DrugPatentWatch Database Preview
TRULANCE Drug Profile
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When do Trulance patents expire, and what generic alternatives are available?
Trulance is a drug marketed by Salix and is included in one NDA. There are eight patents protecting this drug.
This drug has sixty-three patent family members in fifteen countries.
The generic ingredient in TRULANCE is plecanatide. Two suppliers are listed for this compound. Additional details are available on the plecanatide profile page.
US ANDA Litigation and Generic Entry Outlook for Trulance
Trulance was eligible for patent challenges on January 19, 2021.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be June 5, 2034. This may change due to patent challenges or generic licensing.
There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
Summary for TRULANCE
International Patents: | 63 |
US Patents: | 8 |
Applicants: | 1 |
NDAs: | 1 |
Suppliers / Packagers: | 2 |
Bulk Api Vendors: | 7 |
Clinical Trials: | 2 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for TRULANCE |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for TRULANCE |
DailyMed Link: | TRULANCE at DailyMed |


Generic Entry Opportunity Date for TRULANCE
Generic Entry Date for TRULANCE*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for TRULANCE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Synergy Pharmaceuticals Inc. | Phase 2 |
Pharmacology for TRULANCE
Drug Class | Guanylate Cyclase-C Agonist |
Mechanism of Action | Guanylate Cyclase Activators |
US Patents and Regulatory Information for TRULANCE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Salix | TRULANCE | plecanatide | TABLET;ORAL | 208745-001 | Jan 19, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
Salix | TRULANCE | plecanatide | TABLET;ORAL | 208745-001 | Jan 19, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
Salix | TRULANCE | plecanatide | TABLET;ORAL | 208745-001 | Jan 19, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
Salix | TRULANCE | plecanatide | TABLET;ORAL | 208745-001 | Jan 19, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
Salix | TRULANCE | plecanatide | TABLET;ORAL | 208745-001 | Jan 19, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
Salix | TRULANCE | plecanatide | TABLET;ORAL | 208745-001 | Jan 19, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
Salix | TRULANCE | plecanatide | TABLET;ORAL | 208745-001 | Jan 19, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for TRULANCE
Country | Patent Number | Estimated Expiration |
---|---|---|
Japan | 6557138 | Start Trial |
European Patent Office | 2825188 | Start Trial |
Eurasian Patent Organization | 200301070 | Start Trial |
Australia | 2020205349 | Start Trial |
Israel | 242939 | Start Trial |
Canada | 2795396 | Start Trial |
Australia | 2014274812 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |