treating ulcerative colitis.
Dosage:
Colazal is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 750MG | CAPSULE | Prescription | ORAL |