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	7762994	05/23/2024		DP		04/29/2022
003	8114833	08/13/2025		DP		04/29/2022
003	8129343	12/05/2031	DS	DP	U-3355	04/29/2022
003	8536122	03/20/2026	DS	DP	U-3355	04/29/2022
003	8684969	10/20/2025		DP		04/29/2022
003	8920383	07/17/2026		DP		04/29/2022
003	9108002	01/20/2026		DP		04/29/2022
003	9132239	02/01/2032		DP		04/29/2022
003	9457154	09/29/2027		DP		04/29/2022
003	9616180	01/20/2026		DP		04/29/2022
003	9687611	02/27/2027		DP		04/29/2022
003	9775953	07/17/2026		DP		04/29/2022
003	9861757	01/20/2026		DP		04/29/2022
003	10220155	07/17/2026		DP		04/29/2022
003	10357616	01/20/2026		DP		04/29/2022
003	10376652	01/20/2026		DP		04/29/2022
003	11097063	07/17/2026		DP		04/29/2022
003	11311679	01/20/2026		DP		05/20/2022
003	11446443	10/20/2025		DP		10/07/2022
003	RE46363	08/03/2026		DP		04/29/2022

Product No	Exclusivity Code	Exclusivity Expiration
003	D-185	03/28/2025