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	7495103	05/20/2027	DS	DP		10/21/2016
002	7973038	11/08/2026			U-1973	10/21/2016
002	8324242	08/05/2027			U-1911	10/21/2016
002	8410274	12/28/2026		DP		10/21/2016
002	8507534	09/20/2030	DS	DP		10/21/2016
002	8653103	12/04/2028		DP		10/21/2016
002	8716338	09/20/2030		DP	U-1910	10/21/2016
002	8741933	11/08/2026			U-1909	10/21/2016
002	8754224	12/28/2026	DS	DP		10/21/2016
002	8846718	07/02/2029			U-1908	10/21/2016
002	8993600	12/11/2030		DP		10/21/2016
002	9150552	12/04/2028			U-1908	10/21/2016
002	9192606	09/29/2029		DP	U-1912	10/21/2016
002	9216969	11/08/2026		DP		10/21/2016
002	9670163	12/28/2026		DP	U-1911	07/05/2017
002	9931334	12/28/2026		DP	U-2276	05/02/2018
002	10597384	12/04/2028	DS	DP	U-2777	04/23/2020
002	10646481	08/13/2029		DP		06/11/2020
002	11052075	12/04/2028		DP	U-3181	08/04/2021
002	11564916	08/13/2029			U-3529	02/28/2023

Product No	Exclusivity Code	Exclusivity Expiration