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	8623826	11/18/2030			U-2293	11/06/2014
001	8951969	11/18/2030		DP		03/06/2015
001	9186357	11/18/2030			U-2293	12/02/2015
001	9271975	09/09/2031			U-2293	07/14/2016
001	9943515	11/18/2030			U-2293	05/16/2018
001	9951016	09/25/2035	DS	DP		05/16/2018
001	10233154	09/25/2035	DS			03/28/2019
001	10676440	09/25/2035	DS	DP		07/08/2020
001	10828297	12/17/2030			U-2293	12/04/2020
001	10961195	09/25/2035	DS	DP		04/15/2021
001	11559523	11/18/2030		DP	U-3522	02/22/2023

Product No	Exclusivity Code	Exclusivity Expiration