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: N201532

Product 001
ERIBULIN MESYLATE (HALAVEN) SOLUTION 1MG/2ML (0.5MG/ML)

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
001 6214865 07/20/2023 DS
11/30/2010
001 6469182 06/16/2019
U-1096 TREATMENT OF PATIENTS WITH METASTATIC BREAST CANCER
U-1812 TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC LIPOSARCOMA
11/30/2010
001 7470720 06/16/2019 DP
11/30/2010
001 8097648 01/22/2021
U-1096 TREATMENT OF PATIENTS WITH METASTATIC BREAST CANCER
02/15/2012
001 RE46965 01/08/2027 DP
08/07/2018

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
001
I-721 TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC LIPOSARCOMA WHO HAVE RECEIVED A PRIOR ANTHRACYCLINE-CONTAINING REGIMEN.
COMPETITIVE GENERIC THERAPY
01/28/2019
001
ODE-107 TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC LIPOSARCOMA WHO HAVE RECEIVED A PRIOR ANTHRACYCLNE-CONTAINING REGIMEN
COMPETITIVE GENERIC THERAPY
01/28/2023

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View a list of all exclusivity codes

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