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
Summary for TRULANCE
International Patents: | 68 |
US Patents: | 10 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 11 |
Clinical Trials: | 5 |
Patent Applications: | 166 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for TRULANCE |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for TRULANCE |
What excipients (inactive ingredients) are in TRULANCE? | TRULANCE excipients list |
DailyMed Link: | TRULANCE at DailyMed |


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
Sponsor | Phase |
---|---|
Synergy Pharmaceuticals Inc. | Phase 3 |
Bausch Health Americas, Inc. | Phase 3 |
Bausch Health Americas, Inc. | Phase 2 |
Pharmacology for TRULANCE
Drug Class | Guanylate Cyclase-C Agonist |
Mechanism of Action | Guanylate Cyclase Activators |
Anatomical Therapeutic Chemical (ATC) Classes 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 |
Expired US Patents for TRULANCE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Salix | TRULANCE | plecanatide | TABLET;ORAL | 208745-001 | Jan 19, 2017 | See Plans and Pricing | See Plans and Pricing |
Salix | TRULANCE | plecanatide | TABLET;ORAL | 208745-001 | Jan 19, 2017 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent 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 |