Apriso Patent Expiration

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.

Given below is the list of recent legal activities going on the following patents of Apriso.

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 8th Year, Large Entity 21 Apr, 2022 US8865688
Expire Patent 06 Sep, 2021 US8496965
Maintenance Fee Reminder Mailed 22 Mar, 2021 US8496965
Review Certificate Mailed 21 Oct, 2019 US8865688
Review Certificate 11 Sep, 2019 US8865688
Expire Patent 25 Mar, 2019 US8956647
Expire Patent 04 Mar, 2019 US8940328
Expire Patent 21 Jan, 2019 US8911778
Maintenance Fee Reminder Mailed 08 Oct, 2018 US8956647
Maintenance Fee Reminder Mailed 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.

Last updated on December 10, 2024
Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
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

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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

Apriso has patent protection in a total of 13 countries. It's US patent count contributes only to 29.4% of its total global patent coverage. 5 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Apriso.

Family Patents

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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
Asacol Hd
Canasa
Delzicol
Apil
Asacol
Mylan Speciality Lp
Sfrowasa
Takeda Pharms Usa
Lialda


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