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: N202811

Product 003
LINACLOTIDE (LINZESS) CAPSULE 72MCG

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
003 7304036 08/30/2026 DS DP
U-1516 METHOD OF TREATING CHRONIC IDIOPATHIC CONSTIPATION IN ADULT PATIENTS.
02/24/2017
003 7371727 01/28/2024 DS
02/24/2017
003 7704947 01/28/2024 DS DP
02/24/2017
003 7745409 01/28/2024 DS DP
02/24/2017
003 8080526 01/28/2024 DS DP
02/24/2017
003 8110553 01/28/2024
U-1516 METHOD OF TREATING CHRONIC IDIOPATHIC CONSTIPATION IN ADULT PATIENTS.
02/24/2017
003 8933030 02/17/2031 DP
U-1516 METHOD OF TREATING CHRONIC IDIOPATHIC CONSTIPATION IN ADULT PATIENTS.
02/24/2017
003 9708371 08/16/2033 DP
U-1516 METHOD OF TREATING CHRONIC IDIOPATHIC CONSTIPATION IN ADULT PATIENTS.
08/10/2017
003 10675325 08/11/2031 DP
06/22/2020
003 10702576 08/11/2031
U-1516 METHOD OF TREATING CHRONIC IDIOPATHIC CONSTIPATION IN ADULT PATIENTS.
08/04/2020

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration

 

 


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