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 U-2174		12/13/2017
002	8975270	09/05/2031		DP	U-2175 U-2206		12/13/2017
002	9272044	06/06/2031			U-2176 U-2177 U-2178 U-2209		12/13/2017
002	9498432	06/06/2031		DP	U-2179		12/13/2017
002	9782402	06/06/2031		DP	U-2176 U-2180 U-2207 U-2208		12/13/2017
002	9827241	06/06/2031		DP	U-2174 U-2181 U-2206 U-2210 U-2211		12/13/2017
002	10198218	06/06/2031			U-2489		02/15/2019
002	10558394	06/25/2031		DP			07/16/2020
002	10592168	06/06/2031			U-2489		03/19/2020
002	10646484	06/22/2038			U-2489		05/12/2020
002	11000520	11/06/2035			U-3111		05/20/2021
002	11839611	11/06/2035			U-3111		01/08/2024

Exclusivity Data

Product No	Exclusivity Code	Exclusivity Expiration

 

 

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