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	10695329	10/16/2037	DP		07/22/2020
001	10799453	04/11/2039	DP		11/02/2020
001	10894039	10/06/2037		U-3 U-185	02/16/2021
001	10952998	10/06/2037	DP		03/29/2021
001	10959991	10/06/2037		U-39 U-158	04/15/2021
001	11364230	10/06/2037	DP		06/24/2022
001	11471409	10/06/2037		U-3447 U-3448	10/18/2022
001	11484498	10/06/2037	DP		11/04/2022
001	11701326	10/06/2037	DP		07/20/2023
001	11918685	10/06/2037		U-3447 U-3448	03/14/2024

Product No	Exclusivity Code	Exclusivity Expiration