Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Additional Information about Patents

• Patent information is published on or after the submission date as defined in 21 CFR 314.53(d)(5).
• Patent listings published prior to August 18, 2003, only identify method-of-use claims. The listed patents may include drug substance and/or drug product claims that are not indicated in the listing.
• As of December 5, 2016, an NDA holder submitting information on a patent that claims both the drug substance and the drug product (and is eligible for listing on either basis) is required only to specify that it claims either the drug substance or the drug product. Orange Book users should not rely on an Orange Book patent listing, regardless of when first published, to determine the range of patent claims that may be asserted by an NDA holder or patent owner.

Patent and Exclusivity for: N208745

Product 001
PLECANATIDE (TRULANCE) TABLET 3MG

Patent Data

Product No	Patent No	Patent Expiration	Drug Substance	Drug Product	Patent Use Code	Delist Requested	Submission Date
001	7041786	01/30/2028	DS				02/14/2017
001	9610321	09/15/2031			U-1999 U-2230		05/01/2017
001	9616097	08/20/2032		DP			05/01/2017
001	9919024	09/15/2031			U-1999 U-2230		04/10/2018
001	9925231	09/15/2031		DP			04/10/2018
001	10011637	06/05/2034	DS				07/19/2018
001	11142549	06/05/2034		DP			10/25/2021
001	11319346	03/01/2032		DP			05/11/2022
001	11834521	06/05/2034		DP			12/14/2023

Exclusivity Data

Product No	Exclusivity Code	Exclusivity Expiration

 

 

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