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 Product	Patent Use Code	Submission Date
003	9592227	03/13/2034	DP	U-3118	05/26/2021
003	9694079	04/20/2035	DP	U-3118	05/26/2021
003	9744163	03/13/2034	DP		05/26/2021
003	9801945	04/20/2035	DP	U-3118	05/26/2021
003	9913909	03/13/2034		U-3118	05/26/2021
003	10098957	04/20/2035		U-3118	05/26/2021
003	10213510	04/20/2035	DP	U-3118	05/26/2021
003	10398686	03/13/2034	DP		05/26/2021
003	10632199	04/20/2035	DP	U-3118	05/26/2021
003	10898575	04/20/2035	DP	U-3118	05/26/2021
003	10980886	04/20/2035	DP		05/26/2021
003	11083730	04/20/2035	DP	U-3118	08/25/2021
003	11083797	04/20/2035	DP	U-3118	08/25/2021
003	11253504	03/13/2034		U-3118	03/02/2022
003	11413350	04/20/2035		U-3417	09/15/2022
003	11844837	04/21/2036		U-3417	01/03/2024

Product No	Exclusivity Code	Exclusivity Expiration
003	NP	05/12/2024
003	I-933	01/23/2027