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	7737168	09/04/2031			U-3377	06/10/2022
001	8039504	07/23/2027		DP		06/10/2022
001	8124643	06/18/2024	DS	DP		06/10/2022
001	8530509	06/18/2024		DP		06/10/2022
001	8802714	06/18/2024			U-3377	06/10/2022
001	9233097	08/02/2031		DP		06/10/2022
001	9907859	08/02/2031			U-3377	06/10/2022
001	10576165	08/02/2031		DP		06/10/2022

Product No	Exclusivity Code	Exclusivity Expiration