Apriso is a drug owned by Salix Pharmaceuticals Inc. It is protected by 7 US drug patents filed from 2013 to 2015. Out of these, 1 drug patents are active and 6 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be May 01, 2030. Details of Apriso'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). | |||
| US8865688 | Compositions and methods for treatment of bowel diseases with granulated mesalamine |
May, 2030
(5 years from now) | Active |
| US8940328 | Pellet formulation for the treatment of the intestinal tract |
Apr, 2018
(6 years ago) |
Expired
|
| US8496965 | Pellet formulation for the treatment of the intenstinal tract |
Apr, 2018
(6 years ago) |
Expired
|
| US6551620 | Pellet formulation for the treatment of the intestinal tract |
Apr, 2018
(6 years ago) |
Expired
|
| US8337886 | Pellet formulation for the treatment of the intestinal tract |
Apr, 2018
(6 years ago) |
Expired
|
| US8956647 | Pellet formulation for the treatment of the intestinal tract |
Apr, 2018
(6 years ago) |
Expired
|
| US8911778 | Pellet formulation for the treatment of the intestinal tract |
Apr, 2018
(6 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 Apriso's patents.
Latest Legal Activities on Apriso's Patents
Given below is the list of recent legal activities going on the following patents of Apriso.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 21 Apr, 2022 | US8865688 |
| Expire Patent Critical | 06 Sep, 2021 | US8496965 |
| Maintenance Fee Reminder Mailed Critical | 22 Mar, 2021 | US8496965 |
| Review Certificate Mailed | 21 Oct, 2019 | US8865688 |
| Review Certificate | 11 Sep, 2019 | US8865688 |
| Expire Patent Critical | 25 Mar, 2019 | US8956647 |
| Expire Patent Critical | 04 Mar, 2019 | US8940328 |
| Expire Patent Critical | 21 Jan, 2019 | US8911778 |
| Maintenance Fee Reminder Mailed Critical | 08 Oct, 2018 | US8956647 |
| Maintenance Fee Reminder Mailed Critical | 17 Sep, 2018 | US8940328 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Apriso and ongoing litigations to help you estimate the early arrival of Apriso generic.
Apriso's Litigations
Apriso been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Jul 11, 2016, against patent number US8865688. The petitioner MycoNovo, Inc. et al., challenged the validity of this patent, with Salix Pharmaceuticals, Ltd. et al. as the respondent. Click below to track the latest information on how companies are challenging Apriso's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US8865688 | December, 2015 |
FWD Entered
(19 May, 2017) | SALIX PHARMACEUTICALS, LTD. | GeneriCo, LLC |
| US8865688 | July, 2016 |
Terminated
(30 Nov, 2016) | Salix Pharmaceuticals, Ltd. et al. | Mylan Pharmaceuticals Inc. et al. |
| US8865688 | July, 2016 |
Terminated
(30 Nov, 2016) | Salix Pharmaceuticals, Ltd. et al. | MycoNovo, Inc. et al. |
FDA has granted some exclusivities to Apriso. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Apriso, 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 Apriso.
Exclusivity Information
Apriso holds 1 exclusivities. All of its exclusivities have expired in 2011. Details of Apriso's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Oct 31, 2011 |
US patents provide insights into the exclusivity only within the United States, but Apriso 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 Apriso's family patents as well as insights into ongoing legal events on those patents.
Apriso's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Apriso's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be May 01, 2030 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Apriso Generic API suppliers:
Mesalamine is the generic name for the brand Apriso. 21 different companies have already filed for the generic of Apriso, with Zydus Pharms having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Apriso's generic
How can I launch a generic of Apriso before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Apriso's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Apriso'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 Apriso -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.375 g | 03 Apr, 2012 | 1 | 20 Apr, 2018 | Extinguished |
Alternative Brands for Apriso
Apriso which is used for maintaining remission of ulcerative colitis in adults., has several other brand drugs using the same active ingredient (Mesalamine). 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 | |||
|---|---|---|---|---|
| Abbvie |
| |||
| Apil |
| |||
| Mylan Speciality Lp |
| |||
| Takeda Pharms Usa |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Mesalamine, Apriso's active ingredient. Check the complete list of approved generic manufacturers for Apriso
About Apriso
Apriso is a drug owned by Salix Pharmaceuticals Inc. It is used for maintaining remission of ulcerative colitis in adults. Apriso uses Mesalamine as an active ingredient. Apriso was launched by Salix in 2008.
Approval Date:
Apriso was approved by FDA for market use on 31 October, 2008.
Active Ingredient:
Apriso uses Mesalamine as the active ingredient. Check out other Drugs and Companies using Mesalamine ingredient
Treatment:
Apriso is used for maintaining remission of ulcerative colitis in adults.
Dosage:
Apriso is available in capsule, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 375MG | CAPSULE, EXTENDED RELEASE | Prescription | ORAL |