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	8546399	06/27/2031	DS	DP		05/04/2016
001	8722657	01/29/2032	DS			02/13/2020
001	9174982	05/26/2030			U-2323 U-2445 U-2446 U-2537	05/04/2016
001	9539251	09/06/2033			U-2538	06/13/2019
001	10730873	11/21/2031	DS			08/17/2020
001	10993942	09/06/2033			U-3114	05/24/2021
001	11110087	09/06/2033			U-3222 U-3223	10/07/2021
001	11369599	05/23/2032		DP		07/20/2022
001	11413282	09/06/2033			U-3412	09/12/2022
001	11590128	09/06/2033			U-3548	03/24/2023