Get our Free Drug Patent Expiration Updates

Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Deloitte
US Department of Justice
Farmers Insurance
Julphar
US Army
Covington
Chubb
Express Scripts

Generated: November 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 208745

« Back to Dashboard

NDA 208745 describes TRULANCE, which is a drug marketed by Synergy Pharms and is included in one NDA. It is available from one supplier. There are eight 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:Synergy Pharms
Ingredient:plecanatide
Patents:8
Generic Entry Opportunity Date for 208745
Generic Entry Date for 208745*:
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.

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 Synergy Pharmaceuticals Inc. 70194-003 70194-003-30 1 BLISTER PACK in 1 CARTON (70194-003-30) > 30 TABLET in 1 BLISTER PACK

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
Regulatory Exclusivity Use:TREATMENT IN ADULT PATIENTS FOR IRRITABLE BOWEL SYNDROME WITH CONSTIPATION (IBS-C)
Patent:➤ Sign UpPatent Expiration:Jun 5, 2034Product Flag?Substance Flag?YDelist Request?

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
QuintilesIMS
Merck
Moodys
Boehringer Ingelheim
Mallinckrodt
Fish and Richardson
Harvard Business School
Julphar

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 verifification 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.