You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: April 17, 2024

~ Buy the TRULANCE (plecanatide) Drug Profile, 2024 PDF Report in the Report Store ~

TRULANCE Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


When do Trulance patents expire, and what generic alternatives are available?

Trulance is a drug marketed by Salix and is included in one NDA. There are nine patents protecting this drug and one Paragraph IV challenge.

This drug has sixty-eight patent family members in sixteen countries.

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

DrugPatentWatch® Generic Entry Outlook for Trulance

Trulance was eligible for patent challenges on January 19, 2021.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 5, 2034. This may change due to patent challenges or generic licensing.

There have been eight patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

< Available with Subscription >

  Try a Trial

Drug patent expirations by year for TRULANCE
Drug Prices for TRULANCE

See drug prices for TRULANCE

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for TRULANCE
Generic Entry Date for TRULANCE*:
Constraining patent/regulatory exclusivity:
NDA:
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.

Recent Clinical Trials for TRULANCE

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

SponsorPhase
Synergy Pharmaceuticals Inc.Phase 3
Bausch Health Americas, Inc.Phase 3
Bausch Health Americas, Inc.Phase 2

See all TRULANCE clinical trials

Pharmacology for TRULANCE
Paragraph IV (Patent) Challenges for TRULANCE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
TRULANCE Tablets plecanatide 3 mg 208745 2 2021-01-19

US Patents and Regulatory Information for TRULANCE

TRULANCE is protected by eleven US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of TRULANCE is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting TRULANCE

Ultra-pure agonists of guanylate cyclase C, method of making and using same
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Ultra-pure agonists of guanylate cyclase C, method of making and using same
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Ultra-pure agonists of guanylate cyclase C, method of making and using same
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Guanylate cyclase receptor agonists for the treatment of tissue inflammation and carcinogenesis
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Formulations of guanylate cyclase C agonists and methods of use
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: CHRONIC IDIOPATHIC CONSTIPATION

Formulations of guanylate cyclase C agonists and methods of use
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: IRRITABLE BOWEL SYNDROME WITH CONSTIPATION

Formulations of guanylate cyclase C agonists and methods of use
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Formulations of guanylate cyclase C agonists and methods of use
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: IRRITABLE BOWEL SYNDROME WITH CONSTIPATION

Formulations of guanylate cyclase C agonists and methods of use
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: CHRONIC IDIOPATHIC CONSTIPATION

Formulations of guanylate cyclase C agonists and methods of use
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Salix TRULANCE plecanatide TABLET;ORAL 208745-001 Jan 19, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Salix TRULANCE plecanatide TABLET;ORAL 208745-001 Jan 19, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Salix TRULANCE plecanatide TABLET;ORAL 208745-001 Jan 19, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Salix TRULANCE plecanatide TABLET;ORAL 208745-001 Jan 19, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Salix TRULANCE plecanatide TABLET;ORAL 208745-001 Jan 19, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>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 TRULANCE

When does loss-of-exclusivity occur for TRULANCE?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 14274812
Estimated Expiration: ⤷  Try a Trial

Patent: 18226473
Estimated Expiration: ⤷  Try a Trial

Patent: 20205349
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 2015030326
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 13737
Estimated Expiration: ⤷  Try a Trial

China

Patent: 5764916
Estimated Expiration: ⤷  Try a Trial

Patent: 3388007
Estimated Expiration: ⤷  Try a Trial

Eurasian Patent Organization

Patent: 1592263
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 04138
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 21959
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 2939
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 06491
Estimated Expiration: ⤷  Try a Trial

Patent: 16522216
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 2272746
Estimated Expiration: ⤷  Try a Trial

Patent: 160039577
Estimated Expiration: ⤷  Try a Trial

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering TRULANCE around the world.

Country Patent Number Title Estimated Expiration
China 103638514 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2013138352 ⤷  Try a Trial
Japan 2012149071 GUANYLATE CYCLASE RECEPTOR AGONIST FOR TREATMENT OF TISSUE INFLAMMATION AND CARCINOGENESIS ⤷  Try a Trial
China 105764916 鸟苷酸环化酶C的超纯激动剂、制备和使用所述激动剂的方法 (Ultra-pure agonists of guanylate cyclase C, and method of making and using same) ⤷  Try a Trial
Hong Kong 1204454 鳥苷酸環化酶 激動劑的製劑及它們的使用方法 (FORMULATIONS OF GUANYLATE YCLASE AGONISTS AND METHODS OF USE) ⤷  Try a Trial
Japan 2019112452 グアニル酸シクラーゼCアゴニストの製剤および使用方法 (FORMULATIONS OF GUANYLATE CYCLASE C AGONISTS AND METHODS OF USE) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Make Better Decisions: Try a trial or see plans & pricing

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.