Details for New Drug Application (NDA): 208745
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The generic ingredient in TRULANCE is plecanatide. One supplier is listed for this compound. Additional details are available on the plecanatide profile page.
Summary for 208745
Tradename: | TRULANCE |
Applicant: | Salix |
Ingredient: | plecanatide |
Patents: | 9 |
Formulation / Manufacturing: | see details |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 208745
Generic Entry Date for 208745*:
Constraining patent/regulatory exclusivity:
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.
Pharmacology for NDA: 208745
Mechanism of Action | Guanylate Cyclase Activators |
Suppliers and Packaging for NDA: 208745
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TRULANCE | plecanatide | TABLET;ORAL | 208745 | NDA | Salix Pharmaceuticals Inc. | 65649-003 | 65649-003-01 | 1 BOTTLE in 1 CARTON (65649-003-01) / 1 TABLET in 1 BOTTLE |
TRULANCE | plecanatide | TABLET;ORAL | 208745 | NDA | Salix Pharmaceuticals Inc. | 65649-003 | 65649-003-03 | 1 BOTTLE in 1 CARTON (65649-003-03) / 3 TABLET in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 3MG | ||||
Approval Date: | Jan 19, 2017 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Jun 5, 2034 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Jun 5, 2034 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Mar 1, 2032 | Product Flag? | Y | Substance Flag? | Delist Request? |
Expired US Patents for NDA 208745
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Salix | TRULANCE | plecanatide | TABLET;ORAL | 208745-001 | Jan 19, 2017 | ⤷ Sign Up | ⤷ Sign Up |
Salix | TRULANCE | plecanatide | TABLET;ORAL | 208745-001 | Jan 19, 2017 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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