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	7807680	10/19/2024		DP
001	8030313	10/19/2024			U-543 U-1632
001	8338427	03/15/2025		DP	U-543 U-1633
001	8399469	06/29/2025	DS			04/15/2013
001	8722679	10/19/2024		DP		06/09/2014
001	10525057	03/08/2034			U-543 U-1632 U-2723	01/31/2020
001	10980803	09/24/2033			U-543 U-1632	05/19/2021
001	11154553	09/24/2033			U-814 U-1632 U-3245	11/17/2021
001	11344547	09/24/2033			U-814 U-1632 U-3245	06/24/2022
001	11400087	09/24/2033			U-814 U-1632 U-3245	08/29/2022
001	11648347	04/06/2034		DP		06/15/2023

Product No	Exclusivity Code	Exclusivity Expiration