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	Delist Requested	Submission Date
003	7407955	05/02/2025	DS	DP			02/22/2012
003	7407955*PED	11/02/2025
003	8673927	05/04/2027			U-1503	Y	04/15/2014
003	8673927*PED	11/04/2027
003	8846695	06/04/2030			U-1503	Y	10/21/2014
003	8846695*PED	12/04/2030
003	8883805	11/26/2025		DP			12/09/2014
003	8883805*PED	05/26/2026
003	9155705	05/21/2030		DP			10/21/2015
003	9155705*PED	11/21/2030
003	9415016	04/02/2029		DP			08/30/2016
003	9415016*PED	10/02/2029
003	10022379	04/02/2029			U-2339		08/06/2018
003	10022379*PED	10/02/2029
003	10973827	04/02/2029		DP			05/05/2021
003	10973827*PED	10/02/2029
003	11911388	04/10/2030			U-3854		03/25/2024

Product No	Exclusivity Code	Exclusivity Expiration
003	M-295	06/20/2026
003	M-295 *PED	12/20/2026