Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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  • 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: N210259

Product 001
ACALABRUTINIB (CALQUENCE) CAPSULE 100MG

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
001 7459554 11/24/2026 DS
04/13/2018
001 9290504 07/11/2032 DS DP
11/28/2017
001 9758524 07/11/2032
U-2145 TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
11/28/2017
001 9796721 07/01/2036 DS DP
U-2145 TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
U-2666 TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
U-2667 TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LEUKEMIA
U-2668 TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY UNTREATED CHRONIC LYMPHOCYTIC LEUKEMIA IN COMBINATION WITH OBINUTUZUMAB
U-2669 TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY UNTREATED SMALL LYMPHOCYTIC LEUKEMIA IN COMBINATION WITH OBINUTUZUMAB
U-2670 TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA OR SMALL LYMPHOCYTIC LEUKEMIA
U-2671 TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY UNTREATED CHRONIC LYMPHOCYTIC LEUKEMIA OR SMALL LYMPHOCYTIC LEUKEMIA IN COMBINATION WITH OBINUTUZUMAB
11/28/2017
001 10167291 07/01/2036 DP
U-2145 TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
U-2666 TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
U-2667 TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LEUKEMIA
U-2668 TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY UNTREATED CHRONIC LYMPHOCYTIC LEUKEMIA IN COMBINATION WITH OBINUTUZUMAB
U-2669 TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY UNTREATED SMALL LYMPHOCYTIC LEUKEMIA IN COMBINATION WITH OBINUTUZUMAB
U-2670 TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA OR SMALL LYMPHOCYTIC LEUKEMIA
U-2671 TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY UNTREATED CHRONIC LYMPHOCYTIC LEUKEMIA OR SMALL LYMPHOCYTIC LEUKEMIA IN COMBINATION WITH OBINUTUZUMAB
01/24/2019
001 10239883 07/11/2032
U-2666 TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
U-2668 TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY UNTREATED CHRONIC LYMPHOCYTIC LEUKEMIA IN COMBINATION WITH OBINUTUZUMAB
12/12/2019
001 10272083 01/21/2035
U-2519 TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY BY ADMINISTERING 100 MG OF ACALABRUTINIB TWICE DAILY
U-2682 TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA BY ADMINISTERING 100MG OF ACALABRUTINIB TWICE DAILY
U-2683 TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LEUKEMIA BY ADMINISTERING 100MG OF ACALABRUTINIB TWICE DAILY
U-2684 TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY UNTREATED CHRONIC LYMPHOCYTIC LEUKEMIA BY ADMINISTERING 100 MG OF ACALABRUTINIB TWICE DAILY IN COMBINATION WITH OBINUTUZUMAB
U-2685 TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY UNTREATED SMALL LYMPHOCYTIC LEUKEMIA BY ADMINISTERING 100 MG OF ACALABRUTINIB TWICE DAILY IN COMBINATION WITH OBINUTUZUMAB
U-2686 TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA OR SMALL LYMPHOCYTIC LEUKEMIA BY ADMINISTERING 100 MG OF ACALABRUTINIB TWICE DAILY
U-2687 TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY UNTREATED CHRONIC LYMPHOCYTIC LEUKEMIA OR SMALL LYMPHOCYTIC LEUKEMIA IN COMBINATION WITH OBINUTUZUMAB BY ADMINISTERING 100 MG OF ACALABRUTINIB TWICE DAILY
05/22/2019

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
001
NCENEW CHEMICAL ENTITY
COMPETITIVE GENERIC THERAPY
10/31/2022
001
I-817TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL)
COMPETITIVE GENERIC THERAPY
11/21/2022
001
ODE-175TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA (MCL) WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
COMPETITIVE GENERIC THERAPY
10/31/2024
001
ODE-274INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL)
COMPETITIVE GENERIC THERAPY
11/21/2026

 

 


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