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	8425934	04/17/2030		DP		09/30/2015
002	8425934*PED	10/17/2030
002	10300065	01/27/2036			U-2541 U-2542	06/24/2019
002	10300065*PED	07/27/2036
002	RE46276	10/30/2024	DS	DP	U-1935 U-1936 U-1937 U-1938 U-2838 U-2839 U-2988	01/17/2017
002	RE46276*PED	04/30/2025