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	7553828	06/02/2024	DS			07/23/2019
001	9265740	03/05/2029		DP		07/23/2019
001	9724358	03/05/2029			U-1569	07/23/2019
001	10124014	03/05/2029			U-2449	12/11/2018
001	10383884	10/31/2037			U-2576	09/17/2019
001	10835542	10/31/2037			U-2576	12/16/2020

Product No	Exclusivity Code	Exclusivity Expiration
001	NCE	10/02/2023
001	NCE *GAIN	10/02/2028