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 Product	Patent Use Code	Submission Date
001	7214506	02/22/2026		U-281	06/20/2014
001	8039494	07/08/2030		U-281	06/20/2014
001	8486978	10/24/2030	DP		06/20/2014
001	9302009	10/24/2030	DP		04/25/2016
001	9566272	01/03/2028		U-1969	02/22/2017
001	9662394	10/02/2034	DP		05/30/2017
001	9861698	07/08/2030	DP		01/10/2018
001	9877955	01/03/2028		U-1969	01/31/2018
001	10105444	07/08/2030	DP		10/24/2018
001	10342875	10/02/2034	DP	U-2720	07/12/2019
001	10478601	04/25/2035	DP	U-2721	12/17/2019
001	10512640	01/03/2028		U-1969	01/08/2020
001	10828293	10/02/2034		U-2720	12/02/2020
001	10828369	01/03/2028	DP		12/02/2020
001	10864274	10/02/2034		U-2720	01/07/2021
001	11213519	01/03/2028		U-2720	01/20/2022
001	11654139	10/02/2034		U-1969	06/14/2023
001	11872218	01/03/2028		U-1969	02/09/2024

Product No	Exclusivity Code	Exclusivity Expiration