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
003	7947017	03/12/2028	DP		12/15/2017
003	8021344	11/02/2029	DP		12/15/2017
003	8206360	02/27/2027	DP		12/15/2017
003	8226610	04/10/2029	DP		12/15/2017
003	8231573	11/25/2028	DP		12/15/2017
003	8313466	11/23/2024	DP		12/15/2017
003	8361029	11/23/2024	DP		12/15/2017
003	8425462	11/23/2024	DP		12/15/2017
003	8608698	11/23/2024	DP		12/15/2017
003	9737669	11/23/2024	DP		12/15/2017
003	9833573	11/23/2024		U-2172	12/15/2017
003	10314977	11/23/2024	DP		06/11/2019
003	10335549	04/30/2025	DP		07/02/2019
003	10688244	12/21/2037	DP	U-2980	11/04/2020
003	10737028	11/23/2024	DP		08/25/2020
003	10842938	12/21/2037	DP	U-2980	12/10/2020
003	11590286	12/12/2026	DP		03/29/2023
003	11771830	12/21/2037	DP	U-2980	12/20/2023

Product No	Exclusivity Code	Exclusivity Expiration