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
004	8273779	12/17/2025			U-2774	04/14/2021
004	9000018	11/16/2024			U-3102	04/14/2021
004	9062014	05/06/2032	DS	DP	U-2774	04/14/2021
004	10220023	12/10/2035			U-3103	04/14/2021
004	RE43728	11/16/2024	DS	DP		04/14/2021

Product No	Exclusivity Code	Exclusivity Expiration
004	NCE	03/18/2026