Uceris is a drug owned by Salix Pharmaceuticals Inc. It is protected by 16 US drug patents filed from 2013 to 2020. Out of these, 5 drug patents are active and 11 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 07, 2031. Details of Uceris'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). | |||
| US9132093 | Controlled release and taste making oral pharmaceutical composition |
Sep, 2031
(4 years from now) | Active |
| US9192581 | Controlled release and taste masking oral pharmaceutical composition |
Sep, 2031
(4 years from now) | Active |
| US8895064 | Controlled release and taste masking oral pharmaceutical composition |
Sep, 2031
(4 years from now) | Active |
| US10660858 | Controlled release and taste masking oral pharmaceutical composition |
Sep, 2031
(4 years from now) | Active |
| US10307375 | Controlled release and taste masking oral pharmaceutical composition |
Sep, 2031
(4 years from now) | Active |
| US10143698 | Controlled release and taste masking oral pharmaceutical compositions |
Jun, 2020
(6 years ago) |
Expired
|
| US8784888 | Controlled release and taste masking oral pharmaceutical composition |
Jun, 2020
(6 years ago) |
Expired
|
| USRE43799 | Controlled release and taste masking oral pharmaceutical composition |
Jun, 2020
(6 years ago) |
Expired
|
| US7431943 | Controlled release and taste masking oral pharmaceutical compositions |
Jun, 2020
(6 years ago) |
Expired
|
| US9320716 | Controlled release and taste masking oral pharmaceutical compositions |
Jun, 2020
(6 years ago) |
Expired
|
| US8293273 | Controlled release and taste masking oral pharmaceutical composition |
Jun, 2020
(6 years ago) |
Expired
|
| US7410651 | Controlled release and taste masking oral pharmaceutical composition |
Jun, 2020
(6 years ago) |
Expired
|
| US9532954 | Controlled release and taste masking oral pharmaceutical compositions |
Jun, 2020
(6 years ago) |
Expired
|
| US10064878 | Controlled release and taste masking oral pharmaceutical compositions |
Jun, 2020
(6 years ago) |
Expired
|
| US10105374 | Controlled release and taste masking oral pharmaceutical compositions |
Jun, 2020
(6 years ago) |
Expired
|
| US5914122 | Stable budesonide solutions, method of preparing them and use of these solutions as enema preparations and pharmaceutical foams |
Dec, 2015
(10 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 Uceris's patents.
Latest Legal Activities on Uceris's Patents
Given below is the list of recent legal activities going on the following patents of Uceris.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent | 25 Nov, 2024 | US8293273 (Litigated) |
| Maintenance Fee Reminder Mailed
Critical | 10 Jun, 2024 | US8293273 (Litigated) |
| Expire Patent
Critical | 03 Jun, 2024 | US9320716 |
| Maintenance Fee Reminder Mailed
Critical | 18 Dec, 2023 | US9320716 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 08 Nov, 2023 | US10660858 |
| Expire Patent | 06 Nov, 2023 | USRE43799 |
| Maintenance Fee Reminder Mailed | 22 May, 2023 | USRE43799 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 04 May, 2023 | US9192581 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 10 Mar, 2023 | US9132093 |
| Expire Patent
Critical | 09 Jan, 2023 | US10143698 |
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 Uceris and ongoing
litigations to
help you estimate the early arrival of Uceris generic.
Uceris's Litigations
Uceris been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Mar 09, 2017, against patent number US8784888. The petitioner Mylan Pharmaceuticals Inc., challenged the validity of this patent, with Cosmo Technologies Limited et al. as the respondent. Click below to track the latest information on how companies are challenging Uceris's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US9320716 | October, 2017 |
Terminated-Settled
(23 Apr, 2018) | Cosmo Technologies Limited | Argentum Pharmaceuticals LLC |
| US9320716 | March, 2017 |
Terminated-Settled
(17 Jan, 2018) | Cosmo Technologies Limited et al. | Mylan Pharmaceuticals Inc. |
| US8784888 | March, 2017 |
Terminated-Settled
(20 Sep, 2017) | Cosmo Technologies Limited et al. | Mylan Pharmaceuticals Inc. |
FDA has granted some exclusivities to Uceris. Till the time these
exclusivities are
active, no other company can market a generic or bioequivalent version of Uceris,
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
Uceris.
Exclusivity Information
Uceris holds 2 exclusivities. All of its exclusivities have expired in 2017. Details of Uceris's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Dosage Form(NDF) | Jan 14, 2016 |
| New Product(NP) | Oct 07, 2017 |
US patents provide insights into the exclusivity only within the United States, but
Uceris 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 Uceris's family patents as well as insights into
ongoing legal events
on those patents.
Uceris's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Uceris:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
Generic Launch
Generic Release Date:
Uceris's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Sep 07, 2031 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Uceris Generic API suppliers:
Budesonide is the generic name for the brand Uceris. 22 different companies have already filed for the generic of Uceris, with Sandoz having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Uceris's generic
How can I launch a generic of Uceris before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Uceris's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Uceris'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 Uceris -
| Strength | Submission Date | Expiration Date of Last Qualifying Patent | 180-Day Status | First Applicant Approval | Generic Competition Status |
|---|---|---|---|---|---|
| 11 Mar, 2013 | 09 Jun, 2020 | Deferred | 03 Jul, 2018 | Less |
Alternative Brands for Uceris
Uceris which is used for treating active, mild to moderate ulcerative colitis by inducing remission., has several other brand drugs using the same active ingredient (Budesonide). 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 | |||||
|---|---|---|---|---|---|---|
| Astrazeneca |
| |||||
| Astrazeneca Ab |
| |||||
| Calliditas |
| |||||
| Cheplapharm |
| |||||
| Padagis Us |
| |||||
| Sun Pharm Inds Inc |
| |||||
| Takeda Pharms Usa |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Budesonide, Uceris's active ingredient. Check the complete list of approved generic manufacturers for Uceris
About Uceris
Uceris is a drug owned by Salix Pharmaceuticals Inc. It is used for treating active, mild to moderate ulcerative colitis by inducing remission. Uceris uses Budesonide as an active ingredient. Uceris was launched by Salix in 2013.
Approval Date:
Uceris was approved by FDA for market use on 14 January, 2013.
Active Ingredient:
Uceris uses Budesonide as the active ingredient. Check out other Drugs and Companies using Budesonide ingredient
Treatment:
Uceris is used for treating active, mild to moderate ulcerative colitis by inducing remission.
Dosage:
Uceris is available in the following dosage forms - tablet, extended release form for oral use, aerosol, foam form for rectal use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 9MG | TABLET, EXTENDED RELEASE | Prescription | ORAL |
| 2MG/ACTUATION | AEROSOL, FOAM | Prescription | RECTAL |