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: N021372

Product 001
PALONOSETRON HYDROCHLORIDE (ALOXI) INJECTABLE EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
001 7947724 01/30/2024 DP
05/27/2011
001 7947724*PED 07/30/2024
001 7947725 01/30/2024 DP
001 7947725*PED 07/30/2024
001 7960424 01/30/2024 DP
001 7960424*PED 07/30/2024
001 8518981 01/30/2024 DP
09/03/2013
001 8518981*PED 07/30/2024
001 8598218 01/30/2024 DP
001 8598218*PED 07/30/2024
001 8598219 01/30/2024 DP
001 8598219*PED 07/30/2024
001 8729094 01/30/2024 DP
U-528 PREVENTION OF CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING
05/21/2014
001 8729094*PED 07/30/2024
001 9066980 01/30/2024 DP
U-528 PREVENTION OF CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING
07/22/2015
001 9066980*PED 07/30/2024
001 9125905 01/30/2024 DP
09/09/2015
001 9125905*PED 07/30/2024
001 9173942 01/30/2024 DP
11/05/2015
001 9173942*PED 07/30/2024
001 9439854 01/30/2024 DP
09/27/2016
001 9439854*PED 07/30/2024
001 9457020 01/30/2024 DP
10/25/2016
001 9457020*PED 07/30/2024
001 9457021 01/30/2024 DP
10/25/2016
001 9457021*PED 07/30/2024

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration

 

 


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