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Last Updated: April 24, 2024

Details for New Drug Application (NDA): 208745

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NDA 208745 describes TRULANCE, which is a drug marketed by Salix and is included in one NDA. It is available from one supplier. There are nine patents protecting this drug. Additional details are available on the TRULANCE profile page.

The generic ingredient in TRULANCE is plecanatide. One supplier is listed for this compound. Additional details are available on the plecanatide profile page.

Summary for 208745

Tradename:	TRULANCE
Applicant:	Salix
Ingredient:	plecanatide
Patents:	9
Formulation / Manufacturing:	see details

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 208745

Generic Entry Date for 208745^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial 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.

Pharmacology for NDA: 208745

Mechanism of Action	Guanylate Cyclase Activators

Suppliers and Packaging for NDA: 208745

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TRULANCE	plecanatide	TABLET;ORAL	208745	NDA	Salix Pharmaceuticals Inc.	65649-003	65649-003-01	1 BOTTLE in 1 CARTON (65649-003-01) / 1 TABLET in 1 BOTTLE
TRULANCE	plecanatide	TABLET;ORAL	208745	NDA	Salix Pharmaceuticals Inc.	65649-003	65649-003-03	1 BOTTLE in 1 CARTON (65649-003-03) / 3 TABLET in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	3MG
Approval Date:	Jan 19, 2017	TE:		RLD:	Yes
Patent:	⤷ Try a Trial	Patent Expiration:	Jun 5, 2034	Product Flag?		Substance Flag?	Y	Delist Request?
Patent:	⤷ Try a Trial	Patent Expiration:	Jun 5, 2034	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Try a Trial	Patent Expiration:	Mar 1, 2032	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 208745

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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	⤷ Try a Trial	⤷ Try a Trial
Salix	TRULANCE	plecanatide	TABLET;ORAL	208745-001	Jan 19, 2017	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent 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.