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: N021908

Product 002
LUBIPROSTONE (AMITIZA) CAPSULE 8MCG

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
002 7064148 08/30/2022
U-739 METHOD FOR TREATING CONSTIPATION BY OPENING CIC CHANNELS IN A MAMMALIAN SUBJECT
U-873 METHOD OF TREATING CONSTIPATION IN A PATIENT WITH IRRITABLE BOWEL SYNDROME BY OPENING CHLORIDE CHANNELS (CIC)
002 7795312 09/17/2024
U-1085 METHOD FOR TREATING IRRITABLE BOWEL SYNDROME AND METHOD FOR TREATING ABDOMINAL DISCOMFORT ASSOCIATED WITH IRRITABLE BOWEL SYNDROME
002 8026393 10/25/2027 DP
002 8088934 05/18/2021 DS
002 8338639 01/23/2027 DP
002 8748481 09/01/2025
U-1519 METHOD FOR THE LONG TERM TREATMENT OF CHRONIC CONSTIPATION IN A HUMAN SUBJECT WITH IRRITABLE BOWEL SYNDROME
06/20/2014
002 8779187 01/23/2027 DP
08/07/2014

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
002
M-225REVISIONS TO SECTION 8.4 OF THE PRESCRIBING INFORMATION TO INCLUDE A SAFETY AND EFFICACY STUDY IN PEDIATRIC PATIENTS AGES >=6 YEARS TO <18 YEARS WITH CHRONIC IDIOPATHIC CONSTIPATION
COMPETITIVE GENERIC THERAPY
04/26/2021

 

 


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