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	7516741	01/11/2024	DP		04/19/2013
001	7559325	10/27/2025	DP		04/19/2013
001	8664187	06/20/2025		U-909	06/17/2019
001	8869794	09/12/2028	DP	U-909	06/17/2019
001	10207066	11/04/2030	DP	U-909	06/17/2019
001	11484671	11/07/2024	DP	U-909	11/18/2022
001	RE47526	04/09/2024	DP		06/01/2020

Product No	Exclusivity Code	Exclusivity Expiration