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 7799897 06/09/2022 DS
02/14/2017
001 8637451 03/28/2022
U-1964 ELEVATION OF INTRACELLULAR CGMP RESULTING IN INCREASED INTESTINAL FLUID AND ACCELERATED TRANSIT
02/14/2017
001 9610321 09/15/2031
U-1999 CHRONIC IDIOPATHIC CONSTIPATION
U-2230 IRRITABLE BOWEL SYNDROME WITH CONSTIPATION
05/01/2017
001 9616097 08/20/2032 DP
05/01/2017
001 9919024 09/15/2031
U-1999 CHRONIC IDIOPATHIC CONSTIPATION
U-2230 IRRITABLE BOWEL SYNDROME WITH CONSTIPATION
04/10/2018
001 9925231 09/15/2031 DP
04/10/2018
001 10011637 06/05/2034 DS
07/19/2018

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
001
I-764TREATMENT IN ADULT PATIENTS FOR IRRITABLE BOWEL SYNDROME WITH CONSTIPATION (IBS-C)
COMPETITIVE GENERIC THERAPY
01/24/2021
001
NCENEW CHEMICAL ENTITY
COMPETITIVE GENERIC THERAPY
01/19/2022

 

 


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