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	7220742	05/12/2025	DS	DP	U-1703	06/10/2015
001	7284474	08/26/2024		DP		06/10/2015
001	7284474*PED	02/26/2025
001	7396341	10/10/2026		DP		06/10/2015
001	7396341*PED	04/10/2027
001	7727984	01/19/2027	DS			06/10/2015
001	7837235	03/13/2028		DP		06/10/2015
001	7837235*PED	09/13/2028
001	7896264	05/26/2025		DP		06/10/2015
001	8034809	05/12/2025			U-1702	06/10/2015
001	8733341	10/16/2030		DP		06/10/2015
001	9027967	03/31/2027		DP		06/10/2015

Product No	Exclusivity Code	Exclusivity Expiration