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	7964580	03/26/2029	DS	DP	U-1470	06/29/2021
001	7964580*PED	09/26/2029
001	8334270	03/21/2028	DS	DP	U-1470	06/29/2021
001	8334270*PED	09/21/2028
001	8575135	11/16/2032	DS	DP	U-1470	06/29/2021
001	8575135*PED	05/16/2033
001	8580765	03/21/2028	DS	DP	U-1470	06/29/2021
001	8580765*PED	09/21/2028
001	8618076	12/11/2030	DS	DP	U-1470	06/29/2021
001	8618076*PED	06/11/2031
001	8633309	03/26/2029	DS	DP	U-1470	06/29/2021
001	8633309*PED	09/26/2029
001	8735372	03/21/2028			U-1470	06/29/2021
001	8735372*PED	09/21/2028
001	8889159	03/26/2029		DP	U-1470	06/29/2021
001	8889159*PED	09/26/2029
001	8921341	11/16/2032	DS	DP	U-1470	06/29/2021
001	8921341*PED	05/16/2033
001	8940718	11/16/2032	DS	DP	U-1470	06/29/2021
001	8940718*PED	05/16/2033
001	9085573	03/21/2028	DS	DP	U-1470	06/29/2021
001	9085573*PED	09/21/2028
001	9284342	09/13/2030	DS	DP	U-1470	06/29/2021
001	9284342*PED	03/13/2031
001	11116783	01/30/2034		DP	U-1470	10/01/2021
001	11116783*PED	07/30/2034
001	11707479	01/30/2034		DP	U-1470	08/15/2023
001	11707479*PED	07/30/2034