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TRULANCE Drug Profile
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» See Plans and PricingWhen 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 fifty-nine 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 will be eligible for patent challenges on January 19, 2021. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
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 has been one patent litigation case 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: | 59 |
| US Patents: | 8 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 4 |
| 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 |
Recent Litigation for TRULANCE
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Allergan Sales, LLC v. Teva Pharmaceuticals USA, Inc. | 2016-11-30 |
Pharmacology for TRULANCE
| Drug Class | Guanylate Cyclase-C Agonist |
| Mechanism of Action | Guanylate Cyclase Activators |
Synonyms for TRULANCE
| (3-Glutamic acid(D>E))human uroguanylin (UGN) |
| [3-glutamic acid(D>E)]human uroguanylin |
| 467426-54-6 |
| 7IK8Z952OK |
| CHEMBL2103867 |
| DB13170 |
| DTXSID60196933 |
| GTPL9069 |
| Guanilib |
| L-Leucine, L-asparaginyl-L-alpha-aspartyl-L-alpha-glutamyl-L-cysteinyl-L-alpha-glutamyl-L-leucyl-L- cysteinyl-L-valyl-L-asparaginyl-L-valyl-L-alanyl-L-cysteinyl-L-threonylglycyl-L-cysteinyl-, cyclic (4->12),(7->15)-bis(disul |
| PLECANATIDE |
| Plecanatide [USAN:INN] |
| SP-304 |
| SP-304 (SYNERGY) |
| UNII-7IK8Z952OK |
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 | 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 | 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 | Y | Start Trial | |||
| Salix | TRULANCE | plecanatide | TABLET;ORAL | 208745-001 | Jan 19, 2017 | RX | Yes | Yes | Start Trial | Start Trial | 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 |
|---|---|---|
| Hong Kong | 1204454 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2013138352 | Start Trial |
| Japan | 4206272 | Start Trial |
| European Patent Office | 3004138 | Start Trial |
| Spain | 2622468 | Start Trial |
| Eurasian Patent Organization | 006651 | Start Trial |
| Australia | 2018226473 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
