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Last Updated: February 19, 2020

DrugPatentWatch Database Preview

TRULANCE Drug Profile


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Which patents cover Trulance, 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. One supplier is 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

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Drug patent expirations by year for TRULANCE
Drug Prices for TRULANCE

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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

SponsorPhase
Synergy Pharmaceuticals Inc.Phase 2

See all TRULANCE clinical trials

Recent Litigation for TRULANCE

Identify potential future generic entrants

District Court Litigation
Case NameDate
Allergan Sales, LLC v. Teva Pharmaceuticals USA, Inc.2016-11-30

See all TRULANCE litigation

Pharmacology for TRULANCE
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
PLECANATIDE
Plecanatide [USAN:INN]
SP-304
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   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

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Serving leading biopharmaceutical companies globally:

Baxter
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McKesson
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Medtronic
Merck

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.