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
003	7579473	08/14/2026	DS	DP		05/24/2016
003	8497284	09/24/2024			U-1220 U-1480 U-2488	05/24/2016
003	8877776	10/08/2030	DS	DP	U-3225	05/24/2016
003	9724342	07/09/2033		DP		08/25/2017
003	10034873	07/18/2031			U-2488	02/12/2019
003	10039757	07/18/2031			U-1480	09/06/2018
003	11091439	01/15/2030	DS			08/31/2021
003	11091440	01/15/2030		DP		08/31/2021
003	11098015	01/15/2030			U-1220 U-1480 U-2488 U-3225	08/31/2021
003	11298349	02/10/2032		DP		04/12/2022