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	8524733	04/03/2031	DS	DP		04/04/2017
003	8524733*PED	10/03/2031
003	9233959	09/18/2033		DP		04/04/2017
003	9233959*PED	03/18/2034
003	9296739	09/18/2033		DP		04/04/2017
003	9296739*PED	03/18/2034
003	9550780	09/18/2033	DS	DP	U-1995 U-3055	04/04/2017
003	9550780*PED	03/18/2034
003	9814708	09/18/2033		DP		11/16/2017
003	9814708*PED	03/18/2034
003	10959996	03/07/2036			U-3055	03/31/2021
003	10959996*PED	09/07/2036
003	11179386	03/15/2038		DP	U-1995 U-3055	12/02/2021
003	11179386*PED	09/15/2038
003	11357772	03/07/2036			U-1995 U-3055	06/27/2022
003	11357772*PED	09/07/2036
003	11446291	03/07/2036			U-1995	10/13/2022
003	11446291*PED	09/07/2036
003	11564917	03/07/2036			U-1995	02/15/2023
003	11564917*PED	09/07/2036
003	11648244	03/07/2036			U-1995	06/05/2023
003	11648244*PED	09/07/2036
003	11666566	09/18/2033		DP		06/16/2023
003	11666566*PED	03/18/2034
003	11813232	03/15/2038		DP		12/07/2023
003	11813232*PED	09/15/2038