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Last Updated: October 27, 2021

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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 two suppliers. There are eight patents protecting this drug. Additional details are available on the TRULANCE profile page.

The generic ingredient in TRULANCE is plecanatide. Two suppliers are listed for this compound. Additional details are available on the plecanatide profile page.
Summary for 208745
Formulation / Manufacturing:see details
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 208745
Generic Entry Date for 208745*:
Constraining patent/regulatory exclusivity:

*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 ActionGuanylate 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
Paragraph IV (Patent) Challenges for 208745
Tradename Dosage Ingredient NDA Submissiondate
TRULANCE TABLET;ORAL plecanatide 208745

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength3MG
Approval Date:Jan 19, 2017TE:RLD:Yes
Regulatory Exclusivity Expiration:Jan 19, 2022
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Jan 24, 2021
Patent:⤷  Try it FreePatent Expiration:Jun 5, 2034Product Flag?Substance Flag?YDelist Request?

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
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Express Scripts
Harvard Business School

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