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	7495103	05/20/2027	DS	DP
001	8324242	08/05/2027			U-1311 U-1906	01/03/2013
001	8354427	07/06/2026			U-1311 U-1905	01/26/2015
001	8410274	12/28/2026		DP		12/01/2013
001	8629162	06/24/2025			U-2234	02/22/2018
001	8754224	12/28/2026	DS	DP		07/17/2014
001	9670163	12/28/2026		DP	U-1311	07/05/2017
001	10646481	08/13/2029		DP		06/01/2020
001	11564916	08/13/2029			U-3530	02/28/2023