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: N204031

Product 001
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE (XARTEMIS XR) TABLET, EXTENDED RELEASE 325MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Patent Data

Product No	Patent No	Patent Expiration	Drug Substance	Drug Product	Patent Use Code	Delist Requested	Submission Date
001	7976870	06/01/2027			U-1498		04/03/2014
001	8372432	03/11/2029		DP	U-1499		04/03/2014
001	8377453	11/19/2029		DP	U-1499		04/03/2014
001	8394408	03/11/2029		DP			04/03/2014
001	8597681	12/21/2030		DP			04/03/2014
001	8658631	05/16/2032		DP			04/03/2014
001	8668929	03/11/2029			U-1499		04/03/2014
001	8741885	05/16/2032		DP	U-1499		06/17/2014
001	8980319	12/21/2030		DP			04/03/2015
001	8992975	05/16/2032		DP			04/03/2015
001	9050335	05/16/2032		DP			06/25/2015
001	9468636	05/16/2032			U-1499		11/16/2016

Exclusivity Data

Product No	Exclusivity Code	Exclusivity Expiration

 

 

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