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	7893075	05/04/2033	DS			08/28/2019
001	8404700	11/21/2027	DS			08/28/2019
001	8461169	04/19/2028			U-2606	08/28/2019
001	8722702	11/21/2027	DS			08/28/2019
001	9169250	11/21/2027	DS			08/28/2019
001	9358235	06/08/2033			U-2606	08/28/2019
001	9802932	05/05/2036	DS			08/28/2019
001	10189833	05/05/2036			U-2606	08/28/2019
001	10435404	07/24/2038		DP		10/22/2019
001	10730876	05/05/2036	DS			08/31/2020
001	10941142	07/24/2038		DP		03/30/2021
001	10961240	07/24/2038			U-2606	04/21/2021

Product No	Exclusivity Code	Exclusivity Expiration
001	NCE	08/02/2024
001	ODE-250	08/02/2026