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: N208090

Product 003
OXYCODONE (XTAMPZA ER) CAPSULE, EXTENDED RELEASE 18MG

Patent Data

Product No	Patent No	Patent Expiration	Drug Substance	Drug Product	Patent Use Code	Delist Requested	Submission Date
003	7399488	03/24/2025		DP			07/19/2016
003	7771707	03/24/2025		DP			07/19/2016
003	8449909	03/24/2025		DP			07/19/2016
003	8557291	03/21/2025		DP			07/19/2016
003	8758813	06/10/2025			U-1556		07/19/2016
003	9682075	12/10/2030		DP	U-1556		06/20/2017
003	9737530	09/02/2036		DP	U-1556		08/23/2017
003	9968598	09/02/2036		DP	U-1556		05/16/2018
003	10004729	12/10/2030		DP	U-1556		07/10/2018
003	10188644	09/02/2036		DP	U-1556		01/29/2019
003	10646485	09/02/2036		DP	U-1556		05/13/2020
003	10668060	12/10/2030		DP	U-1556		06/03/2020

Exclusivity Data

Product No	Exclusivity Code	Exclusivity Expiration

 

 

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