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
003	7495103	05/20/2027	DS	DP		05/29/2019
003	8324242	08/05/2027			U-1311 U-1906 U-2963	05/29/2019
003	8354427	07/06/2026			U-1311 U-1905 U-2964	05/29/2019
003	8410274	12/28/2026		DP		05/29/2019
003	8629162	06/24/2025			U-2234 U-2965	05/29/2019
003	8754224	12/28/2026	DS	DP		05/29/2019
003	8883206	02/27/2033		DP		05/29/2019
003	9670163	12/28/2026		DP	U-1311 U-2966	05/29/2019
003	10272046	02/27/2033		DP	U-2967	05/29/2019
003	10646481	08/13/2029		DP		06/09/2020
003	11147770	02/27/2033		DP	U-3339	04/14/2022
003	11564916	08/13/2029			U-3528	02/28/2023
003	11752106	02/27/2033		DP	U-3697	10/11/2023