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
002	7390791	04/17/2025	DS	DP		10/28/2021
002	7390791*PED	10/17/2025
002	8754065	08/15/2032	DS	DP	U-257	10/28/2021
002	8754065*PED	02/15/2033
002	9216996	12/19/2033	DS	DP		10/28/2021
002	9296769	08/15/2032	DS	DP	U-257	10/28/2021
002	9296769*PED	02/15/2033
002	9708342	06/19/2035	DS	DP		10/28/2021
002	9732092	12/19/2033	DS	DP		10/28/2021
002	10385067	06/19/2035			U-257	10/28/2021