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	8185176	06/04/2028		U-2462	12/20/2018
001	8406860	04/09/2029		U-2463	12/20/2018
001	8647605	02/11/2029		U-2464 U-2468	12/20/2018
001	9421280	11/24/2025		U-2466 U-2467	12/20/2018
001	10631746	08/04/2035	DP	U-2815	05/27/2020
001	11712320	07/14/2039	DP		08/31/2023

Product No	Exclusivity Code	Exclusivity Expiration
001	I-911	06/05/2026