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	7816379	06/20/2028	DS	DP	U-2507	07/03/2014
001	8420676	02/23/2028	DS	DP	U-282	07/03/2014
001	8426389	12/31/2030	DS	DP	U-282	07/03/2014
001	9624250	02/03/2030	DS	DP	U-2507	04/09/2019
001	9988406	02/03/2030		DP		04/09/2019
001	10065947	02/03/2030		DP		04/09/2019
001	10442829	02/03/2030	DS			11/13/2019

Product No	Exclusivity Code	Exclusivity Expiration
001	NCE	06/20/2019
001	NCE *GAIN	06/20/2024