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	7169791*PED	01/04/2024
001	8163904	08/23/2028	DS	DP		05/10/2012
001	8163904*PED	02/23/2029
001	8293756	09/25/2027		DP		10/08/2014
001	8293756*PED	03/25/2028
001	8389537	07/18/2026			U-1374	03/29/2013
001	8389537*PED	01/18/2027
001	8415363	07/18/2026	DS	DP	U-1374 U-1407	06/13/2013
001	8415363*PED	01/18/2027
001	8501760	07/18/2026		DP		08/09/2013
001	8501760*PED	01/18/2027
001	9061029	04/07/2032	DS		U-1374 U-3231	12/01/2016
001	9061029*PED	10/07/2032