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Last Updated: November 30, 2022

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 ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Plecanatide has sixty-seven patent family members in fifteen countries.

Two suppliers are listed for this compound.

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
Syneos HealthPhase 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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Salix TRULANCE plecanatide TABLET;ORAL 208745-001 Jan 19, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Salix TRULANCE plecanatide TABLET;ORAL 208745-001 Jan 19, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Salix TRULANCE plecanatide TABLET;ORAL 208745-001 Jan 19, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Salix TRULANCE plecanatide TABLET;ORAL 208745-001 Jan 19, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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
Israel 242939 אגוניסטים של גואנילט ציקלז c בדרגת זקוק גבוה, שיטות לייצורם ושימושים בהם (Ultra-pure agonists of guanylate cyclase c, method of making and using same) See Plans and Pricing
Eurasian Patent Organization 038977 СОСТАВЫ АГОНИСТОВ ГУАНИЛАТЦИКЛАЗЫ С И СПОСОБЫ ПРИМЕНЕНИЯ (FORMULATIONS OF GUANYLATE CYCLASE C AGONISTS AND METHODS OF USE) See Plans and Pricing
Japan 6606491 See Plans and Pricing
European Patent Office 2621509 PRÉPARATIONS D'AGONISTES DU GUANYLATE CYCLASE-C ET MÉTHODES D'UTILISATION (FORMULATIONS OF GUANYLATE CYCLASE C AGONISTS AND METHODS OF USE) See Plans and Pricing
China 1551760 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Dow
Moodys
Mallinckrodt
AstraZeneca
Colorcon
Boehringer Ingelheim

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.