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	9561236	04/30/2033		U-2968	10/23/2020
001	9737547	11/07/2031		U-2968	10/23/2020
001	9777007	07/10/2027	DP		10/23/2020
001	9827251	01/13/2034		U-2968	10/23/2020
001	9914738	07/10/2027	DP		10/23/2020
001	10052334	11/07/2031		U-2968	10/23/2020
001	10195210	11/07/2031		U-2968	10/23/2020
001	10342800	11/07/2031		U-2968	10/23/2020
001	10472365	07/10/2027		U-2968	10/23/2020
001	10722522	11/07/2031		U-2968	10/23/2020
001	10961250	07/10/2027	DP	U-2968	07/08/2022

Product No	Exclusivity Code	Exclusivity Expiration
001	NCE	10/06/2025