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: N202880

Product 002
HYDROCODONE BITARTRATE (ZOHYDRO ER) CAPSULE, EXTENDED RELEASE 15MG

Patent Data

Product No	Patent No	Patent Expiration	Drug Substance	Drug Product	Patent Use Code	Delist Requested	Submission Date
002	9132096	09/12/2034		DP			09/22/2015
002	9265760	07/25/2033			U-1810		02/23/2016
002	9326982	07/25/2033			U-1810		05/04/2016
002	9333201	07/25/2033			U-1810		05/18/2016
002	9339499	07/25/2033			U-1810		05/18/2016
002	9421200	07/25/2033			U-1810		09/07/2016
002	9433619	07/25/2033			U-1810		09/07/2016
002	9452163	09/12/2034			U-55		10/11/2016
002	9486451	09/12/2034			U-55		01/12/2017
002	9610286	07/25/2033			U-1810		04/05/2017
002	9713611	09/12/2034		DP	U-55		08/23/2017
002	10028946	07/25/2033			U-1810		07/27/2018
002	10092559	09/12/2034			U-55		11/13/2018
002	10322120	07/25/2033		DP			07/17/2019
002	10456393	07/25/2033			U-1810		10/29/2019
002	10722511	07/25/2033			U-1810		08/25/2020

Exclusivity Data

Product No	Exclusivity Code	Exclusivity Expiration

 

 

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