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Last Updated: April 12, 2024

Plecanatide - Generic Drug Details


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What are the generic drug sources for plecanatide and what is the scope of patent protection?

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

Plecanatide has sixty-eight patent family members in sixteen countries.

One supplier is listed for this compound.

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for plecanatide
Generic Entry Date for plecanatide*:
Constraining patent/regulatory exclusivity:
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 plecanatide

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

SponsorPhase
National Cancer Institute (NCI)Early Phase 1
Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.Phase 3
Synergy Pharmaceuticals Inc.Phase 3

See all plecanatide clinical trials

Pharmacology for plecanatide
Paragraph IV (Patent) Challenges for PLECANATIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
TRULANCE Tablets plecanatide 3 mg 208745 2 2021-01-19

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 ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Salix TRULANCE plecanatide TABLET;ORAL 208745-001 Jan 19, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Salix TRULANCE plecanatide TABLET;ORAL 208745-001 Jan 19, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Salix TRULANCE plecanatide TABLET;ORAL 208745-001 Jan 19, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Salix TRULANCE plecanatide TABLET;ORAL 208745-001 Jan 19, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 plecanatide

Country Patent Number Title Estimated Expiration
Canada 2795396 AGONISTES DU RECEPTEUR DU TYPE GUANYLATE CYCLASE POUR STIMULER LE TRANSPORT D'EAU DANS LE TRACTUS GASTRO-INTESTINAL POUR TRAITER L'INFLAMMATION DES TISSUS (GUANYLATE CYCLASE RECEPTOR AGONISTS FOR STIMULATING WATER TRANSPORT IN THE GASTROINTESTINAL TRACT TO TREAT TISSUE INFLAMMATION) ⤷  Try a Trial
South Korea 102272746 ⤷  Try a Trial
Spain 2622468 ⤷  Try a Trial
Australia 2016216716 Formulations Of Guanylate Cyclase C Agonists And Methods Of Use ⤷  Try a Trial
Canada 2913737 AGONISTES ULTRA-PURS DE GUANYLATE CYCLASE C, LEUR PROCEDE DE PRODUCTION ET D'UTILISATION (ULTRA-PURE AGONISTS OF GUANYLATE CYCLASE C, METHOD OF MAKING AND USING SAME) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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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 verification 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.