Canasa is a drug owned by Abbvie Inc. It is protected by 2 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 Jun 06, 2028. Details of Canasa'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). | |||
| US8217083 | Mesalamine suppository |
Jun, 2028
(3 years from now) | Active |
| US8436051 | Mesalamine suppository |
Jun, 2028
(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 Canasa's patents.
Latest Legal Activities on Canasa's Patents
Given below is the list of recent legal activities going on the following patents of Canasa.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 14 Dec, 2023 | US8217083 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 09 Nov, 2020 | US8436051 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 10 Jan, 2020 | US8217083 |
| Change in Power of Attorney (May Include Associate POA) | 13 Feb, 2015 | US8436051 (Litigated) |
| Email Notification | 13 Feb, 2015 | US8436051 (Litigated) |
| Correspondence Address Change | 12 Feb, 2015 | US8436051 (Litigated) |
| Mail Pre-Exam Notice | 02 Jan, 2015 | US8436051 (Litigated) |
| Mail Pre-Exam Notice | 04 Nov, 2014 | US8436051 (Litigated) |
| Email Notification | 31 Oct, 2014 | US8217083 |
| Change in Power of Attorney (May Include Associate POA) | 31 Oct, 2014 | US8217083 |
FDA has granted several exclusivities to Canasa. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Canasa, 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 Canasa.
Exclusivity Information
Canasa holds 1 exclusivities. All of its exclusivities have expired in 2019. Details of Canasa's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| M(M-187) | Sep 02, 2019 |
US patents provide insights into the exclusivity only within the United States, but Canasa 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 Canasa's family patents as well as insights into ongoing legal events on those patents.
Canasa's family patents
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Generic Launch
Generic Release Date:
Canasa's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 06, 2028 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Canasa Generics:
Mesalamine is the generic name for the brand Canasa. 19 different companies have already filed for the generic of Canasa, with Zydus Pharms having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Canasa's generic
How can I launch a generic of Canasa before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Canasa's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Canasa'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 Canasa -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 1000 mg | 24 May, 2013 | 1 | 24 Nov, 2015 | 06 Jun, 2028 | Eligible |
About Canasa
Canasa is a drug owned by Abbvie Inc. Canasa uses Mesalamine as an active ingredient. Canasa was launched by Abbvie in 2004.
Market Authorisation Date:
Canasa was approved by FDA for market use on 05 November, 2004.
Active Ingredient:
Canasa uses Mesalamine as the active ingredient. Check out other Drugs and Companies using Mesalamine ingredient
Dosage:
Canasa is available in suppository form for rectal use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 1GM | SUPPOSITORY | Prescription | RECTAL |