DrugPatentWatch Database Preview
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
Summary for TRULANCE
| International Patents: | 67 |
| US Patents: | 9 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 9 |
| Clinical Trials: | 5 |
| Patent Applications: | 139 |
| 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 |
|---|---|
| Bausch Health Americas, Inc. | Phase 3 |
| Synergy Pharmaceuticals Inc. | Phase 3 |
| Synergy Pharmaceuticals 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 | 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 |
International Patents for TRULANCE
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Canada | 2867292 | ⤷ Try it Free |
| Eurasian Patent Organization | 006651 | ⤷ Try it Free |
| China | 103638514 | ⤷ Try it Free |
| Denmark | 1379224 | ⤷ Try it Free |
| >Country | >Patent Number | >Estimated Expiration |
