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
001	7964580	03/26/2029	DS	DP	U-1470
001	7964580*PED	09/26/2029
001	8334270	03/21/2028	DS	DP	U-1470
001	8334270*PED	09/21/2028
001	8580765	03/21/2028	DS	DP	U-1470
001	8580765*PED	09/21/2028
001	8618076	12/11/2030	DS	DP	U-1470	01/29/2014
001	8618076*PED	06/11/2031
001	8633309	03/26/2029	DS	DP	U-1470	01/29/2014
001	8633309*PED	09/26/2029
001	8889159	03/26/2029		DP	U-1470	12/09/2014
001	8889159*PED	09/26/2029
001	9085573	03/21/2028	DS	DP	U-1470	08/11/2015
001	9085573*PED	09/21/2028
001	9284342	09/13/2030	DS	DP	U-1470	03/29/2016
001	9284342*PED	03/13/2031
001	9549941	03/26/2029			U-1958	02/07/2017
001	9549941*PED	09/26/2029