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 Product	Patent Use Code	Submission Date
001	7544192	11/29/2026		U-2272	04/26/2018
001	7662141	03/12/2024		U-2272	04/26/2018
001	7713255	03/12/2024		U-2272	04/26/2018
001	7951130	03/12/2024		U-2272	04/26/2018
001	7951131	03/12/2024		U-2272	04/26/2018
001	7951133	03/12/2024		U-2272	04/26/2018
001	8025635	06/12/2027	DP	U-2272	04/26/2018
001	8109918	03/12/2024		U-2272	04/26/2018
001	8763222	02/08/2032	DP		04/26/2018
001	9585681	04/04/2026		U-2272	04/26/2018
001	10232152	11/24/2034	DP	U-2272	12/06/2019
001	10357640	10/03/2031		U-2272	12/06/2019
001	10406332	03/13/2034	DP		12/06/2019

Product No	Exclusivity Code	Exclusivity Expiration