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 001
LUBIPROSTONE (AMITIZA) CAPSULE 24MCG

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
001 6982283 12/04/2022
U-1391 METHOD FOR TREATING OPIOID-INDUCED CONSTIPATION
04/09/2013
001 7064148 08/30/2022
U-739 METHOD FOR TREATING CONSTIPATION BY OPENING CIC CHANNELS IN A MAMMALIAN SUBJECT
U-1404 METHOD FOR TREATING CONSTIPATION IN A PATIENT WITH OPIOID-INDUCED CONSTIPATION BY OPENING CIC CHANNELS
001 8026393 10/25/2027 DP
10/26/2011
001 8088934 05/18/2021 DS
001 8097653 11/14/2022
U-1214 METHOD FOR RELIEVING CONSTIPATION IN A HUMAN PATIENT THAT COMPRISES ADMINISTERING TO THE PATIENT A DOSAGE UNIT COMPRISING (I) 24MCG+/- 10% OF A DRUG SUBSTANCE AND (II) A PHARMACEUTICALLY SUITABLE EXCIPIENT
U-1394 METHOD FOR RELIEVING CONSTIPATION IN A PATIENT WITH OPIOID-INDUCED CONSTIPATION THAT COMPRISES ADMINISTERING TO THE PATIENT A DOSAGE UNIT COMPRISING(I)24MICROG+/- 10% OF A DRUG SUBSTANCE AND (II) A PHARMACEUTICALLY SUITABLE EXCIPIENT
01/18/2012
001 8338639 01/23/2027 DP
12/20/2012
001 8389542 11/14/2022 DP
U-1345 USE IN RELIEVING OR PREVENTING CONSTIPATION IN A HUMAN PATIENT WITH A DOSAGE UNIT COMPRISING 24MICROG+/- 10% OF A DRUG SUBSTANCE AND A PHARMACEUTICALLY SUITABLE EXCIPIENT
U-1395 USE IN RELIEVING OR PREVENTING CONSTIPATION IN A PATIENT WITH OPIOID-INDUCED CONSTIPATION WITH A DOSAGE UNIT COMPRISING 24MICROG +/- 10% OF A DRUG SUBSTANCE AND A PHARMACEUTICALLY SUITABLE EXCIPIENT
02/22/2013
001 8748481 09/01/2025
U-1520 METHOD FOR THE LONG TERM TREATMENT OF CHRONIC CONSTIPATION IN A HUMAN SUBJECT
06/20/2014
001 8779187 01/23/2027 DP
08/07/2014

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
001
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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