Trulance is a drug owned by Salix Pharmaceuticals Inc. It is protected by 12 US drug patents filed from 2017 to 2024. Out of these, 10 drug patents are active and 2 have expired. Trulance's patents have been open to challenges since 19 January, 2021. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 05, 2034. Details of Trulance's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US10011637 | Ultra-pure agonists of guanylate cyclase C, method of making and using same |
Jun, 2034
(8 years from now) | Active |
| US7041786 | Guanylate cyclase receptor agonists for the treatment of tissue inflammation and carcinogenesis |
Jan, 2028
(2 years from now) | Active |
| US7799897 | Guanylate cyclase receptor agonists for the treatment of tissue inflammation and carcinogenesis |
Jun, 2022
(3 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11142549 | Ultra-pure agonists of guanylate cyclase C, method of making and using same |
Jun, 2034
(8 years from now) | Active |
| US12146003 | Ultra-pure agonists of guanylate cyclase C, method of making and using same |
Jun, 2034
(8 years from now) | Active |
| US11834521 | Ultra-pure agonists of guanylate cyclase C, method of making and using same |
Jun, 2034
(8 years from now) | Active |
| US9616097 | Formulations of guanylate cyclase C agonists and methods of use |
Aug, 2032
(6 years from now) | Active |
| US11319346 | Ultra-pure agonists of guanylate cyclase C, method of making and using same |
Mar, 2032
(6 years from now) | Active |
| US9925231 | Formulations of guanylate cyclase C agonists and methods of use |
Sep, 2031
(5 years from now) | Active |
| US9610321 | Formulations of guanylate cyclase C agonists and methods of use |
Sep, 2031
(5 years from now) | Active |
| US9919024 | Formulations of guanylate cyclase C agonists and methods of use |
Sep, 2031
(5 years from now) | Active |
| US8637451 | Guanylate cyclase receptor agonists for the treatment of tissue inflammation and carcinogenesis |
Mar, 2022
(3 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 Trulance's patents.
Latest Legal Activities on Trulance's Patents
Given below is the list of recent legal activities going on the following patents of Trulance.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Sequence Moved to Public Database | 08 Dec, 2023 | US11834521 |
| Recordation of Patent eGrant | 05 Dec, 2023 | US11834521 |
| Email Notification
Critical | 05 Dec, 2023 | US11834521 |
| Recordation of Patent Grant Mailed
Critical | 05 Dec, 2023 | US11834521 |
| Mail Patent eGrant Notification | 05 Dec, 2023 | US11834521 |
| Patent Issue Date Used in PTA Calculation
Critical | 05 Dec, 2023 | US11834521 |
| Patent eGrant Notification | 05 Dec, 2023 | US11834521 |
| Email Notification
Critical | 16 Nov, 2023 | US11834521 |
| Issue Notification Mailed
Critical | 15 Nov, 2023 | US11834521 |
| Application Is Considered Ready for Issue
Critical | 06 Nov, 2023 | US11834521 |
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 Trulance and ongoing
litigations to
help you estimate the early arrival of Trulance generic.
Trulance's Litigations
Trulance been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Jun 10, 2022, against patent number US9925231. The petitioner Mylan Pharmaceuticals Inc. et al., challenged the validity of this patent, with Bausch Health Ireland Limited et al. as the respondent. Click below to track the latest information on how companies are challenging Trulance's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US7041786 | March, 2022 |
Final Written Decision
(08 Sep, 2023) | Bausch Health Ireland Limited et al. | Mylan Pharmaceuticals Inc. et al. |
| US7041786 | March, 2022 |
Final Written Decision - Appealed
(08 Sep, 2023) | Bausch Health Ireland Limited et al. | Mylan Pharmaceuticals Inc. et al. |
| US7041786 | October, 2022 |
Final Written Decision
(08 Sep, 2023) | Bausch Health Ireland Limited et al. | MSN Laboratories Private Ltd. et al. |
| US7041786 | October, 2022 |
Final Written Decision - Appealed
(08 Sep, 2023) | Bausch Health Ireland Limited et al. | MSN Laboratories Private Ltd. et al. |
| US9610321 | June, 2022 |
Institution Denied
(04 Jan, 2023) | Bausch Health Ireland Limited et al. | Mylan Pharmaceuticals Inc. et al. |
| US9616097 | June, 2022 |
Institution Denied
(04 Jan, 2023) | Bausch Health Ireland Limited et al. | Mylan Pharmaceuticals Inc. et al. |
| US9919024 | June, 2022 |
Institution Denied
(04 Jan, 2023) | Bausch Health Ireland Limited et al. | Mylan Pharmaceuticals Inc. et al. |
| US9925231 | June, 2022 |
Institution Denied
(04 Jan, 2023) | Bausch Health Ireland Limited et al. | Mylan Pharmaceuticals Inc. et al. |
FDA has granted some exclusivities to Trulance. Till the time these
exclusivities are
active, no other company can market a generic or bioequivalent version of Trulance,
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
Trulance.
Exclusivity Information
Trulance holds 2 exclusivities. All of its exclusivities have expired in 2022. Details of Trulance's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-764) | Jan 24, 2021 |
| New Chemical Entity Exclusivity(NCE) | Jan 19, 2022 |
Several oppositions have been filed on Trulance's European patents.
EP oppositions
can significantly impact the timeline for the generic launch of drugs. If an opposition results in the
revocation or
amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an
earlier entry
of generic versions into the market. To help you estimate the potential early arrival of Trulance's generic, the next section provides detailed information on
ongoing and past
EP oppositions related to Trulance patents.
Trulance's Oppositions Filed in EPO
Trulance has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Apr 22, 2010, by Combimab, Inc.. This opposition was filed on patent number EP02721604A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
| | |||
| EP02721604A | Apr, 2010 | Hill, Christopher Michael | Patent maintained as amended |
| EP02721604A | Apr, 2010 | CombiMab, Inc. | Patent maintained as amended |
US patents provide insights into the exclusivity only within the United States, but
Trulance 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 Trulance's family patents as well as insights into
ongoing legal events
on those patents.
Trulance's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Trulance's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 05, 2034 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Trulance Generics:
There are no approved generic versions for Trulance as of now.
How can I launch a generic of Trulance before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Trulance's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Trulance'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 Trulance -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 3 mg | 19 Jan, 2021 | 2 | 05 Jun, 2034 |
About Trulance
Trulance is a drug owned by Salix Pharmaceuticals Inc. It is used for treating chronic idiopathic constipation, irritable bowel syndrome with constipation by increasing intracellular cGMP levels to improve intestinal function. Trulance uses Plecanatide as an active ingredient. Trulance was launched by Salix in 2017.
Approval Date:
Trulance was approved by FDA for market use on 19 January, 2017.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Trulance is 19 January, 2017, its NCE-1 date is estimated to be 19 January, 2021.
Active Ingredient:
Trulance uses Plecanatide as the active ingredient. Check out other Drugs and Companies using Plecanatide ingredient
Treatment:
Trulance is used for treating chronic idiopathic constipation, irritable bowel syndrome with constipation by increasing intracellular cGMP levels to improve intestinal function.
Dosage:
Trulance is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 3MG | TABLET | Prescription | ORAL |