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: N022410

Product 004
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE (SUBOXONE) FILM EQ 12MG BASE;EQ 3MG BASE

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
004 8017150 02/13/2023 DP
004 8475832 03/26/2030 DP
U-1411 THIS DRUG IS ADMINISTERED BY SUBLINGUAL ROUTE TO HUMANS FOR MAINTENANCE TREATMENT OF OPIOID DEPENDENCE
004 8603514 04/03/2024 DP
U-1464 TREATMENT OF OPIOID DEPENDENCE/SUBLINGUAL OR BUCCAL APPLICATION
004 9687454 08/07/2029 DP
U-1464 TREATMENT OF OPIOID DEPENDENCE/SUBLINGUAL OR BUCCAL APPLICATION
07/14/2017
004 9855221 02/14/2022 DP
01/03/2018
004 9931305 02/14/2022 DP
04/03/2018
004 10285910 10/11/2022 DP
06/07/2019

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration

 

 


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