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: N207999

Product 002
OBETICHOLIC ACID (OCALIVA) TABLET 10MG

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
002 7138390 11/16/2022 DS DP
06/22/2016
002 8058267 02/21/2022
U-1854 TREATMENT OF PRIMARY BILIARY CHOLANGITIS (PBC)
06/22/2016
002 8377916 02/21/2022
U-1854 TREATMENT OF PRIMARY BILIARY CHOLANGITIS (PBC)
06/22/2016
002 9238673 06/17/2033 DP
06/22/2016
002 10047117 09/06/2033
U-1854 TREATMENT OF PRIMARY BILIARY CHOLANGITIS (PBC)
11/14/2018
002 10052337 04/26/2036 DP
11/08/2018
002 10174073 06/17/2033 DS
01/15/2019
002 10751349 04/26/2036 DP
08/28/2020
002 10758549 04/26/2036
U-2945 TREATMENT OF PRIMARY BILIARY CHOLANGITIS (PBC) IN COMBINATION WITH URSODEOXYCHOLIC ACID (UDCA) IN ADULTS WITH AN INADEQUATE RESPONSE TO UDCA, OR AS MONOTHERAPY IN ADULTS UNABLE TO TOLERATE UDCA
09/10/2020
002 RE48286 11/16/2027 DS DP
10/28/2020

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
002
NCENEW CHEMICAL ENTITY
COMPETITIVE GENERIC THERAPY
05/27/2021
002
ODE-119TREATMENT OF PRIMARY BILIARY CHOLANGITIS (PBC) IN COMBINATION WITH URSODEOXYCHOLIC ACID (UDCA) IN ADULTS WITH AN INADEQUATE RESPONSE TO UDCA, OR AS MONOTHERAPY IN ADULTS UNABLE TO TOLERATE UDCA
COMPETITIVE GENERIC THERAPY
05/27/2023

 

 


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