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	8410088	01/23/2034	DS	DP		02/19/2020
001	8691507	09/12/2031			U-2852	07/16/2020
001	8765732	09/12/2031			U-2852 U-2853	07/16/2020
001	8895245	09/12/2031			U-2852	07/16/2020
001	9090562	09/12/2031	DS	DP		02/19/2020
001	9175331	09/12/2031			U-2852	07/16/2020
001	9333217	09/12/2031			U-2852	07/16/2020
001	9334527	09/12/2031			U-2852	07/16/2020
001	9394283	04/11/2033	DS	DP	U-2852 U-2853	02/19/2020
001	9549931	09/12/2031			U-2736 U-2852 U-2853	02/19/2020
001	9688665	08/22/2034			U-2736	02/19/2020
001	9855275	09/12/2031			U-2736	02/19/2020
001	9889138	10/16/2035			U-2736 U-2852 U-2853	02/19/2020
001	9949999	09/12/2031			U-2851	07/16/2020
001	10155002	09/12/2031			U-2736	02/19/2020
001	10245269	04/11/2033			U-2737 U-2851 U-2854	02/19/2020
001	10369155	10/16/2035			U-2736 U-2852 U-2853	02/19/2020
001	10420775	09/12/2031			U-2736 U-2852 U-2853	02/19/2020
001	10786511	12/19/2035		DP		10/26/2020
001	10821113	04/11/2033	DS	DP		11/24/2020
001	11052093	04/13/2032	DS	DP	U-2736 U-2852 U-2853	08/03/2021
001	11491163	04/11/2033			U-2736 U-2852 U-2853	12/08/2022