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.

Summary for plecanatide

International Patents:	67
US Patents:	10
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	11
Clinical Trials:	12
Patent Applications:	330
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for plecanatide
What excipients (inactive ingredients) are in plecanatide?	plecanatide excipients list
DailyMed Link:	plecanatide at DailyMed

Recent Clinical Trials for plecanatide

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

Sponsor	Phase
National Cancer Institute (NCI)	Early Phase 1
Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.	Phase 3
Syneos Health	Phase 3

See all plecanatide clinical trials

Pharmacology for plecanatide

Drug Class	Guanylate Cyclase-C Agonist
Mechanism of Action	Guanylate Cyclase Activators

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

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Glossary

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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

Expired US Patents for plecanatide

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Salix	TRULANCE	plecanatide	TABLET;ORAL	208745-001	Jan 19, 2017	See Plans and Pricing	See Plans and Pricing
Salix	TRULANCE	plecanatide	TABLET;ORAL	208745-001	Jan 19, 2017	See Plans and Pricing	See Plans and Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for plecanatide

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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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