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Last Updated: February 22, 2020

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Plecanatide - Generic Drug Details

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What are the generic drug sources for plecanatide and what is the scope of freedom to operate?

Plecanatide is the generic ingredient in one branded drug marketed by Salix and is included in one NDA. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Plecanatide has fifty-nine patent family members in fifteen countries.

One supplier is listed for this compound.

Recent Clinical Trials for plecanatide

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
INC ResearchPhase 3
Synergy Pharmaceuticals Inc.Phase 3
Synergy Pharmaceuticals Inc.Phase 2

See all plecanatide clinical trials

Recent Litigation for plecanatide

Identify potential future generic entrants

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

See all plecanatide litigation

Pharmacology for plecanatide
Synonyms for plecanatide
(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 [USAN:INN]
SP-304
Trulance
UNII-7IK8Z952OK

US Patents and Regulatory Information for plecanatide

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   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
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
>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:

Colorcon
Boehringer Ingelheim
Dow
Express Scripts
Mallinckrodt
Baxter

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