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	7439393	05/21/2025	DS	DP	U-2127 U-2957	10/06/2017
001	7439393*PED	11/21/2025
001	7488827	12/18/2027	DS	DP		10/06/2017
001	7498440	04/27/2025	DS	DP		10/06/2017
001	8161968	02/05/2028		DP		10/06/2017
001	8161968*PED	08/05/2028
001	8183257	07/27/2025			U-2128 U-2129	10/06/2017
001	8309572	04/27/2025			U-2129	10/06/2017
001	8511304	06/14/2027		DP	U-2954	10/06/2017
001	8511304*PED	12/14/2027
001	8534281	03/08/2030		DP		10/06/2017
001	8534281*PED	09/08/2030
001	8746242	10/11/2030		DP		10/06/2017
001	8746242*PED	04/11/2031
001	9333310	10/02/2027		DP		10/06/2017
001	9333310*PED	04/02/2028
001	9750726	11/29/2030		DP		10/06/2017
001	11090294	11/29/2030			U-3202	09/14/2021

Product No	Exclusivity Code	Exclusivity Expiration