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	7762994	05/23/2024		DP		12/20/2017
001	8114833	08/13/2025		DP		12/20/2017
001	8129343	12/05/2031	DS	DP	U-2202	12/20/2017
001	8536122	03/20/2026	DS	DP	U-2202	12/20/2017
001	8684969	10/20/2025		DP		12/20/2017
001	8920383	07/17/2026		DP		12/20/2017
001	9108002	01/20/2026		DP		12/20/2017
001	9132239	02/01/2032		DP		12/20/2017
001	9457154	09/27/2027		DP		12/20/2017
001	9616180	01/20/2026		DP		08/17/2018
001	9687611	02/27/2027		DP		12/20/2017
001	9775953	07/17/2026		DP		12/20/2017
001	9861757	01/20/2026		DP		08/17/2018
001	10220155	07/17/2026		DP		04/04/2019
001	10335462	06/21/2033			U-2580	07/25/2019
001	10357616	01/20/2026		DP		08/08/2019
001	10376652	01/20/2026		DP		09/13/2019
001	11097063	07/17/2026		DP		09/21/2021
001	11311679	01/20/2026		DP		05/20/2022
001	11446443	10/20/2025		DP		10/07/2022
001	RE46363	08/03/2026		DP		12/20/2017

Product No	Exclusivity Code	Exclusivity Expiration