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	7468390*PED	05/27/2024
003	8101659	01/15/2025		DP		08/06/2015
003	8101659*PED	07/15/2025
003	8877938	05/27/2027	DS	DP		08/06/2015
003	8877938*PED	11/27/2027
003	9388134	11/08/2026			U-1723	09/07/2016
003	9388134*PED	05/08/2027
003	9517226	08/22/2033			U-3084	03/16/2021
003	9937143	08/22/2033			U-3084	03/16/2021
003	11058667	05/09/2036			U-3170	07/13/2021
003	11135192	08/22/2033			U-3084	10/18/2021

Product No	Exclusivity Code	Exclusivity Expiration
003	M-82	02/16/2024