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	8426450	05/23/2032	DS	DP		05/17/2018
001	8895586	05/23/2032			U-2301	05/17/2018
001	9186357	11/18/2030			U-2301	05/17/2018
001	9403772	05/23/2032	DS		U-2301	05/17/2018
001	9908907	05/23/2032	DS	DP		05/17/2018
001	10208073	05/23/2032			U-2301	03/08/2019
001	10624911	06/02/2037		DP		05/26/2020
001	10717721	05/23/2032	DS			08/19/2020
001	10828297	12/17/2030			U-2301	12/09/2020
001	11312698	05/23/2032	DS	DP		05/13/2022
001	11529362	06/02/2037		DP		01/17/2023

Product No	Exclusivity Code	Exclusivity Expiration