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Last Updated: March 26, 2023

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 ten 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. Two suppliers are 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 six 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

See drug prices for TRULANCE

DrugPatentWatch® Estimated Generic Entry Opportunity 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 twelve US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of TRULANCE is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Ultra-pure agonists of guanylate cyclase C, method of making and using same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Ultra-pure agonists of guanylate cyclase C, method of making and using same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Guanylate cyclase receptor agonists for the treatment of tissue inflammation and carcinogenesis
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Guanylate cyclase receptor agonists for the treatment of tissue inflammation and carcinogenesis
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Guanylate cyclase receptor agonists for the treatment of tissue inflammation and carcinogenesis
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: ELEVATION OF INTRACELLULAR CGMP RESULTING IN INCREASED INTESTINAL FLUID AND ACCELERATED TRANSIT

Formulations of guanylate cyclase C agonists and methods of use
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: CHRONIC IDIOPATHIC CONSTIPATION

Formulations of guanylate cyclase C agonists and methods of use
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: IRRITABLE BOWEL SYNDROME WITH CONSTIPATION

Formulations of guanylate cyclase C agonists and methods of use
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Formulations of guanylate cyclase C agonists and methods of use
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: IRRITABLE BOWEL SYNDROME WITH CONSTIPATION

Formulations of guanylate cyclase C agonists and methods of use
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: CHRONIC IDIOPATHIC CONSTIPATION

Formulations of guanylate cyclase C agonists and methods of use
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting TRULANCE

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Salix TRULANCE plecanatide TABLET;ORAL 208745-001 Jan 19, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Salix TRULANCE plecanatide TABLET;ORAL 208745-001 Jan 19, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Salix TRULANCE plecanatide TABLET;ORAL 208745-001 Jan 19, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Salix TRULANCE plecanatide TABLET;ORAL 208745-001 Jan 19, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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: See Plans and Pricing

Patent: 18226473
Estimated Expiration: See Plans and Pricing

Patent: 20205349
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2015030326
Estimated Expiration: See Plans and Pricing

Canada

Patent: 13737
Estimated Expiration: See Plans and Pricing

China

Patent: 5764916
Estimated Expiration: See Plans and Pricing

Patent: 3388007
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 1592263
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 04138
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 21959
Estimated Expiration: See Plans and Pricing

Israel

Patent: 2939
Estimated Expiration: See Plans and Pricing

Japan

Patent: 06491
Estimated Expiration: See Plans and Pricing

Patent: 16522216
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 2272746
Estimated Expiration: See Plans and Pricing

Patent: 160039577
Estimated Expiration: See Plans and Pricing

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
Japan 2004532208 See Plans and Pricing
Spain 2622468 See Plans and Pricing
Japan 4206272 See Plans and Pricing
Japan 6606491 See Plans and Pricing
Canada 2913737 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) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Colorcon
Moodys
Harvard Business School
Dow
Mallinckrodt
Johnson and Johnson

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.