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Last Updated: October 31, 2024

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TRULANCE Drug Patent Profile


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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 seventy-five patent family members in twenty 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

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Drug patent expirations by year for TRULANCE
Drug Prices for TRULANCE

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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
Synergy Pharmaceuticals 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 ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Ultra-pure agonists of guanylate cyclase C, method of making and using same
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Ultra-pure agonists of guanylate cyclase C, method of making and using same
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Guanylate cyclase receptor agonists for the treatment of tissue inflammation and carcinogenesis
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Formulations of guanylate cyclase C agonists and methods of use
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: CHRONIC IDIOPATHIC CONSTIPATION

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

Formulations of guanylate cyclase C agonists and methods of use
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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

Formulations of guanylate cyclase C agonists and methods of use
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: CHRONIC IDIOPATHIC CONSTIPATION

Formulations of guanylate cyclase C agonists and methods of use
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Salix TRULANCE plecanatide TABLET;ORAL 208745-001 Jan 19, 2017 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Salix TRULANCE plecanatide TABLET;ORAL 208745-001 Jan 19, 2017 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Salix TRULANCE plecanatide TABLET;ORAL 208745-001 Jan 19, 2017 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Salix TRULANCE plecanatide TABLET;ORAL 208745-001 Jan 19, 2017 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>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
Patent: Ultra-pure agonists of guanylate cyclase C, method of making and using same
Estimated Expiration: ⤷  Sign Up

Patent: 18226473
Patent: Ultra-Pure Agonists Of Guanylate Cyclase C, Method Of Making And Using Same
Estimated Expiration: ⤷  Sign Up

Patent: 20205349
Patent: Ultra-pure agonists of guanylate cyclase C, method of making and using same
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 2015030326
Patent: AGONISTAS ULTRAPUROS DE GUANILATO CICLASE C, MÉTODO DE FABRICAR E USAR OS MESMOS
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 13737
Patent: AGONISTES ULTRA-PURS DE GUANYLATE CYCLASE C, LEUR PROCEDE DE PRODUCTION ET D'UTILISATION (ULTRA-PURE AGONISTS OF GUANYLATE CYCLASE C, METHOD OF MAKING AND USING SAME)
Estimated Expiration: ⤷  Sign Up

China

Patent: 5764916
Patent: 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)
Estimated Expiration: ⤷  Sign Up

Patent: 3388007
Patent: 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 methods of making and using same)
Estimated Expiration: ⤷  Sign Up

Croatia

Patent: 0240805
Estimated Expiration: ⤷  Sign Up

Eurasian Patent Organization

Patent: 1592263
Patent: УЛЬТРАЧИСТЫЕ АГОНИСТЫ ГУАНИЛАТЦИКЛАЗЫ C, СПОСОБ ИХ ПОЛУЧЕНИЯ И ИСПОЛЬЗОВАНИЯ
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 04138
Patent: AGONISTES ULTRA-PURS DE GUANYLATE CYCLASE C, LEUR PROCÉDÉ DE PRODUCTION ET D'UTILISATION (ULTRA-PURE AGONISTS OF GUANYLATE CYCLASE C, METHOD OF MAKING AND USING SAME)
Estimated Expiration: ⤷  Sign Up

Patent: 24697
Patent: AGONISTES ULTRA-PURS DE GUANYLATE CYCLASE C, LEUR PROCÉDÉ DE FABRICATION ET D'UTILISATION (ULTRA-PURE AGONISTS OF GUANYLATE CYCLASE C, METHOD OF MAKING AND USING SAME)
Estimated Expiration: ⤷  Sign Up

Hong Kong

Patent: 21959
Patent: 鳥苷酸環化酶 的超純激動劑、製備和使用所述激動劑的方法 (ULTRA-PURE AGONISTS OF GUANYLATE YCLASE , METHOD OF MAKING AND USING SAME)
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 2939
Patent: 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)
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 06491
Estimated Expiration: ⤷  Sign Up

Patent: 16522216
Patent: グアニル酸シクラーゼCの超高純度アゴニスト、その作成および使用方法
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 04138
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 04138
Estimated Expiration: ⤷  Sign Up

Serbia

Patent: 632
Patent: ULTRA-PREČIŠĆENI AGONISTI GUANILAT-CIKLAZE C, POSTUPAK NJIHOVE PRIPREME I UPOTREBE (ULTRA-PURE AGONISTS OF GUANYLATE CYCLASE C, METHOD OF MAKING AND USING SAME)
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 04138
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 2272746
Estimated Expiration: ⤷  Sign Up

Patent: 160039577
Patent: 구아닐레이트 사이클라제 C의 초순수 작용제, 및 이의 제조 및 사용 방법 (ULTRA-PURE AGONISTS OF GUANYLATE CYCLASE C, METHOD OF MAKING AND USING SAME)
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 81866
Estimated Expiration: ⤷  Sign Up

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 107029209 ⤷  Sign Up
China 113388007 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 methods of making and using same) ⤷  Sign Up
Denmark 1379224 ⤷  Sign Up
Japan 6393037 ⤷  Sign Up
Croatia P20240805 ⤷  Sign Up
>Country >Patent Number >Title >Estimated 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.