Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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.

Product No	Patent No	Patent Expiration	Drug Substance	Drug Product	Patent Use Code	Submission Date
005	7598257	12/24/2027	DS	DP	U-3227 U-3228	12/01/2011
005	7598257*PED	06/24/2028
005	8415362	12/24/2027	DS	DP
005	8415362*PED	06/24/2028
005	8722693	06/12/2028	DS	DP		06/03/2014
005	8722693*PED	12/12/2028
005	8822481	06/12/2028			U-1573 U-3226 U-3227 U-3228 U-3230	09/24/2014
005	8822481*PED	12/12/2028
005	8829013	06/12/2028			U-1201 U-1622 U-3227 U-3228	09/24/2014
005	8829013*PED	12/12/2028
005	9079912	12/12/2026			U-3226 U-3227 U-3228 U-3230	08/04/2015
005	9079912*PED	06/12/2027
005	9814722	12/12/2026			U-3226 U-3230	06/12/2019
005	9814722*PED	06/12/2027
005	10016429	06/12/2028			U-3226 U-3230	06/12/2019
005	10016429*PED	12/12/2028