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	7777050	03/13/2025	DS	DP		07/25/2018
001	9314464	07/04/2031			U-2332 U-3737	07/25/2018
001	9562016	10/18/2033	DS	DP		07/25/2018
001	9598376	10/18/2033			U-2330	07/25/2018
001	9850229	08/27/2030			U-2333	07/25/2018
001	9980944	10/18/2033			U-2334	07/25/2018
001	10005761	08/27/2030			U-2331 U-3737	07/25/2018

Product No	Exclusivity Code	Exclusivity Expiration
001	ODE-194	06/27/2025
001	I-928	10/11/2026