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Last Updated: January 27, 2022

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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 sixty-seven patent family members in fifteen 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 two 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
Bausch Health Americas, Inc.Phase 3
Synergy Pharmaceuticals 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 NDA Submissiondate
TRULANCE TABLET;ORAL plecanatide 208745

US Patents and Regulatory Information for TRULANCE

TRULANCE is protected by eleven US patents and two FDA Regulatory Exclusivities.

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

This potential generic entry date is based on patent ⤷  Try it Free.

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 it Free
Patent Expiration: ⤷  Try it Free

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

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

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

Guanylate cyclase receptor agonists for the treatment of tissue inflammation and carcinogenesis
Patent Number: ⤷  Try it Free
Patent Expiration: ⤷  Try it Free
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: ⤷  Try it Free
Patent Expiration: ⤷  Try it Free
Patented Use: CHRONIC IDIOPATHIC CONSTIPATION

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

Formulations of guanylate cyclase C agonists and methods of use
Patent Number: ⤷  Try it Free
Patent Expiration: ⤷  Try it Free

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

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

Formulations of guanylate cyclase C agonists and methods of use
Patent Number: ⤷  Try it Free
Patent Expiration: ⤷  Try it Free

FDA Regulatory Exclusivity protecting TRULANCE

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷  Try it Free

TREATMENT IN ADULT PATIENTS FOR IRRITABLE BOWEL SYNDROME WITH CONSTIPATION (IBS-C)
Exclusivity Expiration: ⤷  Try it Free

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 it Free ⤷  Try it Free ⤷  Try it Free
Salix TRULANCE plecanatide TABLET;ORAL 208745-001 Jan 19, 2017 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Salix TRULANCE plecanatide TABLET;ORAL 208745-001 Jan 19, 2017 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Salix TRULANCE plecanatide TABLET;ORAL 208745-001 Jan 19, 2017 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity 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.