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: N205858

Product 002
IDELALISIB (ZYDELIG) TABLET 150MG

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
002 6800620 04/24/2021 DS
U-1560 A METHOD OF DISRUPTING LEUKOCYTE FUNCTION, INCLUDING AS AN INHIBITOR OF PI3KDELTA KINASE
08/27/2014
002 6949535 04/24/2021 DS
U-1560 A METHOD OF DISRUPTING LEUKOCYTE FUNCTION, INCLUDING AS AN INHIBITOR OF PI3KDELTA KINASE
08/27/2014
002 8138195 04/24/2021 DS DP
U-1549 FOR THE TREATMENT OF PATIENTS WITH RELAPSED CHRONIC LYMPHOCYTIC LEUKEMIA
08/21/2014
002 8492389 04/24/2021 DS DP
08/21/2014
002 8637533 04/24/2021 DS DP
08/21/2014
002 8865730 03/05/2033 DS DP
U-1615 FOR THE TREATMENT OF PATIENTS WITH CLL, FL, OR SLL
11/18/2014
002 8980901 05/12/2025
U-1678 FOR THE TREATMENT OF PATIENTS WITH CLL, FL, OR SLL
04/10/2015
002 9149477 05/12/2025
U-1757 INHIBITION ON PI3K KINASE
11/03/2015
002 9469643 09/02/2033 DS
11/16/2016
002 9492449 03/11/2030
U-1914 IN COMBINATION WITH RITUXIMAB, FOR THE TREATMENT OF PATIENTS WITH RELAPSED CHRONIC LYMPHOCYTIC LEUKEMIA (CLL)
11/16/2016
002 10730879 03/05/2033 DS DP
09/03/2020
002 RE44599 07/21/2025
U-1558 FOR THE TREATMENT OF PATIENTS WITH RELAPSED FOLLICULAR B-CELL NON-HODGKIN LYMPHOMA OR [RELAPSED] SMALL LYMPHOCYTIC LYMPHOMA
U-1615 FOR THE TREATMENT OF PATIENTS WITH CLL, FL, OR SLL
08/21/2014
002 RE44638 08/05/2025 DS DP
08/21/2014

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
002
ODE-70RELAPSED CLL, IN COMBO. WITH RITUXIMAB, IN PATIENTS FOR WHOM RITUXIMAB ALONE WOULD BE CONSIDERED APPROPRIATE THERAPY DUE TO OTHER CO-MORBIDITIES; AND RELAPSED SLL IN PATIENTS WHO HAVE RECEIVED AT LEAST 2 PRIOR SYSTEMIC THERAPIES
COMPETITIVE GENERIC THERAPY
07/23/2021
002
ODE-71RELAPSED FOLLICULAR B-CELL NON-HODGKIN LYMPHOMA (FL) IN PATIENTS WHO HAVE RECEIVED AT LEAST TWO PRIOR SYSTEMIC THERAPIES
COMPETITIVE GENERIC THERAPY
07/23/2021

 

 


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