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: N209819

Product 002
BUPRENORPHINE (SUBLOCADE) SOLUTION, EXTENDED RELEASE 300MG/1.5ML (200MG/ML)

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
002 8921387 01/06/2032 DP
U-2173 TREATING OPIOID DEPENDENCE BY ADMINISTERING BUPRENORPHINE
U-2174 TREATING OPIOID DEPENDENCY BY ADMINISTERING BUPRENORPHINE ONCE PER MONTH
12/13/2017
002 8975270 09/05/2031 DP
U-2175 TREATING OPIOID DEPENDENCY BY ADMINISTERING BUPRENORPHINE ONCE MONTHLY
U-2206 TREATING OPIOID DEPENDENCY BY ADMINISTERING BUPRENORPHINE
12/13/2017
002 9272044 06/06/2031
U-2176 TREATING OPIOID ADDICTION BY ADMINISTERING BUPRENORPHINE
U-2177 TREATING OPIOID ADDICTION BY SUBCUTANEOUS INJECTION OF BUPRENORPHINE
U-2178 TREATING OPIOID ADDICTION BY ADMINISTERING BUPRENORPHINE COMPOSITION WITH 28 DAY DOSE DURATION
U-2209 TREATING OPIOID ADDICTION BY ADMINISTERING BUPRENORPHINE ONCE PER MONTH
12/13/2017
002 9498432 06/06/2031 DP
U-2179 IN SITU FORMATION OF SOLID BUPRENORPHINE COMPOSITION
12/13/2017
002 9782402 06/06/2031 DP
U-2176 TREATING OPIOID ADDICTION BY ADMINISTERING BUPRENORPHINE
U-2180 TREATING ADDICTION WITH 100 MG OR 300 MG DOSE OF BUPRENORPHINE
U-2207 TREATING ADDICTION BY SUBCUTANEOUS INJECTION OF BUPRENORPHINE
U-2208 TREATING ADDICTION BY ONCE PER MONTH ADMINISTRATION OF BUPRENORPHINE
12/13/2017
002 9827241 06/06/2031 DP
U-2174 TREATING OPIOID DEPENDENCY BY ADMINISTERING BUPRENORPHINE ONCE PER MONTH
U-2181 TREATING OPIOID DEPENDENCY BY SUBCUTANEOUSLY ADMINISTERING BUPRENORPHINE
U-2206 TREATING OPIOID DEPENDENCY BY ADMINISTERING BUPRENORPHINE
U-2210 TREATING OPIOID ADDICTION BY 100 MG OR 300 MG DOSE BUPRENORPHINE
U-2211 TREATING OPIOID ADDICTION BY ADMINISTRATION OF BUPRENORPHINE
12/13/2017
002 10198218 06/06/2031
U-2489 TREATMENT OF MODERATE TO SEVERE OPIOID USE DISORDER
02/15/2019
002 10558394 06/25/2031 DP
07/16/2020
002 10592168 06/06/2031
U-2489 TREATMENT OF MODERATE TO SEVERE OPIOID USE DISORDER
03/19/2020
002 10646484 06/22/2038
U-2489 TREATMENT OF MODERATE TO SEVERE OPIOID USE DISORDER
05/12/2020

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
002
NPNEW PRODUCT
COMPETITIVE GENERIC THERAPY
11/30/2020

 

 


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