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: N022272

Product 004
OXYCODONE HYDROCHLORIDE (OXYCONTIN) TABLET, EXTENDED RELEASE 30MG

Patent Data

Product No	Patent No	Patent Expiration	Drug Substance	Drug Product	Patent Use Code	Delist Requested	Submission Date
004	8808741	08/24/2027			U-1556		08/19/2014
004	8894987	03/29/2030		DP			11/25/2014
004	8894988	08/24/2027		DP			11/25/2014
004	9073933	03/30/2025	DS				08/03/2015
004	9492389	08/24/2027		DP			11/16/2016
004	9492391	08/24/2027			U-1556		11/16/2016
004	9492392	08/24/2027		DP			11/16/2016
004	9492393	08/24/2027			U-1556		11/16/2016
004	9522919	03/30/2025	DS	DP			12/20/2016
004	9763933	08/24/2027		DP			09/19/2017
004	9770416	08/24/2027		DP			09/27/2017
004	9775808	08/24/2027		DP			10/04/2017
004	10407434	03/30/2025	DS				09/10/2019
004	10696684	03/30/2025	DS				06/30/2020
004	11304908	08/24/2027		DP			04/21/2022
004	11304909	08/24/2027			U-1556		04/21/2022

Exclusivity Data

Product No	Exclusivity Code	Exclusivity Expiration

 

 

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