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	7176220	08/27/2026	DS	DP	U-257
001	7176220*PED	02/27/2027
001	7635704	10/26/2026	DS	DP	U-257
001	7635704*PED	04/26/2027
001	8148374	09/03/2029	DS	DP	U-1279
001	8148374*PED	03/03/2030
001	8592397	01/13/2024		DP	U-257
001	8633219	04/30/2030		DP	U-257	01/24/2014
001	8633219*PED	10/30/2030
001	8716264	01/13/2024		DP	U-257	06/02/2014
001	8981103	10/26/2026	DS	DP		04/14/2015
001	8981103*PED	04/26/2027
001	9457036	01/13/2024		DP	U-257	11/10/2016
001	9744181	01/13/2024		DP	U-257	09/19/2017
001	9891239	09/03/2029		DP	U-257	03/06/2018
001	9891239*PED	03/03/2030
001	10039718	10/06/2032		DP		09/04/2018
001	10039718*PED	04/06/2033

Product No	Exclusivity Code	Exclusivity Expiration